02320nas a2200325   4500000000100000008004100001260003700042653002400079653005700103100001600160700001400176700001700190700001200207700001400219700001200233700001400245700001300259700001400272700001400286700001500300700001300315700001500328700001600343245016200359856009900521300001300620490000700633520134000640022001401980       2022                            d  bPublic Library of Science (PLoS)10aInfectious Diseases10aPublic Health, Environmental and Occupational Health1 aBiamonte MA1 aCantey PT1 aCoulibaly YI1 aGass KM1 aHamill LC1 aHanna C1 aLammie PJ1 aKamgno J1 aNutman TB1 aOguttu DW1 aSankara DP1 aStolk WA1 aUnnasch TR1 aBasáñez M00aOnchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions  uhttps://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0010682&type=printable  ae00106820 v163 a<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>
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