第四代 HIV 快速检测:提高 HIV-1 原发性感染筛查的灵敏度和缩短诊断窗口期。

Fourth-Generation HIV Rapid Tests: Enhanced Sensitivity and Reduced Diagnostic Window for HIV-1 Primary Infection Screening.

机构信息

Laboratoire de Virologie, INSERM, Institut Pierre Louis d' Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Sorbonne Université, Paris, France.

INSERM UMR-S 1139, 3PHM, Université Paris cité, Paris, France.

出版信息

J Med Virol. 2024 Nov;96(11):e70044. doi: 10.1002/jmv.70044.

Abstract

As most HIV rapid tests (HRT) detect only HIV-1/2 antibodies, their performance during primary HIV infection is poor. Determine HIV Early detect (Abbott) (Determine) is the only HRT with an HIV-1 p24-antigen detection, but the impact of this addition in shortening the diagnostic window remains unclear. A total of 183 HIV-1 primary infection samples were tested using the HRTs Determine and ONE STEP anti-HIV (1&2) Test (InTec Products) (One-Step). The pre-seroconversion subgroup was defined as p24-antigen positivity without Western blot nor Liaison XL (fouth generation enzyme immunoassay with distinct signal for p24-antigen and HIV-1 antibody) HIV-1 antibodies. Global sensitivity (95% CI) was 95% (91-97) for Determine versus 80% (74%-85%) for One-Step (difference p = 1.38e-06). Pre-seroconversion subgroup sensitivity was lower, at 71.9 (54.6%-84.4%) for Determine and 9.7% (3.3%-24.9%) for One-Step. Among the 45 samples with an HIV-1 infection date, no HRT was reactive up to 2 weeks. Between 2 and 3 weeks, Determine sensitivity was 78% (45%-95%) versus 56% (27%-81%) for One-Step. From 3 weeks to 1 month Determine sensitivity was 90% (62%-98%) and One-Step 45% (21%-72%). The last negative sample occurred at 3 weeks for Determine versus 70-90 days for One-Step. HRT with p24-antigen detection significantly shortens the diagnostic window from approximatively 3 months to 1 month. HRTs should be used with caution in the first month after HIV infection.

摘要

由于大多数 HIV 快速检测(HRT)仅检测 HIV-1/2 抗体,因此它们在原发性 HIV 感染期间的性能不佳。Determine HIV Early detect(雅培)(Determine)是唯一具有 HIV-1 p24 抗原检测的 HRT,但这种添加在缩短诊断窗口期方面的影响尚不清楚。共使用 HRT Determine 和 ONE STEP anti-HIV(1&2)Test(InTec Products)(One-Step)检测了 183 例 HIV-1 原发性感染样本。预血清转化亚组定义为 p24 抗原阳性,Western blot 和 Liaison XL(第四代酶免疫测定,具有独特的 p24 抗原和 HIV-1 抗体信号)HIV-1 抗体均为阴性。与 One-Step(差异 p = 1.38e-06)相比,Determine 的总体敏感性(95%CI)为 95%(91-97),One-Step 为 80%(74%-85%)。预血清转化亚组的敏感性较低,Determine 为 71.9(54.6%-84.4%),One-Step 为 9.7%(3.3%-24.9%)。在 45 例具有 HIV-1 感染日期的样本中,没有 HRT 在 2 周内呈反应性。在 2 至 3 周之间,Determine 的敏感性为 78%(45%-95%),而 One-Step 为 56%(27%-81%)。从 3 周到 1 个月,Determine 的敏感性为 90%(62%-98%),One-Step 为 45%(21%-72%)。最后一个阴性样本出现在 3 周时,而 One-Step 为 70-90 天。具有 p24 抗原检测的 HRT 可将诊断窗口期从大约 3 个月缩短至 1 个月。在 HIV 感染后第一个月内应谨慎使用 HRT。

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