Division of HIV and Other Retroviruses, Robert Koch Institute, Berlin, Germany; Charité, Universitätsmedizin, Berlin, Berlin, Germany.
Division of HIV/AIDS, STI and Blood-borne Infections, Robert Koch Institute, Berlin, Germany.
J Virol Methods. 2019 Apr;266:114-120. doi: 10.1016/j.jviromet.2019.02.002. Epub 2019 Feb 7.
Serological methods to differentiate between recently acquired and established HIV-1 infections are a useful tool in the HIV-surveillance to characterize the epidemic, identify groups at risk and assess HIV-preventive interventions. Therefore, an avidity-based, modified BioRad Genscreen™ HIV-1/2 assay (BRA) was evaluated according to the avidity-based, modified BioRad HIV-1/2 Plus O protocol (BRA). Overall, 692 well defined samples (82.5% B and 17.5% non-B subtypes) from recent (<180 days, n = 239), intermediate (181-364 days, n = 35) or long term infections (≥365 days, n = 419) were used to determine a 'mean duration of recent infection' (MDRI), a 'median DRI' (MdDRI), the false recent rate (FRR), and concordance between the BRAs and the Sedia BED HIV-1 Capture enzyme immunoassay (BED). The optimal avidity index cut-off was determined to be 70% resulting in an MDRI of 233 days (95% IQR: 174-351) and an MdDRI of 171 days (95% IQR: 142-212). Concordance with the BRA was high with 96.4%. The FRR of 6.0% as well as the MdDRI are similar to the BED (8.4%; 170 (139-214) days). Therefore, the BRA is a suitable alternative to replace the BED and trend analysis will be feasible after minimal adjustments for the MdDRI and the MDRI.
用于区分新近获得和已建立的 HIV-1 感染的血清学方法是 HIV 监测的有用工具，可用于描述流行情况、确定高危人群并评估 HIV 预防干预措施。因此，根据基于亲和力的改良 BioRad Genscreen™ HIV-1/2 检测（BRA）协议，对基于亲和力的改良 BioRad HIV-1/2 Plus O 检测（BRA）进行了评估。总体而言，使用 692 份明确界定的样本（82.5%为 B 亚型，17.5%为非 B 亚型），包括近期（<180 天，n=239）、中期（181-364 天，n=35）或长期（≥365 天，n=419）感染，以确定“平均近期感染持续时间”（MDRI）、“中位数 DRI”（MdDRI）、假近期率（FRR）以及 BRA 与 Sedia BED HIV-1 捕获酶免疫测定（BED）之间的一致性。确定最佳亲和力指数截断值为 70%，导致 MDRI 为 233 天（95% IQR：174-351），MdDRI 为 171 天（95% IQR：142-212）。与 BRA 的一致性很高，达到 96.4%。FRR 为 6.0%，与 BED（8.4%；170（139-214）天）相似。因此，BRA 是替代 BED 的合适选择，并且在对 MdDRI 和 MDRI 进行最小调整后，趋势分析将是可行的。
