针对MSM人群的HIV-1早期感染检测策略研究

目的建立针对男男性行为人群（MSM）艾滋病病毒（HIV）感染的高敏感检测策略，减少窗口期漏检。方法收集来自黑龙江、辽宁、内蒙古、宁夏和青海省（自治区）的MSM人群专项调查样本，分别用中国现行的HIV抗体常规检测策略、新检测策略一、新检测策略二和新检测策略三进行检测，对常规策略与3种新策略的检测结果进行对比、分析。结果11023份调查样本中，常规策略三代酶联免疫吸附试验（ELISA）＋蛋白免疫印迹试验（WB）]检出的抗体阳性、阴性和不确定标本分别为282份、10716份和25份；新策略一（四代ELISA＋WB）检出的抗体阳性、阴性和不确定标本分别为282份、10676份和65份；新策略二（三代ELISA＋WB＋集合核酸）检出的核酸阳性，抗体阳性、阴性和不确定标本分别为28份、282份、10688份和25份；新策略三（四代ELISA＋WB＋集合核酸）检出的核酸阳性，抗体阳性、阴性、不确定标本分别为13份、282份、10663份和65份。常规策略、新策略一至三的检测敏感性分别为90．96％、90．96％、100％和95．16％，新策略二和新策略三的检测敏感性显著高于常规策略（P〈0．05），且新策略对早期及急性HIV感染者的检测能力优于常规策略。结论针对MSM人群的HIV新检测策略，可以减少早期及急性HIV感染者的漏检，应根据实验室检测能力和样本量尽快在该人群中推广使用。

Evaluation of testing strategies for diagnosis of early HIV-1 infection targeting MSM population

Objective To develop more sensitive HIV-1 testing strategies targeting MSM population for reduc- ing false negative results in window period. Methods In this study,11 023 serum or plasma samples were collected from special investigation of MSM population in Heilongjiang, Liaoning, Inner Mongolia, Ningxia and Qinghai provinces, and detected using routine testing strategy（third-generation ELISA ＋ WB）, new testing strategy one （forth generation ELISA ＋ WB）, new testing strategy two（third-generation ELISA ＋ WB＋ pooling NAT）and new testing strategy three（forth generation ELISA ＋ WB＋ pooling NAT） ,respectively. Finally, a comparison was made between the results from three new testing strategies and the routine one. Results Of 11 023 specimens, 282 were antibody positive, 10716 were antibody negative, and 25 were antibody indeterminate by routine testing strate- gy; 282 were antibody positive, 10676were antibody negative, and 65 were antibody indeterminate by new testing strategy one; 282 were antibody positive, 28 were NAT positive, 10688 were antibody negative, and 25 were anti- body indeterminate by new testing strategy two; 282 were antibody positive, 13 were NAT positive, 10663 were ancute HIV infection than the routine testing strategy. Conclusion Three new testing strategies can reduce false neg- ative results among acute HIV infection in MSM population, and should be applied widely in MSM population as soon as possible based on laboratory testing capability and sample size.