Xây dựng bộ mẫu ngoại kiểm cho xét nghiệm huyết thanh học định tính HBsAg

Taking external quality assessment as one of the helpful tools that makes worthy contribution to ensurement of testing quality in linking test results and improve testing quality, standard samples were established to use in Proficiency Testing Programs for qualitative HBsAg serological tests. The criteria for sample panels including negative, slightly positive and positive characteristics; homogeneity; stability and sterility were evaluated. Finally, the sample panels were implemented in External quality assessment for labaratory qualitative HBsAg serological tests in the Southern and Central Highlands regions. The optimized panel of external samples embodied 8 samples including 3 negative, 2 slightly positive and 3 strongly positive samples and well complied with the criteria for stability, homogeneity and sterility. The other optimal panel included 8 samples, including 3 negative, 2 positive samples with low S/CO ratio and 3 strongly positive samples with high S/CO ratio met the criteria for stability, homogeneity and sterility. The quality of qualitative HBsAg serology testing from 104 laboratories was assessed by External quality assessment using the proposed standard samples.
Keywords: Sample panel, External quality assessment, HBsAg, laboratories.