乙型肝炎病毒YMDD突变室间质量评价调查品制备及应用

摘要

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 ?uorescence polymerase chain reaction (PCR) , ligase detection reaction (LDR) and sequencing were used, the homogeneity and stability were evaluated. The sample panel of2017 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.%目的 制备乙型肝炎病毒 (HBV) YMDD突变室间质量评价 (EQA) 调查品, 评估上海地区临床实验室检测HBV YMDD突变的能力.方法 筛选HBV DNA>5×104 IU/ML的临床样本, 经稀释制成含HBV YMDD不同突变类型的样本盘.采用实时荧光聚合酶链反应 (PCR) 、高温连接酶反应 (LDR) 和测序法筛选EQA候选样本, 并采用PCR评估样本均匀性和稳定性.2017年2次EQA各制备5份样本, 要求参评实验室在规定时间内检测样本并上报检测结果.对回报结果进行分析.结果 2017年2次EQA分别收到12份和10份有效回报结果, 66.67％的实验室检测结果完全正确.HBV YIDD、YVDD、YIDD+YVDD和YMDD不同突变样本的检测符合率分别为90.63％、86.36％、77.27％和88.24％.结论 制备的调查品均匀、稳定, 可用于EQA;部分临床实验室HBV YMDD突变检测能力尚需提高, 应加强质量控制以保证检测结果的准确性.