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Sökning: id:"swepub:oai:DiVA.org:oru-86132" > Developing target p...

  • Ferreyra, CeciliaFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland (författare)

Developing target product profiles for Neisseria gonorrhoeae diagnostics in the context of antimicrobial resistance : An expert consensus

  • Artikel/kapitelEngelska2020

Förlag, utgivningsår, omfång ...

  • 2020-09-01
  • Public Library of Science,2020
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:oru-86132
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-86132URI
  • https://doi.org/10.1371/journal.pone.0237424DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding Agency:Global AMR Innovation Fund (GAMRIF) 
  • Background: There is a need for a rapid diagnostic point of care test to detectNeisseria gonorrhoeae(NG) infection to prevent incorrect, lack or excess of treatment resulting from current syndromic management in low-resource settings. An assay to identify NG antimicrobial resistance (AMR) is also highly desirable to facilitate antibiotic stewardship. Here we describe the development of two target product profiles (TPPs): one for a test for etiological diagnosis of NG andChlamydia trachomatis(CT) (TPP1) and one for the detection of NG AMR/susceptibility (TPP2).Methods: Draft TPPs were initially developed based on a landscape analysis of existing diagnostics and expert input. TPPs were refined via an online Delphi survey with two rounds of input from 68 respondents. TPP characteristics on which <75% of non-industry respondents agreed were further discussed and revised by an expert working group.Results: The need for a test to identify NG in patients with urethral or vaginal discharge was identified as a minimal requirement of TPP1, with a test that can diagnose NG in asymptomatic patients as the optimal requirement. A sensitivity of 80% was considered acceptable, either in context of syndromic management or screening high-risk populations. For TPP2, the agreed minimal requirement was for a test to be used at level 2 healthcare facilities and above, with an optimal requirement of level 1 or above. A lateral flow format was preferred for TPP1, while it was considered likely that TPP2 would require a molecular format. A total of 31 test characteristics were included in TPP1 and 27 in TPP2.Conclusions: Following the working group revisions, TPPs were posted online for public feedback for two months, and are now finalized. The final TPPs are currently guiding the development of new diagnostics that meet the defined characteristics to reach the market within two years.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Osborn, JenniferFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland (författare)
  • Moussy, FrancisWorld Health Organization (WHO), Geneva, Switzerland (författare)
  • Alirol, EmilieGlobal Antibiotic R&D Partnership (GARDP), Geneva, Switzerland (författare)
  • Lahra, MonicaWHO Collaborating Centre for Sexually Transmitted Infections and Antimicrobial Resistance, New South Wales Health Pathology, Microbiology, Prince of Wales Hospital, Randwick, Australia; Faculty of Medicine, University of New South Wales, Sydney NSW, Australia (författare)
  • Whiley, DavidCentre for Clinical Research, University of Queensland, Brisbane QLD, Australia (författare)
  • Shafer, WilliamDepartment of Microbiology and Immunology, Emory University School of Medicine, Atlanta GA, United States; Veterans Affairs Medical Center, Decatur GA, United States (författare)
  • Unemo, Magnus,1970-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for STIs(Swepub:oru)muo (författare)
  • Klausner, JeffreyDivision of Infectious Diseases, University of California and David Geffen School of Medicine Los Angeles, Los Angeles CA, United States (författare)
  • Kelly Cirino, CassandraFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland (författare)
  • Wi, TeodoraWorld Health Organization (WHO), Geneva, Switzerland (författare)
  • Foundation for Innovative New Diagnostics (FIND), Geneva, SwitzerlandWorld Health Organization (WHO), Geneva, Switzerland (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:PLOS ONE: Public Library of Science15:91932-6203

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  • PLOS ONE (Sök värdpublikationen i LIBRIS)

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