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

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

Vincent Guiraud  1 , Angèle Naizet  1 , Habiba Khan  1 , Ghizlane Benhafoun  1 , Pierre Hernandez  1 , Luigi Piccin  1 , Agnès Pichon  1 , Ay Ling Leng  1 , Léna Yousfi  1 , Agnès Gautheret-Dejean  1   2
Affiliations

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

Vincent Guiraud et al. J Med Virol. 2024 Nov.

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.

Keywords: Determine Combo; HIV primary infection; HIV rapid test; One‐Step; diagnostic window; sensitivity.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
HIV‐1 subtypes and Circulating Recombinant Forms of serum samples included in this study.
Figure 2
Figure 2
Determine and One‐Step sensitivity (%) according to seroconversion subgroups (A) or time from infection (B).
Figure 3
Figure 3
p24 antigen determination in serum is dependent on the assay and is poorly correlated with HIV viral loads. Correlation between Vidas HIV p24 II and Liaison XL p24 (A), between Vidas p24 antigen and Viral load (B), between Liaison XL and Viral load (C), and between Determine and Viral load (D). p24 values above limit of quantification were excluded from the figures. p24 was expressed in pg/mL for the Vidas assay, in a quantitative S/CO value for the Liaison XL assay, and as a visual intensity for Determine. Viral loads are expressed as log(copy/mL). Comparisons were performed using Wilcoxon rank sum (D), and the Spearman coefficient was used for correlation (A).
Figure 4
Figure 4
Comparison of pre‐seroconversion subgroup sensitivity of the Determine assay with previous studies.
See this image and copyright information in PMC

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