Tina-quant Lipoprotein (a) Gen.2

Catalog Number: 05852633190

SYSTEM INFORMATION

LPAM2: ACN 8724

INTENDED USE

In vitro test for the quantitative determination of lipoprotein (a) in human serum and plasma on Roche/Hitachi cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.

STORAGE AND STABILITY

LPA2
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 6 weeks
On-board on the Reagent Manager: 24 hours

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 22-33
Wavelength (sub/main) 800 / 660 nm
Reaction direction Increase
Unit mg/dL
Reagent pipetting Diluent (H2O)
R1 133 µL
R3 33 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL 0 µL 0 µL
Decreased 8 µL 10 µL 110 µL
Increased 4 µL 0 µL 0 µL

 Calibration

CALIBRATION

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

6.0-80 mg/dL

LOWER LIMITS OF MEASUREMENT

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17-A2 requirements.

SPECIFIC PERFORMANCE DATA

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

PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

Lipoprotein (a) 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 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, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.