基层实验室HCV抗体检测能力验证评估  

Evaluation of the HCV antibody detection ability in primary laboratories

作　　者：赫晓霞[1,2] 马洁琼 任雅楠 王俊 邢文革 HE Xiaoxia;MA Jieqiong;REN Yanan;WANG Jun;XING Wenge(National Center for AIDS/STD Control and Prevention,China CDC,National HIV/AI DS Reference Laboratory,NARL,Beijing 102206,China;Beijing Engineering Research Center of Food Safety Analysis,Beijing Engineering Technology Research Centre of Gene Sequencing and Gene Function Analysis,Beijing Center for Physical&Chemical Analysis,Beijing 100089)

机构地区：[1]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,北京102206 [2]北京市理化分析测试中心北京市食品安全分析测试工程技术研究中心,北京市基因测序与功能分析工程技术研究中心,北京100089

出　　处：《中国艾滋病性病》2021年第9期926-930,共5页Chinese Journal of Aids & STD

基　　金：丙肝防治技术指导与能力建设项目(131031105000200002);“十三五”重大专项课题(2018ZX10732101-001-010);北京市科学技术研究院创新团队计划(IG201807C1);北京市科学技术研究院改革发展培育项目(PY2020 JK43)。

摘　　要：目的为了了解县级以上检测实验室HCV抗体检测能力,研发制备HCV抗体能力验证质控品,开展基层实验室HCV抗体检测能力的室间比对与评估工作。方法研发制备均一稳定的HCV抗体检测质控样品,组织全国县级以上75家HCV抗体检测实验室开展能力验证,各实验室按照要求在规定时间内完成质控品检测并按时回报结果,以全部回馈结果确定质控品预期结果,以检测水平评价标准差系数(SDI)评估各实验室检测能力。结果质控品190906~190910均一性与稳定性检验均符合要求;完成能力验证结果回报的70家实验室中,30家(42.86%)得分100分,39家(55.71%)得分80分,1家(1.43%)得分20分;使用间接ELISA法和化学发光法检测质控品的结果在不同实验室间差异较大[变异系数(CV)分别为33.92%、117.65%、125.77%、125.00%、32.09%和67.56%、129.15%、35.53%、133.72%、73.80%];间接ELISA法、化学发光法和胶体金法对弱阳性190908的检测准确性偏低(分别为47.50%、50.00%、27.27%);SDI值显示部分实验室可能存在系统误差和随机误差。结论本研究制备的HCV抗体能力验证质控品能够在能力验证工作中稳定有效地发挥作用,参加此次能力验证的实验室普遍具有HCV抗体检测能力,部分实验室可能存在系统误差和随机误差问题。Objectives To understand the HCV antibody detection ability in primary laboratories,samples for quality control were used to verify the detection ability of HCV antibody,through carrying out inter-laboratory comparison,and to evaluate the detection ability of HCV antibody.Methods Uniform and stable HCV antibody detection methods were developed and used for quality control samples that had met the requirements.75 HCV antibody testing laboratories were carrying out the HCV antibody detection capability verification.Each laboratory was asked to complete the quality control samples testing within the specified time and reporting the results on time.All feedbacks were used to determine the expected quality control results,and the standard deviation index(SDI) was calculated and used to evaluate the testing capability of each laboratory.Results Both the homogeneity and stability of quality control samples numbered 190906-190910 met the requirements.All 70 laboratories that reported the competency verification results,with 30(42.86%) of them scored 100,39(55.71%) scored80,and 1(1.43%) scored 20.There were significant differences noticed among the quality control samples and the results of indirect ELISA and chemiluminescence among different laboratories(The CV values were 33.92%、 117.65%、 125.77%、125.00%、 32.09 % and 67.56%、 129.15%、 35.53%、133.72%、 73.80%).The detection accuracy of weak positive sample 190908 by indirect ELISA,chemiluminescence,and colloidal gold method was low(47.50%,50.00%,27.27%).SDI values showed that some laboratories had systematic errors and random errors.Conclusion The HCV antibody quality control samples had played stable and effective roles in the capability verification work.The laboratories that participated in this capability verification had the capability of HCV antibody detection,but some laboratories might have systematic and random errors.

关 键 词：丙型肝炎病毒 抗体检测 能力验证质控品 

分 类 号：R512.6[医药卫生—内科学]