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目的通过能力验证(PT)考核,了解中国部分实验室实验人员丙型肝炎病毒(HCV)检测的能力。方法采用统一的方法、试剂、仪器,组织33家实验室利用17份样本进行PT考核,考核内容包括HCV抗体、抗原、病毒载量及基因分型实验,采用百分制对结果进行评分,并与参比实验室确定的预期结果进行比较,用SAS 9.3统计软件对得分以及结果进行分析。结果参与PT考核的33家实验室的全部抗体实验阴阳性判断正确;得分均为100分;抗原实验阴性样本中有1份结果错判为阳性,其余结果判定正确;共66份阳性样本中,有16份结果错判为阴性,错判率为24%(16/66);核酸载量实验结果均在可信区间内,得分均为100分;亚型实验结果判定全部正确,得分均为100分。结论 33家实验室的实验员HCV抗体实验、病毒载量实验、基因分型实验的检测结果与预期结果一致,而丙型肝炎病毒抗原实验结果与预期结果存在一定差异,需要重点加强。
Objective To assess the ability of some laboratory labs in China to detect hepatitis C virus (HCV) by proficiency testing (PT). Methods A total of 17 samples were used for PT test in 33 laboratories using a uniform method, reagent, instrument and tissue. The examination contents included HCV antibody, antigen, viral load and genotyping experiment. The results were scored by percentile system, Expected results were compared with those determined by the laboratory and the scores and results were analyzed using SAS 9.3 statistical software. Results All the 33 laboratories that participated in the PT test were positive and negative for all the antibody tests. The scores were 100 points. One of the negative results of the antigen test was false positive and the others were correct. A total of 66 positive samples, 16 of the results were misjudged to be negative, and the misjudgment rate was 24% (16/66). The results of nucleic acid loading were all in the confidence interval, with a score of 100; all the sub-type test results were correct and the scores were 100 points. Conclusion The results of HCV antibody test, viral load test and genotyping test in 33 laboratories are consistent with the expected results. However, the experimental results of hepatitis C virus antigen have some differences with the expected results, which need to be strengthened.