Comparison of the performance of rapid HIV tests using samples collected for surveillance in Mozambique

• Published in: Journal of medical virology 2009-12, Vol.81 (12), p.1991-1998
• Main Authors: Melo, Josefa, Nilsson, Charlotta, Mondlane, José, Osman, Nafissa, Biberfeld, Gunnel, Folgosa, Elena, Andersson, Sören
• Format: Article
• Language: English
• Subjects: alternative confirmatory strategy; Biological and medical sciences; Clinical Laboratory Techniques - methods; Epidemiology; evaluation; Female; Fundamental and applied biological sciences. Psychology; HIV antibody diagnosis; HIV Infections - diagnosis; HIV Infections - epidemiology; HIV Infections - immunology; HIV Seroprevalence; HIV-1 - immunology; HIV-2 - immunology; Human viral diseases; Humans; Infectious diseases; Medical sciences; Medicin och hälsovetenskap; Microbiology; Miscellaneous; Mozambique; Mozambique - epidemiology; Nurses; Population Surveillance - methods; Pregnancy; Pregnancy Complications, Infectious - diagnosis; Pregnancy Complications, Infectious - epidemiology; Pregnancy Complications, Infectious - immunology; Reagent Kits, Diagnostic; Sensitivity and Specificity; seroprevalence; simple rapid tests; Viral diseases; Virology
• ISSN: 0146-6615; 1096-9071; 1096-9071
• DOI: 10.1002/jmv.21633

Mozambique had low HIV prevalence until the mid-1990s, but recent data indicate increasing rates. There is little information on HIV-2. Therefore, HIV seroprevalence was assessed among pregnant women and field-ready HIV diagnostic strategies were evaluated. A total of 6,930 samples collected by three health centers from 2002 to 2005 were tested on site by nurses with two simple/rapid tests, Determine HIV-1/2 (Abbott Laboratories; screening) and Uni-Gold HIV (Trinity Biotech; confirmation), which is the national HIV testing strategy. The prevalence of HIV was 14.0% (2002), 17.8% (2003), 16.5% (2004), and 20.2% (2005). A subset of 888 samples collected 2003 was sent to the Central Microbiology Laboratory, Maputo for evaluation of tests and testing strategies. The assays included for comparison were Capillus HIV-1/HIV-2 (Trinity Biotech), DoubleCheckGold HIV-1&2 (Orgenics) and Enzygnost Anti-HIV-1/2 Plus (Behringwerke, reference ELISA). Confirmation of reactive samples was done by Uni-Gold HIV and ImmunoComb II HIV-1&2 BiSpot (for HIV type differentiation). The Capillus HIV-1/ HIV-2 + ImmunoComb II HIV-1&2 BiSpot combination was the gold standard. The sensitivity of the rapid/simple screening assays (Determine HIV-1/2, DoubleCheckGold HIV-1&2) was 100% (N = 160) and their (initial) specificities were 99.6% and 99.7%, respectively. Repeated testing and combinations of assays increased the specificity. Four suspected cases of recent seroconversion were found. Together with the increasing prevalence rates, this may indicate that Mozambique is a high-incidence area, although further studies are needed to confirm this. Testing strategies for on-site screening and confirmation based on the combination of Determine HIV-1/2, Uni-Gold HIV and DoubleCheckGold HIV-1&2 are well suited for local field use. J. Med. Virol. 81:1991-1998, 2009.