Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions.
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...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2022-08-01
|
| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://doi.org/10.1371/journal.pntd.0010682 |
| _version_ | 1797774494430920704 |
|---|---|
| author | Marco A Biamonte Paul T Cantey Yaya I Coulibaly Katherine M Gass Louise C Hamill Christopher Hanna Patrick J Lammie Joseph Kamgno Thomas B Nutman David W Oguttu Dieudonné P Sankara Wilma A Stolk Thomas R Unnasch |
| author_facet | Marco A Biamonte Paul T Cantey Yaya I Coulibaly Katherine M Gass Louise C Hamill Christopher Hanna Patrick J Lammie Joseph Kamgno Thomas B Nutman David W Oguttu Dieudonné P Sankara Wilma A Stolk Thomas R Unnasch |
| author_sort | Marco A Biamonte |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T22:21:57Z |
| format | Article |
| id | doaj.art-9400dcd10c3d4e3fb2a2ce4226848365 |
| institution | Directory Open Access Journal |
| issn | 1935-2727 1935-2735 |
| language | English |
| last_indexed | 2024-03-12T22:21:57Z |
| publishDate | 2022-08-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Neglected Tropical Diseases |
| spelling | doaj.art-9400dcd10c3d4e3fb2a2ce42268483652023-07-23T05:31:38ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352022-08-01168e001068210.1371/journal.pntd.0010682Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions.Marco A BiamontePaul T CanteyYaya I CoulibalyKatherine M GassLouise C HamillChristopher HannaPatrick J LammieJoseph KamgnoThomas B NutmanDavid W OguttuDieudonné P SankaraWilma A StolkThomas R UnnaschIn 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.https://doi.org/10.1371/journal.pntd.0010682 |
| spellingShingle | Marco A Biamonte Paul T Cantey Yaya I Coulibaly Katherine M Gass Louise C Hamill Christopher Hanna Patrick J Lammie Joseph Kamgno Thomas B Nutman David W Oguttu Dieudonné P Sankara Wilma A Stolk Thomas R Unnasch Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions. PLoS Neglected Tropical Diseases |
| title | Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions. |
| title_full | Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions. |
| title_fullStr | Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions. |
| title_full_unstemmed | Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions. |
| title_short | Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions. |
| title_sort | onchocerciasis target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions |
| url | https://doi.org/10.1371/journal.pntd.0010682 |
| work_keys_str_mv | AT marcoabiamonte onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT paultcantey onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT yayaicoulibaly onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT katherinemgass onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT louisechamill onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT christopherhanna onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT patrickjlammie onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT josephkamgno onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT thomasbnutman onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT davidwoguttu onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT dieudonnepsankara onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT wilmaastolk onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions AT thomasrunnasch onchocerciasistargetproductprofilesofinvitrodiagnosticstosupportonchocerciasiseliminationmappingandmassdrugadministrationstoppingdecisions |