Operational Performance of the Onchocerca volvulus “OEPA” Ov16 ELISA Serological Assay in Mapping, Guiding Decisions to Stop Mass Drug Administration, and Posttreatment Surveillance Surveys

Frank O. Richards Jr., The Carter Center, Atlanta, Georgia;

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Moses Katabarwa The Carter Center, Atlanta, Georgia;

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Firdaweke Bekele The Carter Center, Addis Ababa, Ethiopia;

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Zerihun Tadesse The Carter Center, Addis Ababa, Ethiopia;

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Aderajew Mohammed The Carter Center, Addis Ababa, Ethiopia;

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Mauricio Sauerbrey Onchocerciasis Elimination Program for the Americas, Guatemala City, Guatemala;

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Alfredo Dominguez-Vazquez Onchocerciasis Elimination Program for the Americas, Guatemala City, Guatemala;

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Mario A. Rodriguez-Perez Centro de Biotecnologia Genomica, Instituto Politecnico Nacional, Reynosa, Mexico;

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Nadia A. Fernández-Santos Secretaria de Salud de Mexico, Mexico City, Mexico;

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Nidia Rizzo Centro de Estudios en Salud of the Universidad del Valle de, Guatemala (UVG), Guatemala City, Guatemala;

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Harland R. Schuler Martínez Ministerio del Poder Popular para la Salud, Caracas, Venezuela;

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Raquel Lovato Silva Ministerio de Salud Pública del Ecuador, Quito, Ecuador;

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Zoraida Morales Monroy Ministerio de Salud de Guatemala, Guatemala City, Guatemala;

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Peace Habomugisha The Carter Center, Uganda Office, Kampala, Uganda;

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David W. Oguttu NTD Control Program, Vector Control Division, Kampala, Uganda;

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Issam M. A. Zarroug Ministry of Health, Khartoum, Sudan;

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Nabil A. Aziz The Carter Center, Khartoum, Sudan;

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Thomas R. Unnasch Center for Global Health Infectious Disease Research, The University of South Florida, Tampa, Florida

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Onchocerciasis is a neglected tropical disease targeted for elimination. The World Health Organization (WHO) has developed guidelines for the verification of onchocerciasis elimination that include entomological and epidemiological criteria. The latter require demonstrating with statistical confidence that the infection prevalence in children is less than 0.1%, necessitating an assay with a high degree of specificity. We present an analysis of the performance of the Onchocerciasis Elimination Program for the Americas (OEPA) version of the Ov16 enzyme-linked immunosorbant assay (ELISA) when used under operational conditions. In Africa and Latin America, the assay demonstrated 99.98% specificity in 69,888 children in 20 foci where transmission was believed to be interrupted. The assay produced a prevalence estimate equal to that of skin snip microscopy when applied in putatively hypo-endemic zones of Ethiopia. The OEPA Ov16 ELISA demonstrated the specificity required to be effectively deployed to verify transmission elimination under the WHO guidelines, while exhibiting a sensitivity equivalent to skin snip microscopy to identify hypo-endemic areas.

Author Notes

Address correspondence to Thomas R. Unnasch, Center for Global Health Infectious Disease Research, The University of South Florida, 3720 Spectrum Blvd. Suite 304, Tampa, FL 33612. E-mail: tunnasch@health.usf.edu

Financial support: This work received financial support from The Carter Center (with grants from The Margaret A. Cargill Philanthropies, the Centers for Disease Control and Prevention, the Bill & Melinda Gates Foundation, the Lions Clubs International Foundation, the OPEC Fund for International Development, the Carlos Slim Foundation, USAID, and USAID’s ENVISION project led by RTI International).

Authors’ addresses: Frank O. Richards Jr. and Moses Katabarwa, The Carter Center, Atlanta, GA, E-mails: frank.richards@cartercenter.org and moses.katabarwa@cartercenter.org. Firdaweke Bekele, Zerihun Tadesse and Aderajew Mohammed, Onchocerciasis Molecular Laboratory, Addis Ababa, Ethiopia, E-mails: firdaweke.bekele@cartercenter.org, zerihun.tadese@cartercenter.org, and aderajew.mohammed@cartercenter.org. Mauricio Sauerbrey and Alfredo Dominguez-Vazquez, Onchocerciasis Elimination Program for the Americas, Guatemala City, Guatemala, E-mails: oepa@oepa.net and adominguez@oepa.net. Mario A. Rodriguez-Perez and Nadia A. Fernández-Santos, Centro de Biotecnologıa Genomica, Instituto Politecnico, Reynosa, Mexico, E-mails: drmarodriguez@hotmail.com and nadiafriend@hotmail.com. Nidia Rizzo, Residence L’Ambassadeur, Ferney Voltaire, France, E-mail: nirurimo@hotmail.com. Harland R. Schuler Martínez, Servicio Autónomo Instituto de Biomedicina Dr. Jacinto Convit, Ministerio del Poder Popular para la Salud, Venezuela, E-mail: harlandschuler@gmail.com. Raquel Lovato Silva, Ministerio de Salud Pública del Ecuador, Quito, Ecuador, E-mail: raquel.lovato@msp.gob.ec. Zoraida Morales Monroy, Ministerio de Salud de Guatemala, Guatemala City, Guatemala, E-mail: zoraidamoralesmonroy@gmail.com. Peace Habomugisha, The Carter Center, Kampala, Uganda, E-mail: peace.habo@cartercenter.org. David W. Oguttu, NTD Control Program, Vector Control Division, Ministry of Health, Kampala, Uganda, E-mail: dguttu@gmail.com. Issam M. A. Zarroug, Ministry of Health, Khartoum, Sudan, E-mail: imazarroug@gmail.com. Nabil A. Aziz, The Carter Center, Khartoum, Sudan, E-mail: nabilamawadallah@cartercenter-sd.org. Thomas R. Unnasch, Center for Global Health Infectious Diseases, University of South Florida, Tampa, FL, E-mail: tunnasch@health.usf.edu.

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