Tina-quant Antistreptolysin O

Catalog Number: 04489403190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative immunological determination of antistreptolysin O in human serum on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

ASLOT
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 12 weeks
Diluent NaCl 9 %
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 12 weeks

Specimen collection and preparation

APPLICATION FOR SERUM

cobas c 311 test definition
Assay type 2-Point End
Reaction time / Assay points 10/10-19
Wavelength (sub/main) –/700 nm
Reaction direction Increase
Unit IU/mL
Reagent pipetting Diluent (H2O)
R1 124 µL
R2 124 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 4 µL 15 µL 168 µL
Increased 2 µL

 

CALIBRATION

Traceability: This method has been standardized against an internal standard material.

Calibrators S1: H2OS2: C.f.a.s. PAC
Calibration mode Linear
Calibration frequency 2-point calibration▪after reagent lot change▪as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2-POINT CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

20-600 IU/mL

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (3 ALIQUOTS PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

Antistreptolysin O values for human serum samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).