Evaluation of three commercialized rapid point-of-care tests for detection of anti-hepatitis C virus antibodies in Burkina Faso

Abstract

This study aimed to evaluate the diagnostic performance of commercially rapid point-of-care (POC) tests used for HCV antibodies detection. This is a case-control study conducted in Ouagadougou between December 2014 and January 2015. Three POC for HCV antibodies detection (SD Bioline HCV test®, Anti-HCV dipstick® and First response® HCV card test) marketed in Burkina Faso were evaluated. Architect anti-HCV assay and ImmunoComb® II HCV were combined and used as a reference test. All three tests were evaluated with a panel of 62 anti-HCV positive sera and 62 anti-HCV negative sera. The tests performance was calculated using the software OpenEpi. The three rapid POC tests had a specificity of 100% (95% CI: 94.17-100). However, the sensitivities were 33.87% (95% CI: 23.34-46.28) for the SD Bioline HCV test®, 41.94% (95% CI: 30.48-54.33%) for Anti-HCV dipstick® and 45.16% (95%CI: 33.42-57.47%) for First response® HCV card test. The tests evaluated in this study had good specificity but poor sensitivity for the HCV antibodies detection in Burkina Faso. The surveillance of HCV rapid POC tests through the validation of their accuracy in the local context before their approval must be strengthened. Key words: Hepatitis C virus, point-of-care, diagnostic test.