Field test and sensitivity of Onchocerciasis rapid test in Ogun State, Nigeria

O. Surakat, S. Sam-Wobo, A. Golden, T. de Los Santos, M. Adeleke, D. Faulx, K. Ademolu, S. Bankole, M. Kalnoky, Eric Stevens, L. Yokobe
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Abstract

Objective: This study, conducted between March 2015 and July 2016, investigated the sensitivity and specificity of the OV-16 RDT and Dried Blood Spot (DBS) Enzyme-Linked Immunosorbent Assay (ELISA) for skin snip microfilaria (MF) detection in Ogun State. Methods: Five hundred and eighty-eight (588) members of 16 first-line communities in 8 endemic Local Government Areas (LGAs) provided fingerstick whole blood specimens examined for IgG4 antibodies against the O. volvulus antigen OV-16, using DBS OV-16 ELISA and OV-16 RDT. In consort with these specimens, 162 study participants consented to be evaluated by skin snip. Results: Results showed a seroprevalence of 106(18.0%) using ELISA and 102(17.3%) by RDT, with 92.2% agreement. The OV-16 RDT demonstrated a positive and negative agreement of 76.4 (95% CI 67.2 to 84.1%) and 95.6% (95% CI: 93.4 to 97.3), respectively, to the OV-16 ELISA results from the concordant dataset. Against the 64 positive skin snips microscopy results, sensitivity of the RDT was 79.7% (95% CI 73.43% to 85.27) and the ELISA was 70.3% (95% CI 64.72% to 75.37%). Conclusion: The results of this study provided information on the performance of the OV-16 RDT. This information will contribute data for comparison to studies in other areas where treatment is ongoing. In conclusion, the commercial launch of the OV-16 RDT has made available a point-of-care diagnostic tool that could serve to help local and country onchocerciasis elimination programs to measure changes and progress in onchocerciasis intervention.
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尼日利亚奥贡州盘尾丝虫病快速检测的现场试验和灵敏度
目的:本研究于2015年3月至2016年7月在奥贡州进行OV-16 RDT和干血斑(DBS)酶联免疫吸附试验(ELISA)检测皮肤剪断微丝虫病(MF)的敏感性和特异性研究。方法:采用DBS OV-16 ELISA和OV-16 RDT检测方法,对8个疫区16个一线社区588例(588人)采集的弓形虫抗原OV-16 IgG4抗体进行手指全血检测。与这些标本相结合,162名研究参与者同意通过皮肤剪来评估。结果:ELISA检测血清阳性率为106例(18.0%),RDT检测血清阳性率为102例(17.3%),符合率为92.2%。OV-16 RDT与来自一致性数据集的OV-16 ELISA结果分别表现出76.4 (95% CI: 67.2至84.1%)和95.6% (95% CI: 93.4至97.3)的阳性和阴性一致性。对64例阳性皮肤剪镜检结果,RDT检测的灵敏度为79.7% (95% CI 73.43% ~ 85.27), ELISA检测的灵敏度为70.3% (95% CI 64.72% ~ 75.37%)。结论:本研究的结果为OV-16 RDT的性能提供了信息。这一信息将为正在进行治疗的其他领域的研究提供比较数据。总之,OV-16 RDT的商业化推出提供了一种即时诊断工具,可以帮助地方和国家的盘尾丝虫病消除规划衡量盘尾丝虫病干预措施的变化和进展。
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