Kleinman S, Busch M P, Hall L, Thomson R, Glynn S, Gallahan D, Ownby H E, Williams A E
Westat Inc, Rockville, MD, USA.
JAMA. 1998;280(12):1080-5. doi: 10.1001/jama.280.12.1080.
Persons at risk of human immunodeficiency virus 1 (HIV-1) infection, have been classified incorrectly as HIV infected because of Western blot results, but the frequency of false-positive Western blot results is unknown.
To determine the frequency of false-positive HIV-1 Western blot results in US blood donors and to make projections to other screened populations. Secondarily, to validate an algorithm for evaluating possible false-positive cases.
A retrospective cohort study of HIV-1 enzyme immunoassay (EIA) and Western blot results from large blood donor screening programs in which donors with suspected false-positive Western blot results underwent HIV-1 RNA polymerase chain reaction (PCR) testing and follow-up HIV-1 serology.
Five US blood centers participating in the Retrovirus Epidemiology Donor Study.
More than 5 million allogeneic and autologous blood donors who successfully donated blood at 1 of the 5 participating centers from 1991 through 1995.
Rate of false positivity by Western blot and true HIV-1 infection status as determined by HIV-1 RNA PCR and by serologic follow-up of blood donors more than 5 weeks after donation.
Of 421 donors who were positive for HIV-1 by Western blot, 39 (9.3%) met the criteria of possible false positivity because they lacked reactivity to p31. Of these, 20 (51.3%) were proven by PCR not to be infected with HIV-1. The false-positive prevalence was 4.8% of Western blot-positive donors and 0.0004% (1 in 251000) of all donors (95% confidence interval, 1 in 173000 to 1 in 379000 donors).
A false diagnosis of HIV-1 infection can result from the combination of EIA and Western blot testing in blood donor and other HIV-1 screening programs. Individuals with a positive Western blot result lacking the p31 band should be counseled that, although they may be HIV infected, there is uncertainty about this conclusion. These individuals should be further evaluated by RNA PCR testing (if feasible) and HIV serologic analysis on a follow-up sample.
由于免疫印迹检测结果，有感染人类免疫缺陷病毒1型（HIV-1）风险的人被错误分类为HIV感染者，但免疫印迹检测结果假阳性的频率尚不清楚。
确定美国献血者中HIV-1免疫印迹检测结果假阳性的频率，并推算其他筛查人群的情况。其次，验证一种评估可能的假阳性病例的算法。
一项对HIV-1酶免疫测定（EIA）和免疫印迹检测结果的回顾性队列研究，该研究来自大型献血者筛查项目，其中免疫印迹检测结果疑似假阳性的献血者接受了HIV-1 RNA聚合酶链反应（PCR）检测和后续HIV-1血清学检测。
参与逆转录病毒流行病学献血者研究的5个美国血液中心。
1991年至1995年期间在5个参与中心之一成功献血的500多万名异体和自体献血者。
免疫印迹检测的假阳性率以及通过HIV-1 RNA PCR和献血者献血后5周以上的血清学随访确定的真正HIV-1感染状态。
在421名免疫印迹检测HIV-1呈阳性的献血者中，39名（9.3%）符合可能假阳性的标准，因为他们对p31无反应性。其中，20名（51.3%）经PCR证实未感染HIV-1。假阳性患病率在免疫印迹检测阳性的献血者中为4.8%，在所有献血者中为0.0004%（1/251000）（95%置信区间，1/173000至1/379000献血者）。
在献血者和其他HIV-1筛查项目中，EIA和免疫印迹检测相结合可能导致HIV-1感染的误诊。免疫印迹检测结果阳性但缺乏p31条带的个体应被告知，尽管他们可能感染了HIV，但这一结论存在不确定性。这些个体应通过RNA PCR检测（如果可行）和后续样本的HIV血清学分析进行进一步评估。
