Real-time, universal screening for acute HIV infection in a routine HIV counseling and testing population

Real-time, universal screening for acute HIV infection in a routine HIV counseling and testing population
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DOI:
10.1001/jama.288.2.216
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发表时间:
2002-07-10
影响因子:
120.7
通讯作者:
Fiscus, SA
Fiscus, SA
中科院分区:
医学1区
文献类型:
--
作者:
Pilcher, CD;McPherson, JT;Fiscus, SA

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急性人类免疫缺陷病毒(HIV)感染不能通过常规抗体检测诊断,在临床实践中很少被诊断出来。然而,HIV核酸检测被广泛用于筛查低风险献血者的抗抗体阴性急性感染。目的探讨利用标本池法和HIV RNA逆转录聚合酶链反应(RT-PCR)检测技术,在大容量实验室筛查HIV感染率较低的常规HIV检测人群中急性和长期HIV感染的可行性。设计与设置国家资助的公共卫生病毒学和血清学实验室的临床诊断绩效评估。参与者在总共20个工作日内,共有8505人连续参加了常规艾滋病毒咨询和测试,以模拟2001年8月和12月在北卡罗来纳州110个公共资助的测试点进行的一个月的测试。主要结果测量急性和长期HIV感染的流行情况。采用超灵敏的HIV RNA RT-PCR方法对HIV酶免疫测定(EIA)阴性的血清标本进行筛选。个别HIV rna阳性标本的结果根据确认性检测结果重新分类为真或假。结果在接受筛查的8505人中,8194人以前没有HIV检测呈阳性,并且有足够的血清来完成检测方案。其中39人长期感染艾滋病毒(患病率为47.6 / 10000高危人群[95%置信区间,33.8-65.0 / 100001)。在抗体检测为阴性的8155名高危人群中,有5人是HIV RNA阳性。其中4例急性感染为真阳性(患病率为4.9 / 10000[95%置信区间,1.3-12.5 / 100001)。所有4人都是女性;2人在检测后一周出现与急性逆转录病毒综合征一致的症状。筛查所有标本需要进行147次艾滋病毒RNA检测。该策略的总特异性为0.9999。结论利用标本池和核酸检测在常规检测人群中广泛诊断急性HIV感染不仅是可能的,而且是可行的。与传统的艾滋病毒抗体检测相比,这些附加程序可将诊断率提高约10%。
Context Acute human immunodeficiency virus (HIV) infection cannot be diagnosed by routine antibody tests and is rarely diagnosed in clinical practice. However, HIV nucleic acid-based testing is widely used to screen for anti body-negative acute infection among low-risk blood donors.Objective To assess the feasibility of screening in high-volume laboratories for acute and long-term HIV infection in a routine HIV testing population, in which HIV infection prevalence is low, using specimen pooling and HIV RNA reverse transcriptase-polymerase chain reaction (RT-PCR) tests.Design and Setting Clinical diagnostic performance evaluation at a state-funded public health virology and serology laboratory. Participants A total of 8505 consecutive individuals presenting for routine HIV counseling and testing during a total of 20 business days to simulate a month of testing in August and December 2001 at 110 publicly funded testing sites in North Carolina.Main Outcome Measures Prevalence of acute and long-term HIV infection. Serum specimens negative by HIV enzyme immunoassay (EIA) were screened in pools by an ultrasensitive HIV RNA RT-PCR test.Results for individual HIV RNA-positive specimens were reclassified as true or false according to results of confirmatory testing. Results Of the 8505 individuals screened, 8194 had not previously tested HIV positive and had sufficient serum to complete the testing protocol. Of those, 39 had long-term HIV infection (prevalence, 47.6 per 10000 at-risk persons [95% confidence interval, 33.8-65.0 per 100001). Of the 8155 at-risk individuals whose antibody tests were negative, 5 were HIV RNA positive. Four of those had true-positive acute infection (prevalence, 4.9 per 10000 [95% confidence interval, 1.3-12.5 per 100001). All 4 were women; 2 developed symptoms consistent with an acute retroviral syndrome in the week after testing. Screening all specimens required 147 HIV RNA tests. Overall specificity of the strategy was 0.9999.Conclusions These findings suggest the widespread diagnosis of acute HIV infections in a routine testing population is not only possible but feasible using specimen pooling and nucleic acid testing. These additional procedures may increase diagnostic yield by approximately 10% compared with conventional HIV antibody testing.