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