TV-MG PCR

Rx Only
cobas® TV/MG
Qualitative nucleic acid test

for use on the cobas® 5800/6800/8800 Systems
For in vitro diagnostic use
cobas® TV/MG P/N: 09040633190
For use on the cobas® 5800 System

cobas® TV/MG Positive Control Kit P/N: 09040641190
cobas® Buffer Negative Control Kit P/N: 09051953190
For use on the cobas® 6800/8800 Systems

cobas® TV/MG Positive Control Kit P/N: 09040641190 or
P/N: 07948689190
cobas® Buffer Negative Control Kit P/N: 09051953190 or

P/N: 07002238190
cobas® TV/MG
Table of contents
Intended use ............................................................................................................................ 5
Summary and explanation of the test................................................................................. 5
Reagents and materials ......................................................................................................... 9
cobas® TV/MG reagents and controls ...................................................................................................... 9

cobas omni reagents for sample preparation ........................................................................................ 11
Reagent storage and handling requirements ........................................................................................... 12
Reagent handling requirements for cobas® 5800 System ..................................................................... 12
Reagent handling requirements for cobas® 6800/8800 Systems ......................................................... 13
Additional materials required for cobas® 5800 System ........................................................................ 14
Additional materials required for cobas® 6800/8800 Systems ............................................................. 14
Instrumentation and software required ................................................................................................. 15
Additional materials required for sample collection for cobas® TV/MG ......................................... 15
Additional materials required for sample aliquoting and sample loading for cobas® TV/MG ...... 16
Precautions and handling requirements ......................................................................... 17
Warnings and precautions ...................................................................................................................... 17

Reagent handling ...................................................................................................................................... 17
Good laboratory practice ......................................................................................................................... 18
Specimen collection, transport, and storage ................................................................... 19
Specimen collection ................................................................................................................................. 19

Specimen transport .................................................................................................................................. 19
Specimen storage ...................................................................................................................................... 20
Male and female urine specimens .......................................................................................................... 20
Endocervical and vaginal specimens ..................................................................................................... 20
Meatal specimens ..................................................................................................................................... 21
Cervical specimens in PreservCyt® Solution ......................................................................................... 22
cobas® 5800 System .......................................................................................................................... 22
cobas® 5800/6800/8800 System....................................................................................................... 22
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cobas® TV/MG
Instructions for use............................................................................................................... 23
Procedural notes ....................................................................................................................................... 23

Running cobas® TV/MG on cobas® 5800 System .................................................................................. 23
Running cobas® TV/MG on cobas® 6800/8800 Systems ...................................................................... 25
Results ..................................................................................................................................... 27
Quality control and validity of results on the cobas® 5800 System .................................................... 27
Quality control and validity of results on the cobas® 6800/8800 Systems.......................................... 27
cobas® TV/MG for cobas® 5800 System Software ................................................................................. 28
Interpretation of results ..................................................................................................................... 31
Procedural limitations.............................................................................................................................. 32
Non-clinical performance evaluation ............................................................................... 34
Key performance characteristics performed on the cobas® 6800/8800 Systems .............................. 34

Analytical sensitivity (Limit of Detection) ................................................................................... 34
Inclusivity ......................................................................................................................................... 35
Precision (within laboratory) ......................................................................................................... 36
Analytical specificity/cross reactivity ............................................................................................ 40
Interference....................................................................................................................................... 42
Competitive inhibition .................................................................................................................... 43
Cross contamination/Carryover .................................................................................................... 43
Clinical performance evaluation ....................................................................................... 44
Reproducibility study ............................................................................................................................... 44

Negative panels ................................................................................................................................ 44
Trichomonas vaginalis panels ......................................................................................................... 44
Mycoplasma genitalium panels ...................................................................................................... 51
Percentage agreement ..................................................................................................................... 59
Clinical study ............................................................................................................................................ 60
Results ............................................................................................................................................... 61
TV clinical performance ................................................................................................................. 61
Expected values for TV ................................................................................................................... 65
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MG clinical performance ................................................................................................................ 68

Expected values for MG .................................................................................................................. 72
Specimen-specific agreement for the detection of MG ....................................................................... 76
System equivalency .................................................................................................................................. 76
Additional information ......................................................................................................... 77
Key assay features ..................................................................................................................................... 77

Symbols ...................................................................................................................................................... 78
Manufacturer and distributors ............................................................................................................... 79
Trademarks and patents .......................................................................................................................... 79
Copyright................................................................................................................................................... 79
References .................................................................................................................................................. 80
Document Revision.................................................................................................................................. 82
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cobas® TV/MG
Intended use
cobas® TV/MG on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro nucleic acid diagnostic test
that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Trichomonas vaginalis (TV) and
Mycoplasma genitalium (MG) DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical
setting), clinician-collected vaginal swab specimens, and endocervical specimens, all collected in cobas® PCR Media
(Roche Molecular Systems, Inc.). cobas® TV/MG also detects TV DNA in cervical specimens collected in PreservCyt
solution and MG DNA in self-collected meatal swab specimens (collected in a clinical setting) and clinician-collected
meatal swab specimens. This test is intended as an aid in the diagnosis of TV and MG infections in individuals suspected
to have TV or MG infection.
A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to
higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to higher
sensitivity compared to meatal swabs. If vaginal swab or male urine is not used and MG testing is negative, further testing
with the preferred specimen type may be indicated if M. genitalium infection is strongly suspected.
Summary and explanation of the test

Background
Trichomonas vaginalis is the most common non-viral sexually transmitted infection (STI) in the world, with an estimated
276.4 million cases in 2008 with an approximate prevalence in females and males of 8.1% and 1.0%, respectively.1 However,
these rates are thought to be an underestimation because most of the studies have been from methods such as wet mount
microscopy versus nucleic acid amplification tests (NAATs). Global population based studies show prevalence rates ranging
from 3.2% to 42.6%, depending on the geographic region studied.2 Trichomonas vaginalis is also the most prevalent non-viral
STI in the United States (US). A population-based study demonstrated an overall prevalence of 3.1% among women aged 14 to
49 years, with rates as high as 13.3% among black women in the general population.2 Another study found TV prevalence of
11.9% in women aged 36 to 45 years, 7.7% in women aged 51 to 60 years, and 4.2% in women aged 16 to 25 years.3 Molecular
based tests for the detection of TV have shown a detection rate between 7% and 13% among females.4 However, TV is currently
not a reportable disease, and the true estimation of disease prevalence is not currently known. Some of the factors contributing
to this are the lack of routine testing, low sensitivity of the traditional laboratory tests, and non-specific symptomatology.
Trichomonas vaginalis is a parasitic protozoan that is approximately 10 to 20 µm in length and 2 to 14 µm in width, and it has
four anterior flagella. Trichomonas vaginalis trophozoites divide by binary fission, and, in natural infections, give rise to a
population in the lumen and on the mucosal surfaces of the urogenital tract of humans.5 Trichomonas vaginalis primarily
infects the squamous epithelial cells and resides in the lower genital tract in females and in the male urethra and prostate.
Humans are the only known host for TV, and the pathogen is primarily sexually transmitted. Infection may persist for long
periods (months to years) in women, but, in males, it generally persists less than ten days.6
Women who are symptomatic for a TV infection complain of vaginal discharge, pruritus, and irritation. Other signs of
infection include malodor, edema, and/or erythema. Trichomonas vaginalis is also known to cause urethritis in men who
have sex with women. Men with trichomoniasis may feel itching or irritation inside the penis or burning after urination or
ejaculation or have some discharge from the penis. Sviben et al.7 observed a TV polymerase chain reaction (PCR)
detection rate of 8.2% in 500 men with urethritis versus a 2.2% detection rate in asymptomatic males.4
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cobas® TV/MG
Laboratory diagnosis has relied on viewing the organisms under the microscope via a saline wet mount prepared from the
patient’s discharge. Wet mount microscopy is very subjective and can also be affected by a number of limitations that can
decrease the likelihood of observing the motile trichomonads. Although this method is quick and inexpensive, there is
limited sensitivity, which ranges from 60% to 70%.5,8
The current gold standard for the laboratory diagnosis of TV is culture that can be performed in Diamond’s medium.
However, it takes several days to determine that a cultured specimen is negative for the presence of TV and this testing
remains relatively insensitive (73.3%).8 Nucleic acid amplification testing has been shown to be more sensitive than the
culture testing.9
The Centers for Disease Control and Prevention (CDC) recommends that women who test positive for TV be rescreened
3 months after treatment.10 The CDC also recommends that women with human immunodeficiency virus (HIV) infection
also be screened for TV at the initial visit and annually thereafter.
Mycoplasma genitalium is a fastidious bacterium first isolated in 1980 from the urethral swabs of two symptomatic men
with non-gonococcal urethritis (NGU).11 Infections caused by this bacterium have been associated with male and female
urethritis, balanoposthitis, prostatitis, cervicitis, pelvic inflammatory disease, and female infertility.12 Additional
complications, such as preterm delivery and extra-genital infections, have been reported.
There have been few studies showing an accurate prevalence of MG, because historically this bacterium is difficult to culture.
However, a number of molecular assays have been described that show a prevalence as high as 47.5%.13 More recent studies
using nucleic acid testing showed an MG prevalence of 16-17% in females14,15, with a higher rate of detection observed in
vaginal swabs.15 Another study showed that 8.1% of males who presented to a public sexual health clinic had MG detected in
their urine.16 Some of the factors accounting for the wide range in prevalence are related to the sample type collected (vaginal
swab, urine, rectal swabs, or endocervical swabs) and the subjects selected.
Currently, there is no evidence-based consensus or gold-standard test for MG, or a consensus on sample type(s) to be
collected. There are also no recommended guidelines for MG screening or testing, and the lack of a universally accepted,
standardized assay complicates screening efforts for at-risk patient populations. Similar to TV, MG is not a reportable
disease, and it is likely that, without standardized laboratory testing available, some cases of MG infection are treated
empirically as a Chlamydia trachomatis (CT) infection. There are also no recommended guidelines for retesting patients
who have completed treatment for MG, although follow-up testing and reassessment may be indicated, depending on the
patient’s risk factors for re-infection and the history of and compliance with antibiotic treatment. Contributing to the
potential need for retesting is the increased incidence of macrolide resistance when first line treatment may not work or
work sub-optimally.14
Explanation of the test

cobas® TV/MG on the cobas® 5800 System, cobas® 6800 System or cobas® /8800 System is an automated, qualitative in
vitro nucleic acid diagnostic test for the direct detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)
DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal
swab specimens, and endocervical specimens collected in cobas® PCR Media (Roche Molecular Systems, Inc.). cobas®
TV/MG also detects TV DNA in cervical specimens collected in PreservCyt® Solution and MG DNA in self-collected
meatal swab specimens (collected in a clinical setting) and clinician-collected meatal swab specimens. The DNA Internal
Control, used to monitor the entire sample preparation and PCR amplification process, is introduced into each specimen
during sample processing. In addition, the test utilizes external controls (low titer positive control and a negative control).
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cobas® TV/MG
Principles of the procedure

cobas® TV/MG is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR
amplification and detection. The cobas® 5800 System is designed as one integrated instrument. The cobas® 6800/8800
Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module.
Automated data management is performed by the cobas® 5800 System or cobas® 6800/8800 Systems software which assigns
test results for all tests as positive, negative or invalid. Results can be reviewed directly on the system screen, exported, or
printed as a report.
Nucleic acid from patient samples and added internal control DNA (DNA-IC) molecules are simultaneously extracted. In
summary, nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds
to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein,
cellular debris and potential PCR inhibitors are removed with subsequent wash steps and purified nucleic acid is eluted
from the magnetic glass particles with elution buffer at elevated temperature. External controls (positive and negative) are
processed in the same way.
Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and
reverse primers for TV and MG which are selected from highly-conserved regions within the respective target organism.
TV is detected by one selective set of primers and a probe, while MG is detected by using two sets targeting separate regions
(dual-target). Selective amplification of DNA IC is achieved by the use of sequence-specific forward and reverse primers
which are selected to have no homology with either the TV or MG target regions. A thermostable DNA polymerase
enzyme is used for PCR amplification. The target and DNA-IC sequences are amplified simultaneously utilizing a
universal PCR amplification profile with predefined temperature steps and number of cycles. The master mix includes
deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly
synthesized DNA (amplicon). Any contaminating amplicon from previous PCR runs is eliminated by the AmpErase
enzyme, which is included in the PCR master mix, during the first thermal cycling step.17 However, newly formed
amplicons are not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C.
The cobas® TV/MG master mix contains one detection probe specific for the TV target sequence, two detection
probes specific for the MG target sequences and one for the DNA-IC. The probes are labeled with target specific
fluorescent reporter dyes allowing simultaneous detection of TV target, MG targets and DNA-IC in three different
target channels. 18,19 When not bound to the target sequence, the fluorescent signal of the intact probes is suppressed by a
quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template
results in cleavage of the probe by the 5' to 3' exonuclease activity of the DNA polymerase resulting in separation of the
reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved
probes are generated and the cumulative signal of the reporter dye increases concomitantly. Real-time detection and
discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the TV and
MG targets and DNA-IC, respectively.
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cobas® TV/MG
Limitations
 A negative result does not preclude a possible infection.
 Test Results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
 Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe
proper procedures in any one of these steps can lead to incorrect results. See Specimen collection, transport, and
storage for instructions. For detailed information, refer to the appropriate instructions for use.
 A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to
higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to
higher sensitivity compared to meatal swabs. If vaginal swab or male urine is not used and MG testing is negative,
further testing with the preferred specimen type may be indicated if M. genitalium infection is strongly suspected.
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cobas® TV/MG
Reagents and materials

Refer to the Reagents and materials section and Precautions and handling requirements section for the hazard
information for the product.
cobas® TV/MG reagents and controls

All unopened reagents and controls shall be stored as recommended in Table 1 to Table 4.
Table 1 cobas® TV/MG

(TV/MG)
Store at 2-8°C
384 test cassette (P/N 09040633190)
Kit components Reagent ingredients Quantity per kit
384 tests
Proteinase Solution Tris buffer, < 0.05% EDTA, Calcium chloride, Calcium acetate, 8% 38 mL
(PASE) Proteinase
EUH210: Safety data sheet available on request.
EUH208: Contains Subtilisin. May produce an allergic reaction.
DNA Internal Control Tris buffer, < 0.05% EDTA, < 0.001% non-TV/MG related DNA 38 mL
(DNA-IC) construct containing primer and probe specific sequence regions,
< 0.1% Sodium azide
Elution Buffer (EB) Tris buffer, 0.2% Methyl-4 hydroxibenzoate 38 mL
Master Mix Reagent 1 Manganese acetate, Potassium hydroxide, < 0.1% Sodium azide 14.5 mL
(MMX-R1)
TV/MG Master Mix Tricine buffer, Potassium acetate, EDTA, Glycerol, < 18% Dimethyl 17.5 mL
Reagent 2 sulfoxide, < 0.12% dATP, dCTP, dGTP, dUTPs, < 0.1% Tween 20, <
(TV/MG MMX-R2) 0.1% Sodium azide, < 0.1% Z05 DNA polymerase, < 0.1%
AmpErase (uracil-N glycosylase) enzyme (microbial), < 0.01%
Internal Control forward and reverse primers, < 0.01% Upstream
and downstream TV/MG primers, < 0.01% Fluorescent-labeled
oligonucleotide probes specific for TV, MG and the DNA Internal
Control, < 0.01% Oligonucleotide aptamer
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cobas® TV/MG
Table 2 cobas® TV/MG Positive Control Kit

(TV/MG (+) C)
Store at 2–8°C
(P/N 09040641190 or P/N 07948689190)
TV/MG Positive Control Tris buffer, < 0.05% Sodium azide, < 0.005% EDTA, 16 mL
(TV/MG (+) C) < 0.003% Poly rA, <0.01% Non-infectious plasmid DNA (microbial) (16 x 1 mL)
containing T. vaginalis, <0.01% Non-infectious plasmid DNA
(microbial) containing M. Genitalium
Table 3 cobas® Buffer Negative Control Kit

(BUF (-) C)
Store at 2-8°C
(P/N 09051953190 or P/N 07002238190)
cobas® Buffer Negative Tris buffer, < 0.1% sodium azide, EDTA, < 0.002% Poly rA RNA 16 mL
Control (synthetic) (16 x 1 mL)
(BUF (-) C)
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cobas® TV/MG
cobas omni reagents for sample preparation

Table 4 cobas omni reagents for sample preparation*
Reagents Reagent ingredients Quantity Safety symbol and warning**

per kit
cobas omni Magnetic glass particles, Tris buffer, 0.1% 480 tests Not applicable
MGP Reagent methyl-4 hydroxybenzoate, < 0.1% sodium
(MGP) azide
Store at 2–8°C
(P/N 06997546190)
cobas omni Tris buffer, 0.1% methyl-4 4 x 875 mL Not applicable
Specimen Diluent hydroxybenzoate, < 0.1% sodium azide
(SPEC DIL)
Store at 2–8°C
(P/N 06997511190)
cobas omni 42.56% (w/w) guanidine thiocyanate***, 4 x 875 mL
Lysis Reagent 5% (w/v) polydocanol***, 2% (w/v)
(LYS) dithiothreitol***, dihydro sodium citrate
Store at 2–8°C
(P/N 06997538190)
DANGER
H302: Harmful if swallowed.
H314: Causes severe skin burns and eye damage.
H411: Toxic to aquatic life with long lasting effects.
EUH032: Contact with acids liberates very toxic gas.
EUH071: Corrosive to the respiratory tract.
P273: Avoid release to the environment.
P280: Wear protective gloves/ protective clothing/ eye
protection/face protection/ hearing protection.
P303 + P361 + P353 IF ON SKIN (or hair): Take off
immediately all contaminated clothing. Rinse skin with
water.
P304 + P340 + P310 IF INHALED: Remove person to
fresh air and keep comfortable for breathing.
Immediately call a POISON CENTER/ doctor.
P305 + P351 + P338 + P310: IF IN EYES: Rinse
cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue
rinsing. Immediately call a POISON CENTER/doctor.
P391 Collect spillage.
593-84-0 Guanidinium thiocyanate
9002-92-0 Polidocanol
3483-12-3 (R*,R*)-1,4-dimercaptobutane-2,3-diol
cobas omni Sodium citrate dihydrate, 0.1% methyl-4 4.2 L Not applicable
Wash Reagent hydroxybenzoate
(WASH)
Store at 15–30°C
(P/N 06997503190)
* These reagents are not included in the cobas® TV/MG kit. See listing of additional materials required (Table 10 and Table 11).
** Product safety labeling primarily follows EU GHS guidance
***Hazardous substance
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cobas® TV/MG
Reagent storage and handling requirements

Reagents shall be stored and handled as specified in Table 5.
When reagents are not loaded on the cobas® 5800 System or cobas® 6800/8800 Systems, store them at the corresponding
temperature specified in Table 5.
Table 5 Reagent storage (when reagent is not on the system)
Reagent Storage temperature

cobas® TV/MG 2–8°C
cobas® TV/MG Positive Control Kit 2–8°C
cobas® Buffer Negative Control Kit 2–8°C
cobas omni Lysis Reagent 2–8°C
cobas omni MGP Reagent 2–8°C
cobas omni Specimen Diluent 2–8°C
cobas omni Wash Reagent 15–30°C
Reagent handling requirements for cobas® 5800 System

Reagents loaded onto the cobas® 5800 System are stored at appropriate temperatures and their expiration is monitored by
the system. The system allows reagents to be used only if all of the conditions shown in Table 6 are met. The system
automatically prevents use of expired reagents. Table 6 allows the user to understand the reagent handling conditions
enforced by the cobas® 5800 System.
Table 6 Reagent expiry conditions enforced by the cobas® 5800 System
Reagent Kit expiration date Open-kit stability* Number of runs for On-board
which this kit can be stability
used
cobas® TV/MG Date not passed 90 days from first usage Max 40 runs Max 36 days*
cobas® TV/MG Positive Control Kit Date not passed Not applicable** Not applicable Max 36 days*
cobas® Buffer Negative Control Kit Date not passed Not applicable** Not applicable Max 36 days*
cobas omni Lysis Reagent Date not passed 30 days from loading* Not applicable Not applicable
cobas omni MGP Reagent Date not passed 30 days from loading* Not applicable Not applicable
cobas omni Specimen Diluent Date not passed 30 days from loading* Not applicable Not applicable
cobas omni Wash Reagent Date not passed 30 days from loading* Not applicable Not applicable
* Time is measured from the first time that reagent is loaded onto the cobas® 5800 System.
** Single use reagent
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cobas® TV/MG
Reagent handling requirements for cobas® 6800/8800 Systems

Reagents loaded onto the cobas® 6800/8800 Systems are stored at appropriate temperatures and their expiration is
monitored by the system. The cobas® 6800/8800 Systems allow reagents to be used only if all of the conditions shown in
Table 7 are met. The system automatically prevents use of expired reagents. Table 7 allows the user to understand the
reagent handling conditions enforced by the cobas® 6800/8800 Systems.
Table 7 Reagent expiry conditions enforced by the cobas® 6800/8800 Systems
Reagent Kit expiration date Open-kit stability* Number of runs On-board stability
for which this (cumulative time on
kit can be used board outside
refrigerator)
cobas® TV/MG Date not passed 90 days from first Max 40 runs Max 40 hours
usage
cobas® TV/MG Positive Control Kit Date not passed Not applicable** Not applicable Max 10 hours
cobas® Buffer Negative Control Kit Date not passed Not applicable** Not applicable Max 10 hours
cobas omni Lysis Reagent Date not passed 30 days from loading* Not applicable Not applicable
cobas omni MGP Reagent Date not passed 30 days from loading* Not applicable Not applicable
cobas omni Specimen Diluent Date not passed 30 days from loading* Not applicable Not applicable
cobas omni Wash Reagent Date not passed 30 days from loading* Not applicable Not applicable
*Time is measured from the first time that reagent is loaded onto the cobas® 6800/8800 Systems.
** Single use reagent
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cobas® TV/MG
Additional materials required for cobas® 5800 System

Table 8 Material and consumables for use on cobas® 5800 System
Material P/N
cobas omni Processing Plate 24 08413975001
cobas omni Liquid Waste Plate 24 08413983001
cobas omni Amplification Plate 24 08499853001
Tip CORE TIPS with Filter, 1ml 04639642001
Tip CORE TIPS with Filter, 0.3 ml 07345607001
cobas omni Liquid Waste Container 07094388001
cobas omni Lysis Reagent 06997538190
cobas omni MGP Reagent 06997546190
cobas omni Specimen Diluent 06997511190
cobas omni Wash Reagent 06997503190
Solid Waste Bag and Solid Waste Container 07435967001 and 07094361001
or or
Solid Waste Bag With Insert and Kit Drawer 08030073001 and 08387281001
16-position tube S-carrier complete 09224319001
5-position Rack Carrier 09224475001
Cell Collection Media Carrier 09224599001
Additional materials required for cobas® 6800/8800 Systems

Table 9 Materials and consumables for use on cobas® 6800/8800 Systems
Material P/N
cobas omni Processing Plate 05534917001
cobas omni Amplification Plate 05534941001
cobas omni Pipette Tips 05534925001
cobas omni Liquid Waste Container 07094388001
cobas omni Lysis Reagent 06997538190
cobas omni MGP Reagent 06997546190
cobas omni Specimen Diluent 06997511190
cobas omni Wash Reagent 06997503190
Solid Waste Bag and Solid Waste Container 07435967001 and 07094361001
or or
Solid Waste Bag With Insert and Kit Drawer 08030073001 and 08387281001
STD-Rack. re-run R001-R025 PINK 12025639001
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cobas® TV/MG
Instrumentation and software required

The cobas® 5800 software and cobas® TV/MG analysis package (ASAP) for cobas® 5800 shall be installed on the cobas®
5800 instrument(s). The Data Manager software and PC for cobas® 5800 System will be provided with the system.
The cobas® 6800/8800 software and cobas® TV/MG analysis package (ASAPs) for cobas® 6800/8800 shall be installed on
the instrument(s). The Instrument Gateway (IG) server will be provided with the system.
Table 10 Instrumentation
Equipment P/N
cobas® 5800 System 08707464001
cobas® 6800 System (Option Moveable) 05524245001 and 06379672001
cobas® 6800 System (Fix) 05524245001 and 06379664001
cobas® 8800 System 05412722001
Sample Supply Module for cobas® 6800/8800 Systems 06301037001
Note: Refer to the cobas® 5800 System or cobas® 6800/8800 Systems User Assistance and/or User Guide for additional information for primary and
secondary sample tubes accepted on the instruments. Contact your local Roche representative for a detailed order list for sample racks, racks for
clotted tips and rack trays accepted on the instruments.
Additional materials required for sample collection for cobas® TV/MG

Table 11 Specimen collection kits used with cobas® TV/MG
Collection Kit P/N
cobas® PCR Urine Sample Kit 05170486190
cobas® PCR Media Uni Swab Sample Kit 07958030190
cobas® PCR Media Dual Swab Sample Kit 07958021190
ThinPrep Pap Test Physician’s Kit (500 vials & Broom-like collection devices) Hologic: 70136-001
ThinPrep Pap Test Physician’s Kit (500 vials & Cytobrush/spatula collection devices) Hologic: 70136-002
cobas® TV/MG accepts the primary tube used for all listed swab and urine specimens collected in cobas® PCR Media/Urine kits listed above. Refer to
the cobas® 5800 System or the cobas® 6800/8800 Systems User Assistance and/or User Guide for additional information for primary and secondary
sample tubes accepted on the instruments.
Note: Contact your local Roche representative for a detailed order list for sample racks, racks for clotted tips and rack trays accepted on the
instruments
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cobas® TV/MG
Additional materials required for sample aliquoting and sample loading for cobas®
TV/MG
Table 12 Specimen collection kits used with cobas® TV/MG
Material P/N
cobas® PCR Media Secondary Tube Kit 07958048190
cobas® PCR Media Tube Replacement Cap Kit 07958056190
Replacement Caps for PreservCyt® Vials 08037230190
cobas® PCR Media Disposable Tube Stand (Optional) 07958064190
MPA RACK 16 MM LIGHT GREEN 7001-7050a,b,c 03143449001

a,b,c
RD5 RACK – RD Standard rack 0001-0050 LR 11902997001
a
RD5 or MPA racks are required in combination with the 5-position Rack Carrier on the cobas® 5800 System.
b
MPA 16mm rack or 16-position tube carrier are the preferred racks for use with samples collected in cobas® PCR Media tubes.
c
MPA and RD5 racks identified here are example materials and part numbers. Please contact your local Roche representative for a detailed order list
for sample racks and rack carriers accepted on the instruments.
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cobas® TV/MG
Precautions and handling requirements

Warnings and precautions
As with any test procedure, good laboratory practice is essential to the proper performance of this assay. Due to the high
sensitivity of this test, care should be taken to keep reagents and amplification mixtures free of contamination.
 For in vitro diagnostic use only.
 All patient samples should be handled as if infectious, using good laboratory procedures as outlined in
Biosafety in Microbiological and Biomedical Laboratories and in the CLSI Document M29-A4.20,21 Only
personnel proficient in handling infectious materials and in the use of cobas® TV/MG and cobas® 5800 System
or cobas® 6800/8800 Systems should perform this procedure.
 All human-sourced materials should be considered potentially infectious and should be handled with
universal precautions.
 Do not freeze any samples.
 Use only supplied or specified required consumables to ensure established test performance.
 Safety Data Sheets (SDS) are available on request from your local Roche representative.
 Closely follow procedures and guidelines provided to ensure that the test is performed correctly. Any deviation
from the procedures and guidelines may affect established test performance.
 False positive results may occur if carryover of samples is not adequately controlled during sample handling
and processing.
 cobas® PCR Media (from primary specimen tube) contains guanidine hydrochloride. Do not allow direct
contact between guanidine hydrochloride and sodium hypochlorite (bleach) or other highly reactive reagents
such as acids or bases. These mixtures can release a noxious gas. If liquid containing guanidine
hydrochloride is spilled, clean with suitable laboratory detergent and water. If the spilled liquid contains
potentially infectious agents, FIRST clean the affected area with laboratory detergent and water, and then
with 0.5% sodium hypochlorite.
Reagent handling
 Handle all reagents, controls, and samples according to good laboratory practice in order to prevent carryover of
samples, reagents, or controls.
 Before use, visually inspect each reagent cassette, diluent, lysis reagent, and wash reagent to ensure that there are
no signs of leakage. If there is any evidence of leakage, do not use that material for testing.
 cobas omni Lysis Reagent contains guanidine thiocyanate, a potentially hazardous chemical. Avoid contact of
reagents with the skin, eyes, or mucous membranes. If contact does occur, immediately wash with generous
amounts of water; otherwise, burns can occur.
 Expended control kits contain pierced vials with residual reagent; special care should be taken during disposal to
avoid spills and contact.
 cobas® TV/MG kit, cobas® TV/MG Positive Control kit, cobas® Buffer Negative Control kit, cobas omni MGP
Reagent, and cobas omni Specimen Diluent contain sodium azide as a preservative. Avoid contact of reagents
with the skin, eyes, or mucous membranes. If contact does occur, immediately wash with generous amounts of
water; otherwise, burns can occur. If these reagents are spilled, dilute with water before wiping dry.
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cobas® TV/MG
 Do not allow cobas omni Lysis Reagent, which contains guanidine thiocyanate, to contact sodium
hypochlorite (bleach) solution. This mixture can produce a highly toxic gas.
 Dispose of all materials that have come in contact with samples and reagents in accordance with country, state,
and local regulations.
Good laboratory practice

 Do not pipette by mouth.
 Do not eat, drink, or smoke in designated work areas.
 Wear laboratory gloves, laboratory coats, and eye protection when handling samples and reagents. Avoid
contaminating gloves when handling samples and controls. Gloves must be changed between handling
samples and cobas® TV/MG kit, cobas® TV/MG Positive Control kit, cobas® Buffer Negative Control kit, and
cobas omni reagents to prevent contamination.
 Wash hands thoroughly after handling samples and reagents, and after removing the gloves.
 Thoroughly clean and disinfect all laboratory work surfaces with a freshly prepared solution of 0.5% sodium
hypochlorite in distilled or deionized water (dilute household bleach 1:10). Follow by wiping the surface with
70% ethanol.
 If spills occur on the cobas® 5800 instrument or cobas® 6800/8800 instruments, follow the instructions in the
cobas® 5800 System or cobas® 6800/8800 Systems User Assistance and/or User Guide to properly clean and
decontaminate the surface of instrument(s).
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cobas® TV/MG
Specimen collection, transport, and storage

Note: Handle all samples and controls as if they are capable of transmitting infectious agents.
Specimen collection
Endocervical swab specimens collected with the cobas® PCR Media Dual Swab Sample Kit, vaginal swab specimens and
meatal swab specimens collected with either the cobas® PCR Media Uni Swab Sample Kit or cobas® PCR Media Dual Swab
Sample Kit, male and female urine collected with the cobas® PCR Urine Sample Kit and cervical specimens collected in
PreservCyt® Solution may be used with cobas® TV/MG (see for a list of all collection kits). Follow the instructions for
collecting all swab and urine specimens in their respective collection kit IFU. Follow the manufacturer's instructions for
collecting cervical specimens into PreservCyt® Solution.
Specimen transport
All specimen types listed in the “Specimen collection” section above can be transported at 2-30°C. Transportation of
TV/MG specimens in cobas® PCR Media and PreservCyt® Solution must comply with country, federal, state and local
regulations for the transport of etiologic agents.22
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cobas® TV/MG
Specimen storage
Store specimens as shown in Table 13. PreservCyt® and cobas® PCR Media specimens should not be frozen.
Table 13 Summary of acceptable specimen storage conditions prior to testing with cobas® TV/MG
Specimen Type 2-30°C
Samples in cobas® PCR Media 12 months
PreservCyt® in collection device 90 days
PreservCyt® aliquoted to secondary tubes 31 days
Male and female urine specimens

 Use only the cobas® PCR Urine Sample Kit to collect urine specimens for cobas® TV/MG. cobas® TV/MG has
not been validated for use with other urine collection devices or media types. Using cobas® TV/MG with other
urine collection devices or other media types may lead to false negative, false positive, and/or invalid results.
 To avoid cross contamination of processed specimens, additional caps for cobas® PCR Media tubes in an
alternate color (neutral; see Additional materials required for sample aliquoting and sample loading for
cobas® TV/MG) should be used to recap specimens after processing.
 Untested urine specimens must show the top of the liquid level between the two black lines on the cobas® PCR
Media tube label window. If the liquid level is above the upper or below the lower line, the specimen has not been
collected properly and cannot be used for testing.
 If additional testing is required, ensure that there is at least 1.2 mL of specimen remaining in the cobas® PCR
Media tube.
Endocervical and vaginal specimens

 The presence of mucus in endocervical specimens may cause processing delays due to clotting. Mucus free
specimens are required for optimal test performance. Use the large woven polyester swab in the cobas® PCR
Media Dual Swab Sample Kit or an equivalent device to remove cervical secretions and discharge before
obtaining the endocervical specimen.
 Use only the flocked swab in the cobas® PCR Media Dual Swab Sample Kit to collect endocervical specimens. Use
only the woven polyester swab in either the cobas® PCR Media Dual Swab Sample Kit or the cobas® PCR Media
Uni Swab Sample Kit to collect vaginal swab specimens. cobas® TV/MG has not been validated for use with other
swab collection devices or media types. Using cobas® TV/MG with other swab collection devices or media types
may lead to false negative, false positive, and/or invalid results.
 All swab specimens containing a single swab in the cobas® PCR Media tube can be directly processed on the
cobas® 5800 or cobas® 6800/8800 Systems. If desired, the swab may be removed before the specimen tube is
loaded onto the instrument, however utmost care must be exercised to avoid cross contamination.
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cobas® TV/MG
 A properly collected swab specimen should have a single swab with the shaft broken at the scoreline. Swab shafts
which are broken above the score line will appear longer than normal and may also be bent over to fit into the
cobas® PCR Media tube. This can create an obstruction to the pipetting system which may cause the loss of
sample, test results and/or mechanical damage to the instrument. In the event that a swab specimen has an
improperly broken shaft, remove the swab prior to sample processing on the cobas® 5800 System or cobas®
6800/8800 Systems. Use caution when disposing of specimen swabs; avoid splashing or touching swabs to other
surfaces during disposal to prevent contamination.
 Incoming primary swab specimen tubes with no swabs or with two swabs have not been collected according to
the instructions in their respective collection kit IFU and should not be tested.
 Occasionally, incoming swab specimens contain excessive mucus which may induce a pipetting error (e.g., clot
or other obstruction) on the cobas® 5800 System or cobas® 6800/8800 Systems. Prior to retesting of specimens
that exhibited clots during initial processing, remove and discard the swab, then re-cap and vortex these
specimens for 30 seconds to disperse the excess mucus.
 Swab specimens can be assayed twice on the cobas® 5800 System or cobas® 6800/8800 Systems while the swab is in
the collection tube. If additional testing is required, or if the first test fails due to specimen pipetting error (e.g., clot
or other obstruction), the swab must be removed and the remaining fluid must have a minimum volume of 1.0 mL.
Meatal specimens
 Use only the woven polyester swab in either the cobas® PCR Media Dual Swab Sample Kit or the cobas® PCR
Media Uni Swab Sample Kit to collect meatal swab specimens. cobas® TV/MG is validated for use with meatal
swab specimens collected in cobas® PCR Media for the detection of M. genitalium. cobas® TV/MG has not been
validated for use with other swab collection devices or media types. Using cobas® TV/MG with other swab
collection devices or media types may lead to false negative, false positive, and/or invalid results.
 A properly collected swab specimen should have a single swab with the shaft broken at the scoreline. Swab shafts
which are broken above the score line will appear longer than normal and may also be bent over to fit into the
cobas® PCR Media tube. This can create an obstruction to the pipetting system which may cause the loss of
sample, test results and/or mechanical damage to the instrument. In the event that a swab specimen has an
improperly broken shaft, remove the swab prior to sample processing on the cobas® 5800 System or cobas®
6800/8800 Systems. Use caution when disposing of specimen swabs; avoid splashing or touching swabs to other
surfaces during disposal to prevent contamination.
 Incoming primary swab specimen tubes with no swabs or with two swabs have not been collected according to
the instructions in their respective collection kit IFU and should not be tested.
 All meatal swab specimens containing a single swab in the cobas® PCR Media tube can be directly processed on
the cobas® 5800 System or cobas® 6800/8800 Systems while the volume in the collection tube is greater than
1.5mL. If desired, the swab may be removed before the specimen tube is loaded onto the instrument, however
utmost care must be exercised to avoid cross contamination.
 Swab specimens can be assayed twice on the cobas® 5800 System or cobas® 6800/8800 Systems while the swab is in
the collection tube. If additional testing is required, or if the first test fails due to specimen pipetting error (e.g., clot
or other obstruction), the swab must be removed and the remaining fluid must have a minimum volume of 1.2 mL.
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cobas® TV/MG
Cervical specimens in PreservCyt® Solution

cobas® TV/MG is validated for use with cervical specimens collected in PreservCyt® Solution for the detection of T. vaginalis
prior to cytology processing. cobas® TV/MG has not been validated for use with cervical specimens obtained in other media
types. Using cobas® TV/MG with other media types may lead to false negative, false positive, and/or invalid results.
cobas® 5800 System

 The cobas® 5800 System may process cervical specimen in PreservCyt® Solution directly out of their primary
containers with a proper barcode or out of a properly barcoded cobas® PCR Media Secondary Tube (see cobas®
5800/6800/8800 System section below for optional aliquoting instructions for cobas® 5800 System).
1. With clean gloved hands, vortex the capped primary vial for 10 seconds immediately prior to loading.
2. Uncap the primary vial and place on a Cell Collection Media Carrier
 For primary vial loading, the minimum volume required in the PreservCyt® Solution primary containers is 3.0 mL.
cobas® 5800/6800/8800 System

 Cervical specimens in PreservCyt® Solution should be aliquoted into cobas® PCR Media Secondary Tube as
follows, for processing on the cobas® 5800 System or cobas® 6800/8800 System:
1. Prepare a barcoded cobas® PCR Media Secondary Tube for each PreservCyt® specimen to be tested.
2. With clean gloved hands, vortex each PreservCyt® primary specimen vial for 10 seconds immediately
prior to transfer.
3. Uncap a primary vial and transfer at least 1.0 mL but no more than 4.0 mL into the prepared barcoded
secondary tube from step 1.
 Always use caution when transferring specimens from primary containers to secondary tube.
 Always use a new pipette tip for each specimen.
 Always use pipettors with aerosol-barrier or positive-displacement tips to handle specimens.
 To avoid cross contamination, additional caps for these tubes in an alternate color (neutral; see
Additional materials required for sample aliquoting and sample loading for cobas® TV/MG)
should be used to recap these specimens after processing.
 Transfer tube to a rack if testing is to be performed shortly after or cap the secondary tube if testing
will be performed at a future time.
4. Re-cap the primary vial with a replacement cap (see Additional materials required for sample
aliquoting and sample loading for cobas® TV/MG) before moving to the next specimen. Store the
primary vial upright.
5. Only racks of uncapped tubes should be loaded into the systems for TV/MG testing.
 Cervical specimens in PreservCyt® Solution can be assayed twice on the cobas® 5800 System or cobas® 6800/8800
Systems as long as the minimum volume requirements are met.
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cobas® TV/MG
Instructions for use

Procedural notes
● Do not use cobas® TV/MG, cobas® TV/MG Positive Control Kit, cobas® Buffer Negative Control Kit, or cobas
omni reagents after their expiry dates.
● Do not reuse consumables. They are for one-time use only.
● Ensure that specimen barcode labels on sample tubes are visible through the openings on the side of sample
carriers. Refer to the cobas® 5800 System or cobas® 6800/8800 Systems User Assistance and/or User Guide for
proper barcode specifications and additional information on loading sample tubes.
● Refer to the cobas® 5800 System or cobas® 6800/8800 Systems User Assistance and/or User Guide for proper
maintenance of instruments.
Running cobas® TV/MG on cobas® 5800 System

cobas® TV/MG can be run with a minimum required sample volume of 1.0 mL for swab and PreservCyt® specimens, 1.2
mL for meatal swab and urine specimens in cobas® PCR Media Tube, and 3.0 mL for PreservCyt® specimens in primary
vial. The operation of the instrument is described in detail in the cobas® 5800 System User Assistance Guide. Figure 1
below summarizes the procedure.
● Swab and Urine specimens should be uncapped and loaded directly onto racks for processing on the cobas® 5800
System.
● PreservCyt® specimens should be uncapped and run from primary vials.
Note: Note: Use slow and steady movements when loading and unloading the Cell Collection Media Carrier
(holding primary vials) to avoid splashing of specimens.
● Optionally, PreservCyt® specimens may be aliquoted into barcoded 13 mL round-bottom cobas® PCR Media
Secondary tubes for processing on the cobas® 5800 System. Refer to the preparation instructions for cervical
specimens found in section: “Cervical specimens in PreservCyt® Solution”
● A single run can have any combination of specimens (Swab, Urine, Meatal Swab, and PreservCyt®) and each
specimen can be tested for either TV/MG, TV, or MG.
● Specimens collected in cobas® PCR Media or PreservCyt® Solution should be processed using the sample type
selection in the user interface (UI) of the cobas® TV/MG as described in Table 14.
Table 14 Sample type selection in the user interface of the cobas® TV/MG
Specimen Specimen Collection kit type Process as Sample Type
Female Vaginal swab cobas® PCR Media Uni or Dual Swab Sample Kit Swab
Female Endocervical swab cobas® PCR Media Dual Swab Sample Kit Swab
Female Urine cobas® PCR Urine Sample Kit or cobas® PCR Media Kit Urine
Female Cervical specimens PreservCyt® Solution (ThinPrep) PreservCyt®
Male Urine cobas® PCR Urine Sample Kit or cobas® PCR Media Kit Urine
Male Meatal swab cobas® PCR Media Uni or Dual Swab Sample Kit Meatal Swab*
Note: Make sure to select “Meatal Swab”, not “Swab”, as a Sample Type for testing of the meatal swab specimens. “Swab” sample type applies only to vaginal
and endocervical swab specimens.
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cobas® TV/MG
Figure 1 cobas® TV/MG procedure on cobas® 5800 System
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cobas® TV/MG
Running cobas® TV/MG on cobas® 6800/8800 Systems

cobas® TV/MG can be run with a minimum required sample volume of 1.0 mL for endocervical and vaginal swabs and
cervical specimens in PreservCyt®, and 1.2 mL for meatal swab and urine specimens. The operation of the instrument is
described in detail in the cobas® 6800/8800 Systems User Assistance. Figure 2 below summarizes the procedure.
 Swab, meatal swab and urine specimens must be uncapped and loaded directly onto racks for processing on
the cobas® 6800/8800 Systems.
 It is necessary to aliquot cervical specimens collected in PreservCyt® Solution. Refer to the preparation
instructions found in the section: “Cervical specimens in PreservCyt® Solution”
 A single run can have any combination of specimens (Swab, Urine, Meatal Swab, and PreservCyt®).
 Specimens collected in cobas® PCR Media or PreservCyt® Solution should be processed using the sample type
selection in the user interface (UI) of the cobas® TV/MG as described in Table 15.
Table 15 Sample type selection in the user interface of the cobas® TV/MG
Specimen Specimen Collection kit type Process as Sample Type
Female Vaginal swab cobas® PCR Media Uni or Dual Swab Sample Kit Swab
Female Endocervical swab cobas® PCR Media Dual Swab Sample Kit Swab
Female Urine cobas® PCR Urine Sample Kit Urine
Female Cervical specimens PreservCyt® Solution (ThinPrep) PreservCyt®
Male Urine cobas® PCR Urine Sample Kit Urine
Male Meatal swab cobas® PCR Media Uni or Dual Swab Sample Kit Meatal Swab*
*Make sure to select “Meatal Swab”, not “Swab”, as a Sample Type for testing of the meatal swab specimens. “Swab” sample type applies only to vaginal and
endocervical swab specimens.
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cobas® TV/MG
Figure 2 cobas® TV/MG procedure on cobas® 6800/8800 Systems
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cobas® TV/MG
Results
The cobas® 5800 System and cobas® 6800/8800 Systems automatically detects and discriminates TV and/or MG DNA
simultaneously for samples and controls, displaying test validity, overall results, as well as individual target results.
Quality control and validity of results on the cobas® 5800 System

● One cobas® Buffer Negative Control [(-) Ctrl] and one TV/MG Positive Control [TV/MG (+) C] must be
processed at least every 72 hours or with every new kit lot. Positive and/or negative controls can be scheduled
more frequently based on laboratory procedures and/or local regulations.
● The results of the controls are shown in the cobas® 5800 software in the “Controls” app.
● In the cobas® 5800 System software and/or report, check for flags to ensure the validity of the corresponding test
results (Refer to the x800 Data Manager User Assistance and/or User Guide for a ‘List of flag codes’).
● The controls are valid if no flags appear for either control.
● Controls are marked with “Valid” in the column “Control result” if all Targets of the control are reported valid.
● Controls are marked with ‘Invalid’ in the column “Control result” if one or both Target of the control are
reported invalid.Controls marked with ‘Invalid’ show a flag in the “Flags” column. More information on why the
control is reported invalid including flag information will be shown in the detail view. If the positive control is
invalid, repeat testing the positive control and all associated samples. If the negative control is invalid, repeat
testing all controls and all associated samples.
Invalidation of results is performed automatically by the cobas® 5800 software based on control results.
NOTE: The cobas® 5800 System will be delivered with the standard setting of running a set of controls (positive and
negative) with every run, but can be configured to a less frequent scheduling up to every 72 hours based on laboratory
procedures and/or local regulations. Please contact your Roche service engineer and/or Roche customer technical support
for more information.
Quality control and validity of results on the cobas® 6800/8800 Systems

 One cobas® Buffer Negative Control [BUF (-) C] and one TV/MG Positive Control [TV/MG (+) C] are processed
with each batch of a requested result type.
 In the cobas® 6800/8800 software and/or report, check for flags and their associated results to ensure batch validity.
 All flags are described in the cobas® 6800/8800 Systems User Assistance and/or User Guide.
 The batch is valid if no flags appear for any controls. If the batch is invalid, repeat testing of the entire batch.
Validation of results is performed automatically by the cobas® 6800/8800 software based on negative and positive control
performance.
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cobas® TV/MG
cobas® TV/MG for cobas® 5800 System Software

The results of the samples are shown in the cobas® 5800 software in the “Results” app. Display examples for cobas®
TV/MG for cobas® 5800 System Software Figure 3.
Figure 3 Example of cobas® TV/MG results display for cobas® 5800 System Software
Sample ID* Test Control results Flag** Result
TV/MG_01 TV/MG Valid TV Negative MG Negative
MG 01_ MG Valid MG Positive (Ct 36.52)
TV/MG_02 TV/MG Valid TV Invalid MG Invalid
TV 01 TV Valid TV Negative
TV/MG_03 TV/MG Valid TV Positive (Ct 35.44) MG positive (Ct 36.00)

* Table applies for all sample types used.
**The result overview shows a flag symbol in case of invalid results. Detailed flag descriptions are available in the result details.
Check each individual sample for flags in the cobas® 5800 System software and/or report. The result interpretation should
be as follows:
 Samples associated with valid controls are shown as ‘Valid’ in the “Control result” column.
 Samples associated with a failed control are shown as ‘Invalid’ in the “Control result” column.
 If the associated controls of a sample result are invalid, a specific flag will be added to the sample result as follows:
o Q05D : Result validation failure because of an invalid positive control
o Q06D :Result validation failure because of an invalid negative control
 The values in “Results” column for individual sample target result should be interpreted as show in Table 16,
Table 17 and Table 18 below.
 If one or more sample targets are marked with “Invalid” the cobas® 5800 software shows a flag in the “Flags”
column. More information on why the sample target(s) is reported invalid including flag information is shown in
the detail view.
 Invalid results for one or more target combinations are possible with the TV/MG result request and are reported
out specifically for each channel. Refer to retesting instructions for the respective specimen type.
 Results of this test should only be interpreted in conjunction with information available from clinical evaluation of
the patient and patient history.
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cobas® TV/MG for cobas® 6800/8800 Systems

Display examples for cobas® TV/MG for cobas® 6800/8800 Systems are shown in Figure 4, Figure 5, and Figure 6, respectively.
Figure 4 Example of cobas® TV/MG results display for TV/MG result request for cobas® 6800/8800 Systems
Test Sample ID Valid Flags Sample type Overall result Target 1 Target 2
TV/MG 400 µL PC_TVMGNeg_01 NA PreservCyt® NA TV Negative MG Negative
TV/MG 400 µL PC_TVMGInv_01 NA Y40T PreservCyt® NA Invalid Invalid
TV/MG 850 µL UR_TVMGNegPos_B1 NA Urine NA TV Negative MG Positive
TV/MG 850 µL UR_TVMGPos_B2 NA Urine NA TV Positive MG Positive
TV/MG 850 µL MS_TVMGNeg_01 NA Meatal Swab NA TV Negative MG Negative
TV/MG 850 µL MS_TVMGPosNeg_A6 NA Meatal Swab NA TV Positive MG Negative
TV/MG 400 µL SB_TVMGPosInv_01 NA C01H2 Swab NA TV Positive Invalid
TV/MG 400 µL SB_TVMGInvPos_A2 NA C01H1 Swab NA Invalid MG Positive
TV/MG C161420284090428828404 Yes (-) Ctrl Valid Valid Valid
TV/MG C161420284093009580264 Yes TV/MG (+) C Valid Valid Valid
Figure 5 Example of cobas® TV results display for TV result request for cobas® 6800/8800 Systems
TV 400 µL SB_TVInv_01 NA Y40T Swab NA Invalid
TV 400 µL SB_TVNeg_01 NA Swab NA TV Negative
TV 850 µL UR_TVPos_A5 NA Urine NA TV Positive
TV 850 µL UR_TVNeg_01 NA Urine NA TV Negative

®
TV 850 µL PC_TVPos_A3 NA PreservCyt NA TV Positive
®
TV 850 µL PC_TVNeg_01 NA PreservCyt NA TV Negative
TV 400 µL MS_TVInv_01 NA P02T Meatal Swab NA Invalid
TV 400 µL MS_TVNeg_01 NA Meatal Swab NA TV Negative
TV C161420284093009580263 Yes TV/MG (+) C Valid Valid
TV C161420284090428828403 Yes (-) Ctrl Valid Valid
Note: No results are shown under Target 2 because it is reserved for MG results.
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Figure 6 Example of cobas® MG results display for MG result request for cobas® 6800/8800 Systems
MG 850 µL UR_ MGVNeg_A1 NA Urine NA MG Negative
MG 850 µL UR_MGNeg_01 NA Urine NA MG Negative
MG 850 µL MS_MGInv_01 NA Y40T Meatal Swab NA Invalid
MG 850 µL MS_MGPos_A2 NA Meatal Swab NA MG Positive
MG 400 µL PC_MGPos_B1 NA PreservCyt® NA MG Positive
MG 400 µL PC_MGNeg_01 NA PreservCyt® NA MG Negative
MG 400 µL SB_MGPos_A7 NA Swab NA MG Positive
MG 400 µL SB_MGNeg_01 NA Swab NA MG Negative
MG C16142028409300950734 Yes TV/MG (+) C Valid Valid
MG C161420284090428828402 Yes (-) Ctrl Valid Valid
Note: No results are shown under Target 1 because it is reserved for TV results.
For a valid batch, check each individual sample for flags in the cobas® 6800/8800 software and/or report. The result
interpretation should be as follows:
● A valid batch may include both valid and invalid sample results.
● The “Valid” and “Overall Result” columns are not applicable (NA) to sample results for the cobas® TV/MG and
are marked with “NA”. Values reported in these columns are not applicable and do not impact the validity of
results reported within individual Target Result columns.
● Reported target results for individual samples are valid unless indicated as “Invalid” within the individual target
result column.
● Invalid results for one or more target combinations are possible with the TV/MG result request and are reported
out specifically for each channel. Refer to the retesting instructions for respective specimen type.
● Results of this test should only be interpreted in conjunction with information available from clinical evaluation of
the patient and patient history.
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cobas® TV/MG
Interpretation of results
Results and their corresponding interpretation for detecting TV and MG (Table 16), TV only (Table 17) and MG only
(Table 18) are shown below.
Table 16 cobas® TV/MG results and interpretation for the TV/MG result request
Result Interpretation
All requested results were valid.
TV Positive MG Positive
Target signal detected for TV and MG DNA.
TV Positive MG Negative
Target signal detected for TV DNA. No target signal detected for MG DNA.
TV Negative MG Positive
No target signal detected for TV DNA. Target signal detected for MG DNA.
TV Negative MG Negative
No target signal detected for TV or MG DNA.
Not all requested results were valid.
Target signal detected for TV DNA. TV result is valid.
TV Positive Invalid
MG result is invalid. Original specimen should be re-tested to obtain valid MG results. If
the result is still invalid, a new specimen should be obtained.
TV result is invalid. Original specimen should be re-tested to obtain valid TV results. If
Invalid MG Positive
Target signal detected for MG DNA. MG result is valid.
No target signal detected for TV DNA. TV result is valid.
TV Negative Invalid
MG result is invalid. Original specimen should be re-tested to obtain valid MG results. If
TV result is invalid. Original specimen should be re-tested to obtain valid TV results. If
Invalid MG Negative
No target signal detected for MG DNA. MG result is valid.
Both TV and MG results are invalid. Original specimen should be re-tested to obtain
Invalid Invalid valid TV and MG results. If the results are still invalid, a new specimen should be
obtained.
Table 17 cobas® TV/MG results and interpretation for the TV result request
The requested result was valid.
TV Positive
Target signal detected for TV DNA.
TV Negative
No target signal detected for TV DNA
TV result is invalid. Original specimen should be re-tested to obtain valid TV results. If the result is still invalid, a
Invalid
new specimen should be obtained.
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Table 18 cobas® TV/MG results and interpretation for the MG result request
MG Positive
Target signal detected for MG DNA.
MG Negative
No target signal detected for MG DNA
MG result is invalid. Original specimen should be re-tested to obtain valid MG results. If the result is still invalid, a
Invalid
new specimen should be obtained.
Procedural limitations
 cobas® TV/MG has been evaluated only for use in combination with the cobas® TV/MG Positive Control Kit,
cobas® Buffer Negative Control Kit, cobas omni MGP Reagent, cobas omni Lysis Reagent, cobas omni Specimen
Diluent, and cobas omni Wash Reagent for use on the cobas® 5800 System or cobas® 6800/8800 Systems.
 cobas® TV/MG has been validated for the detection of TV and MG DNA in male and female urine, self-collected
vaginal swab specimens (collected in a clinical setting), and clinician-collected vaginal swab specimens and
endocervical specimens. cobas® TV/MG has been validated for the detection of TV DNA from cervical specimens
collected in PreservCyt® Solution and for the detection of MG DNA from self-collected male meatal swab specimens
(collected in a clinical setting) and clinician-instructed self-collected meatal swab specimens. Assay performance
has not been established with other collection media and/or specimen types.
 Products containing carbomer(s), including vaginal lubricants, creams and gels may interfere with the test and should
not be used during or prior to collecting urogenital specimens. See Interference results (Table 26) for further details.
 False negative or invalid results may occur due to polymerase inhibition. The Internal Control is included in
cobas® TV/MG to help identify the specimens containing substances that may interfere with nucleic acid isolation
and PCR amplification.
 Detection of T. vaginalis and M. genitalium is dependent on the number of organisms present in the specimen and
may be affected by specimen collection methods, patient factors (i.e., age, history of STD, presence of symptoms),
stage of infection and/or infecting T. vaginalis and M. genitalium strains.
 Though rare, mutations within the highly conserved regions of the genomic DNA of T. vaginalis or the genomic
DNA of M. genitalium targeted by cobas® TV/MG primers and/or probes may result in failure to detect the
presence of these pathogens.
 Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to
the next, users perform method correlation studies in their laboratory to qualify technology differences.
100% agreement between the results should not be expected due to aforementioned differences between
technologies. Users should follow their own specific policies/procedures.
 cobas® TV/MG is not intended to replace other exams or tests for diagnosis of urogenital infection. Patients may
have cervicitis, urethritis, urinary tract infections, or vaginal infections due to other causes or concurrent
infections with other agents.
 cobas® TV/MG is not recommended for evaluation of suspected sexual abuse and for other medico-legal indications.
 cobas® TV/MG should not be used to determine therapeutic success as nucleic acids may be present after
antimicrobial therapy.
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 cobas® TV/MG for urine testing is recommended to be performed on first catch urine specimens (defined as the first
10 to 50 mL of the urine stream). The effects of other variables such as first-catch vs. mid-stream, post-douching, etc.
have not been evaluated.
 The effects of other potential variables such as vaginal discharge, use of tampons, douching, etc. and specimen
collection variables have not been evaluated.
 cobas® TV/MG has not been evaluated with patients who are currently on treatment with antimicrobial agents
active against TV or MG as well as patients with a history of hysterectomy.
 The addition of AmpErase enzyme into the cobas® TV/MG Master Mix reagent enables selective amplification of
target DNA; however, good laboratory practices and careful adherence to the procedures specified in this
Instructions For Use document are necessary to avoid contamination of reagents.
 cobas® TV/MG has not been evaluated in patients younger than 18 years of age.
 Trichomonas tenax, when present at concentrations greater than 1 x 104 CFU/mL, may interfere with the detection
of TV target.
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cobas® TV/MG
Non-clinical performance evaluation

Key performance characteristics performed on the cobas® 6800/8800 Systems
Analytical sensitivity (Limit of Detection)

The limit of detection of cobas® TV/MG was determined by analysis of serial dilutions of quantified cultures of two T. vaginalis
(RP - metronidazole susceptible and CDC085 - metronidazole resistant) and two M. genitalium (MG37 and M30) strains.
Panels of six to seven concentration levels with 60-72 replicates per specimen type and strain plus a blank were tested
over three unique lots of cobas® TV/MG test reagents, multiple runs, days, operators, and instruments. LoD for each
specimen type is shown in Table 19 as the target concentration which can be detected in ≥ 95% of the replicates for all lots.
Table 19 Analytical sensitivity (Limit of Detection)
T. T. M. M.
T. T. M. M.
vaginalis vaginalis genitalium genitalium
vaginalis vaginalis genitalium genitalium
CDC085 CDC085 MG37 MG37

Specimen Types RP strain RP strain M30 strain M30 strain
strain strain strain strain
LoD Mean Ct LoD Mean Ct

LoD Mean Ct LoD Mean Ct
(cells/mL) Value (copies/mL) Value
(cells/mL) Value (copies/mL) Value
Endocervical Swab in
cobas® PCR Media 0.2 36.3 0.2 35.6 2 35.3 2 36.5
Vaginal Swab in
cobas® PCR Media 0.3 35.5 0.075 36.3 4 34.5 4 35.3
Urine in cobas® PCR

Media 0.1 35.7 0.03 35.6 0.5 35.6 1 35.8
Meatal Swab in
cobas® PCR Media N/A* N/A* N/A* N/A* 0.5 36.0 0.5 36.6
Cervical Samples
collected into 0.1 36.8 0.05 36.6 N/A* N/A* N/A* N/A*
PreservCyt® Solution
*N/A = Not Applicable
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cobas® TV/MG
Inclusivity
Inclusivity of cobas® TV/MG was evaluated by testing eight TV and five MG laboratory strains using one lot of reagents.
Testing was performed using TV and MG cultures diluted into contrived negative matrix. Results are shown in Table 20
and Table 21 for TV and MG strains, respectively. Twenty-four replicates per dilution level were tested for each strain in
each matrix.
Table 20 LoD verification TV strains
Urine Urine PreservCyt® PreservCyt®

Swabs* Swabs*
Specimens Specimens Specimens Specimens
Strain
cells/mL % Pos
cells/mL % Pos cells/mL % Pos
C-1:NIH 0.24 100 0.07 100 0.11 100
123414 0.24 100 0.07 100 0.11 100
129155-8 0.24 100 0.07 100 0.11 100
CDC337 0.24 100 0.07 100 0.11 100
NYH 209 0.24 100 0.07 100 0.11 100
PRA-98 0.24 100 0.07 100 0.11 100
801805 0.24 100 0.07 100 0.11 100
BACT-053LR01 0.24 100 0.07 100 0.11 100
* Contrived vaginal swab matrix was used to represent vaginal and endocervical swab specimens.
Table 21 LoD verification MG strains
Urine Urine Meatal Swab Meatal Swab

Swabs* Swabs*
Specimens Specimens
Strain
copies/mL % Pos
copies/mL % Pos
copies/mL % Pos
SEA-1 5.0 100 0.8 95.8 0.5 100
M2288 5.0 100 0.8 100 0.5 100
M2300 5.0 100 0.8 100 0.5 83.3
M2321 5.0 100 1.6 100 1.0 87.5
M2341 5.0 100 0.8 95.8 0.5 95.8
* Contrived vaginal swab matrix was used to represent vaginal and endocervical swab specimens.
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Precision (within laboratory)

In-house precision was examined using a panel composed of TV and MG cultures diluted into pooled negative urine
stabilized in cobas® PCR Media, as well as in contrived matrices representing vaginal and meatal swab specimens collected
in cobas® PCR Media or in cervical specimens collected in PreservCyt® Solution.
The precision panel for each matrix was designed to include members without TV and/or MG as well as those with
high negative, low and moderate concentrations of TV and MG, corresponding to ~0.3x, ~1x and ~3x LoD. Testing was
performed using three lots of cobas® TV/MG reagents and two instruments over twelve days and with two runs per day for
a total of twenty-four runs. Each run consisted of three replicates of each sample. Description of the precision panels and
the observed positivity rates are shown in Table 22. All negative panel members tested negative throughout the study.
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Table 22 Summary of within laboratory precision

Swabs collected in cobas® PCR Media
95% 95%
95% 95%
Confidence Confidence
Interval Interval
N positive N positive Hit Rate Hit Rate Interval Interval
Level N Tested
TV MG TV MG MG MG
TV TV
Lower Upper
Lower Limit Upper Limit
Limit Limit
Negative 72 0 0 0.0% 0.0% 0.0% 5.0% 0.0% 5.0%
High Negative 72 48 61 66.7% 84.7% 54.6% 77.3% 74.3% 92.1%
Low 71 69 70 97.2% 98.6% 90.2% 99.7% 92.4% 100.0%
Moderate 72 72 72 100.0% 100.0% 95.0% 100.0% 95.0% 100.0%
®
Urine stabilized in cobas PCR Media
95% 95%
95% 95%
Interval Interval
Level N Tested
TV MG TV MG MG MG
TV TV
Lower Upper
Limit Limit
Negative 72 0 0 0.0% 0.0% 0.0% 5.0% 0.0% 5.0%
High Negative 72 44 53 61.1% 73.6% 48.9% 72.4% 61.9% 83.3%
Low 72 72 72 100.0% 100.0% 95.0% 100.0% 95.0% 100.0%
Moderate 72 72 72 100.0% 100.0% 95.0% 100.0% 95.0% 100.0%
Meatal Swab collected in cobas® PCR Media
95% 95%
95% 95%
Level N Tested Interval Interval
TV MG TV MG MG MG
TV TV
Lower Upper
Limit Limit
Negative 72 N/A* 0 N/A 0.0% N/A N/A 0.0% 5.0%
High Negative 72 N/A 41 N/A 56.9% N/A N/A 44.7% 68.6%
Low 72 N/A 69 N/A 95.8% N/A N/A 88.3% 99.1%
Moderate 72 N/A 72 N/A 100.0% N/A N/A 95.0% 100.0%
Cervical specimens collected in PreservCyt® Solution
95% 95%
95% 95%
Level N Tested Interval Interval
TV MG TV MG MG MG
TV TV
Lower Upper
Limit Limit
Negative 72 0 N/A 0.0% N/A 0.0% 5.0% N/A N/A
High Negative 72 39 N/A 54.2% N/A 42.0% 66.0% N/A N/A
Low 72 69 N/A 95.8% N/A 88.3% 99.1% N/A N/A
Moderate 72 72 N/A 100.0% N/A 95.0% 100.0% N/A N/A
*N/A = Not Applicable
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cobas® TV/MG
Analysis of standard deviation and percent coefficient of variation of the Ct values from valid tests performed on positive panel
members (see Table 23 and Table 24) yielded overall CV (%) ranges from 1.5% to 2.8% for TV and from 1.2% to 4.9% for MG.
Table 23 Overall mean, standard deviations and coefficients of variation (%) for cycle threshold, TV positive panels
Within Within Between Between Between Between Between Between Between Between
Hit Mean Total Total
Level run run run run day day instrument instrument lot lot
Rate Ct SD CV%
SD CV% SD CV% SD CV% SD CV% SD CV%
High
66.7% 37.6 0.98 2.6 0.0 0.0 0.0 0.0 0.26 0.7 0.22 0.7 1.04 2.8
Negative
Low 97.2% 36.5 0.62 1.7 0.22 0.6 0.00 0.0 0.60 1.6 0.19 0.5 0.91 2.5
Moderate 100.0% 35.5 0.38 1.1 0.05 0.2 0.03 0.1 0.74 2.1 0.15 0.4 0.85 2.4
®
Me Within Within Between Between Between Between Between Between Between Between
Hit Total Total
Level an run run run run day day instrument instrument lot lot
Rate SD CV%
Ct SD CV% SD CV% SD CV% SD CV% SD CV%
High
61.1% 37.7 0.86 2.3 0.00 0.0 0.25 0.7 0.00 0.0 0.10 0.3 0.90 2.4
Negative
Low 100.0% 36.7 0.62 1.7 0.31 0.8 0.18 0.5 0.11 0.3 0.16 0.4 0.74 2.0
Moderate 100.0% 35.6 0.36 1.0 0.09 0.3 0.14 0.4 0.33 0.9 0.11 0.3 0.53 1.5
®
Cervical specimens collected in PreservCyt Solution
Me Within Within Between Between Between Between Between Between Between Between
Hit Total Total
Level an run run run run day day instrument instrument lot lot
Rate SD CV%
Ct SD CV% SD CV% SD CV% SD CV% SD CV%
High
54.2% 37.6 0.65 1.7 0.30 0.8 0.29 0.8 0.42 1.1 0.00 0.0 0.87 2.3
Negative
Low 95.8% 36.7 0.69 1.9 0.28 0.8 0.00 0.0 0.50 1.4 0.06 0.2 0.90 2.4
Moderate 100.0% 35.6 0.64 1.8 0.15 0.4 0.00 0.0 0.64 1.8 0.00 0.0 0.92 2.6
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Table 24 Overall mean, standard deviations and coefficients of variation (%) for cycle threshold, MG positive panels
Level run run run run day day instrument instrument lot lot
Rate Ct SD CV%
High
84.7% 37.2 1.29 3.5 0.00 0.0 0.00 0.0 0.98 2.6 0.00 0.0 1.62 4.3
Negative
Low 98.6% 35.6 0.56 1.6 0.00 0.0 0.16 0.5 0.71 2.0 0.05 0.1 0.92 2.6
Moderate 100.0% 34.7 0.26 0.7 0.00 0.0 0.05 0.1 0.73 2.1 0.10 0.3 0.78 2.3
®
Level Run Run run run day day instrument instrument lot lot
Rate Ct SD CV%
High
73.6% 37.9 1.19 3.2 0.00 0.0 0.00 0.0 0.00 0.0 0.32 0.8 1.24 3.3
Negative
Low 100.0% 36.3 0.66 1.8 0.21 0.6 0.00 0.0 0.25 0.7 0.20 0.6 0.76 2.1
Moderate 100.0% 35.2 0.25 0.7 0.18 0.5 0.00 0.0 0.28 0.8 0.09 0.3 0.42 1.2
Meatal Swab collected in cobas® PCR Media
Level Run Run run run day day instrument instrument lot lot
Rate Ct SD CV%
High
56.9% 38.1 1.55 4.1 0.37 1.0 0.00 0.0 0.95 2.5 0.00 0.0 1.85 4.9
Negative
Low 95.8% 37.0 0.78 2.1 0.00 0.0 0.00 0.0 0.39 1.1 0.00 0.0 0.87 2.4
Moderate 100.0% 35.7 0.33 0.9 0.00 0.0 0.00 0.0 0.32 0.9 0.18 0.5 0.50 1.4
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Analytical specificity/cross reactivity

A panel of 102 bacteria, fungi and viruses, including those commonly found in the male and female urogenital tract, were
tested with cobas® TV/MG to assess analytical specificity. The organisms listed in Table 25 were spiked at concentrations of
approximately 1 x 106 units/mL for bacteria and approximately 1 x 105 units/mL for viruses into pooled negative urine
stabilized in cobas® PCR Media. Testing was performed with each potential interfering organism in absence and presence of
TV and MG target (spiked at approximately 3x LoD). Three replicates were tested for each organism in absence of target and
one in presence of target. None of the organisms tested interfered with the test performance by generating false positive
results for either TV or MG targets. Detection of MG target was not affected by any of the organisms tested. Trichomonas
tenax interfered with detection of TV target at concentration level of 1 x 106 CFU/mL, but did not interfere with detection of
TV target when tested at concentration level of 1 x 104 CFU/mL. Trichomonas tenax is a commensal of the oral cavity.
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Table 25 Microorganisms tested for analytical specificity/cross reactivity
Microorganism Microorganism Microorganism

Acholeplasma laidlawii Enterococcus avium Mycoplasma faucium
Acholeplasma oculi Enterococcus faecalis Mycoplasma fermentans
Achromobacter xerosis Enterococcus faecium Mycoplasma hominis
Acinetobacter lwoffii Erysipelothrix rhusiopathiae Mycoplasma orale
Actinomyces israelii Escherichia coli Mycoplasma penetrans
Aerococcus viridans Flavobacterium eningosepticum Mycoplasma pirum
Aeromonas hydrophila Fusobacterium nucleatum Mycoplasma pneumoniae
Alcaligenes faecalis Gardnerella vaginalis Mycoplasma primatum
Atopobium vaginae Gemella haemolysans Mycoplasma salivarium
Bacillus subtilis Giardia intestinalis Mycoplasma spermatophilum****
Bacteroides fragilis Haemophilus ducreyi Neisseria gonorrhoeae
Bacteroides ureolyticus Herpes Simplex Virus Type 1* Pentatrichomonas hominis
Bifidobacterium adolescentis Herpes Simplex Virus Type 2* Peptostreptococcus anaerobius
Branhamella catarrhalis Mycoplasma hominis Prevotella bivia
Brevibacterium linens Human Immunodeficiency Virus* Propionibacterium acnes
Campylobacter jejuni Human Papillomavirus type 16 Proteus mirabilis
Candida albicans Kingella denitrificans Providencia stuartii
Candida glabrata Klebsiella oxytoca Pseudomonas aeruginosa
Candida parapilosis Klebsiella pneumoniae Rahnella aquatilis
Candida tropicalis Lactobacillus acidophilus Rhizobium radiobacter
Chlamydia trachomatis Lactobacillus crispatus Rhodospirillum rubrum
Chromobacterium violaceum Lactobacillus jensenii Saccharomyces cerevisiae
Citrobacter braakii Lactobacillus vaginalis Salmonella minnesota
Clostrodium perfringens Leptotrichia buccalis Serratia marcescens
Clostridioides difficile** Leuconostoc mesenteroides Staphylococcus aureus
Corynebacterium genitalium Leuconostoc paramensenteroides Staphylococcus epidermidis
Corynebacterium xerosis Listeria monocytogenes Streptococcus agalactiae
Cryptococcus neoformans Micrococcus luteus Streptococcus pneumoniae
Cytomegalovirus Mobiluncus curtisii Streptococcus pyogenes
Derxia gummosa Moraxella osloensis Trichomonas tenax***
Dientamoeba fragilis Morexella catarrhalis Ureaplasma urealyticum****
Eikenella corrodens Morexella lacunata Veillonella parvula
Enterobacter aerogenes Morganella morganii Vibrio parahaemolyticus
Enterobacter cloacae Mycobacterium smegmatis Yersinia enterocolitica
Unless noted (below), bacteria and fungi were quantified as Colony Forming Units (CFU) and viruses were quantified as International Units (IU).
* Quantified in copies/mL
** Previously known as Clostridium difficile
*** Interference with TV detection observed when tested at 1 x106 CFU/mL. No interference with TV detection observed when tested at 1 x 104 CFU/mL.
****Quantified in color changing units (ccu)
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Interference
The effect of over-the-counter or prescription products that may be present in urogenital specimens (Table 26) were
evaluated. Possible interference from glacial acetic acid occasionally utilized in cytologic evaluation of cervical specimens was
also assessed. Testing was done using pooled negative clinical specimens in the presence of TV and MG (spiked at
approximately 3x LoD) and non-clinical/contrived matrices when testing in the absence of TV and MG. For each specimen
type, three replicates were tested for each substance in the presence of and one in the absence of target organisms.
Eighteen products (including glacial acetic acid) as listed in Table 26 did not interfere with cobas® TV/MG when tested at
concentrations of 1.0mg/mL or 1% v/v as applicable.
Table 26 List of products that do not interfere with test performance in urogenital specimens
Product Name Product Name Product Name

Clindamycin Phosphate Vaginal Cream Monistat® Complete Care Itch Relief Cream Yeast Guard Advanced
CVS tioconazole 1 (Equate tioconazole 1) Gyne-Lotrimin 7 Glacial acetic acid
Equate Vagicaine Anti-Itch Cream Norforms Suppositories Azo Standard
Estrace Premarin Arilin rapid vaginal suppositories
TM
K-Y UltraGel (Replaces KY Silk E) Summer's Eve Feminine Deodorant Spray Vagi Metro Cream
Monistat 3 Vaginal Antifungal Combination Pack Vaginal Contraceptive Foam Nidazea Gel
Only ReplensTM, RepHreshTM Clean Balance, and Metronidazole Vaginal Gel by Sandoz interfered with cobas® TV/MG by
producing false negative or invalid results at the concentrations above those stated in Table 27. These products contain
carbomer(s). Products containing carbomer(s) have been shown to generate false negative and invalid results. Table 26 is
not intended to be a comprehensive list of carbomer containing products. It should be noted that three other products
containing metronidazole (Arilin rapid vaginal suppositories, Vagi Metro Cream and Nidazea Gel), did not cause
interference (Table 27).
Table 27 List of products that interfere with test performance above the concentration stated
PreservCyt®
Swabs* Urine Specimens Meatal Swab
Product Name Specimens
mg/mL mg/mL mg/mL mg/mL
TM
Replens Long-Lasting Vaginal Moisturizer 1.0 0.5 0.3 2.0
RepHreshTM Clean Balance 2.0 1.0 0.5 2.0
Metronidazole Vaginal Gel by Sandoz 1.0 0.2 0.3 1.0
* Vaginal swab samples were used as a representative swab sample type for vaginal and endocervical swab specimens.
Endogenous substances that may be present in urogenital specimens were tested for interference. Testing was done using pooled
negative clinical specimens in the presence of TV and MG (spiked at approximately 3x LoD) and non-clinical/contrived
matrices when testing in the absence of TV and MG. At least twelve replicates were tested in total for each substance per
condition across specimen types where the endogenous substances are expected to be present.
None of the substances interfered with the test performance by generating false-negative or false-positive results. Levels of
endogenous substances tolerated by the assay for all specimen types are shown in Table 28.
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Table 28 Summary of endogenous substance concentrations that do not show interference
PreservCyt®
Interferent Swabs** Meatal Swab Urine
Specimens
Albumin (% w/v) N/A N/A N/A 0.5%
Bilirubin (% w/v) N/A N/A N/A 1.0%
Mucus* present present present present
Glucose (% w/v) N/A N/A N/A 1.0%
Peripheral Blood Mononuclear Cells 1.0E+06 cells/mL N/A 1.0E+06 cells/mL 1.0E+06 cells/mL
pH (acidic and alkaline) N/A N/A N/A pH 4 and pH 9
Semen*** 22 mg/mL 20 mg/mL 4 mg/mL 13 mg/mL
Whole Blood (% v/v) 10% N/A 10% 10%
* One mucus swab (endocervical cleaning swab) per replicate, reflecting a high level that could be found in a patient sample.
**Endocervical swab samples were used as a representative swab sample type for vaginal and endocervical swab specimens.
***Semen tested from swab dipped in fluid. Swab was weighed before and after to determine concentration.
Competitive inhibition
To assess competitive inhibition between TV and MG, samples of swabs, urine and PreservCyt® specimens were tested
with low and moderate concentrations of one target mixed with very high concentrations of the opposite target. Low and
moderate concentrations were defined as ~1x LoD and ~3x LoD, respectively, and high concentrations (≥ 105 cells/mL for
TV and ≥ 105 copies/mL for MG) were defined as those generating a signal greater than observed in 95% of target positive
clinical specimens.
Testing results indicated that when MG was present at a high concentration, TV was detected in all specimen types, at
both the low (~1x LoD) and moderate (~3x LoD) levels. Results also indicated that when TV was present at a high
concentration, MG was detected in all specimen types at both the low (~1x LoD) and moderate (~3x LoD) levels.
Cross contamination/Carryover
Studies were performed to evaluate potential cross-contamination on the cobas® 6800/8800 Systems using
cobas® TV/MG. Cross-contamination can cause false positive results. In this performance study the sample-to-sample
cross-contamination rate of cobas® TV/MG has been determined to be 0.7% (4/576, upper one-sided 95% CI of 1.6%) for
TV and 0.0% (0/480, upper one-sided 95% CI of 0.6%) for MG when alternating very high positive and negative samples
were tested over 11 runs for TV and 10 runs for MG. Run-to-run cross-contamination has not been observed (0/188).
Testing was done using samples prepared with cobas® PCR Media and with PreservCyt® Solution. High positive samples in
the study were prepared to generate a Ct value that exceeds 95% or more of signal obtained from specimens of infected
patients in the intended use population. Cross contamination rates in clinical settings depend on the proportion of high
positive samples and prevalence of the disease. Routine clinical cross-contamination rates need to be assessed in user settings.
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Clinical performance evaluation

Reproducibility study
A reproducibility study was performed across different sites, lots, days, operators/batches, for cobas® TV/MG using panels
prepared from vaginal swabs, meatal swabs, and urine in cobas® PCR Media and cervical specimens in PreservCyt®
Solution. Testing was performed at two external sites and one site that was in-house at Roche Molecular Systems. One
panel consisted of 4 sample matrices, with six concentrations per matrix, and three replicates per concentration for a total
of 72-samples in one panel. A batch was comprised of one 72-sample panel and two controls (one positive and negative
control). Two operators at each site tested one batch each per day. Two valid batches had to be completed within a
24-hour period. Each site received two of three reagent lots and performed 6 days of testing per reagent lot for a total of
12 days of testing.
Negative panels
For each sample type, the percent of correct results for all combined TV negative panel members (i.e., “Negative TV,
Negative MG” and “Negative TV, ~1.0x LoD MG”) ranged from 99.3% to 100% (432/432). All of the valid tests from each
of the urine and PreservCyt® sample types were negative and the percent of correct results was estimated at 100%
(432/432) with a corresponding 95% Clopper–Pearson exact CI of (99.1%, 100%). For vaginal swab, the percent of correct
results was estimated as 99.3% (429/432) with a corresponding 95% Clopper–Pearson exact CI of (98.0%, 99.9%) for TV.
For each sample type, the percent of correct results for all combined MG negative panel members (i.e., “Negative TV,
Negative MG” and “~1.0x LoD TV, Negative MG”) ranged from 99.8% to 100%. All of the valid tests from each of the
urine and vaginal swab sample types were negative and the percent of correct results was estimated at 100% (432/432) with
a corresponding 95% Clopper–Pearson exact CI of (99.1%, 100%). For meatal swab, the percent of correct results for MG
was estimated as 99.8% (431/432) with a corresponding 95% Clopper–Pearson exact CI of (98.7%, 100%).
Trichomonas vaginalis panels

For each positive panel member, precision was evaluated using a random effects model by sample type with terms for lot,
site, day, operator/batch within site, lot and day, and within-batch components by the corresponding analyte cycle
threshold (Ct) values of cobas® TV/MG. Table 29 presents the total SD, and total percent CV (%) from these analyses. The
range of the total CV, across the positive panel members, was from 1.2% to 2.7%. The maximum total CV was observed in
the PCR Media/Urine with the “~1.0x LoD TV, ~3.0x LoD MG” panel member and most of that variability (95.2% of the
total variance) was explained by random error (within-batch).
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Table 29 TV: mean estimate, attributable percentage of total variance, total precision standard deviation, and CV(%) of cobas® TV/MG cycle
threshold (Ct) values by TV positive panel member for each specimen type
Percentage Percentag
Percentage Percentage Percentag
of Total e of Total Total Total
of Total of Total e of Total
Variance Variance Precision Precision
Panel Mean Variance Variance Variance
Specimen Na [CV(%)] [CV(%)]
Member Estimateb [CV(%)] [CV(%)] [CV(%)]
Operator/ Within- SDb CV(%)c

Lot Site Day
Batch Batch
PCR ~0.3x LoD TV, 0.0% 6.5% 0.0% 17.6% 75.9%
121 38.1 0.79 2.1
Media/Urine ~0.3x LoD MG (0.0) (0.5) (0.0) (0.9) (1.8)
PCR ~1.0x LoD TV, 10.3% 3.6% 2.3% 3.6% 80.3%
216 36.7 0.69 1.9
Media/Urine Negative MG (0.6) (0.4) (0.3) (0.4) (1.7)
PCR ~3.0x LoD TV, 10.6% 2.4% 3.0% 2.9% 81.1%
216 35.7 0.48 1.3
PCR ~1.0x LoD TV, 0.0% 0.9% 0.0% 3.9% 95.2%
214 36.4 0.99 2.7
PCR Media/ ~0.3x LoD TV, 0.0% 0.0% 14.7% 0.0% 85.3%
103 37.7 0.77 2.0
Vaginal Swab ~0.3x LoD MG (0.0) (0.0) (0.8) (0.0) (1.9)
PCR Media/ ~1.0xLoD TV, 1.5% 1.4% 0.0% 14.5% 82.6%
215 36.0 0.59 1.6
Vaginal Swab Negative MG (0.2) (0.2) (0.0) (0.6) (1.5)
PCR Media/ ~3.0x LoD TV, 16.4% 2.7% 5.4% 0.0% 75.5%
216 35.0 0.40 1.2
PCR Media/ ~1.0x LoD TV, 0.6% 0.0% 2.1% 0.0% 97.3%
213 36.4 0.85 2.3
PreservCyt®/ ~0.3x LoD TV, 0.0% 0.4% 0.0% 0.0% 99.6%
79 37.7 0.86 2.3
Cervical ~0.3x LoD MG (0.0) (0.1) (0.0) (0.0) (2.3)
190 37.2 0.81 2.2
Cervical Negative MG (0.0) (0.2) (0.0) (0.6) (2.1)
215 35.5 0.45 1.3
Cervical ~1.0x LoD MG (0.2) (0.3) (0.1) (0.1) (1.2)
210 36.7 0.67 1.8
Cervical ~3.0x LoD MG (0.1) (0.4) (0.0) (0.0) (1.8)
Note: The table only includes results with detectable analyte.

CV(%) = Percent Coefficient of Variation; LoD = Limit of Detection; MG = Mycoplasma genitalium; SD = Standard Deviation;
TV = Trichomonas vaginalis.
a
Number of valid tests with a TV positive result that contributed a Ct value to the analysis. Because only TV positive test results were included,
estimates of SD (and CV%) may be underestimated.
b
Calculated using the total variability from the SAS MIXED procedure.
c
CV(%) = (standard deviation / mean) × 100%.
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The TV percent agreement and observed summary statistics are presented by lot, site, day and operator/batch in Table 30 to
Table 34, respectively for cobas® PCR Media/urine, cobas® PCR Media/vaginal swab, and PreservCyt®/cervical sample types.
Table 30 TV percent agreement by panel member for lot, site, day and operator/batch - cobas® PCR Media/urine
PCR PCR PCR PCR PCR PCR PCR PCR PCR PCR PCR PCR
Media/ Media/ Media/ Media/ Media/ Media/ Media/ Media/ Media/ Media/ Media/ Media/
Urine Urine Urine Urine Urine Urine Urine Urine Urine Urine Urine Urine
TV TV TV TV TV TV TV
Observed Observed Observed Observed Positive Positive Positive Positive Positive Positive Positive
- Descriptive Descriptive Descriptive Descriptive Percent Percent Percent Percent Percent Percent Percent
Statisticsa Statisticsa Statisticsa Statisticsa Agree- Agree- Agree- Agree- Agree- Agree- Agree-
mentb mentb mentb mentb mentb mentb mentb
Panel Ct Ct Ct Operator/
- Lot - Site - Day -
Member Mean SD CV(%) Batch
- 55.6% 51.4% 47.2% 56.5%
38.1 0.78 2.1 1 1 1 1
(40/72) (37/72) (17/36) (61/108)
55.6% 58.3% 52.8% 55.6%
- - - - 2 2 2 2
(40/72) (42/72) (19/36) (60/108)
- 56.9% 58.3% 50.0%
- - - 3 3 3 - -
(41/72) (42/72) (18/36)
- 58.3%
- - - - - - - 4 - -
(21/36)
- 61.1%
- - - - - - - 5 - -
(22/36)
- 66.7%
- - - - - - - 6 - -
(24/36)
~1.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
36.7 0.68 1.9 1 1 1 1
Negative MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
- - - 2 2 2 2
Negative MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, 100.0% 100.0% 100.0%
- - - 3 3 3 - -
Negative MG (72/72) (72/72) (36/36)
~1.0x LoD TV, 100.0%
- - - - - - - 4 - -
Negative MG (36/36)
~1.0x LoD TV, 100.0%
- - - - - - - 5 - -
Negative MG (36/36)
~1.0x LoD TV, 100.0%
- - - - - - - 6 - -
Negative MG (36/36)
~1.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
35.7 0.47 1.3 1 1 1 1
Negative MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
- - - 2 2 2 2
Negative MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, 100.0% 100.0% 100.0%
- - - 3 3 3 - -
Negative MG (72/72) (72/72) (36/36)
~1.0x LoD TV, 100.0%
- - - - - - - 4 - -
Negative MG (36/36)
~1.0x LoD TV, 100.0%
- - - - - - - 5 - -
Negative MG (36/36)
~3.0x LoD TV, 100.0%
- - - - - - - 6 - -
~1.0x LoD MG (36/36)
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TV TV TV TV TV TV TV
Observed Observed Observed Observed Positive Positive Positive Positive Positive Positive Positive
- Descriptive Descriptive Descriptive Descriptive Percent Percent Percent Percent Percent Percent Percent
Statisticsa Statisticsa Statisticsa Statisticsa Agree- Agree- Agree- Agree- Agree- Agree- Agree-
mentb mentb mentb mentb mentb mentb mentb
~1.0x LoD TV, 100.0% 98.6% 100.0% 98.1%
36.4 0.99 2.7 1 1 1 1
~3.0x LoD MG (72/72) (71/72) (36/36) (106/108)
~1.0x LoD TV, - - 98.6% 98.6% 97.2% 100.0%
- 2 2 2 2
~3.0x LoD MG (71/72) (71/72) (35/36) (108/108)
~1.0x LoD TV, - - - 98.6% 100.0% 97.2% - -
3 3 3
~3.0x LoD MG (71/72) (72/72) (35/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
4
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
5
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
6
~3.0x LoD MG (36/36)
Note: Ct = Cycle threshold; CV = Coefficient of Variation; LoD = Limit of Detection; MG = Mycoplasma genitalium; SD = Standard Deviation;
Note: CV(%) = (standard deviation / mean) × 100%. Because only TV positive test results were included in the Ct descriptive statistics calculations,
a
Calculated using the SAS MEANS procedure.
b
TV Positive Percent Agreement = (number of TV positive results / number of valid test results) × 100%.
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Table 31 TV: Percent agreement by panel member for lot, site, day and operator/batch- cobas® PCR Media/vaginal swab
Vaginal Vaginal Vaginal Vaginal Vaginal Vaginal Vaginal Vaginal Vaginal Vaginal Vaginal Vaginal
Swab Swab Swab Swab Swab Swab Swab Swab Swab Swab Swab Swab
TV TV TV TV TV TV TV TV
Observed Observed Observed Positive Positive Positive Positive Positive Positive Positive Positive
- Descriptive Descriptive Descriptive Percent Percent Percent Percent Percent Percent Percent Percent
Statisticsa Statisticsa Statisticsa Agree- Agree- Agree- Agree- Agree- Agree- Agree- Agree-
mentb mentb mentb mentb mentb mentb mentb mentb
~0.3x LoD TV, 48.6% 40.3% 52.8% 43.5%
37.7 0.77 2.0 1 1 1 1
~0.3x LoD MG (35/72) (29/72) (19/36) (47/108)
~0.3x LoD TV, - - - 40.3% 61.1% 52.8% 51.9%
2 2 2 2
~0.3x LoD MG (29/72) (44/72) (19/36) (56/108)
~0.3x LoD TV, - - - 54.2% 41.7% 38.9% - -
3 3 3
~0.3x LoD MG (39/72) (30/72) (14/36)
~0.3x LoD TV, - - - - - - - 50.0% - -
4
~0.3x LoD MG (18/36)
~0.3x LoD TV, - - - - - - - 36.1% - -
5
~0.3x LoD MG (13/36)
~0.3x LoD TV, - - - - - - - 55.6% - -
6
~0.3x LoD MG (20/36)
~1.0x LoD TV, 98.6% 100.0% 100.0% 100.0%
36.0 0.59 1.6 1 1 1 1
Negative MG (71/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, - - - 100.0% 98.6% 100.0% 99.1%
2 2 2 2
Negative MG (72/72) (71/72) (36/36) (107/108)
~1.0x LoD TV, - - - 100.0% 100.0% 97.2% - -
3 3 3
Negative MG (72/72) (72/72) (35/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
4
Negative MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
5
Negative MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
6
Negative MG (36/36)
~3.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
35.0 0.40 1.1 1 1 1 1
~1.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~3.0x LoD TV, - - - 100.0% 100.0% 100.0% 100.0%
2 2 2 2
~1.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~3.0x LoD TV, - - - 100.0% 100.0% 100.0% - -
3 3 3
~1.0x LoD MG (72/72) (72/72) (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
4
~1.0x LoD MG (36/36)
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~3.0x LoD TV, - - - - - - - 100.0% - -
5
~1.0x LoD MG (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
6
~1.0x LoD MG (36/36)
~1.0x LoD TV, 97.2% 100.0% 100.0% 98.1%
36.4 0.85 2.3 1 1 1 1
~3.0x LoD MG (70/72) (72/72) (36/36) (106/108)
~1.0x LoD TV, - - - 98.6% 97.2% 94.4% 99.1%
2 2 2 2
~3.0x LoD MG (71/72) (70/72) (34/36) (107/108)
~1.0x LoD TV, - - - 100.0% 98.6% 100.0% - -
3 3 3
~3.0x LoD MG (72/72) (71/72) (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
4
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
5
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 97.2% - -
6
~3.0x LoD MG (35/36)
a
b
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Table 32 TV: Percent agreement by panel member for lot, site, day and operator/batch- cobas® PCR Media/PreservCyt®
Preserv Preserv Preserv Preserv Preserv Preserv Preserv Preserv Preserv Preserv Preserv Preserv
Cyt®/ Cyt®/ Cyt®/ Cyt®/ Cyt®/ Cyt®/ Cyt®/ Cyt®/ Cyt®/ Cyt®/ Cyt®/ Cyt®/
Cervical Cervical Cervical Cervical Cervical Cervical Cervical Cervical Cervical Cervical Cervical Cervical
~0.3x LoD TV, 43.1% 31.0% 40.0% 41.5%
37.7 0.86 2.3 1 1 1 1
~0.3x LoD MG (31/72) (22/71) (14/35) (44/106)
~0.3x LoD TV, - - - 33.3% 36.6% 52.8% 32.4%
2 2 2 2
~0.3x LoD MG (24/72) (26/71) (19/36) (35/108)
~0.3x LoD TV, - - - 34.3% 43.1% 38.9% - -
3 3 3
~0.3x LoD MG (24/70) (31/72) (14/36)
~0.3x LoD TV, - - - - - - - 25.0% - -
4
~0.3x LoD MG (9/36)
~0.3x LoD TV, - - - - - - - 27.8% - -
5
~0.3x LoD MG (10/36)
~0.3x LoD TV, - - - - - - - 37.1% - -
6
~0.3x LoD MG (13/35)
~1.0x LoD TV, 91.7% 87.3% 88.9% 85.0%
37.2 0.81 2.2 1 1 1 1
Negative MG (66/72) (62/71) (32/36) (91/107)
~1.0x LoD TV, - - - 88.7% 87.5% 77.8% 91.7%
2 2 2 2
Negative MG (63/71) (63/72) (28/36) (99/108)
~1.0x LoD TV, - - - 84.7% 90.3% 85.7% - -
3 3 3
Negative MG (61/72) (65/72) (30/35)
~1.0x LoD TV, - - - - - - - 88.9% - -
4
Negative MG (32/36)
~1.0x LoD TV, - - - - - - - 91.7% - -
5
Negative MG (33/36)
~1.0x LoD TV, - - - - - - - 97.2% - -
6
Negative MG (35/36)
~3.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
35.5 0.45 1.3 1 1 1 1
~1.0x LoD MG (72/72) (71/71) (36/36) (108/108)
~3.0x LoD TV, - - - 100.0% 100.0% 100.0% 100.0%
2 2 2 2
~1.0x LoD MG (71/71) (72/72) (36/36) (107/107)
~3.0x LoD TV, - - - 100.0% 100.0% 100.0% - -
3 3 3
~1.0x LoD MG (72/72) (72/72) (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
4
~1.0x LoD MG (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
5
~1.0x LoD MG (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
6
~1.0x LoD MG (35/35)
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PreservCyt®/Cervical
Operator
Panel Ct Ct Ct
- Lot - Site - Day - /
Member Mean SD CV(%)
Batch
~1.0x LoD TV, 98.6% 97.2% 100.0% 99.1%
36.7 0.67 1.8 1 1 1 1
~3.0x LoD MG (71/72) (70/72) (36/36) (107/108)
~1.0x LoD TV, - - - 95.8% 97.2% 94.4% 95.4%
2 2 2 2
~3.0x LoD MG (69/72) (70/72) (34/36) (103/108)
~1.0x LoD TV, - - - 97.2% 97.2% 94.4% - -
3 3 3
~3.0x LoD MG (70/72) (70/72) (34/36)
~1.0x LoD TV, - - - - - - - 97.2% - -
4
~3.0x LoD MG (35/36)
~1.0x LoD TV, - - - - - - - 97.2% - -
5
~3.0x LoD MG (35/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
6
~3.0x LoD MG (36/36)
Note: Ct = Cycle threshold; CV = Coefficient of Variation; LoD = Limit of Detection; MG = Mycoplasma genitalium;
SD = Standard Deviation; TV = Trichomonas vaginalis.
a
b
Mycoplasma genitalium panels

For each positive panel member, precision was evaluated using a random effects model by sample type with terms for lot,
site, day, operator/batch within site, lot and day, and within-batch components on the corresponding analyte cycle
threshold (Ct) values of cobas® TV/MG. Table 33 presents the total SD and total CV (%) from these analyses. The range of
the total coefficient of variation, among positive panel members, was from 0.8% to 4.0%. The higher total coefficient of
variation was observed in the lowest concentration of positive panel members (~0.3x LoD TV, ~0.3x LoD MG) for all
sample types and most of that variability (75.8% for PCR Media/urine, 100% for PCR Media/vaginal swab and 83.7% for
PCR Media/vaginal swab) was explained by random error (within-batch).
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Table 33 MG: attributable percentage of total variance, total precision standard deviation, and CV(%) of cobas® TV/MG cycle threshold (Ct)
values by MG positive panel member for each media type
Percentage Percentage
Percentage Percentage Percentage
of Total of Total of Total Total Total
of Total of Total
Media Panel Mean Variance Variance Variance Precision Precision
Na Variance Variance
Type Member Estimateb [CV(%)] [CV(%)] [CV(%)]
[CV(%)] [CV(%)]
SDb CV(%)c
Operator/ Within-
Lot Site Day
Batch Batch
PCR ~0.3x LoD TV, 2.4% 0.0% 7.7% 14.1% 75.8%
154 38.1 1.01 2.6
PCR Negative TV, 10.2% 0.0% 0.0% 5.7% 84.1%
216 36.5 0.54 1.5
PCR ~3.0x LoD TV, 3.9% 2.8% 9.4% 0.0% 83.9%
214 36.3 0.69 1.9
PCR ~1.0x LoD TV, 7.7% 15.3% 10.2% 20.1% 46.7%
216 29.7 0.26 0.9
PCR Media/
~0.3x LoD TV, 0.0% 0.0% 0.0% 0.0% 100.0%
Vaginal 107 37.9 1.50 4.0
~0.3x LoD MG (0.0) (0.0) (0.0) (0.0) (4.0)
Swab
PCR Media/
Negative TV, 0.0% 0.0% 0.0% 0.0% 100.0%
Vaginal 214 35.7 0.84 2.3
~1.0x LoD MG (0.0) (0.0) (0.0) (0.0) (2.3)
Swab
PCR Media/
~3.0x LoD TV, 4.7% 2.6% 0.0% 0.4% 92.3%
Vaginal 216 35.2 0.42 1.2
~1.0x LoD MG (0.3) (0.2) (0.0) (0.1) (1.1)
Swab
PCR Media/
~1.0x LoD TV, 5.6% 17.2% 0.0% 0.0% 77.2%
Vaginal 216 34.4 0.29 0.8
~3.0x LoD MG (0.2) (0.3) (0.0) (0.0) (0.7)
Swab
PCR Media/
~0.3x LoD TV, 0.0% 0.0% 0.0% 16.3% 83.7%
Meatal 115 38.2 1.09 2.8
~0.3x LoD MG (0.0) (0.0) (0.0) (1.1) (2.6)
Swab
PCR Media/
Negative TV, 11.7% 5.3% 7.6% 0.0% 75.4%
Meatal 216 35.9 0.42 1.2
~1.0x LoD MG (0.4) (0.3) (0.3) (0.0) (1.0)
Swab
PCR Media/
~3.0x LoD TV, 0.0% 0.0% 0.0% 0.0% 100.0%
Meatal 215 36.7 0.81 2.2
~1.0x LoD MG (0.0) (0.0) (0.0) (0.0) (2.2)
Swab
PCR Media/
~1.0x LoD TV, 16.3% 1.0% 0.0% 2.0% 80.7%
Meatal 216 35.8 0.40 1.1
~3.0x LoD MG (0.4) (0.1) (0.0) (0.2) (1.0)
Swab
Note: The table only includes results with detectable analyte.
CV(%) = Percent Coefficient of Variation; LoD = Limit of Detection; MG = Mycoplasma genitalium; SD = Standard Deviation;
a
Number of valid tests with a MG positive result that contributed a Ct value to the analysis. Because only MG positive test results were included,
b
Calculated using the total variability from the SAS MIXED procedure.
c
CV(%) = (standard deviation / mean) × 100%.
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The MG positive percent agreement and observed summary statistics (mean, SD, CV (%)cycle threshold (Ct) value for
MG target) are presented by lot, site, day and operator/batch in Table 34 to Table 36, respectively for cobas® PCR
Media/urine, cobas® PCR Media/vaginal swab and cobas® PCR Media/meatal swab.
Table 34 MG: Percent agreement by panel member for lot, site, day and operator/batch- cobas® PCR Media/urine
MG MG MG MG MG MG MG MG
~0.3x LoD TV, 75.0% 70.8% 63.9% 74.1%
38.1 1.01 2.6 1 1 1 1
~0.3x LoD MG (54/72) (51/72) (23/36) (80/108)
~0.3x LoD TV, - - - 68.1% 75.0% 83.3% 68.5%
2 2 2 2
~0.3x LoD MG (49/72) (54/72) (30/36) (74/108)
~0.3x LoD TV, - - - 70.8% 68.1% 80.6% - -
3 3 3
~0.3x LoD MG (51/72) (49/72) (29/36)
~0.3x LoD TV, - - - - - - - 72.2% - -
4
~0.3x LoD MG (26/36)
~0.3x LoD TV, - - - - - - - 63.9% - -
5
~0.3x LoD MG (23/36)
~0.3x LoD TV, - - - - - - - 63.9% - -
6
~0.3x LoD MG (23/36)
Negative TV, 100.0% 100.0% 100.0% 100.0%
36.5 0.53 1.4 1 1 1 1
~1.0x LoD MG (72/72) (72/72) (36/36) (108/108)
Negative TV, - - - 100.0% 100.0% 100.0% 100.0%
2 2 2 2
~1.0x LoD MG (72/72) (72/72) (36/36) (108/108)
Negative TV, - - - 100.0% 100.0% 100.0% - -
3 3 3
~1.0x LoD MG (72/72) (72/72) (36/36)
Negative TV, - - - - - - - 100.0% - -
4
~1.0x LoD MG (36/36)
Negative TV, - - - - - - - 100.0% - -
5
~1.0x LoD MG (36/36)
Negative TV, - - - - - - - 100.0% - -
6
~1.0x LoD MG (36/36)
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~3.0x LoD TV, 98.6% 100.0% 100.0% 99.1%
36.3 0.68 1.9 1 1 1 1
~1.0x LoD MG (71/72) (72/72) (36/36) (107/108)
~3.0x LoD TV, - - - 100.0% 97.2% 100.0% 99.1%
2 2 2 2
~1.0x LoD MG (72/72) (70/72) (36/36) (107/108)
~3.0x LoD TV, - - - 98.6% 100.0% 97.2% - -
3 3 3
~1.0x LoD MG (71/72) (72/72) (35/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
4
~1.0x LoD MG (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
5
~1.0x LoD MG (36/36)
~3.0x LoD TV, - - - - - - - 97.2% - -
6
~1.0x LoD MG (35/36)
~1.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
29.7 0.26 0.9 1 1 1 1
~3.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, - - - 100.0% 100.0% 100.0% 100.0%
2 2 2 2
~3.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, - - - 100.0% 100.0% 100.0% - -
3 3 3
~3.0x LoD MG (72/72) (72/72) (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
4
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
5
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
6
~3.0x LoD MG (36/36)
Note: Ct = Cycle threshold; CV = Coefficient of Variation; LoD = Limit of Detection; MG = Mycoplasma genitalium;
SD = Standard Deviation; TV = Trichomonas vaginalis.
Note: CV(%) = (standard deviation / mean) × 100%. Because only MG positive test results were included in the Ct descriptive statistics calculations,
a
b
MG Positive Percent Agreement = (number of MG positive results / number of valid test results) × 100%.
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Table 35 MG: Percent agreement by panel member for lot, site, day and operator/batch- cobas® PCR Media/vaginal swab
~0.3x LoD TV, 37.5% 58.3% 44.4% 50.0%
37.9 1.50 4.0 1 1 1 1
~0.3x LoD MG (27/72) (42/72) (16/36) (54/108)
~0.3x LoD TV, - - - 56.9% 51.4% 63.9% 49.1%
2 2 2 2
~0.3x LoD MG (41/72) (37/72) (23/36) (53/108)
~0.3x LoD TV, - - - 54.2% 38.9% 38.9% - -
3 3 3
~0.3x LoD MG (39/72) (28/72) (14/36)
~0.3x LoD TV, - - - - - - - 52.8% - -
4
~0.3x LoD MG (19/36)
~0.3x LoD TV, - - - - - - - 52.8% - -
5
~0.3x LoD MG (19/36)
~0.3x LoD TV, - - - - - - - 44.4% - -
6
~0.3x LoD MG (16/36)
Negative TV, 97.2% 100.0% 100.0% 98.1%
35.7 0.84 2.3 1 1 1 1
~1.0x LoD MG (70/72) (72/72) (36/36) (106/108)
Negative TV, - - - 100.0% 100.0% 100.0% 100.0%
2 2 2 2
~1.0x LoD MG (72/72) (72/72) (36/36) (108/108)
Negative TV, - - - 100.0% 97.2% 100.0% - -
3 3 3
~1.0x LoD MG (72/72) (70/72) (36/36)
Negative TV, - - - - - - - 97.2% - -
4
~1.0x LoD MG (35/36)
Negative TV, - - - - - - - 100.0% - -
5
~1.0x LoD MG (36/36)
Negative TV, - - - - - - - 97.2% - -
6
~1.0x LoD MG (35/36)
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~3.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
35.2 0.42 1.2 1 1 1 1
~1.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~3.0x LoD TV, - - - 100.0% 100.0% 100.0% 100.0%
2 2 2 2
~1.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~3.0x LoD TV, - - - 100.0% 100.0% 100.0% - -
3 3 3
~1.0x LoD MG (72/72) (72/72) (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
4
~1.0x LoD MG (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
5
~1.0x LoD MG (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
6
~1.0x LoD MG (36/36)
~1.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
34.4 0.29 0.8 1 1 1 1
~3.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, - - - 100.0% 100.0% 100.0% 100.0%
2 2 2 2
~3.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, - - - 100.0% 100.0% 100.0% - -
3 3 3
~3.0x LoD MG (72/72) (72/72) (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
4
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
5
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
6
~3.0x LoD MG (36/36)
a
b
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Table 36 MG: Percent agreement by panel member for lot, site, day and operator/batch - cobas® PCR Media/meatal swab
Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal
~0.3x LoD TV, 48.6% 52.9% 69.4% 60.4%
38.2 1.09 2.8 1 1 1 1
~0.3x LoD MG (35/72) (37/70) (25/36) (64/106)
~0.3x LoD TV, - - - 59.7% 55.6% 50.0% 47.2%
2 2 2 2
~0.3x LoD MG (43/72) (40/72) (18/36) (51/108)
~0.3x LoD TV, - - - 52.9% 52.8% 38.9% - -
3 3 3
~0.3x LoD MG (37/70) (38/72) (14/36)
~0.3x LoD TV, - - - - - - - 52.8% - -
4
~0.3x LoD MG (19/36)
~0.3x LoD TV, - - - - - - - 57.1% - -
5
~0.3x LoD MG (20/35)
~0.3x LoD TV, - - - - - - - 54.3% - -
6
~0.3x LoD MG (19/35)
Negative TV, 100.0% 100.0% 100.0% 100.0%
35.9 0.41 1.2 1 1 1 1
~1.0x LoD MG (72/72) (72/72) (36/36) (108/108)
Negative TV, - - - 100.0% 100.0% 100.0% 100.0%
2 2 2 2
~1.0x LoD MG (72/72) (72/72) (36/36) (108/108)
Negative TV, - - - 100.0% 100.0% 100.0% - -
3 3 3
~1.0x LoD MG (72/72) (72/72) (36/36)
Negative TV, - - - - - - - 100.0% - -
4
~1.0x LoD MG (36/36)
Negative TV, - - - - - - - 100.0% - -
5
~1.0x LoD MG (36/36)
Negative TV, - - - - - - - 100.0% - -
6
~1.0x LoD MG (36/36)
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Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal Meatal
~3.0x LoD TV, 100.0% 98.6% 100.0% 100.0%
36.7 0.81 2.2 1 1 1 1
~1.0x LoD MG (72/72) (71/72) (36/36) (108/108)
~3.0x LoD TV, - - - 100.0% 100.0% 100.0% 99.1%
2 2 2 2
~1.0x LoD MG (72/72) (72/72) (36/36) (107/108)
~3.0x LoD TV, - - - 98.6% 100.0% 100.0% - -
3 3 3
~1.0x LoD MG (71/72) (72/72) (36/36)
~3.0x LoD TV, - - - - - - - 97.2% - -
4
~1.0x LoD MG (35/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
5
~1.0x LoD MG (36/36)
~3.0x LoD TV, - - - - - - - 100.0% - -
6
~1.0x LoD MG (36/36)
~1.0x LoD TV, 100.0% 100.0% 100.0% 100.0%
35.8 0.39 1.1 1 1 1 1
~3.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, - - - 100.0% 100.0% 100.0% 100.0%
2 2 2 2
~3.0x LoD MG (72/72) (72/72) (36/36) (108/108)
~1.0x LoD TV, - - - 100.0% 100.0% 100.0% - -
3 3 3
~3.0x LoD MG (72/72) (72/72) (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
4
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
5
~3.0x LoD MG (36/36)
~1.0x LoD TV, - - - - - - - 100.0% - -
6
~3.0x LoD MG (36/36)
a
b
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Percentage agreement
Table 37 shows the percent agreement for each target (TV and MG) with the associated 95% Exact CI.
Table 37 Percent agreement for positive panel members with concentration at or near 1x or 3x the limit of detection
- - TV TV MG MG
95% Exact
95% Exact
Media Panel Percent Percent CI of
CI of Percent
Type Member Agreement Agreement Percent
Agreement
Agreement
PCR ~1.0x LoD TV,
100.0 (216/216) (98.3, 100.0) Not Applicable Not Applicable
Media/Urine Negative MG
PCR Negative TV,
Not Applicable Not Applicable 100.0 (216/216) (98.3, 100.0)
Media/Urine ~1.0x LoD MG
PCR ~3.0x LoD TV,
100.0 (216/216) (98.3, 100.0) 99.1 (214/216) (96.7, 99.9)
PCR ~1.0x LoD TV,
99.1 (214/216) (96.7, 99.9) 100.0 (216/216) (98.3, 100.0)
PCR Media/ ~1.0x LoD TV,
Vaginal Swab 99.5 (215/216) (97.4, 100.0) Not Applicable Not Applicable
Negative MG
PCR Media/ Negative TV,
Not Applicable Not Applicable 99.1 (214/216) (96.7, 99.9)
Vaginal Swab ~1.0x LoD MG
100.0 (216/216) (98.3, 100.0) 100.0 (216/216) (98.3, 100.0)
98.6 (213/216) (96.0, 99.7) 100.0 (216/216) (98.3, 100.0)
Meatal Swab Not Applicable Not Applicable
Negative MG
PCR Media/ Negative TV,
100.0 (216/216) (98.3, 100.0)
Meatal Swab ~1.0x LoD MG
99.5 (215/216) (97.4, 100.0)
100.0 (216/216) (98.3, 100.0)
PreservCyt®/ ~1.0x LoD TV,
88.4 (190/215) (83.3, 92.3)
Cervical Negative MG
PreservCyt®/ Negative TV,
Not Applicable Not Applicable
Cervical ~1.0x LoD MG
100.0 (215/215) (98.3, 100.0)
97.2 (210/216) (94.1, 99.0)
Note: CI = Confidence Interval; LoD= Limit of Detection; MG = Mycoplasma genitalium; TV = Trichomonas vaginalis.
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Clinical study
The clinical performance of cobas® TV/MG was established in a multi-site, prospective study by comparing the results to a
Patient Infected Status (PIS) that used a combination of FDA-cleared TV NAATs, TV culture, and 3 laboratory developed
MG NAATs. Female and male urogenital specimens were collected from subjects enrolled at 10 geographically diverse
sites in the US with testing performed at 6 laboratory testing sites (5 external and 1 internal).
Female subjects provided the following urogenital specimens: first-void urine, 1 self-collected and 4 clinician-collected
vaginal swab specimens (self-collection arm of the study), or 5 clinician-collected vaginal swab specimens (clinician-
collected arm of the study), a clinician-collected endocervical swab in cobas® PCR Media, and a cervical specimen in
PreservCyt® Solution obtained with a spatula/cytobrush broom. If the female subject was in the self-collected arm of the
study, then 1 vaginal swab was self-collected first and placed in cobas® PCR Media and then followed by 4 clinician-collected
vaginal swabs transferred to the respective transport media collection devices. If the female subject was in the clinician-
collected arm of the study, then 5 clinician-collected vaginal swabs were transferred to the respective transport media
collection devices.
Male subjects provided the following urogenital specimens: 1 self-collected penile meatal swab (self-collection arm of the
study) and urine, or 1 clinician-collected penile meatal swab (clinician-collected arm of the study) and urine. Each meatal
swab was placed in cobas® PCR Media. Urine collected from each subject was placed in cobas® PCR Media and the
respective transport media collection devices.
Subjects were classified as symptomatic if they self-reported symptoms or based on the discretion of the examining
clinician were determined to have symptoms indicative of a TV or MG infection as listed below:
 Dysuria (pain and/or discomfort during urination)
 Coital pain, difficulty or bleeding
 Pelvic pain
 Any abnormal vaginal discharge
 Unusual vaginal odor
 Pelvic, uterine or ovarian pain
 Penile discharge
 Testicular pain
 Scrotal pain or swelling, itching, burning, redness, or soreness of genitals
Subjects were classified as asymptomatic based on the absence of symptoms.
Specimens were tested for TV and MG using cobas® TV/MG and the TV or MG assays determining the PIS. All tests were
run according to the respective manufacturers Instructions for Use or as per the laboratory developed MG NAAT SOPs.
The clinical performance of cobas® TV/MG was evaluated by comparing the results from collected specimen types to a
pre-specified PIS algorithm as determined by the combination of 2 commercially available tests (NAAT and culture) for
TV and 3 laboratory developed NAATs for MG. The PIS algorithms were derived from the results of testing vaginal swabs
in women and the results of testing urine in men for the determination of TV PIS and MG PIS respectively as shown in
Table 38 and Table 39.
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Table 38 Determination of TV PIS as derived from vaginal swabs for women and male urine
Culture FDA-Cleared NAAT Patient Infection Status (PIS)
+ + / - / Invalid Infected
+ / - / Invalid + Infected
- - Non-Infected
- Invalid Indeterminate
Invalid - Indeterminate
Invalid Invalid Indeterminate
Table 39 Determination of MG PIS as derived from vaginal swabs for women and male urine
Lab developed NAAT2 Lab developed NAAT3 Lab developed NAAT3 Lab developed NAAT3
+ - Invalid
Lab developed
+ + Infected Infected Infected
NAAT1
Lab developed + - Infected Non-infected Indeterminate
NAAT1
Lab developed + Invalid Infected Indeterminate Indeterminate
NAAT1
Lab developed
- + Infected Non-infected Indeterminate
NAAT1
Lab developed - - Non-infected Non-infected Non-infected
NAAT1
Lab developed - Invalid Indeterminate Non-infected Indeterminate
NAAT1
Lab developed
Invalid + Infected Indeterminate Indeterminate
NAAT1
Lab developed Invalid - Indeterminate Non-infected Indeterminate
NAAT1
Lab developed Invalid Invalid Indeterminate Indeterminate Indeterminate
NAAT1
Sensitivity (SENS), specificity (SPEC), positive predictive value (PPV), and negative predictive value (NPV) of cobas®
TV/MG were calculated separately for the detection of TV or MG using the PIS as the composite reference standard and
evaluated by gender, specimen type, and symptom status.
Results
A total of 2,194 subjects were enrolled and across all specimen types, 6807 samples were tested on cobas® TV/MG, of
which 12 samples had invalid results for TV and/or MG in the first run, hence an invalid rate of 0.18% (12/6807) with 95%
Score CI of (0.10%, 0.31%)). Upon repeat testing of the 12 samples, 5 yielded valid results and 7 yielded invalid results.
From the total of 2,194 subjects enrolled, 2,154 were considered evaluable (1,108 females and 1,046 males) for TV and/or
MG analyses. The 2,154 evaluable subjects contributed a total of 5,285 TV and 5,382 MG results across all specimen types.
TV clinical performance
Table 40 and Table 41 summarize the results by gender from symptomatic and asymptomatic subjects designated as
Infected or Non-Infected with TV according to the PIS algorithm. A total of 171 females and 23 males were infected with
valid TV result. Symptoms were reported in 67% (116/171) of infected and 56% (509/909) of non-infected females.
Symptoms were reported in 56.5% (13/23) of infected and 31% (302/960) of non-infected males.
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Table 40 TV positive/negative analyses for female PIS
cobas® cobas® cobas® cobas® Symptom Symptom

NAAT Culture TV/MG TV/MG TV/MG TV/MG Status Status
VS-C/
Patient Infected Status VS VS UR VS-S PC ES Symp Asymp Total
Infected + N/A + + + - 1 0 1
Infected + N/A + + + + 4 6 10
Infected + - - - - - 0 1 1
Infected + - + + - - 1 0 1
Infected + - + + + - 1 0 1
Infected + - + + - + 3 1 4
Infected + - + + + + 8 2 10
Infected + + - + - + 1 0 1
Infected + + - + + + 2 0 2
Infected + + + + + Failed 1 0 1
Infected + + + + Failed + 1 0 1
Infected + + + + - + 2 0 2
Infected + + + + + + 91 45 136
Total Infected 116 55 171
Non-Infected - - N/A - - - 1 0 1
Non-Infected - - Invalid - - - 2 0 2
Non-Infected - - - N/A - N/A 1 0 1
Non-Infected - - - Failed - N/A 1 0 1
Non-Infected - - - - - N/A 0 1 1
Non-Infected - - - - + N/A 1 0 1
Non-Infected - - - - N/A - 1 3 4
Non-Infected - - - Invalid - - 0 1 1
Non-Infected - - - - - - 476 368 844
Non-Infected - - - + - - 12 10 22
Non-Infected - - - - + - 1 2 3
Non-Infected - - - + + - 1 0 1
Non-Infected - - - - - + 5 6 11
Non-Infected - - - + - + 1 0 1
Non-Infected - - - - + + 0 1 1
Non-Infected - - - + + + 0 2 2
Non-Infected - - + - - - 5 3 8
Non-Infected - - + + + - 1 1 2
Non-Infected - - + - - + 0 1 1
Non-Infected - - + + - + 0 1 1
Total Non-Infected 509 400 909
Note: Asymp = asymptomatic; Symp = symptomatic.
Note: Any positive result in vaginal swab specimen from females determines the PIS as ‘Infected’. When both results are negative, the PIS is defined as
‘Non-Infected’. Any subject with an invalid test result with either test must still have a positive test result
for the remaining comparator test to be interpreted as PIS ‘Infected’. If the remaining valid test is negative, in conjunction with an invalid
test result, then the PIS is considered ‘Indeterminate’.
Note: Subjects with a designated patient infection status (Infected or Non-Infected) and a valid test result with cobas® TV/MG for TV are
considered evaluable and included in this summary table.
Note: + denotes Positive, - denotes Negative, N/A = data not available.
Note: VS = vaginal swab; VS-C = clinician-collected vaginal swab; VS-S = self-collected vaginal swab; UR = urine; PC = PreservCyt®;
ES = endocervical swab.
Note: NAAT = nucleic acid amplification test; TV = Trichomonas vaginalis; MG = Mycoplasma genitalium.
Note: “Invalid” is a sample that either had an instrument amplification/detection error or whose result was excluded due to a protocol deviation.
Note: “Failed” is a sample that had an instrument processing error.
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Table 41 TV positive/negative analyses for male PIS
cobas® Symptom Symptom

NAAT Culture TV/MG Status Status
Patient
Infected
Status UR UR UR Symp Asymp Total
Infected + N/A + 0 1 1
Infected + - + 3 3 6
Infected + + + 10 6 16
Non-Infected - - - 297 648 945
Non-Infected - - + 5 10 15
Note: Any positive result in urine specimen from males determines the PIS as ‘Infected’. When both results are negative, the PIS is defined as ‘Non-
Infected’. Any subject with an invalid test result with either test must still have a positive test result for the remaining comparator
test to be interpreted as PIS ‘Infected’. If the remaining valid test is negative, in conjunction with an invalid test result, then the PIS is
considered ‘Indeterminate’.
Note: Subjects with a designated patient infection status (Infected or Non-Infected) and a valid test result with cobas® TV/MG for TV are
Note: UR = urine.
Note: MG = Mycoplasma genitalium, NAAT = nucleic acid amplification test, TV = Trichomonas vaginalis.
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Sensitivity, specificity, and predictive values of cobas® TV/MG for TV as defined by PIS are presented by gender,
specimen type, and symptom status in Table 42.
Table 42 TV clinical performance compared with PIS by gender, specimen type, and symptom status
Sample Symptom Total PREV PPV NPV
SENS 95% Score CI SPEC 95% Score CI
Typea Statusb (n) (%) (%) (%)
Female Female Female Female Female Female Female Female Female Female
97.4% 98.8%
UR Symp 622 (92.7%, 99.1%) (97.4%, 99.5%) 18.6 95.0 99.4
(113/116) (500/506)
UR 98.2% 98.5%
Asymp 455 (90.4%, 99.7%) (96.8%, 99.3%) 12.1 90.0 99.7
(54/55) (394/400)
UR 97.7% 98.7%
Overall 1077 (94.1%, 99.1%) (97.7%, 99.2%) 15.9 93.3 99.6
(167/171) (894/906)
VS-C/ 100.0% 97.0%
Symp 623 (96.8%, 100.0%) (95.2%, 98.2%) 18.6 88.5 100.0
VS-S (116/116) (492/507)
VS-C/ 98.2% 96.5%
Asymp 454 (90.4%, 99.7%) (94.2%, 97.9%) 12.1 79.4 99.7
VS-S (54/55) (385/399)
VS-C/ 99.4% 96.8%
Overall 1077 (96.8%, 99.9%) (95.4%, 97.8%) 15.9 85.4 99.9
VS-S (170/171) (877/906)
93.9% 99.2%
PC Symp 622 (88.0%, 97.0%) (98.0%, 99.7%) 18.5 96.4 98.6
(108/115) (503/507)
PC 96.4% 98.5%
Asymp 452 (87.7%, 99.0%) (96.7%, 99.3%) 12.2 89.8 99.5
(53/55) (391/397)
PC 94.7% 98.9%
Overall 1074 (90.2%, 97.2%) (98.0%, 99.4%) 15.8 94.2 99.0
(161/170) (894/904)
97.4% 98.8%
ES Symp 620 (92.6%, 99.1%) (97.4%, 99.5%) 18.5 94.9 99.4
(112/115) (499/505)
ES 98.2% 97.2%
Asymp 454 (90.4%, 99.7%) (95.1%, 98.5%) 12.1 83.1 99.7
(54/55) (388/399)
ES 97.6% 98.1%
Overall 1074 (94.1%, 99.1%) (97.0%, 98.8%) 15.8 90.7 99.6
(166/170) (887/904)
Male Male Male Male Male Male Male Male Male Male
100.0% 98.3%
UR Symp 315 (77.2%, 100.0%) (96.2%, 99.3%) 4.1 72.2 100.0
(13/13) (297/302)
UR 100.0% 98.5%
Asymp 668 (72.2%, 100.0%) (97.2%, 99.2%) 1.5 50.0 100.0
(10/10) (648/658)
UR 100.0% 98.4%
Overall 983 (85.7%, 100.0%) (97.4%, 99.1%) 2.3 60.5 100.0
(23/23) (945/960)
a
ES = endocervical swab; PC = PreservCyt®; UR = urine; VS-C = clinician-collected vaginal swab; VS-S = self-collected vaginal swab.
b
Asymp = asymptomatic; Symp = symptomatic.
Note: Subjects with a designated patient infection status (Infected or Non-Infected) and a valid test result with cobas® TV/MG for TV are considered
evaluable and included in this summary table.
Note: CI = confidence interval; NPV = negative predictive value; PPV = positive predictive value; PREV = prevalence;
SENS = sensitivity; SPEC = specificity.
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Expected values for TV

Positivity rate
Table 43 TV positivity rate of cobas® TV/MG observed during the study
Sample Symptom Total cobas® TV

Typea Statusb (n) Positive Result Positivity Rate 95% Score CI
Female Female Female Female Female Female
UR Symp 622 119 19.1% (16.2%, 22.4%)
- Asymp 455 60 13.2% (10.4%, 16.6%)
- Overall 1077 179 16.6% (14.5%, 19.0%)
VS-C/ Symp 623 131 21.0% (18.0%, 24.4%)
VS-S
- Asymp 454 68 15.0% (12.0%, 18.6%)
- Overall 1077 199 18.5% (16.3%, 20.9%)
PC Symp 622 112 18.0% (15.2%, 21.2%)
- Asymp 452 59 13.1% (10.3%, 16.5%)
- Overall 1074 171 15.9% (13.9%, 18.2%)
ES Symp 620 118 19.0% (16.1%, 22.3%)
- Asymp 454 65 14.3% (11.4%, 17.8%)
- Overall 1074 183 17.0% (14.9%, 19.4%)
Male Male Male Male Male Male
UR Symp 315 18 5.7% (3.6%, 8.9%)
- Asymp 668 20 3.0% (1.9%, 4.6%)
- Overall 983 38 3.9% (2.8%, 5.3%)
a
ES = endocervical swab, PC = PreservCyt, UR = urine, VS-C = clinician-collected vaginal swab, VS-S = self-collected vaginal swab.
b
Symp = symptomatic, Asymp = asymptomatic.
Note: Subjects with a designated patient infection status (Infected or Non-Infected) and a valid test result with cobas® TV/MG for TV
are considered evaluable and included in this summary table.
Note: CI = confidence interval
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Positive and negative predictive values for TV

Hypothetical positive and negative predictive values (PPV and NPV) of cobas® TV/MG derived from disease prevalence
of 1 to 50% are shown in Table 44 through Table 48, respectively, per specimen type.
Table 44 Positive Predictive Value and Negative Predictive Value for hypothetical TV prevalence - female urine
Prevalence (%) Sensitivitya (%) Specificitya (%) PPV (%) NPV (%)
1 97.7 98.7 42.69 99.98
3 97.7 98.7 69.52 99.93
5 97.7 98.7 79.51 99.88
10 97.7 98.7 89.12 99.74
15 97.7 98.7 92.86 99.58
20 97.7 98.7 94.85 99.41
30 97.7 98.7 96.93 98.99
50 97.7 98.7 98.66 97.68
Note: NPV = Negative predictive value ; PPV = Positive predictive value.
a
The sensitivity and specificity were estimated by comparing the test results with cobas® TV/MG to patient infected status.
Table 45 Positive Predictive Value and Negative Predictive Value for hypothetical TV prevalence - vaginal swab
1 99.4 96.8 23.88 99.99
3 99.4 96.8 48.99 99.98
5 99.4 96.8 62.04 99.97
10 99.4 96.8 77.53 99.93
15 99.4 96.8 84.57 99.89
20 99.4 96.8 88.59 99.85
30 99.4 96.8 93.01 99.74
50 99.4 96.8 96.88 99.40
Note: NPV = Negative predictive value; PPV = Positive predictive value.
a
Table 46 Positive Predictive Value and Negative Predictive Value for hypothetical TV prevalence - PreservCyt®
1 94.7 98.9 46.37 99.95
3 94.7 98.9 72.59 99.83
5 94.7 98.9 81.84 99.72
10 94.7 98.9 90.49 99.41
15 94.7 98.9 93.79 99.06
20 94.7 98.9 95.54 98.68
30 94.7 98.9 97.35 97.76
50 94.7 98.9 98.85 94.92
a
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Table 47 Positive Predictive Value and Negative Predictive Value for hypothetical TV prevalence - endocervical swab
1 97.6 98.1 34.40 99.98
3 97.6 98.1 61.63 99.93
5 97.6 98.1 73.21 99.87
10 97.6 98.1 85.23 99.73
15 97.6 98.1 90.16 99.58
20 97.6 98.1 92.85 99.40
30 97.6 98.1 95.70 98.98
50 97.6 98.1 98.11 97.66
a
Table 48 Positive Predictive Value and Negative Predictive Value for hypothetical TV prevalence - male urine
1 100.0 98.4 39.26 100.0
3 100.0 98.4 66.44 100.0
5 100.0 98.4 77.11 100.0
10 100.0 98.4 87.67 100.0
15 100.0 98.4 91.87 100.0
20 100.0 98.4 94.12 100.0
30 100.0 98.4 96.48 100.0
50 100.0 98.4 98.46 100.0
a
The sensitivity and specificity were estimated by comparing the test results with cobas® TV/MG V/MG to patient infected status.
Cycle threshold frequency distribution for TV

A total of 770 specimens (combined female and male) were positive for TV. The frequency distribution of Ct values from
cobas® TV/MG positive results for TV infected specimens are shown in Figure 7.
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Figure 7 Cycle threshold distribution of TV positive specimens
MG clinical performance
Table 49 and Table 50 summarize the results from gender by symptomatic and asymptomatic subjects designated as
infected or non-infected with MG according to the PIS algorithm. A total of 59 females and 60 males were infected with
MG. Symptoms were reported in 67% (40/59) of infected and 57% (601/1045) of non-infected females. Symptoms were
reported in 52% (31/60) of infected and 32% (312/986) of non-infected males.
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Table 49 MG positive/negative analysis for female PIS
cobas®
cobas® cobas® Symptom Symptom
NAAT1 NAAT2 NAAT3 TV/MG
TV/MG TV/MG Status Status
Patient Infected VS-C/
Status VS VS VS UR VS-S ES Symp Asymp Total
Infected - + + - - - 0 1 1
Infected - + + - + + 4 1 5
Infected - + + + + - 4 1 5
Infected - + + + + + 7 4 11
Infected + - + - - - 1 0 1
Infected + - + + + + 1 1 2
Infected + + + - + + 1 0 1
Infected + + + + + - 1 2 3
Infected + + + + + + 21 9 30
Non-Infected - - Invalid - - + 1 0 1
Non-Infected - - - N/A - - 1 0 1
Non-Infected - - - Invalid Invalid - 1 0 1
Non-Infected - - - Invalid - - 3 0 3
Non-Infected - - - - Failed N/A 1 0 1
Non-Infected - - - - - N/A 1 0 1
Non-Infected - - - - - Failed 1 0 1
Non-Infected - - - - Invalid - 0 1 1
Non-Infected - - - - - - 533 422 955
Non-Infected - - - - - + 1 0 1
Non-Infected - - - + - - 3 0 3
Non-Infected - - + - - - 12 2 14
Non-Infected - - + - + - 6 2 8
Non-Infected - - + - - + 2 1 3
Non-Infected - - + - + + 1 1 2
Non-Infected - - + + - - 6 1 7
Non-Infected - - + + + - 6 5 11
Non-Infected - - + + + + 9 1 10
Non-Infected - + - - - N/A 0 1 1
Non-Infected - + - - - - 7 1 8
Non-Infected + - - - - - 6 6 12
Note: Asymp = asymptomatic, Symp = symptomatic.
Note: Two or more positive results in vaginal swab specimens from females determines the PIS as ‘Infected’. Any other combination of
valid results defines their PIS as ‘Non-Infected’. If one of the NAATs is invalid, the two remaining NAAT results must be concordant
positive (+) or concordant negative (-) for the PIS to be ‘Infected’ or ‘Non-Infected’, respectively. For any other combination of invalid
results PIS is considered ‘Indeterminate’.
Note: Subjects with a designated patient infection status (Infected or Non-Infected) and a valid test result with cobas® TV/MG for MG
Note: ES = endocervical swab, UR = urine, VS = vaginal swab, VS-C = clinician-collected vaginal swab, VS-S = self-collected vaginal swab.
Note: MG = Mycoplasma genitalium, NAAT = nucleic acid amplification test, TV = Trichomonas vaginalis.
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Table 50 MG positive/negative analyses for male PIS
cobas®
cobas® Symptom Symptom
TV/MG
NAAT1 NAAT2 NAAT3 TV/MG Status Status
Patient Infected MS-C/
Status UR UR UR UR MS-S Symp Asymp Total
Infected - + + + - 1 1 2
Infected - + + + + 1 1 2
Infected + - + + - 0 1 1
Infected + - + + + 3 5 8
Infected + + - + + 0 1 1
Infected + + + + - 2 4 6
Infected + + + + + 24 16 40
Non-Infected N/A - - - - 2 1 3
Non-Infected - Invalid - - - 0 2 2
Non-Infected - - N/A - - 0 1 1
Non-Infected - - - N/A - 0 1 1
Non-Infected - - - - N/A 0 4 4
Non-Infected - - - - Failed 0 1 1
Non-Infected - - - - Invalid 0 2 2
Non-Infected - - - - - 288 634 922
Non-Infected - - - - + 3 3 6
Non-Infected - - - + + 1 1 2
Non-Infected - - + - - 0 2 2
Non-Infected - - + - + 1 0 1
Non-Infected - - + + Invalid 0 1 1
Non-Infected - - + + - 2 6 8
Non-Infected - - + + + 5 6 11
Non-Infected - + - - - 1 4 5
Non-Infected - + - + - 1 0 1
Non-Infected + - - - - 7 5 12
Non-Infected + - - + + 1 0 1

Note: Two or more positive results in urine specimens from males determines the PIS as ‘Infected’. Any other combination of valid results defines the
ir PIS as ‘Non-Infected’. If one of the NAATs is invalid, the two remaining NAAT results must be concordant positive (+) or concordant negative (-)
for the PIS to be ‘Infected’ or ‘Non-Infected’, respectively. For any other combination of invalid results PIS is considered ‘Indeterminate’.
Note: Subjects with a designated patient infection status (Infected or Non-Infected) and a valid test result with cobas® TV/MG for MG
Note: MS-C = clinician-collected meatal swab; MS-S = self-collected meatal swab; UR = urine.
Note: MG = Mycoplasma genitalium; NAAT = nucleic acid amplification test; TV = Trichomonas vaginalis.
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Sensitivity, specificity, and predictive values of cobas® TV/MG for MG as defined by PIS are presented by gender,
specimen type, and symptom status in Table 51.
Table 51 MG clinical performance compared with PIS by gender, specimen type, and symptom status
Sample Symptom Total PREV PPV NPV

SENS 95% Score CI SPEC 95% Score CI
Typea Statusb (n) (%) (%) (%)
Female Female Female Female Female Female Female Female Female Female
85.0% 96.0%
UR Symp 636 (70.9%, 92.9%) (94.1%, 97.3%) 6.3 58.6 99.0
(34/40) (572/596)
UR 89.5% 98.4%
Asymp 463 (68.6%, 97.1%) (96.8%, 99.2%) 4.1 70.8 99.5
(17/19) (437/444)
UR 86.4% 97.0%
Overall 1099 (75.5%, 93.0%) (95.8%, 97.9%) 5.4 62.2 99.2
(51/59) (1009/1040)
VS-C/ 97.5% 96.3%
Symp 639 (87.1%, 99.6%) (94.5%, 97.6%) 6.3 63.9 99.8
VS-S (39/40) (577/599)
VS-C/ 94.7% 98.0%
Asymp 462 (75.4%, 99.1%) (96.2%, 98.9%) 4.1 66.7 99.8
VS-S (18/19) (434/443)
VS-C/ 96.6% 97.0%
Overall 1101 (88.5%, 99.1%) (95.8%, 97.9%) 5.4 64.8 99.8
VS-S (57/59) (1011/1042)
85.0% 97.7%
ES Symp 637 (70.9%, 92.9%) (96.1%, 98.6%) 6.3 70.8 99.0
(34/40) (583/597)
ES 78.9% 99.3%
Asymp 462 (56.7%, 91.5%) (98.0%, 99.8%) 4.1 83.3 99.1
(15/19) (440/443)
ES 83.1% 98.4%
Overall 1099 (71.5%, 90.5%) (97.4%, 99.0%) 5.4 74.2 99.0
(49/59) (1023/1040)
Male Male Male Male Male Male Male Male Male Male
100.0% 96.8%
UR Symp 343 (89.0%, 100.0%) (94.2%, 98.2%) 9.0 75.6 100.0
(31/31) (302/312)
UR 100.0% 97.9%
Asymp 702 (88.3%, 100.0%) (96.5%, 98.8%) 4.1 67.4 100.0
(29/29) (659/673)
UR 100.0% 97.6%
Overall 1045 (94.0%, 100.0%) (96.4%, 98.4%) 5.7 71.4 100.0
(60/60) (961/985)
MS-C/ 90.3% 96.5%
Symp 343 (75.1%, 96.7%) (93.8%, 98.0%) 9.0 71.8 99.0
MS-S (28/31) (301/312)
MS-C/ 79.3% 98.5%
Asymp 695 (61.6%, 90.2%) (97.3%, 99.2%) 4.2 69.7 99.1
MS-S (23/29) (656/666)
MS-C/ 85.0% 97.9%
Overall 1038 (73.9%, 91.9%) (96.7%, 98.6%) 5.8 70.8 99.1
MS-S (51/60) (957/978)
a
ES = endocervical swab; MS-C = clinician-collected meatal swab; MS-S = self-collected meatal swab; UR = urine; VS-C = clinician-collected vaginal
swab; VS-S = self-collected vaginal swab.
b
Note: Subjects with a designated patient infection status (Infected or Non-Infected) and a valid test result with cobas® TV/MG for MG are
Note: CI = confidence interval; NPV = negative predictive value; PPV = positive predictive value; PREV = prevalence; SENS = sensitivity; SPEC =
specificity.
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Expected values for MG
Positivity rate for MG
Table 52 MG positivity rate of cobas® TV/MG observed during the study
Sample Symptom Total cobas® MG

Typea Statusb (n) Positive Result Positivity Rate 95% Score CI
Female Female Female Female Female Female
UR Symp 636 58 9.1% (7.1%, 11.6%)
UR Asymp 463 24 5.2% (3.5%, 7.6%)
UR Overall 1099 82 7.5% (6.1%, 9.2%)
VS-C/ Symp 639 61 9.5% (7.5%, 12.1%)
VS-S
VS-C/ Asymp 462 27 5.8% (4.0%, 8.4%)
VS-S
VS-C/ Overall 1101 88 8.0% (6.5%, 9.7%)
VS-S
ES Symp 637 48 7.5% (5.7%, 9.8%)
ES Asymp 462 18 3.9% (2.5%, 6.1%)
ES Overall 1099 66 6.0% (4.7%, 7.6%)
Male Male Male Male Male Male
UR Symp 343 41 12.0% (8.9%, 15.8%)
UR Asymp 702 43 6.1% (4.6%, 8.1%)
UR Overall 1045 84 8.0% (6.5%, 9.8%)
MS-C/ Symp 343 39 11.4% (8.4%, 15.2%)
MS-S
MS-C/ Asymp 695 33 4.7% (3.4%, 6.6%)
MS-S
MS-C/ Overall 1038 72 6.9% (5.5%, 8.6%)
MS-S
a
ES = endocervical swab, MS-C = clinician-collected meatal swab, MS-S = self-collected meatal swab; UR = urine, VS-C = clinician-
collected vaginal swab, VS-S = self-collected vaginal swab,
b
Note: Subjects with a designated patient infection status (Infected or Non-Infected) and a valid test result with cobas® TV/MG for MG are
Note: CI = confidence interval.
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Positive and negative predictive values for MG

Hypothetical positive and negative predictive values (PPV and NPV) of cobas® TV/MG derived from disease prevalence
of 1 to 50% are shown in Table 53 through Table 58, respectively, per specimen type.
Table 53 Positive Predictive Value and Negative Predictive Value for hypothetical MG prevalence - female urine
1 86.4 97.0 22.66 99.86
3 86.4 97.0 47.28 99.57
5 86.4 97.0 60.42 99.27
10 86.4 97.0 76.32 98.47
15 86.4 97.0 83.65 97.59
20 86.4 97.0 87.88 96.62
30 86.4 97.0 92.55 94.35
50 86.4 97.0 96.67 87.74
a
Table 54 Positive Predictive Value and Negative Predictive Value for hypothetical MG prevalence - vaginal swab
1 96.6 97.0 24.70 99.96
3 96.6 97.0 50.11 99.89
5 96.6 97.0 63.09 99.82
10 96.6 97.0 78.30 99.61
15 96.6 97.0 85.14 99.39
20 96.6 97.0 89.03 99.13
30 96.6 97.0 93.30 98.52
50 96.6 97.0 97.01 96.62
a
Table 55 Positive Predictive Value and Negative Predictive Value for hypothetical MG prevalence - endocervical swab
1 83.1 98.4 33.92 99.83
3 83.1 98.4 61.11 99.47
5 83.1 98.4 72.78 99.10
10 83.1 98.4 84.95 98.12
15 83.1 98.4 89.97 97.05
20 83.1 98.4 92.70 95.87
30 83.1 98.4 95.61 93.12
50 83.1 98.4 98.07 85.30
a
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Table 56 Positive Predictive Value and Negative Predictive Value for hypothetical MG prevalence - male urine
1 100.0 97.6 29.31 100.0
3 100.0 97.6 55.93 100.0
5 100.0 97.6 68.36 100.0
10 100.0 97.6 82.02 100.0
15 100.0 97.6 87.87 100.0
20 100.0 97.6 91.12 100.0
30 100.0 97.6 94.62 100.0
50 100.0 97.6 97.62 100.0
a
Table 57 Positive Predictive Value and Negative Predictive Value for hypothetical MG prevalence - meatal swab
1 85.0 97.9 28.56 99.85
3 85.0 97.9 55.04 99.53
5 85.0 97.9 67.57 99.20
10 85.0 97.9 81.48 98.33
15 85.0 97.9 87.48 97.37
20 85.0 97.9 90.82 96.31
30 85.0 97.9 94.43 93.84
50 85.0 97.9 97.54 86.71
a
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Cycle threshold frequency distribution for MG

A total of 392 specimens (combined female and male) were positive for MG. The frequency distribution of Ct values from
cobas® TV/MG positive results for MG infected specimens are shown in Figure 8.
Figure 8 Cycle threshold distribution of MG positive specimens
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Specimen-specific agreement for the detection of MG

A study was conducted with prospectively collected female and male urogenital specimens from 836 subjects (412 females and
424 males). This study analyzed the performance of cobas® TV/MG for the detection of MG in female (urine, vaginal swab,
PreservCyt®, and endocervical swab) and male (urine and meatal swab) specimen types with respect to an anatomic site-specific
composite reference standard (i.e., cobas® TV/MG urine results were compared to a urine-specific composite reference, and the
same for the other female and male specimen types). The composite reference standard was comprised of 3 MG NAATs where
the determination of truth was based on any 2 positive tests out of the 3 MG reference NAATs used.
Table 58 MG Positive and Negative Percent Agreement of cobas® TV/MG with anatomic site-specific composite reference
Sample ASCRb+/ ASCRb-/ cobas ASCRb+/ PPA

Typea cobas + + b
ASCR -/ cobas - cobas - (95% Exact CI) NPA (95% Exact CI)
Female Female Female Female Female Female Female
100% 98.4%
UR 29 6 377 0
(88.1%, 100%) (96.6%, 99.4%)
VS-C/ 93.1% 99.5%
27 2 381 2
VS-S (77.2%, 99.2%) (98.1%, 99.9%)
94.7% 99.5%
ES 18 2 391 1
(74.0%, 99.9%) (98.2%, 99.9%)
Male Male Male Male Male Male Male
100% 98.7%
UR 39 5 380 0
(91.0%, 100%) (97.0%, 99.6%)
MS-C/ 99.2%
25 3 396 0 100% (86.3%, 100%)
MS-S 97.8%, 99.8%)
a
ES = endocervical swab, MS-C = clinician-collected meatal swab, MS-S = self-collected meatal swab; UR = urine,
VS-C = clinician-collected vaginal swab, VS-S = self-collected vaginal swab.
b
ASCR = Anatomic Site-specific Composite Reference (i.e., cobas® TV/MG urine results were compared to a urine-specific composite reference, and
the same for the other female and male specimen types).
Note: CI = confidence interval, NPA = negative percent agreement, PPA = positive percent agreement.
System equivalency
System equivalency of the cobas® 5800, cobas® 6800 and cobas® 8800 Systems was demonstrated via performance studies.
The data presented in this Instructions for Use support equivalent performance for all systems.
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Additional information
Key assay features
Sample types  Endocervical swab collected in cobas® PCR Media
 Vaginal swab collected in cobas® PCR Media
 Self-collected vaginal swab collected in cobas® PCR Media
 Meatal swab collected in cobas® PCR Media
 Self-collected meatal swab collected in cobas® PCR Media
 Male and female urine stabilized in cobas® PCR Media
 Cervical specimens collected in PreservCyt® Solution
Amount of sample processed  ≥ 1000 µL required in sample tube for endocervical swab and vaginal swab samples,
instrument processes 400 µL
 ≥ 1000 µL required in sample tube for PreservCyt® samples, instrument processes
400 µL
 ≥ 1200 µL required in sample tube for meatal swab samples, instrument processes
850 µL
 ≥ 1200 µL required in sample tube for urine samples, instrument processes 850 µL
 On cobas® 5800 System, ≥3000 µL required in sample tube for PreservCyt® samples
in primary tubes, instrument processes 400 µL
Test duration  < 3.5 hours to first result
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Symbols
The following symbols are used in labeling for Roche PCR diagnostic products.
Table 59 Symbols used in labeling for Roche PCR diagnostics products
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Manufacturer and distributors

Table 60 Manufacturer and distributors
Roche Molecular Systems, Inc.

1080 US Highway 202 South
Branchburg, NJ 08876 USA
www.roche.com
Made in USA
Distributed by Roche Diagnostics

9115 Hague Road
Indianapolis, IN 46250-0457 USA
(For Technical Assistance call the
Roche Response Center
toll-free: 1-800-526-1247)
Trademarks and patents

See https://diagnostics.roche.com/us/en/about-us/patents
Copyright
©2022 Roche Molecular Systems, Inc.
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References
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Document Revision
Document Revision Information
Doc Rev. 1.0 First Publishing.

11/2022
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TV-MG PCR

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TV-MG PCR

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Qualitative nucleic acid test

cobas® TV/MG P/N: 09040633190

For use on the cobas® 5800 System

For use on the cobas® 6800/8800 Systems

cobas® Buffer Negative Control Kit P/N: 09051953190 or

Summary and explanation of the test................................................................................. 5

Reagents and materials ......................................................................................................... 9

cobas® TV/MG reagents and controls ...................................................................................................... 9

Warnings and precautions ...................................................................................................................... 17

Specimen collection ................................................................................................................................. 19

Instructions for use............................................................................................................... 23

Procedural notes ....................................................................................................................................... 23

Key performance characteristics performed on the cobas® 6800/8800 Systems .............................. 34

Reproducibility study ............................................................................................................................... 44

MG clinical performance ................................................................................................................ 68

Key assay features ..................................................................................................................................... 77

Summary and explanation of the test

Explanation of the test

Principles of the procedure

Reagents and materials

cobas® TV/MG reagents and controls

Table 1 cobas® TV/MG

Table 2 cobas® TV/MG Positive Control Kit

Table 3 cobas® Buffer Negative Control Kit

cobas omni reagents for sample preparation

Reagents Reagent ingredients Quantity Safety symbol and warning**

Reagent storage and handling requirements

Table 5 Reagent storage (when reagent is not on the system)

Reagent Storage temperature

Reagent handling requirements for cobas® 5800 System

Table 6 Reagent expiry conditions enforced by the cobas® 5800 System

Reagent handling requirements for cobas® 6800/8800 Systems

Table 7 Reagent expiry conditions enforced by the cobas® 6800/8800 Systems

Additional materials required for cobas® 5800 System

cobas omni Processing Plate 24 08413975001

cobas omni Liquid Waste Plate 24 08413983001

cobas omni Amplification Plate 24 08499853001

Tip CORE TIPS with Filter, 1ml 04639642001

Tip CORE TIPS with Filter, 0.3 ml 07345607001

cobas omni Liquid Waste Container 07094388001

cobas omni Lysis Reagent 06997538190

cobas omni MGP Reagent 06997546190

cobas omni Specimen Diluent 06997511190

cobas omni Wash Reagent 06997503190

5-position Rack Carrier 09224475001

Cell Collection Media Carrier 09224599001

Additional materials required for cobas® 6800/8800 Systems

cobas omni Amplification Plate 05534941001

cobas omni Pipette Tips 05534925001

cobas omni Liquid Waste Container 07094388001

cobas omni Lysis Reagent 06997538190

cobas omni MGP Reagent 06997546190

cobas omni Specimen Diluent 06997511190

cobas omni Wash Reagent 06997503190

Instrumentation and software required

cobas® 5800 System 08707464001

cobas® 6800 System (Option Moveable) 05524245001 and 06379672001

cobas® 6800 System (Fix) 05524245001 and 06379664001

cobas® 8800 System 05412722001