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.

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.

Genetic and phylogenic characterization of hepatitis B virus in the eastern part of the Democratic Republic of Congo.

Hepatitis B virus (HBV) genotypes show a distinctive geographical distribution worldwide and genotypes A, D, and E are the most frequently found in Africa. There are only limited studies on HBV genotype distribution in Democratic Republic of Congo (DRC), all done in the western part showing a vast majority of genotype E. In our study, HBV strains from South Kivu, an eastern province of the DRC, were analyzed. Sequencing of 41 serum samples from HBV infected patients revealed strains of genotype A in 40/41 (97.6%) and genotype E in 1/41 (2.4%). The phylogenetic analysis showed that nearly all genotypes A (38/40) were closely related to A1 subgenotype strains found in Rwanda, Haiti, and Martinique while only two strains attached to the A2 subgenotype cluster were isolated. The remaining genotype E case was linked to the western African E crescent. Only the I169T nucleotide substitution was observed in two genotype A samples. In conclusion, the genotype A seems to be the most predominant genotype in eastern DRC with the majority belonging to the Afro-Asian subgenotype (A1). This contrasts with the western part of DRC where genotype E is predominant. These results support the hypothesis of an East-West genotypic demarcation.