LDL-Cholesterol Gen.3

Catalog Number: 07005768190

SYSTEM INFORMATION

LDLC3: ACN 8552

INTENDED USE

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

STORAGE AND STABILITY

LDLC3

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 Roche/Hitachi cobas c 701 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 c 701/702 test definition

CALIBRATION

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

 Calibrators S1: H2OS2: C.f.a.s. Lipids
Calibration mode Linear
Calibration frequency 2‑point calibration▪after reagent lot change▪as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2‑POINT CALIBRATION

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

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 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 Roche/Hitachi cobas c 701 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.