SO SÁNH PHƯƠNG PHÁP HAI HỆ THỐNG MÁY XÉT NGHIỆM HÓA SINH TẠI BỆNH VIỆN ĐA KHOA TỈNH ĐIỆN BIÊN

Abstract

Evaluate systematic differences between measurement procedures on two or more devices in clinical laboratory to ensure consistency of test results, that supports to diagnosis and monitor of treatment outcomes. Dien Bien Provincial General Hospital is equipped a new Monarch 1200 machine and the Cobas 6000 system. To ensure clinical efficacy, we compared the quality performance between the two machines according to international guidelines CLSI EP15-A3 and EP09- A3. Objectives: (1) Determind the precision and trueness of common biochemical parameters on the Monarch 1200 automatic biochemistry system. (2) Compare the bias of common biochemical test results in Cobas 6000 and Monarch 1200 systems. Methods: This study was designed as applied experient model. Two level of internal control samples were used to evaluate the precision and accuracy of the common biochemical parameter on Monarch 1200; 40 patient samples undergoing routine biochemical investigations that cover entire measuring interval were enrolled to compare the bias of common test results between the two machines. Results: The precision and the trueness of common biochemical parameter on the Monarch 1200 automatic biochemistry system were acceptable when compared with the manufacturer's %CV and the total allowable error (TEa) according to CLIA standard. The differences (%) and their 95% CI for Urea, Glucose, Creatinine, Uric Acid, Triglyceride, Protein, ALT, AST, Cholesterol, Albumin respectively are -5.27%(-7.51%-(-3.03%)); 6.09%(3.61%-8.57%); -8.83%(-12.3%-(-5.34)%); 2.84%(1.29%-4.4%); 5.45%(3.77-7.13%); -10.07% ((-14.3)- (-7.05)); 18.8% (13.4%)-24.2%); 7.16% (3.02)-11.3) 0.86% (-0.63%-2.36); -4.37% ((-5.78%)-(-2.96%)) are all within the acceptable range of biological variability except for albumin, glucose, creatinin, protein and AST, ALT. Conclusions: The difference of common biochemical test results of two machines were in acceptable ranges and both of them can be used simultaneously for clinical analysis except for albumin, glucose, creatinine, protein and AST, ALT.