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, STadesse, 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
Issue Date
2016-08-25Submitted date
2016-08-30
Metadata
Show full item recordJournal
PloS OneAbstract
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 SciencePubMed ID
27559728Language
enISSN
1932-6203ae974a485f413a2113503eed53cd6c53
10.1371/journal.pone.0161721
Scopus Count
Collections
Related articles
- Optimising diagnosis of viraemic hepatitis C infection: the development of a target product profile.
- Authors: Ivanova Reipold E, Easterbrook P, Trianni A, Panneer N, Krakower D, Ongarello S, Roberts T, Miller V, Denkinger C
- Issue date: 2017 Nov 1
- Diagnosis and Treatment of the Febrile Child
- Authors: Herlihy JM, D’Acremont V, Hay Burgess DC, Hamer DH, Black RE, Laxminarayan R, Temmerman M, Walker N
- Issue date: 2016 Apr 5
- [Diagnostic kits in parasitology: which controls?].
- Authors: Rossi P
- Issue date: 2004 Jun
- Host Biomarkers for Distinguishing Bacterial from Non-Bacterial Causes of Acute Febrile Illness: A Comprehensive Review.
- Authors: Kapasi AJ, Dittrich S, González IJ, Rodwell TC
- Issue date: 2016
- Diagnostics for invasive Salmonella infections: Current challenges and future directions.
- Authors: Andrews JR, Ryan ET
- Issue date: 2015 Jun 19