Cardiac C-Reactive Protein (Latex) High Sensitive

Catalog Number: 04628918190

SYSTEM INFORMATION

INTENDED USE

In vitro test for the quantitative determination of C-reactive protein (CRP) in human serum and plasma on COBAS INTEGRA systems. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.

STORAGE AND STABILITY

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 PLUS TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Kinetic
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A 552 nm
Calc. first/last 35/63
Typical prozone effect > 40 mg/L (> 380 nmol/L)
Antigen excess check Yesa)
Unit mg/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R1 82 µL 48 µL
Sample 6 µL
SR 28 µL 14 µL
Total volume 178 µL

  Diluent (H2O)
R1 82 µL 48 µL
Sample 6 µL
SR 28 µL 14 µL
Total volume 178 µL

COBAS INTEGRA 800 test definition

a) Samples with concentrations > 40 mg/L are flagged either >TEST RNG or “HIGH ACT”. Rerun the sample with postdilution or, if the sample has already been postdiluted, rerun the sample with a higher postdilution factor.

COBAS INTEGRA 800 TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Kinetic
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A 552 nm
Calc. first/last 46/96
Typical prozone effect > 40 mg/L (> 380 nmol/L)
Antigen excess check Yesa)
Unit mg/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R1 82 µL 48 µL
Sample 6 µL
SR 28 µL 14 µL
Total volume 178 µL

a) Samples with concentrations > 40 mg/L are flagged either >TEST RNG or “HIGH ACT”. Rerun the sample with postdilution or, if the sample has already been postdiluted, rerun the sample with a higher postdilution factor.

CALIBRATION

CALIBRATION DILUTION RATIO

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

MEASURING RANGE

0.1-20 mg/L (0.952-190 nmol/L) (typical measuring range)

THE UPPER AND LOWER LIMITS OF THE MEASURING RANGE DEPEND ON THE ACTUAL CALIBRATOR VALUE.

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

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:

INTERMEDIATE PRECISION

METHOD COMPARISON

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.