Hepatitis B Virus Diagnosis Using Dried Blood Spots in the D.R. Congo: Overcoming Misdiagnosis to Achieve 2030 WHO Targets
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Population
2.2. Sample Collection
2.3. Serological Assays
2.3.1. Hepatitis B Seroprevalence Study (Spain)
2.3.2. Analytic Performance of HBV Diagnostic Tests
2.4. Statistical Analysis
2.5. Funding and Ethics
3. Results
3.1. Characteristics of Study Participants
3.2. HBV Seroprevalence in Kinshasa
3.3. HBV Infection Among HIV-High Risk and HIV+ Population in Kinshasa
3.4. Analytic Performance of HBV Diagnostic Tests: RDT vs. ECLIA and ELFA
3.5. Analytic Performance of HBV Diagnostic Tests: Immuno-Chemiluminescence Platforms
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
| HBV | Hepatitis B Virus |
| WHO | World Health Organization |
| LMICs | Low- and Middle-Income Countries |
| DRC | Democratic Republic of the Congo |
| RDTs | Rapid Diagnostic Tests |
| HIV | Human Immunodeficiency Virus |
| DBS | Dried Blood Spot |
| OKAPI | Observational Kinshasa AIDS Prevention Initiative |
| VCT | Voluntary Counselling and Testing |
| HCV | Hepatitis C Virus |
| HBs-Ag | Hepatitis B Surface Antigen |
| HBc-Ab | Hepatitis B Core Antibodies |
| BD | Blood donors |
| CCS | Cervical Cancer Screening |
| ART | Anti-Retroviral Therapy |
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| Study Cohort | Recruitment Program | Sample Collection | On-Site RDT | ||
|---|---|---|---|---|---|
| Cohort 1 | HIV Voluntary Counselling and Testing | 2016–2019 N = 251 | Venipuncture whole blood | 5 spots, W-903 card | RDT HIV+ |
| Cohort 2 | Blood donors | 2019–2021 N = 266 | Venipuncture whole blood | 5 spots W-903 card | RDT HIV− RDT HBV 1 |
| Cohort 3 | ELIKIA | 2022 N = 141 | Finger-pricked | 2–3 spots W-903 card | - |
| Cohort 1 n = 251 | Cohort 2 n = 266 | Cohort 3 n = 141 | TOTAL | |
|---|---|---|---|---|
| Recruitment program | VCT | BD | CCS | 658 |
| Sex 1 (female) (%) | 64 | 18.7 | 100 | 56.9 |
| Age (years) (mean, SD) | 42.8 (13.0) | 34.5 (10.9) | 45.1 (11.0) | 39.8 (12.6) |
| HIV positive (%) | 88.5 | 0 | 6.4 | 35.1 |
| HCV positive 2 (%) | 5.5 | 2.2 | 0.7 | 3.0 |
| Active HBV (%) | Resolved HBV (%) | Total (%) | |||
|---|---|---|---|---|---|
| Study population | Cohort 1 | n = 251 | 4.8 | 11.6 | 16.3 |
| Cohort 2 | n = 266 | 4.5 | 16.9 | 21.4 | |
| Cohort 3 | n = 141 | 2.8 | 11.4 | 14.2 | |
| Sex | Male | n = 237 | 4.6 | 16.0 | 20.7 |
| Female | n = 313 | 4.5 | 11.2 | 15.7 | |
| Age | <40 years | n = 318 | 3.8 | 12.6 | 16.4 |
| >40 years | n = 297 | 5.4 | 15.5 | 20.9 | |
| HIV | Positive | n = 231 | 5.2 | 11.7 | 16.9 |
| Negative | n = 427 | 3.8 | 14.8 | 18.5 | |
| HCV * | Positive | n = 17 | 11.8 | 13.3 | 23.5 |
| Negative | n = 550 | 4.2 | 12.4 | 16.6 | |
| TOTAL | 4.3 | 14.3 | 17.9 | ||
| HBV Infection | ||||||||
|---|---|---|---|---|---|---|---|---|
| Active (n = 12) | Resolved (n = 29) | Non-Infected (n = 210) | ||||||
| CD4 count (cells/µL), mean (SD) | 188.6 | (81.6) | 280.2 | (269.7) | 275.3 | (181.8) | ||
| HIV viral load (log), mean (SD) | 3.5 | (1.1) | 3.0 | (1.9) | 3.2 | (1.7) | ||
| (%) | (%) | (%) | ||||||
| HIV-1 subtype | A | 37.5 | 5.6 | 19.0 | ||||
| Other subtypes | - | 27.8 | 23.2 | |||||
| CRF | 12.5 | 5.6 | 11.3 | |||||
| URF/unclassified | 50 | 61.1 | 46.5 | |||||
| ART regimen | Naïve | 16.7 | 48.3 | 39.1 | ||||
| Experienced | 75.0 | 41.4 | 49.1 | |||||
| (of which) | TDF/FTC | 33.3 | 50.0 | 52.4 | ||||
| 3TC | 100 | 91.7 | 98.1 | |||||
| Unknown | 8.3 | 10.3 | 11.9 | |||||
| TOTAL (%) | 4.8 | 11.6 | 83.7 | |||||
| HBs-Ag | HBc-Ab | ||||
|---|---|---|---|---|---|
| RDT (n = 198) | miniVIDAS (n = 178) | COBAS (n = 589) | miniVIDAS (n = 168) | COBAS (n = 584) | |
| True positive | 6/10 | 9/9 | 24/24 | 19/29 | 103/103 |
| True negative | 188/188 | 169/169 | 563/565 | 139/139 | 481/481 |
| SENSITIVITY (%) | 60.0 (26–88) | 100 (66–100) | 100 (86–100) | 65.5 (46–82) | 100 (96–100) |
| SPECIFICITY (%) | 100 (98–100) | 100 (98–100) | 99.6 (99–100) | 100 (97–100) | 100 (99–100) |
| PPV (%) | 100 (54–100) | 100 (66–100) | 92.3 (75–99) | 100 (82–100) | 100 (96–100) |
| NPV (%) | 97.9 (95–99) | 100 (98–100) | 100 (99–100) | 93.3 (88–97) | 100 (99–100) |
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Martínez de Aguirre, P.; Carlos, S.; Mbikayi, S.; Burgueño, E.; Barquín, D.; Tendobi, C.; Chiva, L.; Holguín, Á.; Reina, G. Hepatitis B Virus Diagnosis Using Dried Blood Spots in the D.R. Congo: Overcoming Misdiagnosis to Achieve 2030 WHO Targets. Med. Sci. 2026, 14, 271. https://doi.org/10.3390/medsci14020271
Martínez de Aguirre P, Carlos S, Mbikayi S, Burgueño E, Barquín D, Tendobi C, Chiva L, Holguín Á, Reina G. Hepatitis B Virus Diagnosis Using Dried Blood Spots in the D.R. Congo: Overcoming Misdiagnosis to Achieve 2030 WHO Targets. Medical Sciences. 2026; 14(2):271. https://doi.org/10.3390/medsci14020271
Chicago/Turabian StyleMartínez de Aguirre, Paula, Silvia Carlos, Samclide Mbikayi, Eduardo Burgueño, David Barquín, Céline Tendobi, Luis Chiva, África Holguín, and Gabriel Reina. 2026. "Hepatitis B Virus Diagnosis Using Dried Blood Spots in the D.R. Congo: Overcoming Misdiagnosis to Achieve 2030 WHO Targets" Medical Sciences 14, no. 2: 271. https://doi.org/10.3390/medsci14020271
APA StyleMartínez de Aguirre, P., Carlos, S., Mbikayi, S., Burgueño, E., Barquín, D., Tendobi, C., Chiva, L., Holguín, Á., & Reina, G. (2026). Hepatitis B Virus Diagnosis Using Dried Blood Spots in the D.R. Congo: Overcoming Misdiagnosis to Achieve 2030 WHO Targets. Medical Sciences, 14(2), 271. https://doi.org/10.3390/medsci14020271

