Vincent Guiraud, Quentin Beaulieu, Antoine Fauchois, Pascale Jean-Charles, Marie-Capucine Costes, Bruno Le Labousse, Pr Agnès Gautheret-Dejean
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An identical sensitivity (95% CI) of 76.7% (65.2-84.2%) was observed for HIV 1/2 STAT-PAK<sup>®</sup> Assay (STAT-PAK), INSTI™ HIV-1/HIV-2 antibody Test (INSTI), SURE CHECK<sup>®</sup> 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<sup>®</sup> Test VIH 1-2.O CARTE (FIRST RESPONSE), 83.8% (73.8-90.5%) for VIKIA HIV1/2<sup>®</sup> (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<sup>®</sup> 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. 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引用次数: 0
摘要
快速检测可以在门诊进行低成本、可靠的慢性艾滋病病毒感染筛查。然而，有关其对初次感染敏感性的数据仍然很少。本研究的目的是评估九种 HIV 快速检测方法对 HIV-1 原发感染筛查的敏感性。研究纳入了 75 份 HIV-1 原发感染患者的血清样本。原发性感染的诊断依据是第四代酶联免疫吸附试验（ELISA）阳性和与 HIV-1 原发性感染相关的 Western 印迹模式证实的 HIV-1 RNA 阳性。早期血清转换的定义是在与 HIV-1 RNA 和 p24 抗原阳性相关的 Western 印迹上没有 HIV-1 抗体。HIV 1/2 STAT-PAK® 检测试剂盒（STAT-PAK）、INSTI™ HIV-1/HIV-2 抗体检测试剂盒（INSTI）、SURE CHECK® HIV 1/2 检测试剂盒（SURE CHECK）和 MULTISURE HIV 快速检测试剂盒（MULTISURE）的灵敏度（95% CI）均为 76.7%（65.2-84.2%）。MULTISURE（自动读取）的灵敏度为 74.7%（63.8-83.1%），FIRST RESPONSE® 检测 VIH 1-2.O CARTE（FIRST RESPONSE）的灵敏度为 77.0%（66.3-85.1%），VIKIA HIV1 检测的灵敏度为 83.8%（73.8-90.5%）。VIKIA HIV1/2® (VIKIA)为 83.8%（73.8-90.5%），Genie™ Fast HIV 1/2 (Genie Fast)为 88.0%（78.7-93.6%），Hexagon HIV (Hexagon)为 88.6%（79.0-94.1%），Exacto® TEST HIV Pro (Exacto)为 92.8%（83.6-96.3%）。然而，快速检测在早期血清转换亚组（n = 14）中表现不佳，STAT-PAK、INSTI、SURE CHECK、MULTISURE（自动读取）的灵敏度为 7% (1.3-31.5%)，FIRST RESPONSE 为 29% (12-55%)，VIKIA 为 31% (13-58%)，Hexagon 为 43% (21-67%)，Exacto 和 Genie Fast 为 57.1% (32.6-78.6%)。总体而言，尽管灵敏度存在显著差异，但在怀疑原发感染的情况下，应谨慎使用艾滋病毒快速检测。
Rapid tests should be used with caution for HIV-1 primary infection screening.
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.
期刊介绍：
Medical Microbiology and Immunology (MMIM) publishes key findings on all aspects of the interrelationship between infectious agents and the immune system of their hosts. The journal´s main focus is original research work on intrinsic, innate or adaptive immune responses to viral, bacterial, fungal and parasitic (protozoan and helminthic) infections and on the virulence of the respective infectious pathogens.
MMIM covers basic, translational as well as clinical research in infectious diseases and infectious disease immunology. Basic research using cell cultures, organoid, and animal models are welcome, provided that the models have a clinical correlate and address a relevant medical question.
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manuscripts on the diagnostics of infectious diseases, unless they offer a novel concept to solve a pending diagnostic problem,
case reports or case series, unless they are embedded in a study that focuses on the anti-infectious immune response and/or on the virulence of a pathogen.
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