ĐÁNH GIÁ MẪU NGOẠI KIỂM ĐỊNH LƯỢNG HBV-DNA TRONG MẪU HUYẾT TƯƠNG ĐÔNG KHÔ BẰNG CÁC PHƯƠNG PHÁP XÉT NGHIỆM THÔNG DỤNG

Abstract

Objective: Evaluation of a set of lyophilized quantification HBV-DNA external quality assessment samples on 06 test methods used by the participating units in the proficiency testing. Methods: A cross-sectional study on lyophilized plasma HBV-DNA external quality assessment samples was performed at the participating units using common testing methods. Result: Quantitative HBV-DNA on 168 samples at different concentrations was performed on 6 common methods, resulting in 166 samples with acceptable standard deviation index (SDI) (|SDI| <2), 1 sample belonging to lot S4 has 2 < |SDI| < 3 and 1 sample from batch S6 had SDI at action signal level (|SDI| > 3) and these 2 samples were performed on HBV iVA method; At the same time, the mean HBV-DNA concentration was not significantly different between batch S4 and batch S5 (2 batches of the same concentration). Conclusion: The lyophilized plasma HBV-DNA external quality assessment samples was evaluated as suitable for the quantitative range of the test, the relevant statistics, and the repeatability of the results on 06 methods (chemicals) used by the participating unit in the trial program.