• 1.

    Anonomous, 2012. London Declaration on Neglected Tropical Diseases. Available at: www.UnitingToCombatNTDs.org. Accessed March 26, 2018.

  • 2.

    World Health Organization, 2016. Guidelines for Stopping Mass Drug Administration and Verifying Elimination of Human onchocerciasis: Criteria and Procedures. WHO document WHO/HTM/NTD/PCT/2016.1. Geneva, Switzerland: WHO.

  • 3.

    Lobos E, Altmann M, Mengod G, Weiss N, Rudin W, Karam M, 1990. Identification of an Onchocerca volvulus cDNA encoding a low-molecular-weight antigen uniquely recognized by onchocerciasis patient sera. Mol Biochem Parasitol 39: 135146.

    • Search Google Scholar
    • Export Citation
  • 4.

    Eberhard ML et al. 1995. Onchocerca volvulus: parasitologic and serologic responses in experimentally infected chimpanzees and mangabey monkeys. Exp Parasitol 80: 454462.

    • Search Google Scholar
    • Export Citation
  • 5.

    Unnasch TR, Golden A, Cama V, Cantey P, 2018. Diagnostics for onchocerciasis in the era of elimination. Int Health 10: i20i26.

  • 6.

    Oguttu D et al. 2014. Serosurveillance to Monitor onchocerciasis elimination: the Ugandan experience. Am J Trop Med Hyg 90: 339345.

  • 7.

    Lindblade KA et al. 2007. Elimination of Onchocerca volvulus transmission in the Santa Rosa focus of Guatemala. Am J Trop Med Hyg 77: 334341.

  • 8.

    Rodriguez-Perez MA, Lizarazo-Ortega C, Hassan HK, Dominguez-Vasquez A, Mendez-Galvan J, Lugo-Moreno P, Sauerbrey M, Richards F Jr., Unnasch TR, 2008. Evidence for suppression of Onchocerca volvulus transmission in the Oaxaca focus in Mexico. Am J Trop Med Hyg 78: 147152.

    • Search Google Scholar
    • Export Citation
  • 9.

    Rodriguez-Perez MA, Unnasch TR, Dominguez-Vasquez A, Morales-Castro AL, Richards F, Pena-Flores GP, Orozco-Algarra E, Prado-Velasco G, 2010. Lack of active Onchocerca volvulus transmission in the northern Chiapas focus of Mexico. Am J Trop Med Hyg 83: 1520.

    • Search Google Scholar
    • Export Citation
  • 10.

    Cruz-Ortiz N, Gonzalez RJ, Lindblade KA, Richards FO Jr., Sauerbrey M, Zea-Flores G, Dominguez A, Oliva O, Catu E, Rizzo N, 2012. Elimination of Onchocerca volvulus transmission in the Huehuetenango focus of Guatemala. J Parasitol Res 2012: 638429.

    • Search Google Scholar
    • Export Citation
  • 11.

    Convit J, Schuler H, Borges R, Olivero V, Dominguez-Vazquez A, Frontado H, Grillet ME, 2013. Interruption of Onchocerca volvulus transmission in northern Venezuela. Parasit Vectors 6: 289.

    • Search Google Scholar
    • Export Citation
  • 12.

    Higazi TB et al. 2013. Interruption of Onchocerca volvulus transmission in the Abu Hamed focus, Sudan. Am J Trop Med Hyg 89: 5157.

  • 13.

    Lakwo TL et al. 2013. The disappearance of onchocerciasis from the Itwara focus, western Uganda after elimination of the vector Simulium neavei and 19 years of annual ivermectin treatments. Acta Trop 126: 218221.

    • Search Google Scholar
    • Export Citation
  • 14.

    Rodríguez-Pérez M, Domínguez-Vázquez A, Unnasch TR, Hassan HK, Arredondo-Jiménez JI, Orozco-Algarra ME, Rodríguez-Morales KB, Rodríguez-Luna IC, Prado-Velasco FG, 2013. Interruption of transmission of Onchocerca volvulus in the southern Chiapas focus, México. PLoS Negl Trop Dis 7: e2133.

    • Search Google Scholar
    • Export Citation
  • 15.

    Lovato R, Guevara A, Guderian R, Proano R, Unnasch T, Criollo H, Hassan HK, MacKenzie CD, 2014. Interruption of infection transmission in the onchocerciasis focus of Ecuador leading to the cessation of ivermectin distribution. PLoS Negl Trop Dis 8: e2821.

    • Search Google Scholar
    • Export Citation
  • 16.

    Katabarwa M et al. 2014. Transmission of Onchocerca volvulus by Simulium neavei in Mount Elgon focus of eastern Uganda has been interrupted. Am J Trop Med Hyg 90: 11591166.

    • Search Google Scholar
    • Export Citation
  • 17.

    Lakwo TL et al. 2015. Successful interruption of the transmission of Onchocerca volvulus in Mpamba-Nkusi focus, Kibaale district, mid-western Uganda. East Afr Med J 92: 401407.

    • Search Google Scholar
    • Export Citation
  • 18.

    Richards F Jr. et al. 2015. One hundred years after its discovery in Guatemala by Rodolfo Robles, Onchocerca volvulus transmission has been eliminated from the central endemic zone. Am J Trop Med Hyg 93: 12951304.

    • Search Google Scholar
    • Export Citation
  • 19.

    Katabarwa MN et al. 2016. The Imaramagambo onchocerciasis focus in southwestern Uganda: interruption of transmission after disappearance of the vector Simulium neavei and its associated freshwater crabs. Am J Trop Med Hyg 95: 417425.

    • Search Google Scholar
    • Export Citation
  • 20.

    Lakwo T et al. 2017. Interruption of the transmission of Onchocerca volvulus in the Kashoya-Kitomi focus, western Uganda by long-term ivermectin treatment and elimination of the vector Simulium neavei by larviciding. Acta Trop 167: 128136.

    • Search Google Scholar
    • Export Citation
  • 21.

    Luroni LT et al. 2017. The interruption of Onchocerca volvulus and Wuchereria bancrofti transmission by integrated chemotherapy in the Obongi focus, north western Uganda. PLoS One 12: e0189306.

    • Search Google Scholar
    • Export Citation
  • 22.

    Nicholls RS, Duque S, Olaya LA, Lopez MC, Sanchez SB, Palma GI, Morales AL, 2018. Elimination of onchocerciasis from Colombia: first proof of concept of river blindness elimination in the world. Parasit Vectors 11: 237.

    • Search Google Scholar
    • Export Citation
  • 23.

    Zarroug IM et al. 2016. The first confirmed elimination of an onchocerciasis focus in Africa: Abu Hamed, Sudan. Am J Trop Med Hyg 27: 10371040.

    • Search Google Scholar
    • Export Citation
  • 24.

    Toe L, Merriweather A, Unnasch TR, 1994. DNA probe based classification of Simulium damnosum s.l. borne and human derived filarial parasites in the onchocerciasis control programme area. Am J Trop Med Hyg 51: 676683.

    • Search Google Scholar
    • Export Citation
  • 25.

    Boatin BA, Toe L, Alley ES, Nagelkerke NJ, Borsboom G, Habbema JD, 2002. Detection of Onchocerca volvulus infection in low prevalence areas: a comparison of three diagnostic methods. Parasitology 125: 545552.

    • Search Google Scholar
    • Export Citation
  • 26.

    Johnson WO, Su C-L, Gardner IA, Christensen R, 2004. Sample size calculations for surveys to substantiate freedom of populations from infectious agents. Biometrics 60: 165171.

    • Search Google Scholar
    • Export Citation
  • 27.

    Burbelo PD, Leahy HP, Iadarola MJ, Nutman TB, 2009. A four-antigen mixture for rapid assessment of Onchocerca volvulus infection. PLoS Negl Trop Dis 3: e438.

    • Search Google Scholar
    • Export Citation
  • 28.

    Lagatie O, Verheyen A, Nijs E, Van Dorst B, Batsa Debrah L, Debrah A, Supali T, Sartono E, Stuyver LJ, 2018. Evaluation of the diagnostic performance of Onchocerca volvulus linear epitopes in a peptide enzyme-linked immunosorbent assay. Am J Trop Med Hyg 98: 779785.

    • Search Google Scholar
    • Export Citation
  • 29.

    Lont YL, Coffeng LE, de Vlas SJ, Golden A, de Los Santos T, Domingo GJ, Stolk WA, 2017. Modelling anti-Ov16 IgG4 antibody prevalence as an indicator for evaluation and decision making in onchocerciasis elimination programmes. PLoS Negl Trop Dis 11: e0005314.

    • Search Google Scholar
    • Export Citation
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

 

 

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

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  • 1 The Carter Center, Atlanta, Georgia;
  • | 2 The Carter Center, Addis Ababa, Ethiopia;
  • | 3 Onchocerciasis Elimination Program for the Americas, Guatemala City, Guatemala;
  • | 4 Centro de Biotecnologia Genomica, Instituto Politecnico Nacional, Reynosa, Mexico;
  • | 5 Secretaria de Salud de Mexico, Mexico City, Mexico;
  • | 6 Centro de Estudios en Salud of the Universidad del Valle de, Guatemala (UVG), Guatemala City, Guatemala;
  • | 7 Ministerio del Poder Popular para la Salud, Caracas, Venezuela;
  • | 8 Ministerio de Salud Pública del Ecuador, Quito, Ecuador;
  • | 9 Ministerio de Salud de Guatemala, Guatemala City, Guatemala;
  • | 10 The Carter Center, Uganda Office, Kampala, Uganda;
  • | 11 NTD Control Program, Vector Control Division, Kampala, Uganda;
  • | 12 Ministry of Health, Khartoum, Sudan;
  • | 13 The Carter Center, Khartoum, Sudan;
  • | 14 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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