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

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  • Cecilia Ferreyra
  • Jennifer Osborn
  • Francis Moussy
  • Emilie Alirol
  • Monica Lahra
  • David Whiley
  • William Shafer
  • Magnus Unemo
  • Jeffrey Klausner
  • Cassandra Kelly Cirino
  • Teodora Wi

Abstract

Background: There is a need for a rapid diagnostic point of care test to detect Neisseria 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 and Chlamydia 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

Suggested Citation

  • Cecilia Ferreyra & Jennifer Osborn & Francis Moussy & Emilie Alirol & Monica Lahra & David Whiley & William Shafer & Magnus Unemo & Jeffrey Klausner & Cassandra Kelly Cirino & Teodora Wi, 2020. "Developing target product profiles for Neisseria gonorrhoeae diagnostics in the context of antimicrobial resistance: An expert consensus," PLOS ONE, Public Library of Science, vol. 15(9), pages 1-15, September.
    • Handle: RePEc:plo:pone00:0237424
    DOI: 10.1371/journal.pone.0237424
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    References listed on IDEAS

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    1. Eline L Korenromp & Teodora Wi & Stephen Resch & John Stover & Nathalie Broutet, 2017. "Costing of National STI Program Implementation for the Global STI Control Strategy for the Health Sector, 2016-2021," PLOS ONE, Public Library of Science, vol. 12(1), pages 1-29, January.
    2. Azra C. Ghani & Deborah Hay Burgess & Alison Reynolds & Christine Rousseau, 2015. "Expanding the role of diagnostic and prognostic tools for infectious diseases in resource-poor settings," Nature, Nature, vol. 528(7580), pages 50-52, December.
    3. Mickey Urdea & Laura A. Penny & Stuart S. Olmsted & Maria Y. Giovanni & Peter Kaspar & Andrew Shepherd & Penny Wilson & Carol A. Dahl & Steven Buchsbaum & Gerry Moeller & Deborah C. Hay Burgess, 2006. "Requirements for high impact diagnostics in the developing world," Nature, Nature, vol. 444(1), pages 73-79, November.
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