摘要
目的研发制备尿液1型艾滋病病毒（HIV-1）抗体检测实验室能力验证质控品,并应用于艾滋病检测实验室的尿液HIV-1抗体检测能力的验证工作,提高艾滋病检测实验室对尿液HIV-1抗体的检测水平。方法对20份HIV-1抗体阳性和8份HIV-1抗体阴性的尿液样本,用酶联免疫吸附试验筛选后,选择3份阳性样本和2份阴性样本,制备能力验证质控品,并对能力验证质控品进行稳定性、均一性评价。将能力验证质控品分发给参加尿液HIV-1抗体检测的实验室,对其检测结果进行分析,评价各实验室的尿液HIV-1抗体检测能力。结果能力验证质控品均一性试验中,5份样本的变异系数（CV）分别为5.40%、27.96%、12.04%、20.24%、5.77%。能力验证质控品稳定性试验中,尿液质控品在37℃放置时,5份样本的CV值分别为5.62%、9.19%、7.98%、57.81%、7.43%;在20℃放置时,5份样本的CV值分别为18.57%、3.41%、5.21%、43.93%、5.58%;在4℃放置时,5份样本的CV值分别为7.67%、14.35%、9.61%、6.35%、9.43%;在-20℃放置时,5份样本的CV值分别为25.83%、17.29%、35.97%、20.73%、22.22%。共12家艾滋病检测实验室参加本次尿液HIV-1抗体检测能力验证,得分情况：11家实验室得分为100分,1家实验室对两份样本检测错误,得分为60分;检测数值（S/CO）偏离情况：4家实验室对阳性质控检测结果有偏离,3家实验室分别对3份阳性样本（164 101、164 103和164 105）检测结果有偏离。结论尿液HIV-1抗体能力验证质控品具有较好的稳定性、均一性,可以用于实验室能力验证。参加此次尿液HIV-1抗体能力验证的实验室结果判定大都正确,但是个别实验室在检测数值（S/CO）方面存在偏离。
Objective To prepare proficiency testing（PT）quality control for HIV-1 antibody in urine,evaluate the detectability of HIV-1 antibody in urine and increase the testing level of the AIDS laboratory.Methods 20 HIV-1 positive urine samples and 8 HIV-1 negative urine samples were screened with enzyme-linked immunesorbent assay.According to the results,3 positive samples and 2 negative samples were selected and used to prepare PT quality control for HIV-1 antibody in urine.The stability and the homogeneity of PT quality control were evaluated.Then PT quality control was given out to AIDS laboratories joining PT for HIV-1 antibody in urine.The results were analyzed to evaluate the detectability of these labs.Results For the homogeneity test of PT quality control,CVs of 5 samples were severally 5.40%,27.96%,12.04%,20.24%,and 5.77%.For the stability test of PT quality control,CVs of 5 samples being placed in 37℃ were severally 5.62%,9.19%,7.98%,57.81%,and7.43%;CVs in 20℃ were severally 18.57%,3.41%,5.21%,43.93%,and 5.58%;CVs in 4℃ were severally7.67%,14.35%,9.61%,6.35%,and 9.43%;CVs in subzero 20℃ were severally 25.83%,17.29%,35.97%,20.73%,and 22.22%.There were 12 labs joining PT for HIV-1 antibody in urine.11 labs got 100 scores except 1 lab getting 60 scores because of the wrong detection of 2 samples.The detection values of positive control from 4 labs and 3 positive samples（164101,164103 and 164105）respectively from 3 labs deviated from the mean.Conclusion Both the homogeneity and the stability of PT quality control in urine are better.The qualitative results of mostlabs joining the PT are correct,but the detection values from a few labs are deviated from the mean.
作者
常浩
陈兵
马仲慧
裴丽健
程焕义
王月华
邢文革
CHANG Hao;CHEN Bing;MA Zhonghui;PEI Lijian;CHENG Huanyi;WANG Yuehua;XING Wenge.(Chinese Center for Disease Control and Prevention, Beijing, 102206, China)
出处
《中国艾滋病性病》
CAS
CSCD
北大核心
2018年第4期322-324,329,共4页
Chinese Journal of Aids & STD
