XÁC ĐỊNH GIÁ TRỊ SỬ DỤNG CỦA PHƯƠNG PHÁP XÉT NGHIỆM ELISA ĐỊNH LƯỢNG NỒNG ĐỘ KHÁNG THỂ CHỐNG SARS-COV-2 TRÊN MÁY MIỄN DỊCH BÁN TỰ ĐỘNG TẠI TRƯỜNG ĐẠI HỌC Y TẾ CÔNG CỘNG NĂM 2022

Abstract

Objective: Confirm the precision, trueness, linearity range and reference range of the ELISA method to quantify the concentraion of IgG class antibodies to SARS-CoV-2 on a semi-automatic immune machine at the Hanoi University of Public Health in 2022. Method: We performed  experimental study, collecting data on measuring IgG antibody levels of standard samples, Cal samples and 20 serum samples from study participants using Testline kit on ELISA semi-automatically machine and compared its clinical performance to the CLSI/EP15-A3, EP17-A, CLSI/EP28A-3C kit to evaluate precision, trueness, linear range; confirm the method's reference interval. Result: The precision was not consistent with the manufacturer's announcement; The trueness was confirmed in accordance with the manufacturer's claims at the assigned values of the two QC levels 20 and 80, both within the validation limit (9.22 – 32.06 and 49,418 – 138,922). The linear interval was correlated (r2 = 0.956) between 0.95 and 1, so there was a linear correlation between the measured value and the true value of the sample. Studying a sample size of 20, using the Shapiro-Wilk normal distribution test with a value of sig=0.075 (>0.05), the distribution of anti-SARS-CoV-2 antibody values of 20 volunteers (ages 18-25) was constituted a standard distribution of the study reference range 117.64 – 11243.15U/mL. Conclusion: By confirming the method, the precision of the method at the Testing Center of the University of Public Health was not consistent with the manufacturer's announcement. Laboratories performing test method validation need to adhere to the technical requirements and flexibly apply CLSI guidelines to suit the actual conditions of the laboratory