XÁC NHẬN ĐỘ LẶP LẠI, ĐỘ TÁI LẬP VÀ ĐỘ ĐÚNG CÁC XÉT NGHIỆM PLGF, SFLT-1 TRÊN HỆ THỐNG ROCHE COBAS E801

Abstract

Objective: To evaluate repeatability, within laboratoryprecision, and trueness through experimentation of PlGF and sFlt-1 on the Cobas e801 testing system by Roche using electrochemiluminescence technique at Hùng Vương Hospital in Ho Chi Minh City. Subjects and Methods: Two serum control samples, Precicontrol MultiMarker1 - Roche, were used as experimental materials to evaluate repeatability, within laboratory precision, and trueness of PLGF  and sFlt-1  on the Cobas e801 system according to the CLSI EP15A3 guidelines for the “5×5” testing procedure. Data were collected and analyzed using Excel software. ANOVA test  was employed to compare mean values, standard deviations, variances, coefficients of variation of the experiment, and the range of confirmed values ​​with the manufacturer's published specifications to evaluate the experimental results. Results: The results of the repeatability and within laboratory precision experiments indicated that the PlGF and sFlt-1 values for both serum control samples were less than 2.5%, while the manufacturer reported a PlGF range of approximately 7.86% to 14% and sFlt-1 around 17%. The mean value of PlGF was within the verification limits, and the bias deviation was not statistically significant. The mean value of sFlt-1 fell outside the verification interval; however, the bias percentages for the two serum control samples were 5.88% and 4.38%, both below the allowable limit (6.64%) according to Westgard's guidelines. Conclusion: The experimental of verification repeatability, within laboratoryprecision, and trueness  of PlGF and sFlt-1 tests on the Cobas e801 system by Roche Diagnostic meets the required technical specifications.