Verification of False Reactivity in HIV Rapid Diagnostic Tests and Its Translation Into the Three Tests Algorithm in Cameroon.

Authors

Rogers Ajeh Awoh, Désiré Takou, Isidore Oscar Bienvenu Etogo Ondigui, Roger Onana, Etienne Kembou, Collins Chenwi, Daniel Mabongo, Grace Beloumou Angong, Laetitia Bissai, Aude Christelle Ka'e, Alex Durand Nka, Ezechiel Ngoufack Jagni Semengue, Nadine Fainguem, Daniele Simnoue, Florine Tsimene, Sandrine Djupsa, Jaurès Metambou, Aurelie Kengne, Arlette Messeh, Gilbert Tchatchoua, Naomi-Karell Etame, Michel Tommo, Krystel Zam Nnomo, Edith Temgoua, Basil Yaba, Gregory Edie Halle Ekane, Carlo-Federico Perno, Vittorio Colizzi, Nicaise Ndembi, Diaby Ousmane, Joelle Bouba Pamen, Alexis Ndjolo, Celine Lastrucci, Joseph Fokam, Malachie Manouada

Published in

Journal of clinical laboratory analysis. Pages e70333. Aug 11, 2026. Epub Aug 11, 2026.

Abstract

In a context of HIV seropositivity below 5%, transitioning from a two- to a three-test algorithm is required to secure positive predictive values > 99% for mitigating false reactivity. With Cameroon having 2.7% seroprevalence, we sought to ascertain events of false reactivity from eight WHO-prequalified HIV rapid diagnostic tests (RDTs) and design suitable combinations for the country three-test algorithm.
A facility-based study was conducted in July-August 2021 among 172 consenting clients attending health facilities in Yaoundé-Cameroon. Whole blood was collected and samples characterized in parallel using KHB Diagnostic Kit for HIV (1 + 2) Antibody and INNO-LIA HIV I/II Ag/Ab to rule out reactive cases. Two lots of each selected RDT were tested simultaneously in quadruplicate on HIV non-reactive samples and repeated by a different tester. RDTs were considered false positive if any reactivity was detected.
Following characterization, 25 samples were HIV-reactive (i.e., ruled out) and 147 non-reactive. Following random selection, 100 non-reactive samples tested for false reactivity revealed: 0% (0/100) First Response HIV 1-2-O Card, 0% (0/100) First Response HIV1 + 2/Syphilis Combo, 0% (0/100) STANDARD Q HIV/Syphilis Combo, 0% (0/99) ONE STEP Anti-HIV1&2 (one invalid result); 1% (1/100) Determine HIV Early Detect and Bioline HIV/Syphilis Duo, 2% (2/100) Alere Determine HIV-1/2, 4% (4/100) Rapid Test for Antibody to HIV.
In the Cameroonian context, HIV false reactivity ranged from 0% to 4% across selected RDTs. Thus, a reliable three-test algorithm ranks First Response HIV 1-2-0 Card, First Response HIV1 + 2/Syphilis Combo or STANDARD Q as suitable RDT-1 to mitigate false-positive events at the country-level.

PMID:
42581559
Bibliographic data and abstract were imported from PubMed on 12 Aug 2026.

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