title: Field evaluation of the Abbott ARCHITECT HIV Ag/Ab Combo immunoassay.
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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: 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.
authors.forename: Anfumbom
authors.initials: A
authors.lastname: Kfutwah
authors.affiliation: Laboratoire Associé au Centre National de Référence du VIH, Hôpital Charles Nicolle, CHU de Rouen, 76031 Rouen, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Lemée
authors.affiliation: Service de Virologie, Centre Pasteur du Cameroun, Membre du Réseau International des Instituts Pasteur, Yaounde', Cameroun. BP 1274, Yaounde, Cameroon.
authors.forename: Hélène Valérie
authors.initials: HV
authors.lastname: Ngono
authors.affiliation: Laboratoire Associé au Centre National de Référence du VIH, Hôpital Charles Nicolle, CHU de Rouen, 76031 Rouen, France.
authors.forename: Fabienne
authors.initials: F
authors.lastname: De Oliveira
authors.affiliation: Service de Virologie, Centre Pasteur du Cameroun, Membre du Réseau International des Instituts Pasteur, Yaounde', Cameroun. BP 1274, Yaounde, Cameroon.
authors.forename: Richard
authors.initials: R
authors.lastname: Njouom
authors.affiliation: 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.
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Plantier
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002163:Cameroon; D002648:Child; D002675:Child, Preschool; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D005602:France; D015483:HIV Antibodies / Q000097:blood*; D015488:HIV Antigens / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007223:Infant; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens
keywords: Africa; Field evaluation; Genetic diversity; HIV; HIV immunoassay; PCR; RT; human immunodeficiency virus; polymerase chain reaction; reverse transcriptase