Flu A-B PCR

Rx Only
cobas® SARS-CoV-2 & Influenza A/B
Qualitative nucleic acid test for use

on the cobas® 5800/6800/8800 Systems
For in vitro diagnostic use
cobas® SARS-CoV-2 & Influenza A/B P/N: 09446125190
cobas® SARS-CoV-2 & Influenza A/B Control Kit P/N: 09446133190
cobas® Buffer Negative Control Kit P/N: 09051953190

Table of contents
Summary and explanation of the test................................................................................. 4
Reagents and materials ......................................................................................................... 6
cobas® SARS-CoV-2 & Influenza A/B reagents and controls ............................................................... 6
cobas omni reagents for sample preparation .......................................................................................... 8
Reagent storage requirements ................................................................................................................... 9
Reagent handling requirements for cobas® 5800 System .................................................................... 10
Reagent handling requirements for cobas® 6800/8800 Systems ......................................................... 11
Additional materials required for cobas® 5800 System ........................................................................ 12
Additional materials required for cobas® 6800/8800 Systems ............................................................. 13
Alternative collection kits for swab specimens for use on the cobas® 5800/6800/8800 Systems.... 14
Instrumentation and software required ................................................................................................. 15
Precautions and handling requirements ......................................................................... 16
Warnings and precautions ...................................................................................................................... 16
Reagent handling ...................................................................................................................................... 16
Good laboratory practice ......................................................................................................................... 17
Sample collection, transport, and storage........................................................................ 17
Sample collection...................................................................................................................................... 17
Nasal (anterior nares) swab specimen collection - healthcare worker or self-collected on site18
Transport and storage ............................................................................................................................... 19
Instructions for use............................................................................................................... 20
Procedural notes ....................................................................................................................................... 20
Running cobas® SARS-CoV-2 & Influenza A/B ................................................................................... 20
Specimens collected in cobas® PCR Media, 0.9% physiological saline, UTM-RT® or UVT.... 20
Specimens collected using cobas® PCR Media Uni or Dual Swab Sample Kit ......................... 21
Running cobas® SARS-CoV-2 & Influenza A/B on cobas® 5800 System ........................................... 22
Running cobas® SARS-CoV-2 & Influenza A/B on cobas® 6800/8800 Systems ................................ 23
Results ..................................................................................................................................... 24
Quality control and validity of results on the cobas® 5800 System..................................................... 24

Control results on cobas® 5800 System ......................................................................................... 24
Interpretation of results on the cobas® 5800 System ................................................................... 25
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Quality control and validity of results on the cobas® 6800/8800 Systems ......................................... 26
Interpretation of results on the cobas® 6800/8800 Systems ................................................................. 27
Interpretation of results .................................................................................................................. 28
Procedural limitations.............................................................................................................................. 30
Non-clinical performance evaluation ............................................................................... 31
Analytical sensitivity (Limit of Detection) ............................................................................................ 31

Analytical sensitivity using WHO International Standard ................................................................. 33
Inclusivity .................................................................................................................................................. 34
Precision (repeatability) .......................................................................................................................... 35
Analytical specificity (cross-reactivity and microbial interference) .................................................. 38
Interference ............................................................................................................................................... 40
Co-infection (competitive interference) ............................................................................................... 41
Collection media equivalence ................................................................................................................. 41
Whole system failure................................................................................................................................ 42
Clinical performance evaluation ....................................................................................... 43
Performance with archived and banked clinical specimens ............................................................... 43

Performance with prospective and archived clinical specimens ........................................................ 44
Reproducibility ......................................................................................................................................... 46
System equivalency/system comparison ........................................................................ 48
Additional information ......................................................................................................... 49
Key test features ........................................................................................................................................ 49

Symbols ...................................................................................................................................................... 50
Technical support ..................................................................................................................................... 51
Manufacturer ............................................................................................................................................ 51
Trademarks and patents .......................................................................................................................... 51
Copyright................................................................................................................................................... 51
References .................................................................................................................................................. 52
Document revision ................................................................................................................................... 53
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Summary and explanation of the test

Intended use
cobas® SARS-CoV-2 & Influenza A/B assay for use on the cobas® 5800/6800/8800 Systems (cobas® SARS-CoV-2 & Influenza
A/B) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation
of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal
swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare
provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.
cobas® SARS-CoV-2 & Influenza A/B is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A,
and influenza B in humans and is not intended to detect influenza C.
RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute
phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B RNA;
clinical correlation with patient history and other diagnostic information is necessary to determine patient infection
status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not
be the definite cause of disease.
Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used
as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical
observations, patient history, and epidemiological information.
cobas® SARS-CoV-2 & Influenza A/B is intended for use by qualified clinical laboratory personnel specifically
instructed and trained in the techniques of real-time PCR and on the use of the cobas® 5800/6800/8800 Systems.
Explanation of the test

cobas® SARS-CoV-2 & Influenza A/B is a qualitative nucleic acid test for the use on the cobas® 5800 System, cobas® 6800
System or cobas® 8800 System for the detection of the 2019 novel coronavirus (SARS-CoV-2), influenza A, and
influenza B RNA in both nasal and nasopharyngeal swab samples collected in Copan Universal Transport Medium
System (UTM-RT®) or BD™ Universal Viral Transport System (UVT) and additionally for nasal swab samples collected
in cobas® PCR Media or 0.9% physiological saline. The RNA 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).
Principles of the procedure

cobas® SARS-CoV-2 & Influenza A/B 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(s), which assigns results for all tests. Results can be reviewed directly on the system
screen, and printed as a report.
Nucleic acid from patient samples and added internal control RNA (RNA IC) molecules are simultaneously
extracted. 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
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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 SARS-CoV-2 target nucleic acid from the sample is achieved by the use of target-specific
forward and reverse primers for ORF1a/b non-structural region that is unique to SARS-CoV-2. Additionally, a
conserved region in the structural protein envelope E-gene was chosen for pan-Sarbecovirus detection. The pan-
Sarbecovirus detection set will also detect SARS-CoV-2 virus. For influenza A and influenza B viruses, selective
amplification of target nucleic acid from the sample is achieved by the use of target -specific forward and reverse
primers for the matrix proteins 1 and 2 (M1/M2) for influenza A and the nuclear export protein (NEP) /
nonstructural protein 1(NS1) genes for influenza B, respectively. Selective amplification of RNA Internal Control is
achieved by the use of non-competitive sequence specific forward and reverse primers which have no homology with
the coronavirus or influenza genomes. Amplified target is detected by cleavage of fluorescently labeled
oligonucleotide probe. A thermostable DNA polymerase enzyme is used for amplification.
The cobas® SARS-CoV-2 & Influenza A/B master mix contains detection probes which are specific for the coronavirus type
SARS-CoV-2, members of the Sarbecovirus subgenus, influenza A virus, influenza B virus and the RNA Internal
Control nucleic acid. The coronavirus, influenza A, influenza B and RNA Internal Control detection probes are each
labeled with unique fluorescent dyes that act as a reporter. Each probe also has a second dye which acts as a
quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the
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. Each reporter dye is measured at defined wavelengths, which enables simultaneous detection and
discrimination of the amplified coronavirus targets, influenza targets and the RNA Internal Control. The master mix
includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated
into the newly synthesized DNA (amplicon). Any contaminating amplicons from previous PCR runs are destroyed
by the AmpErase enzyme [uracil-N-glycosylase], which is included in the PCR mix, when heated in the first thermal
cycling step. However, newly formed amplicons are not destroyed since the AmpErase enzyme is inactivated once
exposed to temperatures above 55°C.
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Reagents and materials

The materials provided for cobas® SARS-CoV-2 & Influenza A/B can be found in Table 1. Materials required, but not
provided can be found in Table 2, Table 3, Table 4, Table 8, Table 9, Table 10 and Table 11.
Refer to the Reagents and materials section and Precautions and handling requirements section for the hazard
information for the product.
cobas® SARS-CoV-2 & Influenza A/B reagents and controls

All unopened reagents and controls shall be stored as recommended in Table 1 to Table 4.
Table 1 cobas® SARS-CoV-2 & Influenza A/B

Store at 2-8°C
384 test cassette (P/N 09446125190)
Kit components Reagent ingredients Quantity per kit
384 tests
Proteinase Solution Tris buffer, < 0.05% EDTA, calcium chloride, calcium acetate, 38 mL
(PASE) 8% proteinase, glycerol
EUH210: Safety data sheet available on request.
EUH208: Contains Subtilisin from Bacillus subtilis. May
produce an allergic reaction.
RNA Internal Control Tris buffer, < 0.05% EDTA, < 0.001% non-target related 38 mL
(RNA IC) armored RNA construct containing primer and probe
specific sequence regions (non-infectious RNA in MS2
bacteriophage), < 0.1% sodium azide
Elution Buffer Tris buffer, 0.2% methyl-4 hydroxybenzoate 38 mL
(EB)
Master Mix Reagent 1 Manganese acetate, potassium hydroxide, < 0.1% sodium azide 14.5 mL
(MMX-R1)
SCoV2-FluA/B Master Mix Tricine buffer, potassium acetate, < 18% dimethyl sulfoxide, 17.5 mL
Reagent 2 glycerol, < 0.1% Tween 20, EDTA, < 0.12% dATP, dCTP, dGTP,
(SCoV2-FluA/B MMX-R2) dUTPs, < 0.01% upstream and downstream SARS-CoV-2,
Sarbecovirus, influenza A and influenza B primers, < 0.01%
Internal Control forward and reverse primers, < 0.01%
fluorescent-labeled oligonucleotide probes specific for SARS-
CoV-2, Sarbecovirus, influenza A, influenza B and the RNA
Internal Control, < 0.01% oligonucleotide aptamer, < 0.1%
Z05D DNA polymerase, < 0.10% AmpErase (uracil-N-
glycosylase) enzyme (microbial), < 0.1% sodium azide
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Table 2 cobas® SARS-CoV-2 & Influenza A/B Control Kit

(SCoV2-FluA/B CTL)
Store at 2–8°C
(P/N 09446133190)
SCoV2-FluA/B Tris buffer, < 0.05% Sodium azide, < 0.005% EDTA, 0.003% Poly rA, < 0.01% 16 mL
Positive Control Non-infectious plasmid DNA (microbial) containing SARS-CoV-2 sequence, (16 x 1 mL)
(SCoV2-FluA/B CTL) < 0.01% Non-infectious plasmid DNA (microbial) containing pan-
Sarbecovirus sequence, < 0.01% Non-infectious plasmid DNA (microbial)
containing influenza A sequence, < 0.01% Non-infectious plasmid DNA
(microbial) containing influenza B sequence
Table 3 cobas® Buffer Negative Control Kit

(BUF (-) C)
Store at 2-8°C
(P/N 09051953190)
cobas® Buffer Tris buffer, < 0.1% sodium azide, EDTA, 0.002% Poly rA RNA (synthetic) 16 mL
Negative Control (16 x 1 mL)
(BUF (-) C)
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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, 480 tests Not applicable
MGP Reagent 0.1% methyl-4 hydroxybenzoate,
(MGP) < 0.1% sodium 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 43% (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® SARS-CoV-2 & Influenza A/B test kit. See listing of additional materials required(Table 8 and Table 9).
** Product safety labeling primarily follows EU GHS guidance
***Hazardous substance
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Reagent storage requirements

Reagents shall be stored and will be handled as specified in Table 5.
When reagents are not loaded on the cobas® 5800 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® SARS-CoV-2 & Influenza A/B 2–8°C
cobas® SARS-CoV-2 & Influenza A/B 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
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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 Open-kit stability Number of runs for On-board

date which this kit can be stability
used
cobas® SARS-CoV-2 & Influenza A/B Date not passed 90 days from first usage Max 40 runs Max 36 daysb
cobas® SARS-CoV-2 & Influenza A/B Date not passed Not applicablea Not applicable Max 36 daysb
Control Kit
cobas® Buffer Negative Control Kit Date not passed Not applicablea Not applicable Max 36 daysb
cobas omni Lysis Reagent Date not passed 30 days from loadingb Not applicable Not applicable
cobas omni MGP Reagent Date not passed 30 days from loadingb Not applicable Not applicable
b
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 loadingb Not applicable Not applicable
a
Single use reagents
b
Time is measured from the first time that reagent is loaded onto the cobas® 5800 System.
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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
On-board stability
Number of runs
Kit expiration (cumulative time
Reagent Open-kit stability for which this
date on board outside
kit can be used
refrigerator)
cobas® SARS-CoV-2 & Influenza A/B Date not passed 90 days from first usage Max 40 runs Max 40 hours
cobas® SARS-CoV-2 & Influenza A/B Date not passed Not applicablea Not applicable Max 8 hours
Control Kit
cobas® Buffer Negative Control Kit Date not passed Not applicablea Not applicable Max 10 hours
cobas omni Lysis Reagent Date not passed 30 days from loadingb Not applicable Not applicable
cobas omni MGP Reagent Date not passed 30 days from loadingb Not applicable Not applicable
b
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 loadingb Not applicable Not applicable
a
Single use reagents
b
Time is measured from the first time that reagent is loaded onto the cobas® 6800/8800 Systems.
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Additional materials required for cobas® 5800 System

Table 8 Material and consumables for use on the cobas® 5800 System
Material P/N
cobas omni Processing Plate 24 08413975001
cobas omni Amplification Plate 24 08499853001
cobas omni Liquid Waste Plate 24 08413983001
Tip CORE TIPS with Filter, 1 mL 04639642001
Tip CORE TIPS with Filter, 300 uL 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 07435967001

or or
Solid Waste Bag With Insert 08030073001
cobas omni Secondary Tubes 13x75 (optional) 06438776001
cobas® PCR Media Tube Replacement Cap Kit 07958056190
cobas® PCR Media Disposable Tube Stand (Optional) 07958064190
MPA RACK 16 MM LIGHT GREEN 7001-7050*,** 03143449001
RD5 RACK – RD Standard rack 0001-0050 LR*,** 11902997001
16-position tube carrier*,** 09224319001
5-position rack carrier* 09224475001
* MPA 16 mm, RD5 racks (including the 5-position rack carrier) or the 16-position tube carrier are required to use cobas® SARS-COV-2 &
Influenza A/B only for samples collected in cobas® PCR Media tubes. Contact your local Roche representative for a detailed order list for
sample racks.
**MPA 16 mm rack or 16-position tube carrier are the preferred racks for use with samples collected in cobas® PCR Media tubes. If RD5
racks are used, make sure to fill in the sample tubes with not less than the recommended minimum sample input. The tubes sit higher in an
RD5 rack because of the rubber gasket at the bottom of each tube position. Therefore, it is possible that when using RD5 racks, the system
could accept tubes that are below the minimum sample input volume and cause pipetting errors later in the run.
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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
cobas omni Secondary Tubes 13x75 (optional) 06438776001
cobas® PCR Media Tube Replacement Cap Kit 07958056190

cobas® PCR Media Disposable Tube Stand (Optional) 07958064190
,
MPA RACK 16 MM LIGHT GREEN 7001-7050* ** 03143449001
RD5 RACK – RD Standard rack 0001-0050 LR*,** 11902997001
* MPA 16 mm or RD5 racks are required to use cobas® SARS-COV-2 & Influenza A/B only for samples collected in cobas® PCR Media tubes.
Contact your local Roche representative for a detailed order list for sample racks, racks for clotted tips and rack trays accepted on the
instruments.
**MPA 16 mm rack is the preferred rack for use with samples collected in cobas® PCR Media tubes. If RD5 racks are used, make sure to fill in the
sample tubes with not less than the recommended minimum sample input. The tubes sit higher in an RD5 rack because of the rubber gasket at the
bottom of each tube position. Therefore, it is possible that when using RD5 racks, the system could accept tubes that are below the minimum sample
input volume and cause pipetting errors later in the run.
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Alternative collection kits for swab specimens for use on the cobas®
5800/6800/8800 Systems
Table 10 Alternative specimen collection kits used with cobas® SARS-CoV-2 & Influenza A/B
Collection Kit P/N
cobas® PCR Media Uni Swab Sample Kit 07958030190
cobas® PCR Media Dual Swab Sample Kit 07958021190
cobas® PCR Media 100 tube kit 06466281190
cobas® Uni Swab 100 Kit 09205098190
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Instrumentation and software required

The cobas® 5800 software and cobas® SARS-CoV-2 & Influenza A/B analysis package for the cobas® 5800 System shall be
installed on the cobas® 5800 instrument. The Data Manager software and PC for the cobas® 5800 System will be provided
with the system.
The cobas® 6800/8800 Systems software and cobas® SARS-CoV-2 & Influenza A/B analysis package for the cobas®
6800/8800 Systems must be installed on the instrument(s). The Instrument Gateway (IG) server will be provided with
the system.
Table 11 Instrumentation
Equipment P/N
cobas® 5800 System 08707464001
cobas® 6800 System (Moveable Platform) 05524245001 and 06379672001
cobas® 6800 System (Fixed Platform) 05524245001 and 06379664001
cobas® 8800 System 05412722001
Sample Supply Module (cobas® 6800/8800 Systems only) 06301037001
Refer to the cobas® 5800 System or cobas® 6800/8800 Systems – User Assistance and/or User Guides for additional information.
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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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.
 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-A4.1,2 Only personnel proficient
in handling infectious materials and the use of cobas® SARS-CoV-2 & Influenza A/B and the cobas®
5800/6800/8800 Systems should perform this procedure.
 All human-sourced materials should be considered potentially infectious and should be handled with universal
precautions. If spillage occurs, immediately disinfect with a freshly prepared solution of 0.5% sodium hypochlorite in
distilled or deionized water (dilute household bleach 1:10) or follow appropriate site procedures.
 The use of sterile disposable pipettes and nuclease-free pipette tips is recommended. Use only supplied or
specified required consumables to ensure optimal 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 optimal test performance.
 False positive results may occur if carryover of samples is not adequately controlled during sample handling
and processing.
 Inform your local competent authority about any serious incidents which may occur when using this assay.
Reagent handling
 Handle all reagents, controls, and samples according to good laboratory practice in order to prevent carryover of
samples 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.
 cobas® SARS-CoV-2 & Influenza A/B test kit, cobas® SARS-CoV-2 & Influenza A/B 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.
 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.
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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. Gloves must be
changed between handling samples and cobas® SARS-CoV-2 & Influenza A/B kits, cobas® SARS-CoV-2 &
Influenza A/B Control kit, cobas® Buffer Negative Control kit and cobas omni reagents to prevent
contamination. Avoid contaminating gloves when handling samples and controls.
 Wash hands thoroughly after handling samples and kit 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 or cobas® 6800/8800 instruments, follow the instructions in the cobas® Systems –
User Assistance and/or User Guides to properly clean and decontaminate the surface of instrument(s).
Sample collection, transport, and storage

Note: Handle all samples and controls as if they are capable of transmitting infectious agents.
Sample collection
Table 12 summarizes what collection devices can be used with specific sample types.
Table 12 Overview of collection devices and sample types
Collection Device Nasopharyngeal Nasal
Copan Universal Transport Media (UTM-RT®) √ √
BD™ Universal Viral Transport (UVT) √ √
0.9% Physiological Saline √
cobas® PCR Media Uni Swab Sample Kit √
cobas® PCR Media Dual Swab Sample Kit √
cobas® PCR Media Kit (and 100 tube PCR Media Kit) √
 Collect nasal and nasopharyngeal specimens according to standard collection technique using flocked or
polyester-tipped swabs and immediately place in 3 mL of Copan Universal Transport Medium (UTM-RT®)
or BD™ Universal Viral Transport (UVT) or equivalent.
 Collect nasal specimens according to standard collection technique using flocked or polyester-tipped swabs
and immediately place into cobas® PCR Media tube from cobas® PCR Media Kit (P/N 06466281190).
 Collect nasal specimens using the cobas® PCR Media Uni Swab Sample Kit (P/N 07958030190) or cobas®
PCR Media Dual Swab Sample Kit (P/N 07958021190) according to instructions below.
 Refer to the Instructions for Use of the Collection Devices for hazard information.
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Nasal (anterior nares) swab specimen collection - healthcare worker or self-collected

on site
WARNING: DO NOT PRE-WET SWAB IN cobas® PCR MEDIA BEFORE COLLECTION!
OR
The cobas® PCR Media Uni Swab Sample kit contains: The cobas® PCR Media Dual Swab Sample kit contains:
cobas® PCR Media Tube cobas® PCR Media Tube

Woven Swab: A Woven Swab: A
Flocked Swab: B
DO NOT PRE-WET SWAB IN cobas® PCR MEDIA BEFORE COLLECTION!

1. COLLECT: Hold the woven swab (Swab A) or the flocked swab (Swab B) with the scoreline above
your hand. Insert the swab 1-2 cm into one of the anterior nares. Rotate the swab against the nasal
mucosa for about 3 seconds and withdraw. Repeat with the other anterior nare using the same swab.
Do not let the swab touch any surface before placing it into the collection tube.
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2. ALIGN: Remove the cap from the 3. BREAK: Carefully 4. CLOSE: Tightly re-cap
cobas® PCR Media Tube and lower the leverage the swab the cobas® PCR Media
swab specimen into the tube until the against the tube rim Tube. The specimen is
visible scoreline on the swab is aligned to break the swab now ready for transport.
with the tube rim. shaft at the Discard the top portion
scoreline. of the swab.
 Collect nasal specimens according to standard collection technique using flocked or polyester-tipped swabs and
immediately place in 3 mL of 0.9% physiological saline.
Transport and storage

 Transportation of collected specimens must comply with all applicable regulations for the transport of etiologic agents.
 Samples collected in UTM-RT®,
o After collection, specimens can be stored for up to 48 hours at 2-25°C followed by up to 3 days at 2-8°C
and at ≤-18°C for up to 30 days.
 Samples collected in cobas® PCR Media,
 Samples collected in 0.9% physiological saline,
 Specimens are stable for up to two freeze/thaw cycles when frozen at ≤ -18°C.
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Instructions for use

Procedural notes
 Do not use cobas® SARS-CoV-2 & Influenza A/B reagents, cobas® SARS-CoV-2 & Influenza A/B 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 the sample
racks. Refer to the cobas® 5800 System or cobas® 6800/8800 Systems User Assistance and/or User Guides 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 Guides for proper
maintenance of instruments.
Running cobas® SARS-CoV-2 & Influenza A/B

cobas® SARS-CoV-2 & Influenza A/B can be run with a minimum required sample volume of 0.6 mL in the cobas omni
Secondary Tube for specimens collected in Copan Universal Transport Medium (UTM-RT®), BD™ Universal Viral
Transport (UVT), cobas® PCR Media or 0.9% physiological saline. Specimens collected using cobas® PCR Media Uni Swab
Sample Kit or cobas® PCR Media Dual Swab Sample Kit can be run in their primary collection tube with a minimum
required sample volume of 1.0 mL.
Specimens collected in cobas® PCR Media, 0.9% physiological saline, UTM-RT® or UVT
Specimens collected in tubes compatible with the cobas® 5800 and cobas® 6800/8800 Systems may be loaded directly
onto the cobas® 5800 and cobas® 6800/8800 Systems. Specimens collected in Copan Universal Transport Medium
(UTM-RT), BD™ Universal Viral Transport (UVT), cobas® PCR Media or 0.9% physiological saline tubes which are not
compatible with the cobas® 5800 and cobas® 6800/8800 Systems must be transferred into a secondary tube prior to
processing on the cobas® 5800 and cobas® 6800/8800 Systems. The cobas omni Secondary Tube is the preferred
option. Samples should be processed using the sample type selection in the user interface (UI) as described in Table 13.
Additional tubes for testing cobas® SARS-CoV-2 & Influenza A/B are available. Contact your local Roche representative
for detailed testing instructions and an order list of primary tubes and secondary tubes compatible with the
instruments.
Always use caution when transferring specimens from a primary collection tube to a secondary tube.
Use pipettes with aerosol-barrier or positive-displacement tips to handle specimens.
Always use a new pipette tip for each specimen.
Ensure samples are equilibrated to room temperature prior to transfer into a cobas omni Secondary Tube.
Follow the steps below to transfer patient sample from a primary collection tube into a cobas omni Secondary Tube:
 Unscrew the primary sample tube cap.
 Lift the cap and any attached swab to allow a pipette to be inserted into the sample tube.
 Transfer 0.6 mL into the prepared barcoded secondary tube.
 Transfer secondary tube to a rack. Close the primary sample tube cap.
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Specimens collected using cobas® PCR Media Uni or Dual Swab Sample Kit
Samples collected using cobas® PCR Media Uni Swab Sample Kit or cobas® PCR Media Dual Swab Sample Kit must be
uncapped and can be loaded directly onto racks for processing on the cobas® 5800/6800/8800 Systems. Transfer into a
secondary tube is not necessary. cobas® PCR Media tubes fit on to the MPA RACK 16 MM LIGHT GREEN 7001-7050
(P/N 03143449001) or the 16-position tube carrier on (P/N 09224319001) on the cobas® 5800 and can be processed with
the swab remaining in the tube. Samples collected using cobas® PCR Media Uni Swab Sample Kit or cobas® PCR Media Dual
Swab Sample Kits should be processed using the ‘cobas® PCR Media swab’ sample type selection in the user interface (UI) of
the cobas® SARS-CoV-2 & Influenza A/B as described in Table 13.
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 may create an obstruction to the pipetting system which might 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® 5800/6800/8800 Systems. Use caution when disposing of
specimen swabs; avoid splashing or touching swabs to other surfaces during disposal to prevent contamination.
Incoming cobas® PCR Media primary swab specimen tubes with no swabs or with two swabs have not been collected
according to the instructions in their respective collection kit instruction for use and should not be tested. If the sample
containing two swabs in the cobas® PCR Media primary tubes must be tested, transfer 0.6 mL into the prepared barcoded
secondary tube.
Occasionally, incoming swab specimens contain excessive mucus which may induce a pipetting error (e.g., clot or other
obstruction) on the cobas® 5800/6800/8800 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 processed twice on the cobas® 5800/6800/8800 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.
Table 13 Sample type selection in the user interface of the cobas® SARS-CoV-2 & Influenza A/B
Minimum volume (mL)

Collection kit/Matrix type Process as Sample Type
Processing tube
Copan Universal Transport Medium

BD™ Universal Viral Transport 0.6 mL
VTM
0.9% physiological saline cobas omni Secondary Tube
cobas® PCR Media Kit
1.0 mL
cobas® PCR Media Uni or Dual Swab Sample Kit cobas® PCR Media swab
Primary tube
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Running cobas® SARS-CoV-2 & Influenza A/B on cobas® 5800 System

The test procedure is described in detail in the cobas® 5800 Systems User Assistance and/or User Guide. Figure 1 below
summarizes the procedure.
Figure 1 cobas® SARS-CoV-2 & Influenza A/B test procedure on cobas® 5800 System
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Running cobas® SARS-CoV-2 & Influenza A/B on cobas® 6800/8800 Systems

The test procedure is described in detail in the cobas® 6800/8800 Systems User Assistance and/or User Guide. Figure 2
below summarizes the procedure.
Figure 2 cobas® SARS-CoV-2 & Influenza A/B procedure on the cobas® 6800/8800 Systems
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Results
The cobas® 5800 System and cobas® 6800/8800 Systems automatically detects the SARS-CoV-2, influenza A and influenza B,
for each individually processed sample and control, displaying individual target results for samples as well as test
validity and overall results for controls.
Quality control and validity of results on the cobas® 5800 System

 One cobas® Buffer Negative Control [BUF (-) C] and one positive control [SCoV2-FluA/B CTL) are 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.
 In the cobas® 5800 System software and/or report, check for flags and their associated results to ensure the
result validity.
Invalidation of results is performed automatically by the cobas® 5800 software based on negative or positive control failures.
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.
Control results on cobas® 5800 System

The results of the controls are shown in the cobas® 5800 software in the “Controls” app.
 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 all or one 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 is shown in the detail view.
 If one of the controls is invalid, repeat testing of all controls and all associated samples is required.
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Interpretation of results on the cobas® 5800 System

The results of the samples are shown in the cobas® 5800 software in the “Results” app.
For a valid control batch, check each individual sample for flags in the cobas® 5800 System software and/or report. The
result interpretation should be as follows:
Table 14 Example of cobas® SARS-CoV-2 & Influenza A/B results display on cobas® 5800 System
Control Flags Creation
Sample ID* Test Status Result
Result ** date/time
SCoV2- SCoV2 PanSarb FluB 7/7/2021 8:27:39
Sample_01 Valid Released FluA Negative
FluA/B Negative Negative Negative AM
SCoV2- 7/7/2021 8:27:39
Sample_C1 Invalid Released Invalid Invalid Invalid Invalid
FluA/B AM
Sample_B1 Valid Released FluA Negative
SCoV2- FluA Positive SCoV2 PanSarb FluB 7/7/2021 8:27:39
Sample_B2 Valid Released
FluA/B (Ct 36.41) Negative Negative Negative AM
Sample_D1 Valid Released FluA Negative
SCoV2
SCoV2- PanSarb FluB 7/7/2021 8:27:39
Sample_A6 Valid Released FluA Negative Positive (Ct
FluA/B Negative Negative AM
35.25)
SCoV2- FluA Positive PanSarb FluB 7/7/2021 8:27:39
Sample_E1 Valid Released Invalid
FluA/B (Ct 37.69) Negative Negative AM
PanSarb
SCoV2- SCoV2 FluB 7/7/2021 8:27:39
Sample_A2 Valid Released Invalid Positive
FluA/B Negative Negative AM
(Ct 36.68)
* 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.
 Samples associated with a valid control batch are shown as “Valid” in the “Control result” column if all Control
Target Results reported valid. Samples associated with a failed control batch are shown as “Invalid” in the
“Control result” column if Control Results are reported invalid.
 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
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.
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Quality control and validity of results on the cobas® 6800/8800 Systems

 One cobas® Buffer Negative Control [BUF (-) C] and one positive control [SCoV2-FluA/B CTL] are processed
with each batch.
 In the cobas® 6800/8800 Systems software and/or report, check for flags and their associated results to ensure the batch
validity.
 The batch is valid if no flags appear for any controls. If the batch is invalid, repeat testing of the entire batch.
 All flags are described in the cobas® 6800/8800 Systems User Assistance and/or User Guide.
Validation of results is performed automatically by the cobas® 6800/8800 Systems software based on negative and
positive control performance.
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Interpretation of results on the cobas® 6800/8800 Systems

For a valid batch, check each individual sample for flags in the cobas® 6800/8800 Systems 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 to sample results for the cobas® SARS-CoV-2 &
Influenza A/B..
 Invalid results for one or more target combinations are possible and are reported out specifically for each target.
If any individual target result is invalid, the presence or absence of that individual target cannot be determined.
 Other initial valid target results can be interpreted as described in the table. Results and their corresponding
interpretation for detecting SARS-CoV-2 & Influenza A/B are shown in Table 16.
Results display examples for cobas® SARS-CoV-2 & Influenza A/B are shown in Table 15.
Table 15 Example of cobas® SARS-CoV-2 & Influenza A/B results display on cobas® 6800/8800 System
Overall
Test Sample ID Valid* Flags Sample type Target 1 Target 2 Target 3 Target 4
result*
SCoV2-FluA/B FluA SCoV2 PanSarb FluB
Sample_01 NA VTM NA
400 µL Negative Negative Negative Negative
SCoV2-FluA/B
Sample _02 NA Y40T VTM NA Invalid Invalid Invalid Invalid
400 µL
SCoV2-FluA/B FluA
SCoV2 PanSarb FluB
Sample _03 NA VTM NA Positive
400 µL Negative Negative Negative
SCoV2-FluA/B FluA
SCoV2 PanSarb FluB
Sample _04 NA VTM NA Negative
400 µL Positive Positive Negative
SCoV2-FluA/B FluA
SCoV2 PanSarb FluB
400 µL Negative Negative Positive
SCoV2-FluA/B FluA
SCoV2 PanSarb FluB
400 µL Negative Positive Negative
SCoV2-FluA/B FluA
Sample _07 NA C01H2 VTM NA Invalid Invalid Invalid
400 µL Positive
SCoV2-FluA/B SCoV2 FluB

Sample _08 NA C01H1 VTM NA Invalid Invalid
400 µL Positive Positive
SCoV2-FluA/B C161420284090428828404 Yes (-) Ctrl Valid Valid Valid Valid Valid
SCoV2-FluA/B
SCoV2-FluA/B C161420284093009580264 Yes Valid Valid Valid Valid Valid
(+) C
*The “Valid” and “Overall Result” columns are not applicable to sample results for cobas® SARS-CoV-2 & Influenza A/B. Refer to Table 16,
cobas® SARS-CoV-2 & Influenza A/B results interpretation, for specific instructions on test results interpretation.
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Interpretation of results
For a valid batch, check each individual sample for flags in the cobas® 5800 System and 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.
 Invalid results for one or more target combinations are possible and are reported out specifically for each channel.
 Results of this test should only be interpreted in conjunction with information available from clinical evaluation
of the patient and patient history.
Results display examples for cobas® SARS-CoV-2 & Influenza A/B are shown in Table 14 and Table 15.
Results and their corresponding interpretation for detecting SARS-CoV-2 & Influenza A/B are shown below (Table 16).
Table 16 Target results for individual target result interpretation
Target 3
Target 1 Target 2 Target 4
Pan- Interpretation
Influenza A SARS-CoV-2 Influenza B
Sarbecovirus
Negative Negative Negative Negative No target RNA Detected
Negative Negative Negative Positive Influenza B RNA Detected
Positive Negative Negative Negative Influenza A RNA Detected
Positive Negative Negative Positive Influenza A and Influenza B RNA Detected
Presumptive Positive for SARS-CoV-2 RNA. A negative SARS-CoV-2 result and a
positive pan-Sarbecovirus results is suggestive of 1) a sample at concentrations
near or below the limit of detection of the test, 2) a mutation in the SARS-CoV-2
target region in the oligo binding site, 3) infection with some other Sarbecovirus
(e.g., SARS-CoV or some other Sarbecovirus previously unknown to infect humans),
Negative Negative Positive Negative
or 4) other factors.
For samples with a Presumptive Positive result, additional confirmatory testing may
be conducted, if it is necessary to differentiate between SARS-CoV-2 and SARS-
CoV-1 or other Sarbecovirus currently unknown to infect humans, for
epidemiological purposes or clinical management.
Presumptive Positive for SARS-CoV-2 RNA and Influenza B RNA Detected. A
negative SARS-CoV-2 result and a positive pan-Sarbecovirus results is suggestive
of 1) a sample at concentrations near or below the limit of detection of the test, 2) a
mutation in the SARS-CoV-2 target region in the oligo binding site, 3) infection with
some other Sarbecovirus (e.g., SARS-CoV or some other Sarbecovirus previously
Negative Negative Positive Positive
unknown to infect humans), or 4) other factors.
Influenza A RNA Detected and Presumptive Positive for SARS-CoV-2 RNA. A
negative SARS-CoV-2 result and a positive pan-Sarbecovirus results is suggestive
of 1) a sample at concentrations near or below the limit of detection of the test, 2) a
mutation in the SARS-CoV-2 target region in the oligo binding site, 3) infection with
some other Sarbecovirus (e.g., SARS-CoV or some other Sarbecovirus previously
Positive Negative Positive Negative
unknown to infect humans), or 4) other factors.
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Target 3
Target 1 Target 2 Target 4
Pan- Interpretation
Influenza A SARS-CoV-2 Influenza B
Sarbecovirus
Influenza A RNA Detected, Presumptive Positive for SARS-CoV-2 RNA, and
Influenza B RNA Detected. A negative SARS-CoV-2 result and a positive pan-
Sarbecovirus results is suggestive of 1) a sample at concentrations near or below
the limit of detection of the test, 2) a mutation in the SARS-CoV-2 target region in
the oligo binding site, 3) infection with some other Sarbecovirus (e.g., SARS-CoV or
Positive Negative Positive Positive
some other Sarbecovirus previously unknown to infect humans), or 4) other factors.
SARS-CoV-2 RNA Detected. A positive SARS-CoV-2 result and a negative pan-
Sarbecovirus results is suggestive of 1) a sample at concentrations near or below
Negative Positive Negative Negative
the limit of detection of the test, 2) a mutation in the pan-Sarbecovirus target
region, or 3) other factors.
SARS-CoV-2 RNA and Influenza B RNA Detected. A positive SARS-CoV-2 result
and a negative pan-Sarbecovirus results is suggestive of 1) a sample at
Negative Positive Negative Positive
concentrations near or below the limit of detection of the test, 2) a mutation in the
pan-Sarbecovirus target region, or 3) other factors.
Influenza A RNA and SARS-CoV-2 RNA Detected. A positive SARS-CoV-2 result
and a negative pan-Sarbecovirus results is suggestive of 1) a sample at
Positive Positive Negative Negative
concentrations near or below the limit of detection of the test, 2) a mutation in the
pan-Sarbecovirus target region, or 3) other factors.
Influenza A RNA, SARS-CoV-2 RNA, and Influenza B RNA Detected. A positive
SARS-CoV-2 result and a negative pan-Sarbecovirus results is suggestive of 1) a
Positive Positive Negative Positive
sample at concentrations near or below the limit of detection of the test, 2) a
mutation in the pan-Sarbecovirus target region, or 3) other factors.
Negative Positive Positive Negative SARS-CoV-2 RNA Detected
Negative Positive Positive Positive SARS-CoV-2 RNA and Influenza B RNA Detected
Positive Positive Positive Negative Influenza A RNA and SARS-CoV-2 RNA Detected
Positive Positive Positive Positive Influenza A RNA, SARS-CoV-2 RNA, and Influenza B RNA Detected
If any individual target result is invalid, the presence or absence of that individual target cannot be determined. Other
initial valid target results can be interpreted as described in Table 16.
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Procedural limitations
 cobas® SARS-CoV-2 & Influenza A/B has been evaluated only for use in combination with the cobas® SARS-CoV-2
& Influenza A/B 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® 5800/6800/8800
Systems.
 Reliable results depend on proper sample collection, storage and handling procedures.
 This test is intended to be used for the detection of SARS-CoV-2, Influenza A, and Influenza B RNA in
nasopharyngeal and nasal swab samples collected in a Copan Universal Transport Medium (UTM-RT®) or BD™
Universal Viral Transport System (UVT), and nasal swab samples collected in cobas® PCR Media and 0.9%
physiological saline. Testing of other sample types with cobas® SARS-CoV-2 & Influenza A/B may result in
inaccurate results.
 Detection of SARS-CoV-2 and Influenza A/B RNA may be affected by sample collection methods, patient factors
(e.g., presence of symptoms), and/or stage of infection.
 As with any molecular test, mutations within the target regions of cobas® SARS-CoV-2 & Influenza A/B could
affect primer and/or probe binding resulting in failure to detect the presence of virus.
 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. One hundred percent agreement between the results should not be expected due to aforementioned
differences between technologies. Users should follow their own specific policies/procedures.
 False negative or invalid results may occur due to interference. The Internal Control is included in
cobas® SARS-CoV-2 & Influenza A/B to help identify the specimens containing substances that may interfere
with nucleic acid isolation and PCR amplification.
 The addition of AmpErase enzyme into the cobas® SARS-CoV-2 & Influenza A/B Master Mix reagent enables
selective amplification of target RNA; however, good laboratory practices and careful adherence to the
procedures specified in this Instructions For Use document are necessary to avoid contamination of reagents.
 Results (positive and negative) for influenza should be interpreted with caution. If an influenza result is
inconsistent with clinical presentation and/or other clinical and epidemiological information, authorized or
licensed Influenza NAATs are available for confirmation if clinically indicated.
 The performance of this test was established based on the evaluation of a limited number of clinical specimens.
The clinical performance has not been established in all circulating variants but is anticipated to be reflective of
the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of
testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and
their prevalence, which change over time.
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Non-clinical performance evaluation

Analytical sensitivity (Limit of Detection)
The LoD study determines the lowest detectable concentration of SARS-CoV-2, influenza A, and influenza B at
which greater or equal to 95% of all (true positive) replicates test positive.
To determine the LoD, six cultured viruses – two each of influenza A and influenza B strains as well as the live and
the heat-inactivated form of SARS-CoV-2 isolate from a US patient – were serially diluted in simulated clinical
matrix to build two co-formulated target panels and three target single-formulated panels with one strain per virus.
Seven to eight concentration levels, with two-fold serial dilutions between the levels, were prepared on three days and
tested with a total of 63 replicates per concentration across three reagent lots for co-formulated panels and with a
total of 21 replicates per concentration using one reagent lot for single-formulated panels. Table 17 to Table 20
summarize the established LoD values.
Table 17 Summary of LoD for influenza A
95% Probit 95% CI of Probit Hit rate ≥ 95% Mean Ct at ≥ 95%

Viral Strain Kit lot Panel Hit rate
[TCID50/mL] [TCID50/mL] [TCID50/mL]
Lot 1 single-formulated 0.050 0.034 – 0.098 0.036 38.2
Lot 1 co-formulated 0.12 0.073 – 0.28 0.071 36.6

A/Kansas/14/2017 (H3N2)
Cat No 0810586CF Lot 2 co-formulated 0.083 0.054 – 0.17 0.14 36.7
Lot 323540
Lot 1-3 co-formulated 0.086 0.065 – 0.12 0.071 37.5
A/Brisbane/02/2018 (H1N1) Lot 2 co-formulated 0.020 0.013 – 0.064 0.026 38.4

Cat No 0810585CF
Lot 323771 Lot 3 co-formulated 0.025 0.016 – 0.059 0.026 38.1
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Table 18 Summary of LoD for influenza B
95% Probit 95% CI of Probit Hit rate ≥95% Mean Ct at ≥95%

B/Phuket/3073/2013 Lot 1 co-formulated 0.019 0.012 – 0.044 0.034 35.1

(Yamagata lineage)
Cat No 0810515CF

B/Colorado/06/2017
(Victoria lineage) Lot 2 co-formulated 0.032 0.019 – 0.084 0.053 34.5
Cat No 0810573CF 35.0
Lot 3 co-formulated 0.019 0.012 – 0.050 0.026
Lot 323459
Table 19 Summary of LoD for SARS-CoV-2
95% Probit 95% CI of Probit Hit rate ≥95% Mean Ct at ≥95%

USA-WA1/2020 Lot 1 co-formulated 0.14 0.086 – 0.35 0.12 36.3

heat-inactivated
Cat No 0810587CFHI

USA-WA1/2020
infectious culture Lot 2 co-formulated 0.0071 0.0044 – 0.018 0.0079 36.2
Cat No NR-52281 Lot 3 co-formulated 0.0052 0.0032 – 0.013 0.0079 35.9
Lot 70033175*
*Based on the information provided in the Certificate of Analysis from the vendor, 1 TCID50/mL is equal to 7,393 genome equivalents by ddPCR.
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Table 20 Summary of LoD for pan-Sarbecovirus
95% Probit 95% CI of Probit Hit rate ≥95% Mean Ct at

Viral Strain Kit lot Panel ≥95% Hit rate
USA-WA1/2020 Lot 1 co-formulated 0.28 0.17 – 0.67 0.55 34.5

heat-inactivated
Cat No 0810587CFHI

USA-WA1/2020
infectious culture
Cat No NR-52281 Lot 3 co-formulated 0.0080 0.0053 – 0.017 0.0079 35.3
Lot 70033175*
*Based on the information provided in the Certificate of Analysis from the vendor, 1 TCID50/mL is equal to 7,393 genome equivalents by ddPCR.
Analytical sensitivity using WHO International Standard

The SARS-CoV-2 and pan-Sarbecovirus specific limit of detection of the cobas® SARS-CoV-2 & Influenza A/B was
evaluated additionally by using the following standard.
 WHO International Standard SARS-CoV-2 RNA (NIBSC code: 20/146)
The WHO International Standard) was diluted in simulated clinical matrix stabilized in UTM™ to prepare a low
positive panel.
Five concentration levels plus blank, with two-fold serial dilutions between the levels, were prepared on three days
and tested with a total of 62 replicates per concentration and lots. Table 21 and Table 22 summarize the established
LoD values.
Table 21 Summary of WHO Standard LoD for Target 1 (SARS-CoV-2)
95% CI of Probit Hit rate ≥95% Mean Ct at ≥95% Hit

Kit Lot 95% Probit [IU/mL]
[IU/mL] [IU/mL] rate
Lot 1 45 29-114 63 36.9
Lot 2 28 20-71 63 36.5
Lot 3 24 18-47 31 36.6
Combined 32 26-46 63 36.7
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Table 22 Summary of WHO Standard LoD for Target 2 (Pan-Sarbecovirus)
95% CI of Probit Hit rate ≥95% Mean Ct at ≥95% Hit

Kit Lot 95% Probit [IU/mL]
[IU/mL] [IU/mL] rate
Lot 1 82 53-192 63 35.0
Lot 2 54 35-141 63 34.8
Lot 3 33 24-64 63 35.0
Combined 56 43-82 63 35.1
Inclusivity
The inclusivity of cobas® SARS-CoV-2 & Influenza A/B for the detection of influenza A, influenza B and SARS-CoV-2 was
confirmed by testing ten influenza A, five influenza B and three SARS-CoV-2 strains. The lowest target analyte at which all
four tested replicates were positive are reported in Table 23 and Table 24. Further, cobas® SARS-CoV-2 & Influenza A/B was
shown to be inclusive for the CDC Human Influenza Virus Panel (2020) (Cat. Number VP2020, Lot Number 200330). The
lowest concentration where at least one out of five replicates was positive is reported as the minimum reactive concentration
in Table 25.
Table 23 Summary of inclusivity
Catalog Lowest Concentration

Viral Target Strain Lot Number
Number Detected
A/Canada/6294/09 (H1N1) 0810109CFJ 315868 (sublot: 527158) 0.002 TCID50/mL
A/California/07/09 (H1N1) 0810165CF 319956 (sublot: 533042) 0.026 TCID50/mL
A/Mexico/4108/09 (H1N1) 0810166CF 313217 (sublot: 514161) 0.0062 TCID50/mL
A/Texas/50/12 (H3N2) 0810238CF 318887 (sublot: 529536) 0.45 TCID50/mL
A/Singapore/63/04 (H1N1) 0810246CF 315905 (sublot: 525169) 0.0069 TCID50/mL
Influenza A
A/Perth/16/09 (H3N2) 0810251CF 313218 (sublot: 522582) 0.014 TCID50/mL
A/Wisconsin/67/05 (H3N2) 0810252CF 318888 (sublot: 531612) 0.041 TCID50/mL
A/Switzerland/9715293/13 (H3N2) 0810511CF 319398 (sublot: 526171) 0.0069 TCID50/mL
A/HongKong/4801/14 (H3N2) 0810526CF 317320 (sublot: 529140) 0.097 TCID50/mL
A/Michigan/45/15 (H1N1) 0810538CF 321053 (sublot: 533618) 0.013 TCID50/mL
B/Brisbane/60/2008 (Victoria lineage) 0810254CF 313257 (sublot: 513438) 0.002 TCID50/mL
B/Utah/9/14 (Yamagata lineage) 0810516CF 317295 (sublot: 527062) 0.017 TCID50/mL
Influenza B B/Alabama/2/17 (Victoria lineage) 0810572CF 322548 0.0064 TCID50/mL
B/Florida/78/2015 (Victoria Lineage) VR-1931 70020870 0.076 TCID50/mL
B/Wisconsin/1/2010 (Yamagata Lineage) VR-1883 70012127 0.070 CEID50/mL
BetaCoV/France/IDF0372/2020 014V-03890 Not available 0.038 PFU/mL
SARS-CoV-2 BetaCoV/Munich/BavPat1/2020 026V-03883 Not available 0.0036 PFU/mL
2019-nCoV/Italy-INMI1 008V-03893 Not available 0.062 TCID50/mL
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Table 24 Summary SARS-CoV-2 variant testing
Variant Catalog Number Lot Number Lowest Concentration Detected
UK (B.1.1.7) 0810614CFHI 326230 7.1E+00 cp/mL
Japan/Brazil (P.1) NR-54982 70042875 1.4E+02 cp/mL
South Africa (B.1.351) 0810613CFHI 326229 7.0E+00 cp/mL

US NY (B.1.526) NR-55359 70043342 2.8E+02 cp/mL
India (B.1.617.1) NR-55486 70044706 2.5E+02 cp/mL
India (B.1.617.2) NR-55611 70045238 4.7E+01 cp/mL
Table 25 Summary of CDC Human Influenza Virus Panel (2020)
Minimum Reactive Concentration

Virus Strain
[EID50/mL]
A/Perth/16/2009 (H3N2) 2.62E+00
A/Hong Kong/2671/2019 (H3N2) 8.29E-02
Influenza A
A/Christ Church/16/2010 (H1N1 pdm) 2.08E+01
A/Guangdong-maonan/1536/2019 (H1N1 pdm) 6.00E-01
B/Michigan/09/2011 1.30E-02
B/Washington/02/2019 2.08E+00
Influenza B
B/Texas/81/2016 6.54E-02
B/Phuket/3073/2013 2.08E+01
Precision (repeatability)
Within-laboratory precision was examined using a panel composed of co-spiked influenza A (A/Kansas/14/2017),
influenza B (B/Phuket/3073/2013) and SARS-CoV-2 (USA-WA1/2020, heat-inactivated) cultures diluted in
simulated clinical matrix in UTM-RT®. Sources of variability were examined with a panel consisting of three
concentration levels, using three lots of cobas® SARS-CoV-2 & Influenza A/B reagents and two instruments over a
time course of 15 days for a total of 30 runs. A description of the precision panel and the observed positivity rates are
shown in Table 26. All negative panel members tested negative throughout the study. Analysis of standard deviation
and percent coefficient of variation (CV) of the Ct values from tests performed on positive panel members (see Table 27)
yielded overall CV percentage ranging from 1.1% to 5.2% for influenza A, influenza B, and SARS-CoV-2.
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Table 26 Summary of within laboratory precision
95% Confidence Interval

Target Concentration N Tested N Positive Positivity Rate
Lower Limit Upper Limit
Influenza A
Negative 90 0 0% 0% 4.1%
Weak Positive
~ 0.3x LoD 90 87 96.7%% 90.7% 98.9%
(0.043 TCID50/mL)
Low Positive
~ 1x LoD 90 90 100% 95.9% 100%
(0.14 TCID50/mL)
Moderate Positive
~ 3x LoD 90 90 100% 95.9% 100%
(0.43 TCID50/mL)
Influenza B
Negative 90 0 0% 0% 4.1%
Weak Positive
~ 0.3x LoD 90 81 90.0% 82.1% 94.7%
(0.010 TCID50/mL)
Low Positive
~ 1x LoD 90 90 100% 95.9% 100%
(0.034 TCID50/mL)
Moderate Positive
~ 3x LoD 90 90 100% 95.9% 100%
(0.10 TCID50/mL)
SARS-CoV-2
Negative 90 0 0% 0% 4.1%
Weak Positive
~ 0.3x LoD 90 83 92.2% 84.8% 96.2%
(0.035 TCID50/mL)
Low Positive
~ 1x LoD 90 87 96.7% 90.7% 98.9%
(0.12 TCID50/mL)
Moderate Positive 90
~ 3x LoD 90 100% 95.9% 100%
(0.35 TCID50/mL)
pan-Sarbecovirus
Negative 90 0 0% 0% 4.1%
Weak Positive 90
~ 0.06x LoD 73 81.1% 71.8% 87.9%
(0.035 TCID50/mL)
Low Positive 90
~ 0.2x LoD 87 96.7% 90.7% 98.9%
(0.12 TCID50/mL)
Moderate Positive 90
~ 0.6x LoD 90 100% 95.9% 100%
(0.35 TCID50/mL)
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Table 27 Overall mean, standard deviation, and percent coefficient of variation for Ct values by positive panel member
Between
Target Positivity Mean Between lot Between day Between run Within run Total
instrument
Concentration Rate Ct
SD CV% SD CV% SD CV% SD CV% SD CV% SD CV%
Influenza A
Weak Positive ~
0.3x LoD 96.7% 38.3 0.00 0.0 0.29 0.8 0.43 1.1 0.00 0.0 1.90 5.0 1.97 5.1
(0.042 TCID50/mL)
Low Positive
~ 1x LoD 100% 35.7 0.00 0.0 0.00 0.0 0.19 0.5 0.15 0.4 0.90 2.5 0.93 2.6
(0.14 TCID50/mL)
Moderate Positive
~ 3x LoD 100% 34.3 0.11 0.3 0.00 0.0 0.11 0.3 0.00 0.0 0.43 1.2 0.46 1.3
(0.42 TCID50/mL)
Influenza B
Weak Positive
~ 0.3x LoD 90.0% 35.6 0.11 0.3 0.00 0.0 0.23 0.6 0.09 0.3 0.62 1.7 0.67 1.9
(0.010 TCID50/mL)
Low Positive
~ 1x LoD 100% 34.7 0.00 0.0 0.00 0.0 0.19 0.5 0.21 0.6 0.51 1.5 0.58 1.7
(0.034 TCID50/mL)
Moderate Positive
~ 3x LoD 100% 33.8 0.07 0.2 0.00 0.0 0.17 0.5 0.00 0.0 0.82 2.4 0.84 2.5
(0.10 TCID50/mL)
SARS-CoV-2
Weak Positive
~ 0.3x LoD 92.2% 36.6 0.00 0.0 0.00 0.0 0.32 0.9 0.07 0.2 0.6 1.6 0.68 1.9
(0.035 TCID50/mL)
Low Positive
~ 1x LoD 96.7% 35.7 0.06 0.2 0.07 0.2 0.00 0.0 0.05 0.1 0.40 1.1 0.42 1.2
(0.12 TCID50/mL)
Moderate Positive
~ 3x LoD 100% 34.6 0.17 0.5 0.00 0.0 0.19 0.6 0.00 0.0 0.57 1.7 0.63 1.8
(0.35 TCID50/mL)
pan-Sarbecovirus
Weak Positive
~ 0.06x LoD 81.1% 35.8 0.00 0.0 0.00 0.0 0.16 0.4 0.11 0.3 0.63 1.8 0.66 1.8
(0.035 TCID50/mL)
Low Positive
~ 0.2x LoD 96.7% 34.9 0.00 0.0 0.06 0.2 0.00 0.0 0.00 0.0 0.52 1.5 0.52 1.5
(0.12 TCID50/mL)
Moderate Positive
~ 0.6x LoD 100% 33.9 0.13 0.4 0.00 0.0 0.10 0.3 0.00 0.0 0.54 1.6 0.57 1.7
(0.35 TCID50/mL)
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Analytical specificity (cross-reactivity and microbial interference)

A panel of 41 viruses, bacteria, and fungi (including those commonly found in respiratory tract) were tested with
cobas® SARS-CoV-2 & Influenza A/B to assess analytical specificity. The organisms listed in Table 28 were spiked at
concentrations of 1 x 105 units/mL for viruses and 1 x 106 units/mL for other organisms, unless otherwise noted.
Testing was performed with each potential interfering organism in the absence and presence of influenza A,
influenza B, and SARS-CoV-2 target (spiked at ~3x LoD – 0.42, 0.10 and 0.36 TCID50/mL, respectively). None of the
organisms interfered with the test performance by generating false positive results. Testing of SARS-CoV-1 generated
an expected pan-Sarbecovirus positive result. Detection of influenza A, influenza B, and SARS-CoV-2 targets was not
affected in the presence of the organisms tested. Potential cross-reactivity of influenza C, Leptospira interrogans,
Chlamydia psittaci, Bacillus anthracis and Coxiella burnetii was evaluated in silico. Based on the in silico analyses,
selected organisms are highly unlikely to interfere with the performance of cobas® SARS-CoV-2 & Influenza A/B.
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Table 28 Microorganisms tested for analytical specificity/cross reactivity

Microorganism Concentration
Adenovirus (AdV-1) 1.0E+05 TCID50/mL

Bordetella pertussis 1.0E+06 CFU/mL
Candida albicans 1.0E+06 CFU/mL
Chlamydia pneumoniae 7.9E+04 TCID50/mL
Corynebacterium diphtheriae 1.0E+06 CFU/mL
Cytomegalovirus 1.0E+05 IU/mL
Enterovirus (EV68) 1.0E+05 TCID50/mL
Epstein Barr Virus 1.0E+05 cp/mL
Escherichia coli 1.0E+06 CFU/mL
Haemophilus influenzae 1.0E+06 CFU/mL
Human coronavirus 229E 1.0E+05 TCID50/mL
Human coronavirus HKU1 1.0E+05 genome cp/mL
Human coronavirus NL63 2.5E+04 TCID50/mL
Human coronavirus OC43 1.0E+05 TCID50/mL
Human Metapneumovirus 1.0E+05 TCID50/mL
Lactobacillus acidophilus 1.0E+06 CFU/mL
Legionella pneumophila 1.0E+06 CFU/mL
Legionella longbeachae 1.0E+06 CFU/mL
Measles virus 1.0E+05 TCID50/mL
MERS-coronavirus 1.0E+05 cp/mL
Moraxella catarrhalis 1.0E+06 CFU/mL
Mumps Virus 1.0E+05 TCID50/mL
Mycobacterium tuberculosis 1.0E+06 CFU/mL
Mycoplasma pneumoniae 1.0E+06 CCU/mL
Neisseria elongata 1.0E+06 CFU/mL
Neisseria meningitidis 1.0E+06 CFU/mL
Parainfluenza virus 1 1.0E+05 TCID50/mL
Parechovirus 1.0E+05 TCID50/mL
Pseudomonas aeruginosa 1.0E+06 CFU/mL
Pneumocystis jirovecii 5.0E+03 organisms/mL
Respiratory Syncytial Virus 1.0E+05 PFU/mL
Human Rhinovirus 1.0E+05 PFU/mL
SARS-coronavirus (SARS-CoV-1) 1.0E+05 PFU/mL
Staphylococcus aureus 1.0E+06 CFU/mL
Staphylococcus epidermidis 1.0E+06 CFU/mL
Streptococcus salivarius 1.0E+06 CFU/mL
Streptococcus pneumoniae 1.0E+06 CFU/mL
Streptococcus pyogenes 1.0E+06 CFU/mL
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Interference
The effect of exogenous substances potentially secreted into respiratory specimens was evaluated (Table 29). Each potentially
interfering substance was tested at or above clinically relevant levels in negative simulated clinical matrix stabilized in UTM™
in absence and presence of influenza A, influenza B, and SARS-CoV-2 target (spiked at ~3x LoD – 0.42, 0.10 and 0.36
TCID50/mL, respectively).
None of the substances interfered with the test performance by generating false-negative or false-positive results. None of
the substances interfered with the test performance by generating invalid results.
Table 29 List of exogenous substances tested for interference
Substance Concentration
Oxymetazoline 0.011 mg/mL
Luffa operculata 2.99 mg/mL
Thryallis glauca 2.99 mg/mL
Histaminum 1.50 mg/mL
Sulfur 1.50 mg/mL
Lidocaine 2.68 mg/mL
Budesonide 0.039 mg/mL
Glycerin 10.31 mg/mL
Phenol 0.47 mg/mL
Fluticasone propionate 166.67 µg/mL
Mupirocin 0.20 mg/mL
Zanamivir 0.0015 mg/mL
Oseltamivir 0.0073 mg/mL
Benzocaine 5.00 mg/mL
Menthol 1.20 mg/mL
Tobramycin 0.018 mg/mL
Additionally, FluMist® Quadrivalent, a live quadrivalent vaccine for administration by intranasal spray, and containing
two Influenza A and two Influenza B vaccine virus strains, was tested (Table 30) in negative simulated clinical matrix
stabilized in UTM™ in absence and presence of influenza A, influenza B, and SARS-CoV-2 target (spiked at ~3x LoD –
0.42, 0.10 and 0.36 TCID50/mL, respectively). As expected, cobas® SARS-CoV-2 & Influenza A/B generated positive results
for the Influenza A and Influenza B targets and negative results for the SARS-CoV-2 targets when solely testing FluMist®
Quadrivalent and all positive results for influenza A, influenza B and SARS-CoV-2 targets when additionally spiking with
low levels of co-formulated influenza A, influenza B and SARS-CoV-2.
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Table 30 FluMist® Quadrivalent tested for interference
Product Substance Concentration

influenza A virus
A/Hawaii/6 6/20 19 (H1N1) live
(attentuated) antigen
influenza A virus
A/Hong Kong/26 71/20 19 (H3N2) live
FluMist® Quadrivalent (Influenza
1336620.81 FFU/mL
Vaccine Live, Intranasal)
influenza B virus
B/Phuket/30 73/20 13 live
influenza B virus
B/Washington/0 2/20 19 live
Endogenous substances that may be present in respiratory specimens were tested for interference (Table 31). Each potentially
interfering substance was tested at or above clinically relevant levels in negative simulated clinical matrix stabilized in
UTM™ in absence and presence of influenza A, influenza B, and SARS-CoV-2 target (spiked at ~3x LoD – 0.42, 0.10 and
0.36 TCID50/mL, respectively).
None of the substances interfered with the test performance by generating false-negative, false-positive or invalid/non-
reportable results.
Table 31 List of endogenous substances tested for interference
Substance Concentration
Mucin 0.5 % (w/v)
Human Whole Blood 1.5 % (v/v)
Co-infection (competitive interference)

To assess potential competitive interference between influenza A, influenza B, and SARS-CoV-2, samples were
tested in replicates of 5 where low (approximately 3x LoD) concentrations of any two targets were mixed with very
high (1.0E+05 TCID50/mL) concentrations of the third target. None of the targets present at very high concentration
interfered with the detection of low levels of the other two targets.
Collection media equivalence

Equivalence between different collection media (UTM-RT®, cobas® PCR Media, and saline) was evaluated using one
strain each for influenza A (A/Kansas/14/2017 (H3N2)), influenza B (B/Phuket/3073/2013 (Yamagata lineage)) and
SARS-CoV-2 (USA-WA1/2020, heat-inactivated culture). Virus cultures were co-formulated to a target
concentration of approximately 2x LoD into simulated clinical matrix formulated either in Universal Transport
Media (UTM-RT®), cobas® PCR Media (CPM), or in 0.9% physiological saline. A total of 21 replicates were tested for
each collection media type. All replicates tested were positive in all simulated matrices for influenza A and influenza B.
For SARS-CoV-2, positivity rates were 100% for both UTM-RT® and CPM and 95.2% for saline.
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Whole system failure

The whole system failure rate was assessed by testing 100 specimens of simulated clinical matrix co-spiked with one strain
each for influenza A (A/Kansas/14/2017 (H3N2)), influenza B (B/Phuket/3073/2013 (Yamagata lineage)) and SARS-CoV-2
(USA-WA1/2020, heat-inactivated culture) to a concentration of approximately 3x LoD of the respective target. The results
of this study determined that all replicates were valid and positive for influenza A, influenza B and SARS-CoV-2, resulting
in a whole system failure rate of 0% with an upper one-sided 95% confidence interval of 3.0%.
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Clinical performance evaluation

Performance with archived and banked clinical specimens
The performance of cobas® SARS-CoV-2 & Influenza A/B was evaluated at one external site using archived
nasopharyngeal swab (NPS) samples from patients with signs and symptoms of a respiratory infection, collected in UTM-
RT® or UVT. Clinical samples were collected by qualified personnel according to the package insert of the collection device.
The clinical evaluation study included a total of 349 NPS samples, 57 of which were longitudinal samples from COVID-19
patients. cobas® SARS-CoV-2 and cobas® Influenza A/B & RSV for use on the cobas® Liat® System were utilized as the
comparator test for assessment of performance of the cobas® SARS-CoV-2 & Influenza A/B for SARS-CoV-2 and
Influenza A/B, respectively, in the clinical evaluation. One of the 349 NPS samples did not have a valid comparator SARS-
CoV-2 result and five of the 349 NPS samples did not have valid comparator influenza A/B results, therefore, were
excluded from the performance calculations for SARS-CoV-2 and influenza A and influenza B, respectively.
As shown in Table 32, the cobas® SARS-CoV-2 & Influenza A/B demonstrated high percent agreement with the
comparator tests for the detection of SARS-CoV-2, influenza A, and influenza B.
Table 32 Comparison of cobas® SARS-CoV-2 & Influenza A/B with cobas® SARS-CoV-2 and cobas® Influenza A/B & RSV for use on the
cobas® Liat® System
Test Results Agreement Statistics

Number of Concordant Discordant Concordant Discordant Percent
Virus Agreement 95% CI
Samples Positive Positive Negative Negative Agreement
Parameter (LCL, UCL)*
(N) (N) (N) (N) (%)
PPA 96.0% (86.5%, 98.9%)
SARS-CoV-2 348 48 10 288 2
NPA 96.6% (93.9%, 98.2%)
Pan- PPA 96.2% (87.2%, 99.0%)
348 51 4 291 2
Sarbecovirus NPA 98.6% (96.6%, 99.5%)
Combined PPA 96.4% (87.7%, 99.0%)
348 53 6 287 2
SARS-CoV-2 # NPA 98.0% (95.6%, 99.1%)
PPA 100.0% (94.0%, 100.0%)
Influenza A 344 60 1 283 0
NPA 99.6% (98.0%, 99.9%)
PPA 100.0% (90.6%, 100.0%)
Influenza B 344 37 1 306 0
NPA 99.7% (98.2%, 99.9%)
PPA = Positive Percent Agreement
NPA = Negative Percent Agreement
CI = confidence interval; LCL = Lower confidence Limit; UCL = Upper confidence Limit
*Confidence interval is calculated using Wilson's Score method
# A positive result is defined as detection of either of the two SARS-CoV-2 or pan-Sarbecovirus target of the assay
Discordant results between the cobas® SARS-CoV-2 & Influenza A/B assay and the comparator methods were observed
for 10 samples. Of these, 8 were longitudinal samples with discordant results for SARS-CoV-2 that showed late Ct values
(between 35-43), which are indicative of samples from recovery/convalescent patients with decreasing viral loads close to
or below the limit of detection of both the cobas® SARS-CoV-2 & Influenza A/B and cobas® SARS-CoV-2 tests. cobas®
SARS-CoV-2 & Influenza A/B detected an additional influenza A virus and an additional influenza B virus positive sample
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compared to cobas® Influenza A/B & RSV for use on the cobas® Liat® System. Post-PCR analysis of the amplicon from all
discordant samples confirmed the presence of SARS-CoV-2 and influenza A but not influenza B.
Performance with prospective and archived clinical specimens

The performance of cobas® SARS-CoV-2 & Influenza A/B was evaluated in a multi-center study with three external testing
sites evaluating prospectively collected clinical specimens in viral transport media (VTM) from individuals with signs and
symptoms of respiratory infection. Participants from 12 geographically distributed enrollment centers provided
nasopharyngeal (NPS) and nasal swab (NS, anterior nares) specimens as part of a dual collection procedure where (a) the
collection order was varied such that the first specimen collected will be ~50% NPS and ~50% NS, and (b) the collection
method for NS specimens was also varied to yield ~50% self-collected and ~50% healthcare worker–collected.
The study used a commercial, clinically-validated test as the comparator for influenza A and influenza B. For SARS-CoV-2,
the study used a composite comparator method wherein laboratory sites used up to 3 highly-sensitive EUA SARS-CoV-2
assays to determine the infective status by majority rule. The SARS-CoV-2 composite comparator status was defined as the
concordant results from 2 comparator assays (test A and test B). In case of discordance between the initial 2 comparator
assays, the sample was tested by a third assay (test C) and the result of the third test determined the composite comparator
status. The composite comparator status was indeterminant when valid results could not be obtained from all required
methods (i.e., insufficient volume for repeat testing of invalid/failed results). For candidate or comparator methods
reporting results from multiple detection channels, i.e., both targets of a dual target assay, samples were determined to be
positive if target was detected in 1 or more individual detection channels.
From March to June 2021, a total of 1154 participants were enrolled, of which samples from 968 participants were
included in the evaluation. Samples from 186 participants were not included; 184 primarily due to issues associated with
specimen shipments and/or being unable to complete testing within the times identified by manufacturer’s instructions,
and 2 for being previously enrolled in the study (exclusion criteria). Approximately 30% of the 968 participants self-
reported having at least one dose of a COVID-19 vaccine and 7% reported having received an intramuscular influenza
vaccination within six weeks prior to enrollment.
The 968 participants each provided at least one specimen, resulting in testing of 961 NPS and 964 NS fresh prospective
specimens. In addition, to support the assessment of the influenza A and influenza B performance, 218 archived NPS
specimens collected during the 2014-2015 and 2019-2020 winter seasons were included in the evaluation.
The disposition of NPS specimens, by target, are as follows:
 SARS-CoV-2: Of the 961 paired NPS prospective specimens, 22 were non-evaluable pairs (1 for invalid/failed tests
on cobas® SARS-CoV-2 & Influenza A/B, 7 for indeterminate composite comparator status, and 14 non-evaluable
for both). The remaining 939 were evaluable pairs and used to determine the NPS performance estimates.
 Influenza A: Of the 1,179 paired NPS specimen results (961 prospective and 218 archived), 22 were non-evaluable
pairs (8 for invalid/failed tests on cobas® SARS-CoV-2 & Influenza A/B and 14 with both invalid/failed tests on
cobas® SARS-CoV-2 & Influenza A/B and the comparator method). The remaining 1,157 were evaluable pairs and
used to determine the NPS performance estimates for influenza A.
 Influenza B: Of the same 1,179 paired NPS specimen results, 21 were non-evaluable pairs (7 for invalid/failed tests
on cobas® SARS-CoV-2 & Influenza A/B and 14 with both invalid/failed tests on cobas® SARS-CoV-2 & Influenza
A/B and the comparator method). The remaining 1,158 were evaluable pairs and used to determine the NPS
performance estimates for influenza B.
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The disposition of the 964 prospective NS specimens, by target, are as follows:

 SARS-CoV-2: 22 specimens were non-evaluable (7 for indeterminate composite comparator status and 15 with
both invalid/failed tests on cobas® SARS-CoV-2 & Influenza A/B and indeterminate composite comparator status).
The remaining 942 were evaluable pairs and used to determine the NPS performance estimates.
 Influenza A and influenza B: 16 were non-evaluable pairs (1 for an invalid/failed test on the comparator method
and 15 with both invalid/failed tests on cobas® SARS-CoV-2 & Influenza A/B and the comparator method). The
remaining 948 were evaluable pairs and used to determine the NS performance estimates for influenza A and
influenza B.
The NPS performance estimates of cobas® SARS-CoV-2 & Influenza A/B in are shown in Table 33. The sensitivity (PPA)
and specificity (NPA), by virus are as follows:
 SARS-CoV-2: sensitivity (PPA) of 97.5% (77/79) and specificity (NPA) of 99.5% (856/860)
 Influenza A: sensitivity (PPA) of 98.8% (85/86) and specificity (NPA) of 99.6% (1,067/1,071)
 Influenza B: sensitivity (PPA) of 100% (56/56) and specificity (NPA) of 100% (1,102/1,102)
Table 33 Summary of clinical performance of cobas® SARS-CoV-2 & Influenza A/B by specimen category - nasopharyngeal swab
PPA LCL PPA UCL NPA LCL NPA UCL

Specimen Total
Target PPA 95% Score 95% Score NPA 95% Score 95% Score
Category (n)
CI CI CI CI
97.5 % 99.5 %
SARS-CoV-2 Prospective 939 91.2% 99.3% 98.8% 99.8%
(77/79) (856/860)
100.0%
Influenza A Prospective 946 NCa NCa NCa 99.6% 100.0%
(946/946)
98.8 % 96.8 %
Influenza A Archived 211 93.7% 99.8% 92.1% 98.7%
(85/86) (121/125)
99.6 %
98.8 %
Influenza A Overall 1157 93.7% 99.8% (1067/ 99.0% 99.9%
(85/86)
1071)
100.0%
Influenza B Prospective 946 NCa NCa NCa 99.6% 100.0%
(946/946)
100.0% 100.0%
Influenza B Archived 212 93.6% 100% 97.6% 100.0%
(56/56) (156/156)
100.0%
100.0%
Influenza B Overall 1158 93.6% 100% (1102/ 99.7% 100.0%
(56/56)
1102)
Note: CI = confidence interval, PPA = Positive Percent Agreement, NPA = Negative Percent Agreement, LCL = Lower Confidence Limit,
UCL = Upper Confidence Limit.
a
NC = Not Calculable due to insufficient sample size.
The summary of the NS clinical performance of cobas® SARS-CoV-2 & Influenza A/B for each target is presented in Table
34 by collection method (self-collected versus healthcare worker–collected). Overall, the clinical performance of cobas®
SARS-CoV-2 & Influenza A/B was similar between both collection methods.
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Table 34 Summary of clinical performance of cobas® SARS-CoV-2 & Influenza A/B - nasal swab by collection method
Specimen
type/ PPA LCL PPA UCL NPA LCL NPA UCL
Collection Total 95% Score 95% Score 95% Score 95% Score
Target method (N) PPA CI CI NPA CI CI
SARS-CoV-2 NS-S 481 100.0% 91.2% 100.0% 100.0% 99.1% 100.0%

(40/40) (441/441)
SARS-CoV-2 NS-H 461 92.5% 80.1% 97.4% 100.0% 99.1% 100.0%

(37/40) (421/421)
SARS-CoV-2 Overall 942 96.3% 89.5% 98.7% 100.0% 99.6% 100.0%

(77/80) (862/862)
Influenza A NS-S 483 0.0% 0.0% 79.3% 100.0% 99.2% 100.0%

(0/1) (482/482)
Influenza A NS-H 465 NCa NCa NCa 99.8% 98.8% 100.0%

(464/465)
Influenza A Overall 948 0.0% 0.0% 79.3% 99.9% 99.4% 100.0%

(0/1) (946/947)
Influenza B NS-S 483 NCa NCa NCa 100.0% 99.2% 100.0%

(483/483)
Influenza B NS-H 465 NCa NCa NCa 100.0% 99.2% 100.0%

(465/465)
Influenza B Overall 948 NCa NCa NCa 100.0% 99.6% 100.0%

(948/948)
Note: CI = confidence interval, PPA = Positive Percent Agreement, NPA = Negative Percent Agreement, LCL = Lower Confidence Limit,
UCL = Upper Confidence Limit. NS-S = Self Collected Nasal Swab Specimen. NS-H = Healthcare Collected Nasal Swab Specimen.
a
NC = Not Calculable
Reproducibility
The reproducibility of cobas® SARS-CoV-2 & Influenza A/B was evaluated across multiple factors that theoretically could
affect reported results, such as the following: reagent lot, testing site/instrument, day, and run. The evaluation was
conducted at 3 external testing sites, using 3 reagent lots, with a 4-member panel of positive and negative samples resulting
in a total number 180 tests per concentration (not including controls). The positive panel members contained viral culture
material of influenza A (Kansas/14/2017), influenza B (Phuket/3073/2013), and SARS-CoV-2 (USA-WA1/2020, heat-
inactivated) in universal transport medium (UTM) based simulated clinical matrix. Each site tested two reagent lots for 5
days. Two runs were performed each day and 3 replicates of each panel member were performed for each run. An overall
SARS-CoV-2 positive result was determined by a positive detection in either or both of the SARS-CoV-2 or/and
pan-Sarbecovirus channels. The overall evaluation results are summarized in Table 35.
The cobas® SARS-CoV-2 & Influenza A/B results showed good lot-to-lot, instrument-to-instrument (site), day or between
batch variation for the ~0.3x LoD, ~1x LoD and ~3x LoD panel members (Table 35). For all positive panel members, the
total CV (%) was ≤4.6% and within each component, the CV (%) was ≤4.2% with most of the variability attributable to
within-run.
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Table 35 Overall Mean Estimate, Standard Deviations, and Coefficients of Variation (%) for Cycle Threshold Values by Viral Target and Expected Viral Concentration (Positive Panel Members)
Panel
Within Within
Viral Member Mean Site Site Lot Lot Day Day Run Run Total Total
na/N Run Run
Target Concen- Ctb SD CV% SD CV% SD CV% SD CV% SDb CV(%)c
SD CV%
tration
SARS-CoV-2 ~0.3x LoD 124/180 37.3 0.00 0.0 0.00 0.0 0.00 0.0 0.24 0.6 0.74 2.0 0.78 2.1
SARS-CoV-2 ~1x LoD 178/180 36.3 0.02 0.1 0.00 0.0 0.00 0.0 0.22 0.6 0.82 2.2 0.85 2.3
SARS-CoV-2 ~3x LoD 180/180 35.4 0.21 0.6 0.00 0.0 0.00 0.0 0.00 0.0 0.43 1.2 0.48 1.3
Pan-Sarbecovirus ~0.3x LoD 120/180 36.4 0.27 0.7 0.00 0.0 0.22 0.6 0.14 0.4 0.80 2.2 0.88 2.4
Pan-Sarbecovirus ~1x LoD 176/180 35.5 0.04 0.1 0.00 0.0 0.13 0.4 0.19 0.5 0.70 2.0 0.74 2.1
Pan-Sarbecovirus ~3x LoD 180/180 34.6 0.15 0.4 0.08 0.2 0.06 0.2 0.00 0.0 0.38 1.1 0.42 1.2
Influenza A ~0.3x LoD 139/180 39.4 0.00 0.0 0.06 0.2 0.15 0.4 0.71 1.8 1.66 4.2 1.82 4.6
Influenza A ~1x LoD 178/180 37.4 0.41 1.1 0.00 0.0 0.27 0.7 0.00 0.0 1.25 3.4 1.35 3.6
Influenza A ~3x LoD 180/180 35.6 0.16 0.5 0.00 0.0 0.06 0.2 0.00 0.0 0.61 1.7 0.64 1.8
Influenza B ~0.3x LoD 130/180 36.1 0.00 0.0 0.00 0.0 0.06 0.2 0.00 0.0 0.62 1.7 0.62 1.7
Influenza B ~1x LoD 177/180 35.5 0.00 0.0 0.00 0.0 0.09 0.3 0.00 0.0 0.52 1.5 0.53 1.5
Influenza B ~3x LoD 180/180 34.7 0.07 0.2 0.06 0.2 0.00 0.0 0.00 0.0 0.32 0.9 0.33 1.0
Ct = cycle threshold; LoD = limit of detection; SD = standard deviation; CV(%) = percent coefficient of variation; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
Note: SARS-CoV-2 is a dual target assay. Inactivated viral culture material was diluted to ~0.3/1/3x LoD based on the target 2 (SARS-CoV-2) LoD.
a
n is the number of positive tests which contribute Ct values to the analysis. N is the total number of valid tests for the panel member.
b
The mean and total standard deviation (SD) estimates were calculated from the PROC MIXED procedure.
c
Total CV(%) = (SD/Mean)*100.
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The assay showed a 99.4% (95% CI = 96.9-100.0%) negative percent agreement when evaluating the negative panel
member. Of the 180 valid tests, 1 test was positive for both SARS-CoV-2 and Influenza B. While post-amplification DNA
sequencing was inconclusive due to PCR product degradation, the Ct values (SARS-CoV-2: 38.77; pan-Sarbecovirus:
negative; Influenza B: 36.35) and the curve analysis of the reactive negative panel member suggested a low level of
contamination during specimen handling.
System equivalency/system comparison

System equivalency of the cobas® 5800, cobas® 6800 and cobas® 8800 Systems was demonstrated via performance studies.
The results presented in the Instructions for Use support equivalent performance for all systems.
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Additional information
Key test features
Sample type Nasopharyngeal swab samples collected in the Copan UTM-RT® System
or the BD™ UVT System
Nasal swab samples collected in the Copan UTM-RT® System, the BD™
UVT System, the cobas® PCR Media, and 0.9% physiological saline
Minimum amount of sample required 0.6 mL or 1.0 mL*

Sample processing volume 0.4 mL
*Dead volume of 0.2 mL is identified for the cobas omni Secondary Tubes. Dead volume of 0.6 mL is identified for the
cobas® PCR Media primary tubes. Other tubes compatible with cobas® 5800 and cobas® 6800/8800 Systems (consult User Assistance and/or
User Guides) may have different dead volume and require more or less minimum volume.
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Symbols
The following symbols are used in labeling for Roche PCR diagnostic products.
Table 36 Symbols used in labeling for Roche PCR diagnostics products
Device not for
Age or Date of Birth QS IU per PCR reaction,
near-patient testing
use the QS International
Units (IU) per PCR reaction
Device not for in calculation of
Ancillary Software
self-testing the results.
Distributor
Assigned Range (Note: The applicable
Serial number
(copies/mL) country/region may be
designated beneath the symbol)
Assigned Range (IU/mL) Do not re-use Site
Authorized representative in
Female Standard Procedure
the European Community
Barcode Data Sheet For IVD performance Sterilized using

evaluation only ethylene oxide
Batch code Global Trade Item Number Store in dark
Biological risks Importer Temperature limit
In vitro diagnostic
Catalogue number Test Definition File
medical device
CE marking of conformity; Lower Limit of

this device is in conformity This way up
Assigned Range
with the applicable
requirements for CE marking
of an in vitro diagnostic Male Ultrasensitive Procedure
medical device
Collect date Manufacturer Unique Device Identifier
Consult instructions Upper Limit of

Negative control
for use Assigned Range
Contains sufficient
Non-sterile Urine Fill Line
for <n> tests
US Only: Federal law
restricts this device to sale
Content of kit Patient Name
by or on the order of a
physician.
Control Patient number Use-by date
Date of manufacture Peel here
Device for
Positive control
near-patient testing
QS copies per PCR

reaction, use the QS copies
Device for self-testing
per PCR reaction in
calculation of the results.
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Technical support
For technical support (assistance) please reach out to your local affiliate:
https://www.roche.com/about/business/roche_worldwide.htm
Manufacturer
Table 37 Manufacturer
Roche Molecular Systems, Inc.

1080 US Highway 202 South
Branchburg, NJ 08876 USA
www.roche.com
Made in USA
Trademarks and patents

See https://diagnostics.roche.com/us/en/about-us/patents
Copyright
©2023 Roche Molecular Systems, Inc.
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References
1. Center for Disease Control and Prevention. Biosafety in Microbiological and Biomedical Laboratories, 5th ed. U.S.
Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National
Institutes of Health HHS Publication No. (CDC) 21-1112, revised December 2009.
2. Clinical and Laboratory Standards Institute (CLSI). Protection of laboratory workers from occupationally acquired
infections. Approved Guideline-Fourth Edition. CLSI Document M29-A4:Wayne, PA;CLSI, 2014.
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Document revision
Document Revision Information
Doc Rev. 1.0 First Publishing
03/2023
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Doc Rev. 1.0 53

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cobas® SARS-CoV-2 & Influenza A/B

Qualitative nucleic acid test for use

cobas® SARS-CoV-2 & Influenza A/B P/N: 09446125190

cobas® SARS-CoV-2 & Influenza A/B Control Kit P/N: 09446133190

cobas® Buffer Negative Control Kit P/N: 09051953190

Quality control and validity of results on the cobas® 5800 System..................................................... 24

Analytical sensitivity (Limit of Detection) ............................................................................................ 31

Performance with archived and banked clinical specimens ............................................................... 43

Additional information ......................................................................................................... 49

Key test features ........................................................................................................................................ 49

Summary and explanation of the test

Explanation of the test

Principles of the procedure

Reagents and materials

cobas® SARS-CoV-2 & Influenza A/B reagents and controls

Table 1 cobas® SARS-CoV-2 & Influenza A/B

Table 2 cobas® SARS-CoV-2 & Influenza A/B Control Kit

Table 3 cobas® Buffer Negative Control Kit

cobas omni reagents for sample preparation

** Product safety labeling primarily follows EU GHS guidance

Reagent storage requirements

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

Reagent Storage temperature

cobas® SARS-CoV-2 & Influenza A/B 2–8°C

cobas® SARS-CoV-2 & Influenza A/B 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

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

Reagent Kit expiration Open-kit stability Number of runs for On-board

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 Amplification Plate 24 08499853001

cobas omni Liquid Waste Plate 24 08413983001

Tip CORE TIPS with Filter, 1 mL 04639642001

Tip CORE TIPS with Filter, 300 uL 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 07435967001

cobas omni Secondary Tubes 13x75 (optional) 06438776001

cobas® PCR Media Tube Replacement Cap Kit 07958056190

cobas® PCR Media Disposable Tube Stand (Optional) 07958064190

MPA RACK 16 MM LIGHT GREEN 7001-7050*,** 03143449001

RD5 RACK – RD Standard rack 0001-0050 LR*,** 11902997001

16-position tube carrier*,** 09224319001

5-position rack carrier* 09224475001

Additional materials required for cobas® 6800/8800 Systems

cobas omni Amplification Plate 05534941001

cobas omni Pipette Tips 05534925001

cobas omni Liquid Waste Container 07094388001