Anfumbom Kfutwah1, Véronique Lemée2, Hélène Valérie Ngono3, Fabienne De Oliveira2, Richard Njouom3, Jean-Christophe Plantier4. 1. Service de Virologie, Centre Pasteur du Cameroun, Membre du Réseau International des Instituts Pasteur, Yaounde', Cameroun. BP 1274, Yaounde, Cameroon. Electronic address: kfutwah@pasteur-yaounde.org. 2. Laboratoire Associé au Centre National de Référence du VIH, Hôpital Charles Nicolle, CHU de Rouen, 76031 Rouen, France. 3. Service de Virologie, Centre Pasteur du Cameroun, Membre du Réseau International des Instituts Pasteur, Yaounde', Cameroun. BP 1274, Yaounde, Cameroon. 4. Laboratoire Associé au Centre National de Référence du VIH, Hôpital Charles Nicolle, CHU de Rouen, 76031 Rouen, France. Electronic address: jean-christophe.plantier@univ-rouen.fr.
Abstract
BACKGROUND: Fourth generation assays for HIV diagnosis are progressively being introduced into routine services, due to their improvement of diagnosis. In spite of this, HIV diagnosis remains a challenge in sub-Saharan Africa, due to false positive reactivity. There is a continuous need for field evaluations and routine validations of fourth generation HIV tests in African populations. OBJECTIVES: Evaluate the performances of the ARCHITECT HIV Ag/Ab kit (Abbott) in a population living in an African setting-Cameroon compared to a population living in a European setting-France. STUDY DESIGN: 645 HIV samples from both France and Cameroon were evaluated. The positive panel (378 samples) included a diverse series of HIV-1 variants (groups M, N, O, and P) as well as HIV-2 samples. Results were compared to original diagnosis done with other 4th generation assays (AxSYM HIV Ag/Ab (Abbott) and Vidas HIV DUO QUICK) (bioMérieux). RESULTS: Sensitivity of the ARCHITECT was 100% in both sites. It diagnosed all variants of the panel with different reactivity profiles following strain diversity. A wider range of reactivity was observed for group O. Specificity was slightly lower (97.6%) in Cameroon than in France (98.6%), probably due to a higher rate of false positive reactivity. ARCHITECT HIV Ag/Ab assay had high performances in clinical sensitivity and specificity and is adapted to the wide genetic diversity of viruses circulating in West Central Africa. CONCLUSION: Our results further highlight the need to evaluate HIV diagnostic tests before introduction into routine diagnostic services both in the North and in the South.
BACKGROUND: Fourth generation assays for HIV diagnosis are progressively being introduced into routine services, due to their improvement of diagnosis. In spite of this, HIV diagnosis remains a challenge in sub-Saharan Africa, due to false positive reactivity. There is a continuous need for field evaluations and routine validations of fourth generation HIV tests in African populations. OBJECTIVES: Evaluate the performances of the ARCHITECT HIV Ag/Ab kit (Abbott) in a population living in an African setting-Cameroon compared to a population living in a European setting-France. STUDY DESIGN: 645 HIV samples from both France and Cameroon were evaluated. The positive panel (378 samples) included a diverse series of HIV-1 variants (groups M, N, O, and P) as well as HIV-2 samples. Results were compared to original diagnosis done with other 4th generation assays (AxSYM HIV Ag/Ab (Abbott) and Vidas HIV DUO QUICK) (bioMérieux). RESULTS: Sensitivity of the ARCHITECT was 100% in both sites. It diagnosed all variants of the panel with different reactivity profiles following strain diversity. A wider range of reactivity was observed for group O. Specificity was slightly lower (97.6%) in Cameroon than in France (98.6%), probably due to a higher rate of false positive reactivity. ARCHITECT HIV Ag/Ab assay had high performances in clinical sensitivity and specificity and is adapted to the wide genetic diversity of viruses circulating in West Central Africa. CONCLUSION: Our results further highlight the need to evaluate HIV diagnostic tests before introduction into routine diagnostic services both in the North and in the South.
Authors: Sarah E Rutstein; Jintanat Ananworanich; Sarah Fidler; Cheryl Johnson; Eduard J Sanders; Omar Sued; Asier Saez-Cirion; Christopher D Pilcher; Christophe Fraser; Myron S Cohen; Marco Vitoria; Meg Doherty; Joseph D Tucker Journal: J Int AIDS Soc Date: 2017-06-28 Impact factor: 5.396