A Novel Biplex Onchocerca volvulus Rapid Diagnostic Test Evaluated Among 3- to 9-Year-Old Children in Maridi, South Sudan
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Setting
2.2. Study Procedures
2.3. Data Analysis
3. Results
3.1. Description of Study Participants
3.2. Comparison Between the Prototype DDTD Biplex A RDT and the Ov16 SD Bioline RDT Results
3.3. DDTD Biplex A RDT: Analysis of Test Lines
3.4. Effect of Timing on the Test Results
3.5. Feasibility and Acceptability of the Prototype DDTD Biplex A RDT
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
CDC | Centers for Disease Control and Prevention |
CDTi | Community-directed treatment with ivermectin |
DBS | Dried blood spot |
DDTD | Drugs & Diagnostics for Tropical Diseases |
ELISA | Enzyme-linked immunosorbent assay |
HCW | Healthcare worker |
LFA | Lateral flow assay |
MDA | Mass drug administration |
OEPA | Onchocerciasis Elimination Program for the Americas |
O. volvulus | Onchocerca volvulus |
RDT | Rapid diagnostic test |
TPP | Target product profile |
WHO | World Health Organization |
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Factor | Level | Ov16 SD Bioline RDT Prevalence of Positive Test Result (%; 95%CI) | DDTD Biplex A RDT Prevalence of Positive T1 and T2 Lines Test Result (%; 95%CI) |
---|---|---|---|
Village | Hai-Gabat | 2/50 (4.0; 0.7–14.9) | 0/50 (0; 0–8.9) |
Kazana 1 | 22/50 (44.0; 30.3–58.7) | 11/50 (22.0; 12.0–36.3) | |
Kazana 2 | 20/38 (52.6; 36.0–68.7) | 14/38 (36.8; 22.3–54.0) | |
Hai-Matara | 17/51 (33.3; 21.2–48.0) | 9/51 (17.7; 8.9–31.4) | |
Hai-Tarawa | 11/50 (22.0; 12.0–36.3) | 3/50 (6.0; 1.6–17.5) | |
Sex | Female | 40/129 (31.0; 23.3–39.8) | 21/129 (16.3; 10.6–24.0) |
Male | 32/110 (29.1; 21.0–38.7) | 16/110 (14.6; 8.8–22.9) | |
Ivermectin Intake (2022) | No | 46/165 (27.9; 21.3–35.5) | 27/165 (16.4; 11.2–23.1) |
Yes | 26/74 (35.1; 24.6–47.2) | 10/74 (13.5; 7.0–23.9) | |
Dermatitis | No | 34/151 (22.5; 16.3–30.2) | 19/151 (12.6; 7.9–19.2) |
Yes | 37/87 (42.5; 32.1–53.6) | 18/87 (20.7; 13.0–31.0) | |
Epilepsy | No | 72/235 (30.6; 24.9–37.0) | 37/235 (15.7; 11.5–21.2) |
Yes | 0/4 (0; 0–60.4) | 0/4 (0; 0–60.4) | |
Age group (years) | Age 3–6 | 46/147 (31.3; 24.0–39.5) | 18/147 (12.2; 7.6–18.9) |
Age 7–9 | 26/92 (28.3; 19.6–38.8) | 19/92 (20.7; 13.2–30.6) | |
Total | 72/239 (30.1; 24.5-36.4) | 37/239 (15.5; 11.3–20.8) |
DDTD Biplex A Positivity Assumption | Seroprevalence (%; 95%CI) |
---|---|
Seroprevalence T1 and T2 | 37/239 (15.5; 11.3–20.8) |
Seroprevalence T1 or T2 | 91/239 (38.1; 31.9–44.6) |
Seroprevalence All T1 | 84/239 (35.2; 29.2–41.6) |
Seroprevalence All T2 | 44/239 (18.4; 13.8–24.0) |
Seroprevalence Only T1 | 47/239 (19.7; 14.9–25.4) |
Seroprevalence Only T2 | 7/239 (2.9; 1.3–6.2) |
DDTD Biplex A RDT | ||||||
---|---|---|---|---|---|---|
No line | Only T1 | Only T2 | T1 and T2 | TOTAL | ||
Ov16 SD Bioline RDT | Negative | 147 | 7 | 7 | 6 | 167 |
Positive | 1 | 40 | 0 | 31 | 72 | |
TOTAL | 148 | 47 | 7 | 37 |
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Hadermann, A.; Jada, S.R.; Lubbers, C.; Amaral, L.-J.; Biamonte, M.; de Souza, D.K.; Bol, Y.Y.; Siewe Fodjo, J.N.; Colebunders, R. A Novel Biplex Onchocerca volvulus Rapid Diagnostic Test Evaluated Among 3- to 9-Year-Old Children in Maridi, South Sudan. Diagnostics 2025, 15, 563. https://doi.org/10.3390/diagnostics15050563
Hadermann A, Jada SR, Lubbers C, Amaral L-J, Biamonte M, de Souza DK, Bol YY, Siewe Fodjo JN, Colebunders R. A Novel Biplex Onchocerca volvulus Rapid Diagnostic Test Evaluated Among 3- to 9-Year-Old Children in Maridi, South Sudan. Diagnostics. 2025; 15(5):563. https://doi.org/10.3390/diagnostics15050563
Chicago/Turabian StyleHadermann, Amber, Stephen Raimon Jada, Charlotte Lubbers, Luís-Jorge Amaral, Marco Biamonte, Dziedzom Komi de Souza, Yak Yak Bol, Joseph Nelson Siewe Fodjo, and Robert Colebunders. 2025. "A Novel Biplex Onchocerca volvulus Rapid Diagnostic Test Evaluated Among 3- to 9-Year-Old Children in Maridi, South Sudan" Diagnostics 15, no. 5: 563. https://doi.org/10.3390/diagnostics15050563
APA StyleHadermann, A., Jada, S. R., Lubbers, C., Amaral, L.-J., Biamonte, M., de Souza, D. K., Bol, Y. Y., Siewe Fodjo, J. N., & Colebunders, R. (2025). A Novel Biplex Onchocerca volvulus Rapid Diagnostic Test Evaluated Among 3- to 9-Year-Old Children in Maridi, South Sudan. Diagnostics, 15(5), 563. https://doi.org/10.3390/diagnostics15050563