Pilcher Christopher D, McPherson J Todd, Leone Peter A, Smurzynski Marlene, Owen-O'Dowd Judy, Peace-Brewer Amy L, Harris Juanita, Hicks Charles B, Eron Joseph J, Fiscus Susan A
Department of Medicien, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7030, USA.
JAMA. 2002 Jul 10;288(2):216-21. doi: 10.1001/jama.288.2.216.
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 antibody-negative acute infection among low-risk blood donors.
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.
Clinical diagnostic performance evaluation at a state-funded public health virology and serology laboratory.
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.
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.
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 10,000 at-risk persons [95% confidence interval, 33.8-65.0 per 10,000]). 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 10,000 [95% confidence interval, 1.3-12.5 per 10,000]). 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.
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.
急性人类免疫缺陷病毒（HIV）感染无法通过常规抗体检测诊断，在临床实践中也很少被诊断出来。然而，基于HIV核酸的检测被广泛用于在低风险献血者中筛查抗体阴性的急性感染。
评估在HIV感染患病率较低的常规HIV检测人群中，使用样本混合和HIV RNA逆转录聚合酶链反应（RT-PCR）检测，在大容量实验室中筛查急性和长期HIV感染的可行性。
在一家由国家资助的公共卫生病毒学和血清学实验室进行临床诊断性能评估。
在20个工作日内，共有8505名连续前来接受常规HIV咨询和检测的个体，以模拟2001年8月和12月在北卡罗来纳州110个由公共资金资助的检测点进行的一个月检测。
急性和长期HIV感染的患病率。通过超灵敏HIV RNA RT-PCR检测对HIV酶免疫测定（EIA）阴性的血清样本进行混合筛查。根据确证检测结果，将单个HIV RNA阳性样本的结果重新分类为真阳性或假阳性。
在筛查的8505名个体中，8194名之前未检测出HIV阳性，且有足够的血清完成检测方案。其中，39名患有长期HIV感染（患病率为每10000名高危人群中47.6例[95%置信区间为每10000名中33.8 - 65.0例]）。在抗体检测为阴性的8155名高危个体中，5名HIV RNA呈阳性。其中4名患有真阳性急性感染（患病率为每10000名中4.9例[95%置信区间为每10000名中1.3 - 12.5例]）。这4名均为女性；2名在检测后一周内出现了与急性逆转录病毒综合征一致的症状。筛查所有样本需要147次HIV RNA检测。该策略的总体特异性为0.9999。
这些发现表明，在常规检测人群中广泛诊断急性HIV感染不仅是可能的，而且使用样本混合和核酸检测是可行的。与传统的HIV抗体检测相比，这些额外的程序可能会使诊断率提高约10%。
