Published in PLOS One on 2026-05-04, this study is presented as an attributed evidence briefing. The excerpts below are the original researchers’ words, reproduced under their Creative Commons Attribution licence. HealthSignal has selected the abstract and, where needed, opening background paragraphs; the complete methods, results, limitations and references remain in the linked paper.
Original authors: Shilpa S. Iyer, Jake M. Pry, Herbert Kapesa, Misinzo Moono, Chilambwe Mwila, Christiana Frimpong, Mirriam Nanyangwe, Lumbani Phiri, Ruth Ngandu, Precious Sakanya, Sharon Mwansa, Talandila Phiri, Mizinga Haciwa, Patricia Maritim, Kemba Lee, Melissa Arons, Tiffiany Aholou, Peter Minchella, Theodora Savory – van Huis, Carolyn Bolton, Michael E. Herce
Source: PLOS One • DOI 10.1371/journal.pone.0346868
Read the complete primary study ↗ · Creative Commons Attribution licence
From the researchers
Abstract
Zambia established a recent infection testing algorithm (RITA) incorporating a novel point-of-care (POC) rapid test—the Asanté™ HIV-1 Rapid Recency® Assay (RTRI)—plus a HIV-1 viral load (VL) test to distinguish recent (≤12 months) from long-term (>12 months) HIV acquisition. This study evaluated the field performance of RTRI when implemented by healthcare workers at the POC.
We enrolled individuals newly diagnosed with HIV between 20 May 2021 and 10 March 2022 at two Ministry of Health facilities in Lusaka, Zambia. Participants received on-site RTRI testing and provided an additional sample for repeat RTRI and VL testing at a central laboratory. Final recent infection testing algorithm (RITA) results were returned to the study sites and were made available to clients at their study follow-up visit. Agreement between POC- and laboratory-RTRI was assessed using Cohen’s Kappa. We compared recent versus long-term HIV classification across testing locations using the national RITA as the reference standard. Four focus group discussions (FGDs) with health staff explored perceptions surrounding POC-RTRI implementation.
Agreement between POC and laboratory RTRI was 96.5%, with a Kappa of 0.812 (95% CI: 0.704–0.920). The POC-RTRI results indicated numerically more recent infections than laboratory-RTRI (30 vs 27), with three POC-RTRI false positives resulting in reduced sensitivity 85.0% for the POC-RTRI compared to 100.0% sensitivity for the laboratory-RTRI against the RITA reference standard. FGD participants (n = 28) agreed that POC RTRI was feasible and acceptable with adequate training, human resources, client counselling, and quality assurance measures.
There was strong concordance between POC- and laboratory-RTRI results. The findings support the feasibility of implementing RTRI at POC by non-laboratory health workers, provided adequate training and health system resources are in place.
Introduction
Despite increasing availability of HIV testing service (HTS) globally, important gaps remain in ensuring all people living with HIV (PLHIV) know their HIV status, particularly in high prevalence countries in sub-Saharan Africa (SSA). In Zambia, results from the most recent population-based HIV/AIDS impact assessment (ZamPHIA), completed in 2021, revealed that approximately 11% of PLHIV are unaware of their HIV status [1]. These data suggest a need for scale up of varied, innovative, and evidence-based HTS platforms such as index testing. While index testing has been a successful strategy for newly diagnosing PLHIV, the current practice of engaging sexual and needle-sharing contacts of persons living with, or at high risk of, HIV without regard to HIV viremia or the phase of infection (i.e., chronic versus acute and early HIV infection [AEHI]), may be insufficient, in and of itself, to increase program gains [2].
Indeed, AEHI has complicated efforts to achieve HIV epidemic control through high replication of viruses with increased infectivity [3,4], disproportionately contributing to onward HIV transmission, particularly during the first 6 months after HIV acquisition [5]. Yet, AEHI is hard to identify in real-world program settings where availability of viral load (VL) or combination antigen/ antibody testing at the point-of-care (POC) is limited for this purpose [6]. In the absence of these POC technologies and other tools that can routinely identify AEHI for public health intervention, interest has grown in developing new assays that can reliably differentiate between individuals with recent HIV infection (i.e., occurring within 6–12 months of HIV acquisition, including AEHI) and those with more chronic infection (i.e., occurring after 12 months from acquisition). Such tests, called tests for recent infection, cannot be used to diagnose AEHI, but may still have utility in national HIV surveillance programs intended to identify geographic areas of potentially ongoing, and increased, HIV transmission to inform a precise public health response [1]. One such test, the Asanté HIV-1 Rapid Recency test (Sedia Biosciences, Oregon, USA), is a POC rapid test for recent infection (RTRI) developed by the U.S. Centers for Disease Control and Prevention (CDC) to differentiate, under research conditions, people with long-term HIV infection from those with seroconversion in the last 6–12 months [7,8]. Results from these tests are often used in combination with one or more of VL, CD4 + count, ART history, plasma antiretroviral metabolites, and/or clinical evaluation for AIDS-defining illnesses as part of a recent infection testing algorithm (RITA) to assess HIV recent infection status.
Reading this evidence
Use the full paper to check the study design, participant selection, comparator and outcome definitions before drawing a practical conclusion. An association does not by itself show cause and effect. A reported performance measure needs its denominator and uncertainty. A finding from a particular facility, sample or time period should retain that scope when it is discussed elsewhere.
This briefing makes the source accessible within the wider technology & industry desk. It does not assess an individual patient or certify a product. When considering relevance to another health system, examine the original authors’ account of context and limitations, then seek local implementation evidence. The related reporting below provides other studies to read alongside this one; it is a topic connection, rather than a claim that their results are directly comparable.
© 2026 Shilpa S. Iyer, Jake M. Pry, Herbert Kapesa, Misinzo Moono, Chilambwe Mwila, Christiana Frimpong, Mirriam Nanyangwe, Lumbani Phiri, Ruth Ngandu, Precious Sakanya, Sharon Mwansa, Talandila Phiri, Mizinga Haciwa, Patricia Maritim, Kemba Lee, Melissa Arons, Tiffiany Aholou, Peter Minchella, Theodora Savory – van Huis, Carolyn Bolton, Michael E. Herce. Excerpts reproduced under CC BY. Selection, formatting and contextual notes by HealthSignal. The researchers are the authors of the source study, not members of HealthSignal’s staff.
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