Kothe Denise, Byers Robert H, Caudill Samuel P, Satten Glen A, Janssen Robert S, Hannon W Harry, Mei Joanne V
Division of Laboratory Sciences, National Center for Environmental Health, Atlanta, Georgia 30341, USA.
J Acquir Immune Defic Syndr. 2003 Aug 15;33(5):625-34. doi: 10.1097/00126334-200308150-00012.
Less sensitive (LS) HIV-1 enzyme immunoassays (EIAs) have significantly improved the quantity and quality of HIV surveillance data. The first LS-HIV-1 EIA, the Abbott 3A11-LS, provided reliable incidence data, but the assay required specialized equipment, and the lack of available reagents made testing difficult. This study evaluated the use of an alternate assay, a modified version of the Vironostika HIV-1 EIA (Vironostika-LS), to be used for LS testing. The Vironostika-LS has similar performance characteristics to the Abbott 3A11-LS with additional advantages. This 96-well formatted assay is commonly found in public health laboratories for routine HIV-1 testing and can be used with both serum and dried blood spot specimens. The estimated mean time from seroconversion (defined using a standardized optical density cutoff of 1.0) with the Vironostika-LS was 170 days (95% CI, 145-200 days). When the Vironostika-LS was applied to a matched serum set previously tested with the Abbott 3A11-LS, the Vironostika-LS accurately identified 97% of specimens with recent or long-standing HIV infection. The paper also reports Vironostika-LS quality control guidelines and the results from 3 rounds of proficiency testing.
敏感性较低（LS）的HIV-1酶免疫测定法（EIA）显著提高了HIV监测数据的数量和质量。首个LS-HIV-1 EIA，即雅培3A11-LS，提供了可靠的发病率数据，但该检测需要专门设备，且缺乏可用试剂使得检测困难。本研究评估了另一种检测方法，即改良版的Vironostika HIV-1 EIA（Vironostika-LS）用于LS检测的情况。Vironostika-LS具有与雅培3A11-LS相似的性能特征且还有其他优势。这种96孔格式的检测方法在公共卫生实验室中常用于常规HIV-1检测，并且可用于血清和干血斑样本。使用Vironostika-LS从血清转化（使用标准化光密度截断值1.0定义）到检测出阳性的估计平均时间为170天（95%置信区间，145 - 200天）。当将Vironostika-LS应用于先前用雅培3A11-LS检测过的匹配血清样本集时，Vironostika-LS准确识别出97%近期或长期感染HIV的样本。该论文还报告了Vironostika-LS的质量控制指南以及三轮能力验证的结果。
