Evaluation of the analytical performance of six rapid diagnostic tests for the detection of viral hepatitis B and C in Lubumbashi, Democratic Republic of Congo

Abstract

Rapid diagnostic tests (RDTs) are widely used in Lubumbashi for the diagnosis of viral hepatitis B and C. To date, there are no works that have been carried out in Lubumbashi to independently assess the performance of such tests. This study aimed at assessing the effectiveness of RDTs for the detection of HBsAg and anti-HCV antibodies in order to identify infected blood donors in Lubumbashi. A total of 300 serum samples (100 HBsAg positive samples; 100 anti-HCV positive samples and 100 HBsAg and anti-HCV negative samples) were tested simultaneously using the 6 locally used RDTs and as gold standard the chemiluminescent assays for HBsAg and the RT-TMA for HCV detection.The six evaluated RDTs demonstrated a sensitivity and a negative predictive value (NPV) of 100 % whereas the specificity and positive predictive value (PPV) varied from 46 % to 98.1 %. SB BioLine HBsAg test performed best in this study with 100 % of sensitivity, 97.1 % of specificity, 100 % of NPV and 96.9 % of PPV. Furthermore, sensitivity, specificity, NPV and PPV for SB BioLine HCV test were as follows: 100 %, 98.1 %, 100 % and 93.9 %. Therefore, SD BioLine tests (HBsAg, HCV) would be selected as the first line RDTs for the detection and the diagnostic of hepatitis B and C. They can prevent blood-borne transmission of HBV and HCV in areas with limited incomes as Lubumbashi.