Service de Virologie, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Paris, F- 75013, France.
Université Paris cité, INSERM UMR-S 1139 Physiopathologie et pharmacotoxicologie placentaire humaine : microbiote pré & post-natal, Paris, F-75006, France.
Med Microbiol Immunol. 2024 Jun 22;213(1):10. doi: 10.1007/s00430-024-00792-1.
Rapid tests allow outpatient, low cost, reliable, screening for chronic HIV infection. However, data regarding their sensitivity on primary infection remain scarce. The objective of this study was to assess sensitivity of nine HIV rapid tests for primary HIV-1 infection screening. Seventy-five serum samples from patients during HIV-1 primary infection were included. Primary infection was diagnosed by a positive 4th generation ELISA and HIV-1 RNA positivity confirmed by Western blot patterns associated with HIV-1 primary infection. Early seroconversion was defined as the absence of antibodies on HIV-1 Western blot associated with HIV-1 RNA and p24-antigen positivity. An identical sensitivity (95% CI) of 76.7% (65.2-84.2%) was observed for HIV 1/2 STAT-PAK Assay (STAT-PAK), INSTI™ HIV-1/HIV-2 antibody Test (INSTI), SURE CHECK HIV 1/2 (SURE CHECK) and MULTISURE HIV rapid test (MULTISURE) with visual reading. Sensitivity was 74.7% (63.8-83.1%) for MULTISURE (automatic reading), 77.0% (66.3-85.1%) for FIRST RESPONSE Test VIH 1-2.O CARTE (FIRST RESPONSE), 83.8% (73.8-90.5%) for VIKIA HIV1/2 (VIKIA), 88.0% (78.7-93.6%) for Genie™ Fast HIV 1/2 (Genie Fast), 88.6% (79.0-94.1%) for Hexagon HIV (Hexagon), and 92.8% (83.6-96.3%) for Exacto TEST HIV Pro (Exacto). However, rapid tests performed poorly for the early seroconversion subgroup (n = 14), with sensitivities ranging from 7% (1.3-31.5%) for STAT-PAK, INSTI, SURE CHECK, MULTISURE (automatic reading), to 29% (12-55%) for FIRST RESPONSE, 31% (13-58%) for VIKIA, 43% (21-67%) for Hexagon and 57.1% (32.6-78.6%) for Exacto and Genie Fast. Overall, despite significant discrepancies in sensitivity, HIV rapid tests should be used with caution in the context of a suspected primary infection.
快速检测可用于门诊、低成本、可靠的慢性 HIV 感染筛查。然而，关于它们在初次感染中的敏感性的数据仍然很少。本研究的目的是评估九种 HIV 快速检测在初次 HIV-1 感染筛查中的敏感性。纳入了 75 例初次 HIV-1 感染患者的血清样本。初次感染通过 4 代 ELISA 阳性和 Western blot 模式证实的 HIV-1 RNA 阳性来诊断，该模式与 HIV-1 初次感染相关。早期血清转换定义为 HIV-1 Western blot 上无抗体，与 HIV-1 RNA 和 p24 抗原阳性相关。HIV 1/2 STAT-PAK 检测 (STAT-PAK)、INSTI™ HIV-1/HIV-2 抗体检测 (INSTI)、SURE CHECK HIV 1/2 (SURE CHECK) 和 MULTISURE HIV 快速检测 (MULTISURE) 的敏感性为 76.7%（95%CI，65.2-84.2%），具有相同的视觉阅读结果。MULTISURE（自动阅读）的敏感性为 74.7%（63.8-83.1%），FIRST RESPONSE Test VIH 1-2.O CARTE（FIRST RESPONSE）为 77.0%（66.3-85.1%），VIKIA HIV1/2（VIKIA）为 83.8%（73.8-90.5%），Genie™ Fast HIV 1/2（Genie Fast）为 88.0%（79.0-94.1%），Hexagon HIV（Hexagon）为 88.6%（79.0-94.1%），Exacto TEST HIV Pro（Exacto）为 92.8%（83.6-96.3%）。然而，对于早期血清转换亚组（n=14），快速检测的敏感性较差，范围从 STAT-PAK、INSTI、SURE CHECK、MULTISURE（自动阅读）的 7%（1.3-31.5%）到 FIRST RESPONSE 的 29%（12-55%），VIKIA 的 31%（13-58%），Hexagon 的 43%（21-67%），Exacto 和 Genie Fast 的 57.1%（32.6-78.6%）。总体而言，尽管敏感性存在显著差异，但在疑似初次感染的情况下，应谨慎使用 HIV 快速检测。
