Changes in Onchocerciasis Ov16 IgG4 Rapid Diagnostic Test Results Over One-Month Follow-up: Lessons for Reading Timeframe and Decision-Making

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  • 1 Centre for Research on Filariasis and other Tropical Diseases, Yaoundé, Cameroon;
  • | 2 Institut de Recherche pour le Développement, UMI 233-Inserm U1175-Montpellier University, Montpellier, France;
  • | 3 Parasitology and Ecology Laboratory, Department of Animal Biology and Physiology, Faculty of Science, University of Yaoundé 1, Yaoundé, Cameroon;
  • | 4 Diagnostics Global Program, PATH, Seattle, Washington;
  • | 5 Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland;
  • | 6 Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon

The SD Bioline® IgG4 rapid diagnostic test (RDT) detects IgG4 antibodies induced by the Onchocerca volvulus-specific antigen Ov16. We evaluated the stability of the RDT results over 1 month, at different time points after completion of each assay, using eluted dried blood spots collected in central Cameroon. Agreement coefficients regarding positivity between 30 minutes and 24 hours, 1, 2, 3, and 4 weeks were, 96.4%, 93.4%, 93.3%, 93.2%, and 93.2%, respectively. Between 30 minutes and 24 hours, 3.6% of the 15,444 tests showed inconsistent results with 81.2% of these tests changing from negative to positive, increasing O. volvulus antibody prevalence from 23.9% to 26.2% (P < 0.0001). This change from negative to positive outcome was confirmed at the subsequent timepoints. Depending on the desired accuracy of prevalence estimates, reading time may have to be redefined more strictly.

Author Notes

Address correspondence to Hugues C. Nana-Djeunga, Centre for Research on Filariasis and other Tropical Diseases (CRFilMT), Street 1411 Quartier Fouda, PO Box 5797, Yaoundé, Cameroon, E-mail: nanadjeunga@crfilmt.orgor Sébastien D. Pion, Institut de Recherche pour le Développement, UMI 233-Inserm U1175-Montpellier University, 911 Avenue Agropolis, 34394 Montpellier, France, E-mail: sebastien.pion@ird.fr.

Disclosure: This study received ethical clearance from the Cameroon National Ethics Committee for Research in Human Health (CNERSH) (2013/11/370/L/CNERSH/SP). Administrative authorization was granted by the Ministry of Public Health (D30- 571/L/MINSANTE/SG/DROS/CRSPE/BBM). An individual barcode was attributed to each participant for anonymized data analysis. Before any procedure, all participants provided written informed consent or assent/parental consent in the case of minors. Written authorization was also provided for further use of stored samples (including DBS).

Financial support: This study was supported by the Bill and Melinda Gates Foundation (Grant no. OPP1033740). This study was funded in part by the Intramural Research Program of the NIH.

Authors’ addresses: Hugues C. Nana-Djeunga, Centre for Research on Filariasis and other Tropical Diseases, Yaoundé, Cameroon, E-mail: nanadjeunga@crfilmt.org. Capucine M. Sicard, Institut de Recherche pour le Développement, UMI 233-Inserm U1175-Montpellier University, Montpellier, France, E-mail: capucine.sicard@etu.umontpellier.fr. Aude E. Mogoung-Wafo, Centre for Research on Filariasis and other Tropical Diseases, Yaoundé, Cameroon, E-mail: audewafo@yahoo.fr. Cédric B. Chesnais and Hugo Deléglise, Institut de Recherche pour le Développement, UMI 233-Inserm U1175-Montpellier University, Montpellier, France, E-mails: cedric.chesnais@ird.fr and hugo.deleglise@cirad.fr. Rufine Touka-Nounkeu, Centre for Research on Filariasis and other Tropical Diseases, Yaoundé, Cameroon, E-mail: rufine.touka@gmail.com. André Domche, Centre for Research on Filariasis and other Tropical Diseases, Yaoundé, Cameroon, and Parasitology and Ecology Laboratory, Department of Animal Biology and Physiology, Faculty of Science, University of Yaoundé 1, Yaoundé, Cameroon, E-mail: domche_andre@yahoo.fr. Allison Golden, Diagnostics Global Program, PATH, Seattle, WA, E-mail: algolden@path.org. Amy D. Klion and Thomas B. Nutman, Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD, E-mails: aklion@niaid.nih.gov and tnutman@niaid.nih.gov. Michel Boussinesq, Institut de Recherche pour le Développement, UMI 233-Inserm U1175-Montpellier University, Montpellier, France, E-mail: michel.boussinesq@ird.fr. Joseph Kamgno, Centre for Research on Filariasis and other Tropical Diseases, Yaoundé, Cameroon and Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon, E-mail: kamgno@crfilmt.org. Sébastien D. Pion, Institut de Recherche pour le Développement, UMI 233-Inserm U1175-Montpellier University, Montpellier, France, E-mail: sebastien.pion@ird.fr.

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