Field evaluation of the performance of HCV Serological Rapid Diagnostic Tests among HCV/HIV co-infected patients

P R O T O C O L S U M M A R Y
 Title: Field evaluation of the performance of HCV Serological Rapid Diagnostic Tests among
HCV/HIV co-infected patients.
 Aim: To evaluate the performance of serological HCV Rapid Diagnostic Tests (RDTs) to identify tests
adapted to resource-limited settings, reliable for HIV-infected patients.
 Study design: Prospective evaluation of the performance of serological RDTs for HCV screening.
 Primary objective:
o To evaluate the performance of serological HCV RDTs under field conditions using as reference
standard a combination of enzyme immunoassay (EIA) and recombinant immunoblot assay
(RIBA) for the detection of antibodies anti-HCV in HIV infected patients.
 Secondary objectives:
o To describe the accuracy (sensitivity, specificity) of the RDTs as screening tests
o To describe the performance of the RDTs according to the HCV genotype and HCV VL
o To describe the performance of the RDTs according to the CD4 counts and HIV VL
o To describe the performance of the RDTs in presence of HBV co-infection (presence of antigen
anti-HBs (HBsAg))
o To describe the operational characteristics of the tests including ease of use, technical
complexity and inter-reader variability.
o To evaluate predictive values of each HCV RDT based on the prevalence of the testing center.