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. 2022 Jun 29;14(7):1426.
doi: 10.3390/v14071426.

The Impact of Early Antiretroviral Treatment (ART) for HIV on the Sensitivity of the Latest Generation of Blood Screening and Point of Care Assays

Marion Vermeulen  1   2 , Cari van Schalkwyk  3 , Genevieve Jacobs  1 , Karin van den Berg  1   2   4 , Mars Stone  5   6 , Sonia Bakkour  5   6 , Brian Custer  5   6 , Ute Jentsch  1 , Michael P Busch  5   6 , Edward Murphy  5   6 , Eduard Grebe  3   5   6
Affiliations

The Impact of Early Antiretroviral Treatment (ART) for HIV on the Sensitivity of the Latest Generation of Blood Screening and Point of Care Assays

Marion Vermeulen et al. Viruses. .

Abstract

Introduction: Rapid initiation of antiretroviral therapy (ART) in early HIV infection is important to limit seeding of the viral reservoir. A number of studies have shown that if ART is commenced prior to seroconversion, the seroconversion may, or may not, occur. We aimed to assess whether seroreversion or no seroconversion occurs using samples collected during an early treatment study in South Africa.

Methods: We tested 10 longitudinal samples collected over three years from 70 blood donors who initiated ART after detection of acute or early HIV infection during donation screening on fourth- and fifth-generation HIV antibody and RNA assays, and three point of care (POC) rapid tests. Donors were allocated to three treatment groups: (1) very early, (2) early, and (3) later. Longitudinal samples were grouped into time bins post-treatment initiation.

Results: On all three high-throughput HIV antibody assays, no clear pattern of declining signal intensity was observed over time after ART initiation in any of the treatment initiation groups and 100% detection was obtained. The Abbott Determine POC assay showed 100% detection at all time points with no seroreversion. However, the Abbott ABON HIV1 and OraSure OraQuick POC assays showed lower proportions of detection in all time bins in the very early treated group, ranging from 50.0% (95% CI: 26.8-73.2%) to 83.1% (95% CI: 64.2-93.0%), and moderate detection rates in the early and later-treated groups.

Conclusion: While our findings are generally reassuring for HIV detection when high-throughput serological screening assays are used, POC assays may have lower sensitivity for detection of HIV infection after early treatment. Findings are relevant for blood safety and other settings where POC assays are used.

Keywords: HIV; antiretroviral therapy; point of care testing; serological screening.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Quantitative signal intensity over time since treatment (Rx) initiation, stratified by time from infection to treatment initiation, in three high-throughput HIV blood screening assays. Panel (A): Abbott HIV Combo on the Alinity s platform, Panel (B): Roche Elecsys HIV Duo on the cobas e801 platform, and Panel (C): Bio-Rad BioPlex 2200 HIV assay. The dotted red lines indicate the cut- offs for positivity.
Figure 2
Figure 2
Proportion of donors returning reactive results on POC HIV antibody assays, stratified by 180-day intervals from infection to treatment (Rx) initiation. The points and whiskers indicate means and 95% confidence bounds.
Figure 3
Figure 3
Distribution of signal to cut-off ratios in HIV positive samples in which ARVs were detected or not detected on the Abbott PRISM and Abbott Alinity s blood-screening systems. Panel (A): Abbott PRISM (third generation Ab assay); Panel (B): Abbott Alinity (4th-generation Ag/Ab combo assay). Horizontal lines in the boxes indicate medians, and, diamonds indicate means.
See this image and copyright information in PMC

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