Tina-quant Myoglobin Gen.2

Catalog Number: 05950759190

SYSTEM INFORMATION

MYO2: ACN 8620

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 to 8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 12 weeks
On-board on the Reagent Manager: 24 hours
Diluent NaCl 9 %
Shelf life at 2 to 8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 4 weeks
On-board on the Reagent Manager: 24 hours

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 21-38
Wavelength (sub/main) 800/570 nm
Reaction direction Increase
Units µg/L (nmol/L, ng/mL)
Reagent pipetting Diluent (H2O)
R1 90 µL
R3 30 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 3 µL
Decreased 3 µL 15 µL 135 µL
Increased 6 µL

CALIBRATION

Traceability: This method has been standardized against a selected manufacturer's measurement procedure (immunological method).

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 6-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• and 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 6-POINT CALIBRATION CURVE:

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

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

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

THE TECHNICAL LIMIT OF THE HIGH END OF MEASURING RANGE IN THE INSTRUMENT SETTING IS DEFINED AS 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. 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

Myoglobin values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the same reagent on a Roche/Hitachi cobas c 501 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,