Tina-quant Myoglobin Gen.2

Catalog Number: 04580010190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of myoglobin in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

 MYO2
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

APPLICATION FOR SERUM AND PLASMA

cobas c 311 test definition
Assay type 2‑Point End
Reaction time / Assay points 10 / 7‑29
Wavelength (sub/main) 800/570 nm
Reaction direction Increase
Units µg/L (nmol/L, ng/mL)
Reagent pipetting Diluent (H2O)
R1 90 µL
R2 30 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 3 µL
Decreased 3 µL 15 µL 135 µL
Increased 3 µL

 

CALIBRATION

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Calibrators S1: H2OS2‑6: C.f.a.s. MyoglobinMultiply the lot‑specific C.f.a.s. Myoglobin calibrator value by the factors below to determine the standard concentrations for the six‑point calibration curve:
S2: 0.0625 S5: 0.5
S3: 0.125 S6: 1
S4: 0.25
Calibration mode RCM
Calibration frequency Full calibration• after reagent lot change• as required following quality control procedures

MULTIPLY THE LOT‑SPECIFIC C.F.A.S. MYOGLOBIN CALIBRATOR VALUE BY THE FACTORS BELOW TO DETERMINE THE STANDARD CONCENTRATIONS FOR THE SIX‑POINT CALIBRATION CURVE:

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION• AFTER REAGENT LOT CHANGE• AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

15‑500 µg/L (0.86‑28.6 nmol/L, 15‑500 ng/mL)

THE TECHNICAL LIMIT IN THE INSTRUMENT SETTING IS DEFINED AS 7‑492 ΜG/L DUE TO THE INSTRUMENT FACTOR FOR MYO2 (B = 8 ΜG/L; SEE ABOVE CHAPTERS CALIBRATION AND CALCULATION)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below.

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

Myoglobin values for human serum and plasma 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).

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY,