Developing target product profiles for Neisseria gonorrhoeae diagnostics in the context of antimicrobial resistance: An expert consensus
| Autor: | Magnus Unemo, Jennifer Osborn, Monica M Lahra, Jeffrey D. Klausner, David M. Whiley, William M. Shafer, Teodora Wi, Francis Moussy, Cecilia Ferreyra, Cassandra Kelly Cirino, Emilie Alirol |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Economics Delphi method Social Sciences Chlamydia trachomatis Drug resistance Economic Geography Surveys Pathology and Laboratory Medicine medicine.disease_cause Gonorrhea 0302 clinical medicine Antibiotics Health care Medicine and Health Sciences 030212 general & internal medicine Multidisciplinary Tripeptidyl-Peptidase 1 Geography Antimicrobials Drugs Bacterial Pathogens Test (assessment) Point-of-Care Testing Research Design Medical Microbiology Low and Middle Income Countries Medicine Pathogens medicine.symptom Neisseria Research Article Vaginal discharge medicine.medical_specialty Science Point-of-care testing 030106 microbiology Men WHO Have Sex with Men Context (language use) Research and Analysis Methods Microbiology 03 medical and health sciences Diagnostic Medicine Microbial Control Drug Resistance Bacterial medicine Humans Medical physics Microbial Pathogens Pharmacology Survey Research Bacteria Diagnostic Tests Routine business.industry Organisms Biology and Life Sciences Chlamydia Infections Neisseria gonorrhoeae Antibiotic Resistance People and Places Earth Sciences Population Groupings Antimicrobial Resistance business Sexuality Groupings |
| Zdroj: | PLoS ONE, Vol 15, Iss 9, p e0237424 (2020) PLoS ONE |
| ISSN: | 1932-6203 |
| Popis: | BackgroundThere 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).MethodsDraft 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 ResultsThe 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.ConclusionsFollowing 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. |
| Databáze: | OpenAIRE |
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