ÁP DỤNG HƯỚNG DẪN EP15A3 CỦA CLSI XÁC NHẬN ĐỘ CHỤM, ĐỘ ĐÚNG CHO MỘT SỐ CHỈ SỐ HÓA SINH TRÊN HỆ THỐNG ROCHE COBAS 6000

Abstract

Method verification is imperative to provide reliable test results before the method is implemented. The purpose of this study was to verify the precision and truness of some biochemistry tests on the Roche Cobas 6000 system. The Roche’s quality control materials of 02 levels were used to conduct the experiments of precision and trueness of 10 biochemistry tests including serum Uric acid, Albumin, ALT, Amylase, AST, Creatinin, GGT, Glucose, total Protein, Ure according to CLSI EP15-A3. Results: for the majority of the analytes, repeatability and within-laboratory CV were below the manufacturer’s claim or below the upper verification limit, the mean values of the conducted data were within the verification intervals or bias were less than acceptable bias based on desireable biological variation database, total error were less than acceptable total error (TEa) base on CLIA analytical quality requirements. All the analytes on this study are reliable and can be used to provide medical services.