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Published on: March 13, 2015
Hepatitis B Virus Diagnosis Using Dried Blood Spots in the D.R. Congo: Overcoming Misdiagnosis to Achieve 2030 WHO
Paula Martínez de Aguirre1, Silvia Carlos2,3, Samclide Mbikayi4
1Microbiology Department, Clínica Universidad de Navarra, 31008 Pamplona, Spain.
Insights
Hepatitis B virus (HBV) testing in Kinshasa revealed moderate transmission. Rapid diagnostic tests (RDTs) showed poor accuracy, while dried blood spot (DBS) testing offered reliable results for HBV screening in resource-limited settings.
Area of Science:
- Public Health
- Infectious Diseases
- Diagnostic Accuracy
Background:
- Hepatitis B virus (HBV) infection is a significant public health issue in the Democratic Republic of the Congo (DRC).
- Accurate diagnostic tools are crucial for managing HBV in resource-limited settings.
Purpose of the Study:
- To determine HBV seroprevalence in Kinshasa, DRC.
- To evaluate the diagnostic performance of rapid diagnostic tests (RDTs) against dried blood spot (DBS)-based immunoassays for HBV detection.
Main Methods:
- Dried blood spot (DBS) samples were collected between 2016 and 2022 and tested for HBsAg and HBc-Ab using chemiluminescence platforms (ECLIA-COBAS and ELFA-miniVIDAS).
- On-site HBsAg screening was performed using Abbott Determine™ RDTs.
- Diagnostic accuracy, sensitivity, specificity, and inter-method agreement were analyzed.
Main Results:
- Active HBV infection was found in 4.3% and resolved infection in 14.3% of participants.
- RDTs demonstrated low sensitivity (60%) but high specificity (100%), leading to a 40% misdiagnosis rate.
- DBS-based immunoassays showed excellent diagnostic accuracy for HBsAg (100% sensitivity and specificity).
- Platform-dependent variability was observed in HBc-Ab detection.
Conclusions:
- There is moderate HBV transmission in Kinshasa.
- RDTs are unreliable for HBV screening in this setting.
- DBS testing is a practical, robust, and scalable method with high diagnostic performance, suitable for HBV testing in low-resource areas.
Abstract:
Background/Objectives: Hepatitis B remains a major public health concern in the Democratic Republic of the Congo (DRC). This study investigated HBV seroprevalence in Kinshasa and evaluated the diagnostic performance of rapid diagnostic tests (RDTs) compared with dried blood spot (DBS)-based immunoassays. Methods: DBS samples collected between 2016 and 2022 were transported to Spain for HBsAg and HBc-Ab testing using two chemiluminescence platforms (ECLIA-COBAS (Roche) and ELFA-miniVIDAS (bioMerieux)). A subset of participants also underwent on-site HBsAg screening using Determine™ (Abbott) RDTs. Results: Overall, active HBV infection was detected in 4.3% of participants and resolved infection in 14.3%, with no significant differences by age, sex, cohort, or HIV/HCV status. The RDT showed poor sensitivity (60% (95% CI: 26-88)) but high specificity (100% (95% CI: 98-100)), resulting in a 40% misdiagnosis rate. In contrast, DBS-based HBsAg immunoassays demonstrated excellent diagnostic accuracy, with both platforms achieving 100% 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). HBc-Ab detection showed platform-dependent variability, with lower sensitivity on ELFA-miniVIDAS (66% (95% CI: 46-82)) compared with ECLIA-COBAS (100% (95% CI: 96-100)). Predictive values were high across all assays, and inter-method agreement for HBsAg between RDT and chemiluminescence was good (Cohen's kappa 0.71, p < 0.001). Conclusions: These findings indicate moderate HBV transmission in Kinshasa and highlight the limited reliability of RDT-based screening. DBS proved to be a practical, robust, and scalable sampling method with outstanding diagnostic performance, making it well-suited for HBV testing in low-resource settings.
