Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection

Gal, Micaela ORCID: https://orcid.org/0000-0002-1326-190X, Francis, Nicholas A. ORCID: https://orcid.org/0000-0001-8939-7312, Hood, Kerenza ORCID: https://orcid.org/0000-0002-5268-8631, Villacian, Jorge, Goossens, Herman, Watkins, Angela ORCID: https://orcid.org/0000-0002-1212-513X and Butler, Christopher C. 2018. Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection. PLoS ONE 13 (8) , e0200531. 10.1371/journal.pone.0200531

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Abstract

Background Point of care tests (POCTs) are increasingly being promoted for guiding the primary medical care of community acquired lower respiratory tract infections (CA-LRTI). POCT development has seldom been guided by explicitly identified clinical need and requirements of the intended users. Approaches for identifying POCT priorities and developing target product profiles (TPPs) for POCTs in primary medical care are not well developed, and there is no published TPP for a CA-LRTI POCT aimed at developed countries. Methods We conducted workshops with expert stakeholders and a survey with primary care clinicians to produce a target product profile (TPP) to guide the development of a clinically relevant and technologically feasible POCT for CA-LRTI. Results Participants with clinical, academic, industrial, technological and basic scientific backgrounds contributed to four expert workshops, and 45 practicing primary care clinicians responded to an online survey and prioritised community-acquired pneumonia (CAP) as the CA-LRTI where a new POCT was most urgently needed. Consensus was reached on a TPP document that included information on the intended niche in the clinical pathway in primary medical care; diagnostic product specification (intended use statement and test concept), and minimum and ideal user specifications. Clinicians minimum requirements of a CA-LRTI POCT included the use of minimally invasive samples, a result in less than 30 minutes, no more than a single preparation step, minimum operational requirements, and detection of common respiratory pathogens and their resistance to commonly prescribed antibiotics. Conclusions This multidisciplinary, multistage partnership approach generated a clinically-driven TPP for guiding the development of a new POCT, and this approach as well as the TPP itself may be useful to others developing a new POCT.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine Centre for Trials Research (CNTRR)
Publisher:	Public Library of Science
ISSN:	1932-6203
Date of First Compliant Deposit:	3 September 2018
Date of Acceptance:	28 June 2018
Last Modified:	25 Jul 2023 18:20
URI:	https://orca.cardiff.ac.uk/id/eprint/114590

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