Abstract
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.
