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Journal of clinical laboratory analysis · 2026

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

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

Аннотация

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты