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Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation

BACKGROUND & OBJECTIVES: Sepsis, including neonatal sepsis, remains a prevalent cause of morbidity and mortality in low- and middle-income countries such as India, representing 85 per cent of all sepsis-related deaths globally. Early diagnosis and timely initiation of treatment is challenging du...

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Autores principales: Sharma, Monica, Jain, Meenu, Veeraraghavan, Balaji, Rodrigues, Camilla, Bansal, Nitin, Nambi, P. Senthur, Nangia, Sushma, Singhal, Tanu, Walia, Kamini
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10443725/
https://www.ncbi.nlm.nih.gov/pubmed/37322632
http://dx.doi.org/10.4103/ijmr.ijmr_1936_22
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author Sharma, Monica
Jain, Meenu
Veeraraghavan, Balaji
Rodrigues, Camilla
Bansal, Nitin
Nambi, P. Senthur
Nangia, Sushma
Singhal, Tanu
Walia, Kamini
author_facet Sharma, Monica
Jain, Meenu
Veeraraghavan, Balaji
Rodrigues, Camilla
Bansal, Nitin
Nambi, P. Senthur
Nangia, Sushma
Singhal, Tanu
Walia, Kamini
author_sort Sharma, Monica
collection PubMed
description BACKGROUND & OBJECTIVES: Sepsis, including neonatal sepsis, remains a prevalent cause of morbidity and mortality in low- and middle-income countries such as India, representing 85 per cent of all sepsis-related deaths globally. Early diagnosis and timely initiation of treatment is challenging due to non-specific clinical manifestations and non-availability of rapid diagnostic tests. There is an urgent need for affordable diagnostics with fast turnaround time catering to the needs of end-users. Target product profiles (TPPs) have been found instrumental in developing ‘fit-for-use’ diagnostics, thus reducing the time taken to facilitate development and improving diagnosis. Hitherto, no such guidance or criteria has been defined for rapid diagnostics for sepsis/neonatal sepsis. We propose an innovative approach for developing the diagnostics for sepsis screening and diagnosis which can be utilized by diagnostic developers in the country. METHODS: Three-round Delphi method, including two online surveys and one virtual consultation, was adopted to define criteria for minimum and optimum attributes of TPPs and build consensus on characteristics. Expert panel (n=23) included infectious disease physicians, public health specialists, clinical microbiologists, virologists, researchers/scientists and technology experts/innovators. RESULTS: We present a three-component product profile for sepsis diagnosis, (i) screening with high sensitivity, (ii) detection of aetiological agent, and (iii) profiling of antimicrobial susceptibility/resistance, in adults and neonates with an option of testing different considerations. An agreement of >75 per cent was achieved for all TPP characteristics by Delphi. These TPPs are tailored to the Indian healthcare settings and can also be extrapolated to other resource-constraint and high-disease burden settings. INTERPRETATION & CONCLUSIONS: Diagnostics developed using these TPPs will facilitate utilization of invested resources leading to development of the products that have potential to ease the economic burden on patient and save lives.
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spelling pubmed-104437252023-08-23 Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation Sharma, Monica Jain, Meenu Veeraraghavan, Balaji Rodrigues, Camilla Bansal, Nitin Nambi, P. Senthur Nangia, Sushma Singhal, Tanu Walia, Kamini Indian J Med Res Programme: Original Article BACKGROUND & OBJECTIVES: Sepsis, including neonatal sepsis, remains a prevalent cause of morbidity and mortality in low- and middle-income countries such as India, representing 85 per cent of all sepsis-related deaths globally. Early diagnosis and timely initiation of treatment is challenging due to non-specific clinical manifestations and non-availability of rapid diagnostic tests. There is an urgent need for affordable diagnostics with fast turnaround time catering to the needs of end-users. Target product profiles (TPPs) have been found instrumental in developing ‘fit-for-use’ diagnostics, thus reducing the time taken to facilitate development and improving diagnosis. Hitherto, no such guidance or criteria has been defined for rapid diagnostics for sepsis/neonatal sepsis. We propose an innovative approach for developing the diagnostics for sepsis screening and diagnosis which can be utilized by diagnostic developers in the country. METHODS: Three-round Delphi method, including two online surveys and one virtual consultation, was adopted to define criteria for minimum and optimum attributes of TPPs and build consensus on characteristics. Expert panel (n=23) included infectious disease physicians, public health specialists, clinical microbiologists, virologists, researchers/scientists and technology experts/innovators. RESULTS: We present a three-component product profile for sepsis diagnosis, (i) screening with high sensitivity, (ii) detection of aetiological agent, and (iii) profiling of antimicrobial susceptibility/resistance, in adults and neonates with an option of testing different considerations. An agreement of >75 per cent was achieved for all TPP characteristics by Delphi. These TPPs are tailored to the Indian healthcare settings and can also be extrapolated to other resource-constraint and high-disease burden settings. INTERPRETATION & CONCLUSIONS: Diagnostics developed using these TPPs will facilitate utilization of invested resources leading to development of the products that have potential to ease the economic burden on patient and save lives. Wolters Kluwer - Medknow 2023-05 2023-06-20 /pmc/articles/PMC10443725/ /pubmed/37322632 http://dx.doi.org/10.4103/ijmr.ijmr_1936_22 Text en Copyright: © 2023 Indian Journal of Medical Research https://creativecommons.org/licenses/by-nc-sa/4.0/This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Programme: Original Article
Sharma, Monica
Jain, Meenu
Veeraraghavan, Balaji
Rodrigues, Camilla
Bansal, Nitin
Nambi, P. Senthur
Nangia, Sushma
Singhal, Tanu
Walia, Kamini
Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation
title Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation
title_full Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation
title_fullStr Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation
title_full_unstemmed Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation
title_short Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation
title_sort target product profiles for diagnosis of sepsis: proposing a new approach for diagnostic innovation
topic Programme: Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10443725/
https://www.ncbi.nlm.nih.gov/pubmed/37322632
http://dx.doi.org/10.4103/ijmr.ijmr_1936_22
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