Constantine N T, van der Groen G, Belsey E M, Tamashiro H
Global Programme on AIDS, World Health Organization, Geneva, Switzerland.
AIDS. 1994 Dec;8(12):1715-20. doi: 10.1097/00002030-199412000-00012.
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.
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).
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$ 15,150 and 151 million per unit detected at the above incidence rates.
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.
使用血清转化和其他含有不同滴度血浆的样本组，确定HIV抗体检测方法检测低水平HIV抗体的敏感性。
根据世界卫生组织批量采购协议获得的8种HIV抗体检测方法，对来自11名近期感染HIV（血清转化样本组）的个体的系列血浆样本进行了评估。此外，使用了两个非血清转化样本组，分别由低效（滴度）和混合滴度样本组成，以进一步确定检测方法的敏感性。这8种检测方法包括两种快速检测、一种简易检测和五种酶联免疫吸附测定（ELISA）。
平均而言，这8种检测方法比参考试验（雅培HIV-1/HIV-2第3代ELISA）晚0.5 - 4.8天检测到抗体；这8种检测方法中有6种的差异具有统计学意义。所有检测方法在低效和混合滴度样本组上表现良好。在一大组已知阳性血浆样本上，所有8种检测方法的敏感性也与参考试验相当。分别以每年1%和0.0001%的HIV发病率计算，在血清转化期间使用最不敏感的检测方法而非参考试验遗漏一个感染性血液单位的额外风险估计分别为7600分之一和7600万分之一。按照上述发病率，使用参考试验消除这种额外风险的成本为每检测一个单位15150美元至1.51亿美元之间。
虽然在血清转化过程中用于检测个体血液时，各检测方法之间的敏感性存在差异，但差异很小，所有8种检测方法均适合用作筛查检测。
