@article{97287,
  keywords = {Infectious Diseases, Public Health, Environmental and Occupational Health},
  author = {Biamonte MA and Cantey PT and Coulibaly YI and Gass KM and Hamill LC and Hanna C and Lammie PJ and Kamgno J and Nutman TB and Oguttu DW and Sankara DP and Stolk WA and Unnasch TR},
  editor = {Basáñez M},
  title = {Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions},
  abstract = {<p>In June 2021, the World Health Organization (WHO), recognizing the need for new diagnostics to support the control and elimination of onchocerciasis, published the target product profiles (TPPs) of new tests that would support the two most immediate needs: (a) mapping onchocerciasis in areas of low prevalence and (b) deciding when to stop mass drug administration programs. In both instances, the test should ideally detect an antigen specific for live, adult O. volvulus female worms. The preferred format is a field-deployable rapid test. For mapping, the test needs to be ≥ 60% sensitive and ≥ 99.8% specific, while to support stopping decisions, the test must be ≥ 89% sensitive and ≥ 99.8% specific. The requirement for extremely high specificity is dictated by the need to detect with sufficient statistical confidence the low seroprevalence threshold set by WHO. Surveys designed to detect a 1–2% prevalence of a given biomarker, as is the case here, cannot tolerate more than 0.2% of false-positives. Otherwise, the background noise would drown out the signal. It is recognized that reaching and demonstrating such a stringent specificity criterion will be challenging, but test developers can expect to be assisted by national governments and implementing partners for adequately powered field validation.</p>
},
  year = {2022},
  journal = {PLOS Neglected Tropical Diseases},
  volume = {16},
  pages = {e0010682},
  publisher = {Public Library of Science (PLoS)},
  issn = {1935-2735},
  url = {https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0010682&type=printable},
  doi = {10.1371/journal.pntd.0010682},
  language = {eng},
}