Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus

Hdl Handle:
http://hdl.handle.net/10144/618731
Title:
Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus
Authors:
Dittrich, S; Tadesse, BT; Moussy, F; Chua, A; Zorzet, A; Tängdén, T; Dolinger, DL; Page, AL; Crump, JA; D'Acremont, V; Bassat, Q; Lubell, Y; Newton, PN; Heinrich, N; Rodwell, TJ; González, IJ
Journal:
PloS One
Abstract:
Acute fever is one of the most common presenting symptoms globally. In order to reduce the empiric use of antimicrobial drugs and improve outcomes, it is essential to improve diagnostic capabilities. In the absence of microbiology facilities in low-income settings, an assay to distinguish bacterial from non-bacterial causes would be a critical first step. To ensure that patient and market needs are met, the requirements of such a test should be specified in a target product profile (TPP). To identify minimal/optimal characteristics for a bacterial vs. non-bacterial fever test, experts from academia and international organizations with expertise in infectious diseases, diagnostic test development, laboratory medicine, global health, and health economics were convened. Proposed TPPs were reviewed by this working group, and consensus characteristics were defined. The working group defined non-severely ill, non-malaria infected children as the target population for the desired assay. To provide access to the most patients, the test should be deployable to community health centers and informal health settings, and staff should require <2 days of training to perform the assay. Further, given that the aim is to reduce inappropriate antimicrobial use as well as to deliver appropriate treatment for patients with bacterial infections, the group agreed on minimal diagnostic performance requirements of >90% and >80% for sensitivity and specificity, respectively. Other key characteristics, to account for the challenging environment at which the test is targeted, included: i) time-to-result <10 min (but maximally <2 hrs); ii) storage conditions at 0-40°C, ≤90% non-condensing humidity with a minimal shelf life of 12 months; iii) operational conditions of 5-40°C, ≤90% non-condensing humidity; and iv) minimal sample collection needs (50-100μL, capillary blood). This expert approach to define assay requirements for a bacterial vs. non-bacterial assay should guide product development, and enable targeted and timely efforts by industry partners and academic institutions.
Publisher:
Public Library of Science
Issue Date:
25-Aug-2016
URI:
http://hdl.handle.net/10144/618731
DOI:
10.1371/journal.pone.0161721
PubMed ID:
27559728
Submitted date:
2016-08-30
Language:
en
ISSN:
1932-6203
Appears in Collections:
Laboratory

Full metadata record

DC FieldValue Language
dc.contributor.authorDittrich, Sen
dc.contributor.authorTadesse, BTen
dc.contributor.authorMoussy, Fen
dc.contributor.authorChua, Aen
dc.contributor.authorZorzet, Aen
dc.contributor.authorTängdén, Ten
dc.contributor.authorDolinger, DLen
dc.contributor.authorPage, ALen
dc.contributor.authorCrump, JAen
dc.contributor.authorD'Acremont, Ven
dc.contributor.authorBassat, Qen
dc.contributor.authorLubell, Yen
dc.contributor.authorNewton, PNen
dc.contributor.authorHeinrich, Nen
dc.contributor.authorRodwell, TJen
dc.contributor.authorGonzález, IJen
dc.date.accessioned2016-12-09T21:34:10Z-
dc.date.available2016-12-09T21:34:10Z-
dc.date.issued2016-08-25-
dc.date.submitted2016-08-30-
dc.identifier.citationTarget Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus. 2016, 11 (8):e0161721 PLoS ONEen
dc.identifier.issn1932-6203-
dc.identifier.pmid27559728-
dc.identifier.doi10.1371/journal.pone.0161721-
dc.identifier.urihttp://hdl.handle.net/10144/618731-
dc.description.abstractAcute fever is one of the most common presenting symptoms globally. In order to reduce the empiric use of antimicrobial drugs and improve outcomes, it is essential to improve diagnostic capabilities. In the absence of microbiology facilities in low-income settings, an assay to distinguish bacterial from non-bacterial causes would be a critical first step. To ensure that patient and market needs are met, the requirements of such a test should be specified in a target product profile (TPP). To identify minimal/optimal characteristics for a bacterial vs. non-bacterial fever test, experts from academia and international organizations with expertise in infectious diseases, diagnostic test development, laboratory medicine, global health, and health economics were convened. Proposed TPPs were reviewed by this working group, and consensus characteristics were defined. The working group defined non-severely ill, non-malaria infected children as the target population for the desired assay. To provide access to the most patients, the test should be deployable to community health centers and informal health settings, and staff should require <2 days of training to perform the assay. Further, given that the aim is to reduce inappropriate antimicrobial use as well as to deliver appropriate treatment for patients with bacterial infections, the group agreed on minimal diagnostic performance requirements of >90% and >80% for sensitivity and specificity, respectively. Other key characteristics, to account for the challenging environment at which the test is targeted, included: i) time-to-result <10 min (but maximally <2 hrs); ii) storage conditions at 0-40°C, ≤90% non-condensing humidity with a minimal shelf life of 12 months; iii) operational conditions of 5-40°C, ≤90% non-condensing humidity; and iv) minimal sample collection needs (50-100μL, capillary blood). This expert approach to define assay requirements for a bacterial vs. non-bacterial assay should guide product development, and enable targeted and timely efforts by industry partners and academic institutions.en
dc.language.isoenen
dc.publisherPublic Library of Scienceen
dc.rightsPublished by Public Library of Science, [url]http://www.plosone.org/[/url] Archived on this site by Open Access permissionen
dc.titleTarget Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensusen
dc.identifier.journalPloS Oneen

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