02918nas a2200301   4500000000100000008004100001260005300042653001900095653001700114653001500131653002700146653001000173653001600183100001300199700001300212700001200225700001600237700001300253700001300266700001400279700001500293700001500308245018100323856008300504300001100587520200400598022001402602       2026                            d  c10/2026bSpringer Science and Business Media LLC10aOnchocerciasis10aSD Ov-16 RDT10aO-150 qPCR10aDiagnostic performance10aGhana10aElimination1 aNyarko A1 aAshong Y1 aDogbe S1 aAfatodzie M1 aGyamfi G1 aNketia K1 aLogonia B1 aFrempong K1 ade Souza D00aAssessing the diagnostic accuracy of the SD-Ov16 rapid diagnostic test compared to the O-150 qPCR for the diagnosis of onchocerciasis in high- and low-endemic settings of Ghana  uhttps://link.springer.com/content/pdf/10.1186/s12879-026-14645-0_reference.pdf  a1 - 183 a<p><strong>Background</strong></p>

<p>Accurate diagnostic tools are essential for onchocerciasis elimination programs. The SD-Bioline Ov-16 rapid diagnostic test (RDT) has been widely adopted for field surveillance, but its performance compared to molecular methods requires evaluation. This study assesses the concordance between the SD-Bioline Ov-16 RDT and quantitative polymerase chain reaction (qPCR) assay for diagnosing onchocerciasis in selected endemic communities in Ghana.</p>

<p><strong>Methods</strong></p>

<p>A community-based cross-sectional study was conducted between September and November 2023 in seven communities across three districts in the Volta and Oti Regions of Ghana. Participants aged ≥ 5 years were recruited using convenience sampling. Dried blood spots were tested using the SD-Bioline Ov-16 RDT, and skin snips were analysed by qPCR targeting the O-150 repeat sequence from the same individuals. Concordance was assessed using kappa statistics, and diagnostic performance was estimated with qPCR as the reference standard for this assessment.</p>

<p><strong>Results</strong></p>

<p>Out of 1,705 participants recruited, 901 with complete paired samples were analysed. The overall prevalence was 27.5% (248/901) by Ov-16 RDT and 2.9% (26/901) by qPCR. Overall concordance between the Ov-16 RDT and qPCR as reference was 73.4% with a kappa score of 0.0759 (<em>p</em> &lt; 0.001), indicating poor agreement. The Ov-16 RDT showed 65.4% sensitivity (95% CI: 44.3–82.8%) and 73.6% specificity (95% CI: 70.5–76.6%) when compared to qPCR.</p>

<p><strong>Conclusion</strong></p>

<p>The poor concordance between Ov-16 RDT and qPCR reflects the fundamental difference between antibody detection (exposure) and parasite DNA detection (active infection). While the Ov-16 RDT remains useful for surveillance, its limitations in detecting low-level infections necessitate improved diagnostic tools to support WHO’s 2030 elimination goals.</p>
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