XÁC NHẬN GIÁ TRỊ SỬ DỤNG XÉT NGHIỆM ĐỊNH LƯỢNG sdLDL THEO HƯỚNG DẪN CLSI EP15-A3

Abstract

Verification of measurement method is a very important component in laboratory quality management. CLSI EP15-A3 is intended for verifying manufacturer’s claim for precision and estimating bias when an established measurement procedure is initially set up in the laboratory. Small dense LDL (sdLDL) cholesterol is a subtype of LDL cholesterol and is a strong risk factor for atherosclerosis. sdLDL also plays a role in predicting cardiovascular disease. This study was conducted to evaluate the precision and bias of the sdLDL assay on Roche Cobas C702 Chemistry Analyzer, using Denka's internal quality control (QC) materials and sdLDL reagents, following CLSI EP15-A3 guideline. Repeatability and within-laboratory imprecision CV of QC 1 were 1.25% and 2.05%; of QC 2 were 0.77% and 1.95%; all were smaller than the manufacturer's claim. The mean QC 1 value of 21.41mg/dL was within the verification interval (VI). The mean QC 2 value of 64.72 mg/dL was not within the VI but the bias between the observed mean and the target value was less than the user-defined allowable bias. The precision and bias of the sdLDL quantitative assay were confirmed, and the test could be used for medical diagnosis and treatment.