ÁP DỤNG HƯỚNG DẪN EP15A3 CỦA CLSI XÁC NHẬN ĐỘ CHỤM VÀ ĐỘ ĐÚNG CỦA XÉT NGHIỆM GALT TRÊN HỆ THỐNG VICTOR 2D PERKIN ELMER

Abstract

Verification of precision and accuracy is an essential requirement recommended when performing method validation in the laboratory. The above work is intended to demonstrate that the method can be implemented and provide evidence that the results are consistent with the technical requirements announced by the manufacturer at the user unit. The study was conducted with the goal of confirming the precision and accuracy of the GALT test in dried blotted blood samples on Perkin Elmer's VICTOR 2D system, using two-level Neonatal GALT internal control kit materials and Neonatal GALT kit chemicals, to conduct experiments to evaluate the accuracy and precision of the GALT test according to EP15A3-CLSI instructions. The precision results of the test, corresponding to 2 QC levels, are 17.18% and 10.24%, respectively, smaller than the manufacturer's standards of 23.2% and 16.6%, the accuracy of the method is confirmed to meet standards according to the manufacturer's announcement. The precision and accuracy of the GALT test have been confirmed and the test can be performed to provide services to patients in the laboratory.