HIV口腔黏膜渗出液快速检测试剂的方法学评价  

Methodology evaluation for human immunodeficiency virus rapid diagnostic tests by oral mucosal transudate

作　　者：马仲慧 宫赛赛 裴丽健[1] 赫晓霞[1] 程焕义 蒋岩[1] 肖瑶[1] 潘品良[1] 邢文革[1] MA Zhonghui;GONG Saisai;PEI Lijian;HE Xiaoxia;CHENG Huanyi;JIANG Yan;XIAO Yao;PAN Pinliang;XING Wenge.(National Center for AIDS/STD Control and Prevention, China CDC, National HIV/AIDS Reference Laboratory, NARL Beijing 102206, China)

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

出　　处：《中国艾滋病性病》2018年第5期436-439,共4页Chinese Journal of Aids & STD

基　　金：中美艾滋病防治合作项目~~

摘　　要：目的构建艾滋病病毒（HIV）口腔黏膜渗出液（OMT）快速检测试剂（RDTs）评价盘,评价HIV OMT RDTs的质量。方法采集健康志愿者的口腔黏膜渗出液,用稀释液稀释HIV抗体阳性和阴性的血浆样本,分别构建实验室基础盘、实验室干扰盘、实验室线性稀释系列盘和实验室精密度盘。用6家HIV OMT RDTs（编号：试剂AF）分别检测构建的评价盘和HIV抗体口腔黏膜渗出液快速试剂的国家参考品,肉眼判读检测结果并测定GOD值。结果根据肉眼判读,试剂AF的敏感性、特异性、阳性参考品符合率、阴性参考品符合率均为100%,分析特异性≥95.12%（39/41）,分析灵敏度≥3/5;试剂D的批内精密度高于其他试剂,试剂F的线性范围为28214。根据GOD值,试剂AE的特异性,阴性参考品符合率均为100%,分析特异性≥95.12%（39/41）,敏感性≥92.50%（37/40）,阳性参考品符合率≥95.00%（19/20）,分析灵敏度≥3/5,线性范围分别为28216、27217、26216、26215、25212,批内精密度介于4.91%34.28%之间。结论试剂AF的敏感性、特异性、阳性参考品符合率、阴性参考品符合率、分析灵敏度、分析特异性较好,试剂BD的线性范围较宽,但饮食因素可能造成试剂D、E出现假反应性,试剂的批内精密度差别较大。Objective To construct the evaluation panels for HIV OMT rapid diagnostic tests（RDTs）and evaluate the quality of HIV OMT RDTs.Methods The OMT samples collected from healthy volunteers and prepared by diluting anti-HIV positive plasma and negative plasma were used to construct the evaluation panels for HIV OMT RDTs including the basic panel,the specificity panel,the linear dilution panel and the precision panel.The 4 constructed evaluation panels and HIV antibody panel for oral fluid rapid test were tested with 6 HIV OMT RDTs（labeled as reagent A to F）.The results were visually read and detected by the reader to get GOD value.Results According to visually read,for reagent A to F,sensitivities,specificities and consistencies of positive and negative reference were all 100%;analytical specificities were greater than or equal to 95.12%;and analytical sensitivities were greater than or equal to 3/5.Within-lot precision of reagent D was better than that of other reagents.Linear range of reagent F was ranged from 28 to 214.Based on GOD values,for reagent A to E,specificities and consistencies of negative reference were all 100%;analytical specificities were at least 95.12%,sensitivities were at least 92.5%;consistencies of positive reference were greater than or equal to 95%;analytical sensitivities were at least 3/5;liner ranges were 28-216,27-217,26-216,26-215 and 25-212 respectively;and within-run precisions were ranged from4.91%to 34.28%.Conclusion Sensitivity,specificity,consistencies of positive and negative reference,analytical specificity and analytical sensitivity of 6 reagents are higher,and reagent B,C and D has wider linear range.Eating may cause falsely reactive results of reagent D and E,and different reagents has different within-run precision.

关 键 词：艾滋病病毒 口腔黏膜渗出液 快速检测试剂 方法学评价 

分 类 号：R373.9[医药卫生—病原生物学]