0104489403190c501V10.

ASLOT
Tina-quant Antistreptolysin O
Order information
Analyzer(s) on which cobas c pack(s) can be used
04489403 190 Tina‑quant Antistreptolysin O, 150 tests System‑ID 07 6865 0 Roche/Hitachi cobas c 311, cobas c 501/502
03555941 190 C.f.a.s. PAC (3 x 1 mL) Code 589
10557897 122 Precinorm Protein (3 x 1 mL) Code 302
11333127 122 Precipath Protein (3 x 1 mL) Code 303
05117003 190 PreciControl ClinChem Multi 1 (20 x 5 mL) Code 391
05947626 190 PreciControl ClinChem Multi 1 (4 x 5 mL) Code 391
05117216 190 PreciControl ClinChem Multi 2 (20 x 5 mL) Code 392
05947774 190 PreciControl ClinChem Multi 2 (4 x 5 mL) Code 392
04489357 190 Diluent NaCl 9 % (50 mL) System‑ID 07 6869 3

English
System information
For cobas c 311/501 analyzers:
ASLOT: ACN 037
For cobas c 502 analyzer: Warning
ASLOT: ACN 8037
H317 May cause an allergic skin reaction.
Intended use
Prevention:
In vitro test for the quantitative immunological determination of
antistreptolysin O in human serum and plasma on P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
Roche/Hitachi cobas c systems.
Summary1,2,3 P272 Contaminated work clothing should not be allowed out of
Group A streptococci cause different infections: skin diseases or angina the workplace.
tonsillaris that may be followed by glomerulonephritis, acute endocarditis,
Sydenham’s Chorea, and acute rheumatic fever, when the upper P280 Wear protective gloves.
respiratory tract is infected. These infections can later lead to damage of
the heart or the kidneys. Early diagnosis, efficient treatment and monitoring Response:
of the patient can reduce these risks. Several metabolites of β‑hemolyzing
streptococci are exogenous toxins for the human body, e.g. NAD P333 + P313 If skin irritation or rash occurs: Get medical
glycohydrolase, streptodornases (ADNases), and hyaluronidase which advice/attention.
induce immunological defense reactions. The most clinically important
antibody reactions are found against streptolysin O, streptococcal P362 + P364 Take off contaminated clothing and wash it before reuse.
deoxyribonuclease and streptococcal hyaluronidase. Disposal:
Immunological testing for specific antibodies provides useful information
about the degree of the streptococcal infection and the course of disease. P501 Dispose of contents/container to an approved waste
The determination of the level of antistreptolysin O antibodies (ASO) is the disposal plant.
most widely used. 85 % of patients with acute rheumatic fever show
increased ASO levels. ASO levels should be monitored several times at Product safety labeling primarily follows EU GHS guidance.
weekly intervals to obtain useful data. The titer development can indicate Contact phone: all countries: +49-621-7590
either a successful antibiotic treatment or the persisting antigen stimulus
even if the clinical signs of the infection have already disappeared. Reagent handling
Test principle4,5,6,7 Ready for use
Immunoturbidimetric assay. Mix cobas c pack well before placing on the analyzer.
Human antistreptolysin O antibodies agglutinate with latex particles coated Carefully invert reagent container several times prior to use to ensure that
with streptolysin O antigens. The precipitate is determined turbidimetrically. the reagent components are mixed.
Reagents - working solutions Storage and stability
R1 TRIS buffer: 170 mmol/L, pH 8.2 ASLOT
R2 Borate buffer: 10 mmol/L, pH 8.2; latex particles coated with Shelf life at 2‑8 °C: See expiration date
streptolysin O: 2 mL/L on cobas c pack
R1 is in position B and R2 is in position C. label.
Precautions and warnings On‑board in use and refrigerated on the analyzer: 12 weeks
For in vitro diagnostic use. Diluent NaCl 9 %
Exercise the normal precautions required for handling all laboratory Shelf life at 2‑8 °C: See expiration date
reagents.
Disposal of all waste material should be in accordance with local guidelines. on cobas c pack
Safety data sheet available for professional user on request. label.
This kit contains components classified as follows in accordance with the On‑board in use and refrigerated on the analyzer: 12 weeks
Regulation (EC) No. 1272/2008:
Specimen collection and preparation
For specimen collection and preparation only use suitable tubes or
collection containers.

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ASLOT
Tina-quant Antistreptolysin O

Only the specimens listed below were tested and found acceptable. Sample Diluent (NaCl)
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma Normal 2 µL – –
The use of plasma can lead to a decrease in antistreptolysin O activity of Decreased 4 µL 15 µL 168 µL
approximately 7 %. For samples with an activity below 100 IU/mL the Increased 2 µL – –
recovery in plasma can be either decreased or increased in comparison to
serum. cobas c 502 test definition
The sample types listed were tested with a selection of sample collection
tubes that were commercially available at the time of testing, i.e. not all Assay type 2‑Point End
available tubes of all manufacturers were tested. Sample collection systems Reaction time / Assay points 10 / 16‑28
from various manufacturers may contain differing materials which could
affect the test results in some cases. When processing samples in primary Wavelength (sub/main) –/700 nm
tubes (sample collection systems), follow the instructions of the tube Reaction direction Increase
manufacturer.
Centrifuge samples containing precipitates before performing the assay. Unit IU/mL
Reagent pipetting Diluent (H2O)
Stability:8 2 days at 20‑25 °C
R1 124 µL –
8 days at 4‑8 °C
R2 124 µL –
6 months at -20 °C
Sample volumes Sample Sample dilution
Materials provided
Sample Diluent (NaCl)
See “Reagents – working solutions” section for reagents.
Normal 2 µL – –
Materials required (but not provided)
Decreased 4 µL 15 µL 168 µL
▪ See “Order information” section
▪ General laboratory equipment Increased 4 µL – –
Assay Calibration
For optimum performance of the assay follow the directions given in this Calibrators S1: H2O
document for the analyzer concerned. Refer to the appropriate operator’s
manual for analyzer‑specific assay instructions. S2: C.f.a.s. PAC
The performance of applications not validated by Roche is not warranted Calibration mode Linear
and must be defined by the user.
Calibration frequency 2‑point calibration
Application for serum • after reagent lot change
cobas c 311 test definition • as required following quality control procedures
Assay type 2‑Point End Traceability: This method has been standardized against an internal
standard material.
Reaction time / Assay points 10 / 10‑19
Quality control
Wavelength (sub/main) –/700 nm
For quality control, use control materials as listed in the "Order information"
Reaction direction Increase section.
Unit IU/mL In addition, other suitable control material can be used.
Reagent pipetting Diluent (H2O) The control intervals and limits should be adapted to each laboratory’s
individual requirements. Values obtained should fall within the defined
R1 124 µL – limits. Each laboratory should establish corrective measures to be taken if
values fall outside the defined limits.
R2 124 µL –
Follow the applicable government regulations and local guidelines for
Sample volumes Sample Sample dilution quality control.
Sample Diluent (NaCl) Calculation
Normal 2 µL – – Roche/Hitachi cobas c systems automatically calculate the analyte
concentration of each sample.
Decreased 4 µL 15 µL 168 µL
Limitations - interference
Increased 2 µL – –
Criterion: Recovery within ± 10 % of initial value at an
antistreptolysin O activity of 200 IU/mL.
cobas c 501 test definition
Icterus:9 No significant interference up to an I index of 60 for conjugated
Assay type 2‑Point End and unconjugated bilirubin (approximate conjugated and unconjugated
Reaction time / Assay points 10 / 16‑28 bilirubin concentration: 1026 µmol/L or 60 mg/dL).
Wavelength (sub/main) –/700 nm Hemolysis:9 No significant interference up to an H index of 1000
(approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).
Reaction direction Increase Lipemia (Intralipid):9 No significant interference up to an L index of 1000.
Unit IU/mL There is poor correlation between the L index (corresponds to turbidity) and
triglycerides concentration.
Reagent pipetting Diluent (H2O)
Rheumatoid factors up to 180 IU/mL do not interfere.
R1 124 µL – High dose hook‑effect: No false result occurs up to an antistreptolysin O
R2 124 µL – concentration of 4000 IU/mL.
Sample volumes Sample Sample dilution Drugs: No interference was found at therapeutic concentrations using
common drug panels.10,11

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Tina-quant Antistreptolysin O

In very rare cases, gammopathy, in particular type IgM (Waldenström’s Precinorm Protein 151 4 2.6
macroglobulinemia), may cause unreliable results.12
Precipath Protein 277 6 2.2
For diagnostic purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical examination and other Human serum 3 123 3 2.5
findings. Human serum 4 256 4 1.7
ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory Method comparison
when certain test combinations are run together on Roche/Hitachi Antistreptolysin O values for human serum samples obtained on a
cobas c systems. The latest version of the carry‑over evasion list can be Roche/Hitachi cobas c 501 analyzer (y) were compared with those
found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further determined using the corresponding reagent on a
instructions refer to the operator’s manual. cobas c 502 analyzer: All Roche/Hitachi 917 analyzer (x).
special wash programming necessary for avoiding carry‑over is available Sample size (n) = 88
via the cobas link, manual input is not required.
Where required, special wash/carry‑over evasion programming must Passing/Bablok16 Linear regression
be implemented prior to reporting results with this test. y = 0.987x - 0.268 IU/mL y = 0.978x + 1.44 IU/mL
Limits and ranges τ = 0.981 r = 0.999
Measuring range
The sample concentrations were between 28.8 and 594 IU/mL.
20‑600 IU/mL
Determine samples having higher concentrations via the rerun function. References
Dilution of samples via the rerun function is a 1:6.1 dilution. Results from 1 Stollerman GH. Streptococcal antibodies in the diagnosis of rheumatic
samples diluted using the rerun function are automatically multiplied by a fever. In: Cohen AS, ed. Laboratory Diagnostic Procedures in the
factor of 6.1. Rheumatic Diseases. Boston: Little, Brown 1967;168-215.
Lower limits of measurement 2 Thomas L. Bakterielle Infektionen. In: Thomas L, ed. Labor und
Lower detection limit of the test Diagnose. 4th ed. Marburg: Die Medizinische Verlagsgesellschaft
20 IU/mL 1992;1492-1530.
The lower detection limit represents the lowest measurable analyte level 3 Greiling H, Gressner AM, Kleesiek K. Pathobiochemie und klinisch-
that can be distinguished from zero. It is calculated as the value lying chemische Diagnostik der Gelenkserkrankungen. In: Greiling H,
3 standard deviations above that of the lowest standard (standard 1 + 3 SD, Gressner AM, eds. Lehrbuch der Klinischen Chemie und
repeatability, n = 21). Pathobiochemie. Stuttgart: Schattauer 1987:912-927.
Expected values2 4 Galvin JP, Looney CE, Leflar CC, et al. Particle enhanced photometric
immunoassay systems. In: Nakamura RM, Dito WR, Tucker ES, eds.
Adults up to 200 IU/mL Clinical Laboratory Assays. New York: Masson 1983:73-95.
Children up to 150 IU/mL 5 Singer JM, Plotz CM. The latex fixation test. Am J Med
1956;21:888-892.
In some cases of streptococcal infections, particularly skin infections, there
may be no observable increase in the ASO titer. As antistreptolysin O is 6 Otsuji S, Kamada T, Matsuura T, et al. A rapid turbidimetric
only detectable in 85 % of all patients with rheumatic fever, the immunoassay for serum antistreptolysin O. J Clin Lab Anal
determination of anti‑streptococcal deoxyribonuclease antibodies and anti- 1990;4:241-245.
streptococcal hyaluronidase antibodies may also be necessary.2 7 Curtis GDW, Kraak WAG, Mitchell RG. Comparison of latex and
An appropriate evaluation of streptococcal infection is possible only if the haemolysin tests for determination of antistreptolysin O (ASO)
test is repeated after one or two weeks.13 Both clinical and laboratory antibodies. J Clin Pathol 1988;41:1331-1333.
findings should be correlated in reaching a diagnosis. 8 Guder WG, da Fonseca-Wollheim F, Heil W, et al. Quality of Diagnostic
ASO levels are age dependent and change with geographic location and Samples. Recommendations of the Working Group on Preanalytical
with the local frequency of streptococcal infections.14,15 Quality of the German Society for Clinical Chemistry and Laboratory
Each laboratory should investigate the transferability of the expected values Medicine, 3rd ed. 2010:34-35.
to its own patient population and if necessary determine its own reference 9 Glick MR, Ryder KW, Jackson SA. Graphical Comparisons of
ranges. Interferences in Clinical Chemistry Instrumentation. Clin Chem
Specific performance data 1986;32:470-475.
Representative performance data on the analyzers are given below. 10 Breuer J. Report on the Symposium “Drug effects in Clinical Chemistry
Results obtained in individual laboratories may differ. Methods”. Eur J Clin Chem Clin Biochem 1996;34:385-386.
Precision 11 Sonntag O, Scholer A. Drug interference in clinical chemistry:
recommendation of drugs and their concentrations to be used in drug
Precision was determined using human samples and controls in an internal interference studies. Ann Clin Biochem 2001;38:376-385.
protocol with repeatability (n = 21) and intermediate precision (3 aliquots
per run, 1 run per day, 21 days). The following results were obtained: 12 Bakker AJ, Mücke M. Gammopathy interference in clinical chemistry
assays: mechanisms, detection and prevention.
Repeatability Mean SD CV Clin Chem Lab Med 2007;45(9):1240-1243.
IU/mL IU/mL % 13 Tietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia,
PA: WB Saunders Company 1995;919.
Precinorm Protein 145 2 1.6 14 Coburn AF, Pauli RH. Limited observations on the antistreptolysin titer
Precipath Protein 263 3 1.1 in relation to latitude. J Immunol 1935;29:515-521.
Human serum 1 115 1 1.1 15 Renneberg J. Age related variations in anti-streptococcal antibody
levels. Eur J Clin Microbiol Infect Dis 1989;8:792-795.
Human serum 2 246 2 0.8 16 Bablok W, Passing H, Bender R, et al. A general regression procedure
for method transformation. Application of linear regression procedures
Intermediate Mean SD CV for method comparison studies in clinical chemistry, Part III. J Clin
precision Chem Clin Biochem 1988 Nov;26(11):783-790.
IU/mL IU/mL %

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Tina-quant Antistreptolysin O

A point (period/stop) is always used in this Method Sheet as the decimal

separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard.
Contents of kit
Volume after reconstitution or mixing
GTIN Global Trade Item Number

COBAS, COBAS C, PRECINORM, PRECIPATH, PRECICONTROL and TINA‑QUANT are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
© 2015, Roche Diagnostics

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