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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 11 023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、10 716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、10 676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、10 688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、10 663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。
Objective To establish a highly sensitive detection strategy for HIV infection among men who have sex with men (MSM) and reduce the number of missed tests in the window period. Methods Specific samples of MSM from Heilongjiang, Liaoning, Inner Mongolia, Ningxia and Qinghai (autonomous regions) were collected and tested by the current HIV antibody routine test, the new test strategy 1, the new test strategy 2 and the new test strategy 3 respectively , The conventional strategy and three kinds of new strategy test results were compared and analyzed. RESULTS: Of the 11 023 survey samples, 282 positive, negative and indeterminate antibodies were detected in the conventional strategy [three-generation ELISA (Western blot) and Western blotting (WB)], respectively, with 282, 10 716 and 25 ; The second strategy (four-generation ELISA + WB) detected positive, negative and indefinite antibody samples were 282, 10676 and 65; new strategy two (three generations of ELISA + WB + collection of nucleic acids) detected nucleic acid Positive, negative, and negative were 28 samples, 282 copies, 10 688 copies and 25 copies respectively. The new strategy three (four generations of ELISA + WB + collection of nucleic acid) detected nucleic acid positive, antibody positive, negative, indefinite The specimens were 13, 282, 10 663 and 65 respectively. The detection sensitivities of the conventional and new strategies were 90.96%, 90.96%, 100% and 95.16% respectively. The sensitivity of the new strategies II and III was significantly higher than that of the conventional strategies (P <0.05) Detection of early and acute HIV infection is superior to conventional strategies. Conclusion The new HIV testing strategy for MSM population can reduce the number of undetected patients with early and acute HIV infection and should be popularized in this population based on laboratory testing ability and sample size.