Published in PLOS One on 2026-06-18, this study is presented as an attributed evidence briefing. The excerpts below are the original researchers’ words, reproduced under their Creative Commons Attribution licence. Health Signal has selected the abstract and, where needed, opening background paragraphs; the complete methods, results, limitations and references remain in the linked paper.
Original authors: Agness Thawani, Ethel Rambiki, Jacqueline Huwa, Layout Gabriel, Aubrey Kudzala, Christine Kiruthu-Kamamia, Pachawo Bisani, Shameem Buleya, Nathan P. Ford, Cheryl C. Johnson, Ajay Rangaraj, Robert Luo, Celine Lastrucci, Busisiwe Msimanga, Rose Nyirenda, Bilaal Wilson Matola, Andreas Jahn, Claudia Wallrauch, Rachael Burke, Tom Heller
Source: PLOS One • DOI 10.1371/journal.pone.0340955
Read the complete primary study ↗ · Creative Commons Attribution licence
From the researchers
Abstract
CD4 testing is essential for identifying people with advanced HIV(AHD) disease and enabling delivery of the recommended diagnostic package including serum cryptococcal antigen (CrAG)and urine lipoarabinomannan(LAM) testing and prophylaxis. Suboptimal access to CD4 testing remains a major barrier to the scale-up of advanced HIV disease services, and there is limited evidence to inform strategies for improving access within constrained health systems. Although task-sharing for advanced HIV disease is being promoted, evidence on the performance of these diagnostics when delivered by lay providers in routine program settings remains limited. Lay providers (HIV diagnostic assistants) might be able to perform CD4 testing, serum cryptococcal antigen (CrAg) and urine lipoarabinomannan (LAM) tests using lateral flow assays (LFAs). We conducted a prospective diagnostic accuracy study comparing VISITECT® CD4 lateral flow assay results performed by HDAs and laboratory technicians, using paired quantitative PIMA CD4 results performed by nurses as the reference standard. We also compared serum cryptococcal antigen and urine lipoarabinomannan test results performed by HDAs and nurses. Implementation costs were estimated to assess the potential efficiency of task-sharing. We recruited 308 participants, the median CD4 was 248 cells/mm3; and 115 participants (37.3%) had values below 200 cells/mm3. Sensitivity and specificity for determining CD4 below 200 cells/mm3 using the VISITECT® CD4 LFA operated by HDAs were 94.8% (95% CI: 89.1–97.6%) and 92.2% (95% CI: 87.6–95.2%), respectively. HDAs achieved higher sensitivity and specificity than laboratory technicians. Subsequent serum-CrAg and urine-LAM test performed by HDAs and nurses showed an agreement of 98.1% (κ = 0.74) and 98.1% (k = 0.85), respectively. Incremental cost per CD4 test was US$8.69 when performed using the PIMA® CD4 quantitative device by a nurse and US$5.24 when performed using the VISITECT® CD4 semi-quantitative lateral flow assay by HDAs (2024 US dollars). Trained lay providers can accurately perform CD4, urine TB-LAM, and serum cryptococcal antigen testing. Our findings support task-sharing for decentralized advanced HIV disease testing; CD4 lateral flow assay testing is particularly suitable for peripheral health facilities that rely on lay providers and lack reliable electricity and laboratory infrastructure. This approach could play a critical role in expanding access to advanced HIV disease services.
Introduction
Despite the remarkable progress with antiretroviral therapy (ART) rollout in sub-Saharan Africa, approximately one quarter to one third of people living with HIV (PLHIV) presenting to care continue to have advanced HIV disease (AHD) [1–5]. In 2017, the World Health Organization (WHO) recommended a package of care for AHD, which included screening, treatment or prophylaxis for major opportunistic infections, rapid initiation of ART, and intensified adherence support for all patients presenting with AHD [6]. AHD remains a leading cause of hospital admissions among PLHIV globally [7]. Enhanced infection prophylaxis has been shown to reduce mortality in severely immunosuppressed adults and older children initiating ART [8]. Most reporting countries have fully (75%) or partially (17%) adopted this recommended AHD package of care [9].
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 Agness Thawani, Ethel Rambiki, Jacqueline Huwa, Layout Gabriel, Aubrey Kudzala, Christine Kiruthu-Kamamia, Pachawo Bisani, Shameem Buleya, Nathan P. Ford, Cheryl C. Johnson, Ajay Rangaraj, Robert Luo, Celine Lastrucci, Busisiwe Msimanga, Rose Nyirenda, Bilaal Wilson Matola, Andreas Jahn, Claudia Wallrauch, Rachael Burke, Tom Heller. Excerpts reproduced under CC BY. Selection, formatting and contextual notes by Health Signal. The researchers are the authors of the source study, not members of Health Signal’s staff.
Explore connected evidence
- Evidence brief: Feasibility and testing outcomes of task-shared implementation of advanced HIV disease point of care tests in Beira (Mozambique) and Kinshasa (DRC)
- Evidence brief: Contribution of xpert MTB/RIF assay and Urine LF-LAM for the diagnosis of tuberculosis in children aged 5 – 14 years, at selected health facilities in Ethiopia, 2016 – 2019
- Evidence brief: The Asanté™ HIV-1 Rapid Recency® Assay is reliable, feasible, and acceptable for use at the point-of-care in Lusaka, Zambia
