Evaluation of the WHO human immunodeficiency virus (HIV) antibody testing strategy for the diagnosis of HIV infection.
Evaluation of the WHO human immunodeficiency virus (HIV) antibody testing strategy for the diagnosis of HIV infection.
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DOI：
10.1016/0928-0197(94)90030-2
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发表时间：
1994-02-01
期刊：
影响因子：
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通讯作者：
Biberfeld, G
中科院分区：
文献类型：
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作者：
Urassa, W;Matunda, S;Biberfeld, G
目的：为了评估一个世界卫生组织的检测策略的基础上使用两个连续的酶联免疫吸附试验（ELISA）作为一种替代ELISA，然后通过蛋白质印迹法（WB）的血清学诊断HIV infection.Study设计：该研究是2069连续血清标本从疑似HIV感染的患者收到的HIV诊断检测在HIV实验室，Muhimbili医疗中心，达累斯萨拉姆。该策略包括用Behring间接抗HIV 1 + 2肽ELISA检测所有血清，然后对第一次ELISA反应的血清进行Wellcozyme抗HIV-1重组竞争性ELISA。对两种ELISA均具有反应性的血清样本和所有两种ELISA结果不一致的血清样本进行WB。结果：在2069份血清中，837份（40.5%）第一次ELISA均为阴性，1172份（56.6%）第二次ELISA均为阳性，60份（2.9%）第一次ELISA均为阳性，第二次ELISA均为阴性，329份（28.1%）WB均为阳性。以WB确认为“金”标准的WHO替代检测策略的诊断准确性如下：敏感性99.4%（326/328），特异性99.7%（893/896），阳性预测值99.1%（328/331）和阴性预测值99.8%（893/895）。通过ELISA对最初在两种ELISA上给出不一致结果的血清进行重复检测，将灵敏度提高至100%。两种ELISA均为假阳性反应的3份血清在复检后两种ELISA均为阴性。为了达到100%的特异性和阳性预测值，这将是必要的所有血清反应两个ELISAs重新测试上一个ELISAs.CONCLUSIONS：第二个ELISA的基础上不同的抗原和不同的测试原理相比，第一ELISA可以被用来作为一种替代WB检测确认HIV抗体。然而，需要对世卫组织的艾滋病毒抗体诊断检测战略进行一些修改，以最大限度地提高诊断准确性。
OBJECTIVE: To evaluate a WHO testing strategy based on the use of two consecutive enzyme-linked immunosorbent assays (ELISA) as an alternative to ELISA followed by Western blotting (WB) for the serologic diagnosis of HIV infection.STUDY DESIGN: The study was of 2069 consecutive serum specimens from patients suspected of HIV infection received for HIV diagnostic testing at the HIV laboratory, Muhimbili Medical Centre, Dar es Salaam. The strategy involved testing all sera with Behring indirect anti-HIV 1 + 2 peptide ELISA, followed by Wellcozyme anti-HIV-1 recombinant competitive ELISA on those sera reactive by the first ELISA. WB was done on a sample of the sera reactive on both ELISAs and on all those giving discordant results on the two ELISAs. Of the 2069 sera tested, 837 (40.5%) were negative on the first ELISA, 1172 (56.6%) were reactive on both ELISAs and 60 (2.9%) were initially reactive on the first test but not on the second assay.RESULTS: Of the 1172 sera reactive on both ELISAs, 329 (28.1%) were tested by WB. The diagnostic accuracy of the WHO alternative testing strategy using WB confirmation as the 'gold' standard was as follows: sensitivity 99.4% (326/328), specificity 99.7%, (893/896), positive predictive value 99.1% (328/331) and negative predictive value 99.8% (893/895). Repeated testing by ELISA of the sera which initially gave discordant results on the two ELISAs increased the sensitivity to 100%. Three sera giving false positive reactions on both ELISAs became negative on both ELISAs after retesting. In order to achieve a specificity and a positive predictive value of 100%, it would have been necessary to subject all sera reacting on both ELISAs to retesting on one ELISA.CONCLUSIONS: A second ELISA based on different antigens and a different test principle compared with the first ELISA could be used as an alternative to the WB assay for confirmation of HIV antibodies. However, some modifications of the WHO strategy for diagnostic HIV antibody testing were required in order to maximize the diagnostic accuracy.