LDL-Cholesterol Gen.3

Catalog Number: 07005717190

SYSTEM INFORMATION

Test LDLC3, test ID 0‑452

INTENDED USE

In vitro test for the quantitative determination of LDL‑cholesterol in human serum and plasma on COBAS INTEGRA systems.

STORAGE AND STABILITY

 LDLC3
Shelf life at 2‑8 °C See expiration date on cobas c pack label
On‑board in use at 10‑15 °C 12 weeks
Diluent NaCl 9 %
Shelf life at 2‑8 °C See expiration date on cobas c pack label
On‑board in use at 10‑15 °C 4 weeks

Specimen collection and preparation

THE EFFECT OF THE PRESENCE OF ANTICOAGULANTS ON ANALYTE RECOVERY WAS DETERMINED BY METHOD COMPARISON, OBTAINED FROM SAMPLES DRAWN INTO SERUM AND PLASMA COLLECTION TUBES OF K‑EDTA, K‑EDTA, LI‑HEPARIN, AND GEL SEPARATION.

LDL‑cholesterol values for human serum samples obtained on a COBAS INTEGRA 400 plus analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 plus test definition

COBAS INTEGRA 400 PLUS TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A/B 583/659 nm
Calc. first/last 33/69
Unit mmol/L

 Pipetting parameters

CALIBRATION

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

 Calibrator C.f.a.s. LipidsUse deionized water as zero calibrator
Calibration mode Linear regression
Calibration replicate Duplicate recommended
Calibration interval Each lot and as required following quality control procedures

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

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

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

3.87‑549 mg/dL (0.10‑14.2 mmol/L)

LOWER LIMITS OF MEASUREMENT

Limit of Blank, Limit of Detection, and Limit of Quantitation

SPECIFIC PERFORMANCE DATA

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

PRECISION

Repeatability and intermediate precision were determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5 requirements (4 aliquots per run, 1 run per day, 21 days). The following results were obtained:

REPEATABILITY AND INTERMEDIATE PRECISION WERE DETERMINED USING HUMAN SAMPLES AND CONTROLS IN ACCORDANCE WITH THE CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE) EP5 REQUIREMENTS (4 ALIQUOTS PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

LDL‑cholesterol values for human serum samples obtained on a COBAS INTEGRA 400 plus analyzer (y) were compared with those determined using the corresponding 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, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.