• Multi-site evaluation of HIV testing algorithms

      Kosack, Cara; Page, Anne-Laure; Shanks, Leslie; Chaillet, Pascale; Beelaert, Greet; Fransen, Katrien; Benson, Tumwesigye T.; Savane, Aboubacar; Nganga, Anne; MSF-OCA (2018-07)
      Objectives 3.1 Primary objective  To evaluate the overall and site-specific performance of the diagnostic algorithm performed at 6 MSF African program sites (i.e. using RDT results from the program sites) comparing using the diagnostic algorithm with ELISA, LIA, EIA-Ag and DNA-PCR as gold standard. 3.2 Secondary objectives  To evaluate the accuracy (sensitivity, specificity and predictive values) of Orgenics ImmunoComb® II HIV 1&2 Combfirm as an HIV confirmatory test.  To model different HIV RDT testing algorithms in order to define acceptable testing algorithm in each study setting (i.e. using RDT results from reference laboratory).  To determine the inter-user reliability of RDT testing (i.e. program sites vs. reference laboratory)  To evaluate accuracy of each HIV RDT measured by the sensitivity (SN), specificity (SP) and predictive values based on the prevalence of each testing centre.  To evaluate the accuracy of HIV testing using DPS samples for quality control purpose in HIV testing.  To assess whether additional confirmatory testing (i.e. Orgenics ImmunoComb® II HIV 1&2 Combfirm) improves the accuracy of the diagnostic algorithm used at the different study sites.  To perform a descriptive analysis on the differentiation between HIV 1 and 2 of the discriminative RDTs.