Screening Yield of HIV Antigen/Antibody Combination and Pooled HIV RNA Testing for Acute HIV Infection in a High-Prevalence Population
Screening Yield of HIV Antigen/Antibody Combination and Pooled HIV RNA Testing for Acute HIV Infection in a High-Prevalence Population
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HIV抗原/抗体联合筛查和HIV-RNA联合检测在高发人群中的应用
DOI：
10.1001/jama.2016.0286
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发表时间：
2016-02-16
影响因子：
120.7
通讯作者：
Gay, Cynthia L.
中科院分区：
文献类型：
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作者：
Peters, Philip J.;Westheimer, Emily;Gay, Cynthia L.
目的评估HIV抗原/抗体(Ag/Ab)联合检测与联合检测HIV RNA检测急性HIV感染的性能。设计、设置和参与者2011年9月至2013年10月在纽约、加利福尼亚州和北卡罗来纳州的7个性传播感染诊所和5个社区项目中进行的多点、前瞻性、个体内比较研究。受试者年龄在12岁或以上，正在进行HIV检测，没有已知的HIV感染。结果86836名检测结果完整的受试者(中位年龄29岁；男性占75.0%；男男性行为者占51.8%)，确诊为HIV感染者1158人(1.33%)，确诊为急性HIV感染者168人(0.19%)。在134名HIV Ag/Ab联合检测的参与者中发现了急性HIV感染(0.15%[95%CI，0]3%-0.18%]；敏感性79.8%[95%CI，72.9%-85.6%]；特异性99.9%[95%CI，99.9%-99.9%]；阳性预测值为59.0%[95%CI，52.3%-65.5%]；164名HIV RNA联合检测受试者的阳性预测值为0.19%[95%CI，0.16%-0.22%]；敏感性，97.6%[95%CI，94.0%-99.4%]；特异性，100%[95%CI，100%-100%]；阳性预测值，96.5%[95%CI，92.5%-98.7%]；敏感性比较，P<；.001)。总体而言，HIV Ag/Ab联合检测检测到了通过混合HIV RNA检测可检测到的82%的急性HIV感染。与单独的HIV快速检测相比，HIV Ag/Ab联合检测可使HIV相对诊断率提高10.4%(95%可信区间，8.8%~12.2%)，而混合HIV RNA检测的相对HIV诊断率提高12.4%(95%可信区间，10.7%~14.3%)。结论在高发人群中，HIV Ag/Ab联合检测可检出82%的急性HIV感染，阳性预测值为59%。需要在低流行率人群和使用暴露前预防措施预防艾滋病毒的人群中评估这一战略，还需要进一步研究。
IMPORTANCE Although acute HIV infection contributes disproportionately to onward HIV transmission, HIV testing has not routinely included screening for acute HIV infection.OBJECTIVE To evaluate the performance of an HIV antigen/antibody (Ag/Ab) combination assay to detect acute HIV infection compared with pooled HIV RNA testing.DESIGN, SETTING, AND PARTICIPANTS Multisite, prospective, within-individual comparison study conducted between September 2011 and October 2013 in 7 sexually transmitted infection clinics and 5 community-based programs in New York, California, and North Carolina. Participants were 12 years or older and seeking HIV testing, without known HIV infection.EXPOSURES All participants with a negative rapid HIV test result were screened for acute HIV infection with an HIV Ag/Ab combination assay (index test) and pooled human immunodeficiency virus 1(HIV-1) RNA testing. HIV RNA testing was the reference standard, with positive reference standard result defined as detectable HIV-1 RNA on an individual RNA test.MAIN OUTCOMES AND MEASURES Number and proportion with acute HIV infections detected.RESULTS Among 86 836 participants with complete test results (median age, 29 years; 75.0% men; 51.8% men who have sex with men), established HIV infection was diagnosed in 1158 participants (1.33%) and acute HIV infection was diagnosed in 168 participants (0.19%). Acute HIV infection was detected in 134 participants with HIV Ag/Ab combination testing (0.15% [95% CI, 0]3%-0.18%]; sensitivity, 79.8% [95% CI, 72.9%-85.6%]; specificity, 99.9% [95% CI, 99.9%-99.9M; positive predictive value, 59.0% [95% CI, 52.3%-65.5%]) and in 164 participants with pooled HIV RNA testing (0.19% [95% CI, 0.16%-0.22%]; sensitivity, 97.6% [95% CI, 94.0%-99.4%]; specificity, 100% [95% CI, 100%-100%]; positive predictive value, 96.5% [95% CI, 92.5%-98.7%]; sensitivity comparison, P < .001). Overall HIV Ag/Ab combination testing detected 82% of acute HIV infections detectable by pooled HIV RNA testing. Compared with rapid HIV testing alone, HIV Ag/Ab combination testing increased the relative HIV diagnostic yield (both established and acute HIV infections) by 10.4% (95% CI, 8.8%-12.2%) and pooled HIV RNA testing increased the relative HIV diagnostic yield by 12.4% (95% CI, 10.7%-14.3%).CONCLUSIONS AND RELEVANCE In a high-prevalence population, HIV screening using an HIV Ag/Ab combination assay following a negative rapid test detected 82% of acute HIV infections detectable by pooled HIV RNA testing, with a positive predictive value of 59%. Further research is needed to evaluate this strategy in lower-prevalence populations and in persons using preexposure prophylaxis for HIV prevention.