Abstract:

Objective To prepare hepatitis B virus（HBV） YMDD mutation detection research material,which will be used for evaluating the performance of HBV YMDD mutation detection in Shanghai laboratories by external quality assessment（EQA）. Methods The candidate samples of HBV DNA >5×10⁴ IU/mL with different HBV YMDD mutations were diluted. Real-time fluorescence polymerase chain reaction（PCR）,ligase detection reaction（LDR） and sequencing were used,the homogeneity and stability were evaluated. The sample panel of 2017 2-time EQA program contained 5 samples. The participating laboratories were asked to report their results before deadline. The results from the participants were summarized and analyzed. Results A total of 12 and 10 valid results were received in 2017 2-time EQA program,respectively. There were 66.67%（8/12） laboratories submitted correct results for all samples. The overall consistency rates of HBV YIDD,YVDD,YIDD+YVDD and YMDD samples were 90.63%,86.36%,77.27% and 88.24%,respectively. Conclusions The samples are homogeneous and stable. The results of 2017 EQA program suggest that it is necessary for laboratories to improve the operation for HBV YMDD mutation detection. Quality control in clinical laboratories is essential to assure the accuracy of results.

Key words: Hepatitis B virus, High temperature ligase detection reaction, Sequencing, Polymerase chain reaction