Replication Data for: Hepatitis B virus diagnosis using dried blood spots in the D.R.Congo: overcoming misdiagnosis to achieve 2030 WHO targets

Purpose: In the Democratic Republic of the Congo, hepatitis B is a public health problem. The aim of this study was to provide insight into HBV seroprevalence in the country and asses the diagnostic accuracy of rapid diagnostic tests against dried blood spot eluates in HBV screening. Methods: DBS were obtained in Kinshasa (2016-2022) and sent to Spain, were the presence of HBsAg and HBc-Ab was determined by chemiluminescence. In some patients, capillary blood samples were tested on-site (Determine, Abbott). Results: Global seroprevalence was 4.1% for active and 14.3% for resolved HBV. No significant differences were found between age groups, sexes, cohorts, nor HIV or HCV status. The HBV RDT had 60% (95%CI: 26-88) sensitivity and 100% (95%CI:98-100) specificity. HBs-Ag immunoassays showed outstanding sensitivity (ECLIA-COBAS 100%, 95%CI: 66-100; ELFA-miniVIDAS 100%, 95%CI: 99-100) and specificity (ECLIA-COBAS 100%, 95%CI: 98-100; ELFA-miniVIDAS 100%, 95%CI: 99-100) against the same standard. The inter-rate concordance between RDT and chemiluminescence was good (Cohen´s kappa 0.71, p<0.001). HBc-Ab sensitivity was lower in the ELFA-miniVIDAS (66%, 95%CI:46-82) than the ECLIA-COBAS (100%, 95%CI: 96-100) platform. Both positive and negative predictive values were adequate across all tests. Conclusions: HBV seroprevalence results correspond with moderate HBV transmission in Kinshasa. The use of RDTs results in 40% misdiagnosis, whilst immunodiagnosis of DBS eluates showed outstanding sensitivity and specificity. This study demonstrates DBS are convenient and reliable samples applicable in real-life low-resource settings.