SENSITIVITY OF HIV-ANTIBODY ASSAYS DETERMINED BY SEROCONVERSION PANELS
SENSITIVITY OF HIV-ANTIBODY ASSAYS DETERMINED BY SEROCONVERSION PANELS
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DOI：
10.1097/00002030-199412000-00012
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发表时间：
1994-12-01
期刊：
影响因子：
3.8
通讯作者：
TAMASHIRO, H
中科院分区：
文献类型：
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作者：
CONSTANTINE, NT;VANDERGROEN, G;TAMASHIRO, H
目的：利用血清转换和其他含有不同滴度血浆的检测板，确定HIV抗体检测低水平HIV抗体的敏感性。方法：根据世界卫生组织批量采购协议提供的8种艾滋病毒抗体测定方法，对最近感染艾滋病毒的11人（血清转化组）的连续血浆样本进行了评估。此外，使用两个非血清转换面板，由低效价（滴度）和混合滴度样品组成，以进一步确定检测的敏感性。8项检测包括2项快速检测、1项简单检测和5项酶联免疫吸附检测（ELISA）。结果：8种方法检测抗体的时间平均比参考方法（雅培HIV-1/HIV-2第3代ELISA）晚0.5 ~ 4.8天；这些差异在8个测试中有6个具有统计学意义。所有测试在低性能和混合滴度面板上都表现良好。所有8种检测方法在大量已知阳性血浆的参考试验中也具有相当的敏感性。在HIV年发病率分别为1%和0.0001%的情况下，使用最不敏感的检测而不是参考检测，在血清转化过程中丢失感染性血液单位的额外风险估计分别为1 / 7600和1 / 7600万。按照上述发病率，通过使用参考检测来消除这一额外风险的成本为每单位15.15亿至1.51亿美元。结论：虽然在血清转化过程中用于检测个体血液的检测方法之间存在敏感性差异，但差异很小，所有8种检测方法都适合用作筛查试验。
Objectives: To determine the sensitivity of HIV-antibody assays for detecting low levels of HIV antibody using seroconversion and other panels containing plasma of varying titres.Methods: Eight HIV-antibody assays, available under the World Health Organization bulk-procurement agreement, were evaluated on sets of sequential plasma samples derived from 11 individuals who had recently become HIV-infected (seroconversion panels). In addition, two non-seroconversion panels, consisting of low performance (titre) and mixed titre samples were used to further define the sensitivity of the assays. The eight assays included two rapid tests, one simple test, and five enzyme-linked immunosorbent assays (ELISA).Results: On average, the eight assays detected antibody 0.5-4.8 days later than the reference test (Abbott HIV-1/HIV-2 3rd generation ELISA); these differences were statistically significant for six of the eight tests. All tests performed well on the low performance and mixed titre panels. All eight assays also had comparable sensitivity to that of the reference test on a large panel of known positive plasma. The additional risk of missing an infectious unit of blood during seroconversion by using the least sensitive rather than the reference test was estimated to be 1 in 7600 and 1 in 76 million at annual HIV incidence rates of 1 and 0.0001%, respectively. The cost of eliminating this additional risk by using the reference test is between US$15150 and 151 million per unit detected at the above incidence rates.Conclusions: Although there are differences in sensitivity between the assays when used to test blood from individuals during the course of seroconversion, the differences are small, and all eight tests are appropriate for use as screening tests.