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

Matching diagnostics development to clinical need: target product profile development for a point of care test for community-acquired lower respiratory tract infection
Matching diagnostics development to clinical need: target product profile development for a point of care test for community-acquired lower respiratory tract infection
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.
1932-6203
Gal, Micaela
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Francis, Nicholas A.
9b610883-605c-4fee-871d-defaa86ccf8e
Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Villacian, Jorge
4843c218-6dbf-42ed-afcb-9f3c32df0181
Goossens, Herman
31f8e1ae-7da0-473c-bd49-f911c2187451
Watkins, Angela
d8a5365d-56db-4f3c-8b18-1fbe908778d4
Butler, Christopher C.
8bf4cace-c34a-4b65-838f-29c2be91e434
Gal, Micaela
2d266726-f171-4a55-a381-29c5a2e42ec1
Francis, Nicholas A.
9b610883-605c-4fee-871d-defaa86ccf8e
Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Villacian, Jorge
4843c218-6dbf-42ed-afcb-9f3c32df0181
Goossens, Herman
31f8e1ae-7da0-473c-bd49-f911c2187451
Watkins, Angela
d8a5365d-56db-4f3c-8b18-1fbe908778d4
Butler, Christopher C.
8bf4cace-c34a-4b65-838f-29c2be91e434

Gal, Micaela, Francis, Nicholas A., Hood, Kerenza, Villacian, Jorge, Goossens, Herman, Watkins, Angela 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). (doi:10.1371/journal.pone.0200531).

Record type: Article

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.

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Accepted/In Press date: 28 June 2018
Published date: 1 August 2018

Identifiers

Local EPrints ID: 435589
URI: http://eprints.soton.ac.uk/id/eprint/435589
ISSN: 1932-6203
PURE UUID: cd1252a8-0a52-409f-b544-f8081009e54d
ORCID for Nicholas A. Francis: ORCID iD orcid.org/0000-0001-8939-7312

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Date deposited: 12 Nov 2019 17:30
Last modified: 22 Nov 2021 03:25

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Contributors

Author: Micaela Gal
Author: Kerenza Hood
Author: Jorge Villacian
Author: Herman Goossens
Author: Angela Watkins
Author: Christopher C. Butler

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