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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00005076naa a2200445 4500
001oai:DiVA.org:oru-86132
003SwePub
008201005s2020 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-861322 URI
0247 a https://doi.org/10.1371/journal.pone.02374242 DOI
040 a (SwePub)oru
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Ferreyra, Ceciliau Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland4 aut
2451 0a Developing target product profiles for Neisseria gonorrhoeae diagnostics in the context of antimicrobial resistance :b An expert consensus
264 c 2020-09-01
264 1b Public Library of Science,c 2020
338 a print2 rdacarrier
500 a Funding Agency:Global AMR Innovation Fund (GAMRIF) 
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Infektionsmedicin0 (SwePub)302092 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Infectious Medicine0 (SwePub)302092 hsv//eng
7001 a Osborn, Jenniferu Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland4 aut
7001 a Moussy, Francisu World Health Organization (WHO), Geneva, Switzerland4 aut
7001 a Alirol, Emilieu Global Antibiotic R&D Partnership (GARDP), Geneva, Switzerland4 aut
7001 a Lahra, Monicau WHO 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, Australia4 aut
7001 a Whiley, Davidu Centre for Clinical Research, University of Queensland, Brisbane QLD, Australia4 aut
7001 a Shafer, Williamu Department of Microbiology and Immunology, Emory University School of Medicine, Atlanta GA, United States; Veterans Affairs Medical Center, Decatur GA, United States4 aut
7001 a Unemo, Magnus,d 1970-u Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for STIs4 aut0 (Swepub:oru)muo
7001 a Klausner, Jeffreyu Division of Infectious Diseases, University of California and David Geffen School of Medicine Los Angeles, Los Angeles CA, United States4 aut
7001 a Kelly Cirino, Cassandrau Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland4 aut
7001 a Wi, Teodorau World Health Organization (WHO), Geneva, Switzerland4 aut
7102 a Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerlandb World Health Organization (WHO), Geneva, Switzerland4 org
7730 t PLOS ONEd : Public Library of Scienceg 15:9q 15:9x 1932-6203
8564 u https://doi.org/10.1371/journal.pone.0237424y Fulltext
8564 u https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0237424&type=printable
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-86132
8564 8u https://doi.org/10.1371/journal.pone.0237424

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