HCV实验室实验人员检测能力验证结果分析

发布时间：2018-03-31 06:00

本文选题：丙型肝炎病毒　切入点：实验室检验　出处：《中国艾滋病性病》2015年07期

【摘要】：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。
[Abstract]:Objective to understand the ability of hepatitis C virus (HCV) detection in some laboratory workers in China by means of ability test. Methods 33 laboratories were organized to use 17 samples for PT examination by using uniform methods, reagents, instruments and instruments. The tests included HCV antibodies, antigens, viral loads and genotyping tests. The results were scored by a percentage system and compared with the expected results determined by the reference laboratory. The score and results were analyzed by SAS 9.3 software. Results all the antibody tests in 33 laboratories participating in PT test were correct, the scores were 100, and one of the negative samples of antigen test was found to be positive. The remaining results were correct; of the 66 positive samples, 16 were negative, with a misjudgment rate of 24 / 66 / 66; the results of nucleic acid loading experiments were all within the confidence interval with 100 points; the results of the subtype tests were all correct. Conclusion the results of HCV antibody test, viral load test and genotyping test in 33 laboratories were consistent with the expected results, while the results of hepatitis C virus antigen test were different from those of the expected results. The emphasis needs to be strengthened.
【作者单位】：中国疾病预防控制中心性病艾滋病预防控制中心参比实验室;
【分类号】：R512.63

【参考文献】