National Blood Services Center, Magen David Adom, Ramat-Gan, Israel.
Central Virology Laboratory, Sheba Medical Center, Ministry of Health, Ramat-Gan, Israel.
Transfusion. 2019 Jun;59(6):2054-2060. doi: 10.1111/trf.15245. Epub 2019 Mar 20.
Screening blood donations for human immunodeficiency virus 1/2 (HIV-1/2) infection in blood centers is often done with a highly sensitive 3rd-generation immunoassay which may cause false-positive results. Donations found repeatedly reactive (RR) are discarded regardless of negative HIV-1/2 nucleic acid testing (NAT) and confirmatory assays results. These donors are notified and deferred if RR in a subsequent donation. We evaluated the introduction of a secondary 4th-generation serological assay to the overall algorithm performance.
All donations collected between January 2016 and May 2018 (574,338) were screened using 3rd-generation immunoassay (PRISM HIV O Plus) and NAT (Procleix Ultrio/Ultrio Elite). Serology RR donations were tested with 4th-generation Architect HIV Ag/Ab Combo and Vidas HIV Duo Ultra and a confirmatory assay (Geenius HIV-1/2).
The two 4th-generation assays found that 86% (179/209 on Architect) and 94% (182/193 on Vidas) of the 3rd-generation immunoassay RR were negative for HIV-1/2, which were also negative by confirmatory assay. Only 14% (30/209 on Architect) and 6% (11/193 on Vidas) that were 3rd-generation HIV-1/2 RR required confirmation, of which eight donors were confirmed as HIV positive. The probability of missing an HIV-1 infected donor by this algorithm is one in a million RR cases.
The introduction of a two-step serological screening algorithm in blood centers whereby 4th-generation assay will be performed for all 3rd-generation RR blood donors will reduce the number of donations requiring confirmation, save time and money, and most importantly, reduce the number of discarded blood donations and allow re-entry processes.
血液中心通常使用高度敏感的第三代免疫分析法筛查血液中是否存在人类免疫缺陷病毒 1/2（HIV-1/2）感染，这可能导致假阳性结果。无论 HIV-1/2 核酸检测（NAT）和确证检测结果如何，只要发现重复反应性（RR）的献血，都会将其丢弃。如果在随后的献血中 RR，这些献血者会收到通知并被延期。我们评估了将第二代四代血清学检测引入总体算法性能的效果。
2016 年 1 月至 2018 年 5 月期间采集的所有献血（574,338 份）均使用第三代免疫分析法（PRISM HIV O Plus）和 NAT（Procleix Ultrio/Ultrio Elite）进行筛查。RR 血清学献血者使用第四代 Architect HIV Ag/Ab Combo 和 Vidas HIV Duo Ultra 进行检测，并使用确证检测（Geenius HIV-1/2）进行检测。
两种四代检测法发现，第三代免疫分析法 RR 中 86%（Architect 上的 179/209）和 94%（Vidas 上的 182/193）的 HIV-1/2 为阴性，确证检测也为阴性。只有 14%（Architect 上的 30/209）和 6%（Vidas 上的 11/193）的第三代 HIV-1/2 RR 需要确证，其中 8 名献血者被确认为 HIV 阳性。这种算法漏检感染 HIV-1 的献血者的概率为百万分之 1 RR。
血液中心引入两步血清学筛查算法，对所有第三代 RR 献血者进行四代检测，将减少需要确证的献血数量，节省时间和金钱，更重要的是，减少丢弃的献血数量，允许重新进入流程。
