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Significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics

With the continuing rise of multiresistant pathogens, reliable, cost-effective, and novel diagnostics are urgently required by clinicians and clinical trialists to diagnose conditions such as respiratory tract infections to enable rational antimicrobial choice and enhance clinical outcomes. However,...

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Autores principales: Dollow, Joshua M, Green, Justin A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3904809/
https://www.ncbi.nlm.nih.gov/pubmed/24489460
http://dx.doi.org/10.2147/DDDT.S52446
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author Dollow, Joshua M
Green, Justin A
author_facet Dollow, Joshua M
Green, Justin A
author_sort Dollow, Joshua M
collection PubMed
description With the continuing rise of multiresistant pathogens, reliable, cost-effective, and novel diagnostics are urgently required by clinicians and clinical trialists to diagnose conditions such as respiratory tract infections to enable rational antimicrobial choice and enhance clinical outcomes. However, during product development, validation of these in vitro diagnostic devices, a key regulatory hurdle, requires sputum samples in large numbers. The Rapid Point-of-Care test Platform for Infectious Diseases (RAPP-ID) consortium is tasked with producing point of care test (POCT) platforms for rapid diagnosis of lower respiratory tract infections, including tuberculosis and blood stream infections. Validation of diagnostic platforms would ideally use well-characterized samples in a sputum library taken from a range of clinical settings to allow for a wide panel of pathogens to be assessed. These samples would be stored in specific stable conditions (monitored temperature, specific medium) until required for validation. Therefore we reviewed the current literature for details of storage conditions of sputum samples and for previous validation studies of other diagnostic tests using this methodology. However, we conclude that little data exists, and thus the acquisition and successful storage of good quality clinical samples are major roadblocks in the validation of novel POCT platforms, and that while not without limitations, spiked sputum samples appear the best solution until sputum library laboratory techniques allowing careful preservation of pathogens are improved.
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spelling pubmed-39048092014-01-31 Significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics Dollow, Joshua M Green, Justin A Drug Des Devel Ther Review With the continuing rise of multiresistant pathogens, reliable, cost-effective, and novel diagnostics are urgently required by clinicians and clinical trialists to diagnose conditions such as respiratory tract infections to enable rational antimicrobial choice and enhance clinical outcomes. However, during product development, validation of these in vitro diagnostic devices, a key regulatory hurdle, requires sputum samples in large numbers. The Rapid Point-of-Care test Platform for Infectious Diseases (RAPP-ID) consortium is tasked with producing point of care test (POCT) platforms for rapid diagnosis of lower respiratory tract infections, including tuberculosis and blood stream infections. Validation of diagnostic platforms would ideally use well-characterized samples in a sputum library taken from a range of clinical settings to allow for a wide panel of pathogens to be assessed. These samples would be stored in specific stable conditions (monitored temperature, specific medium) until required for validation. Therefore we reviewed the current literature for details of storage conditions of sputum samples and for previous validation studies of other diagnostic tests using this methodology. However, we conclude that little data exists, and thus the acquisition and successful storage of good quality clinical samples are major roadblocks in the validation of novel POCT platforms, and that while not without limitations, spiked sputum samples appear the best solution until sputum library laboratory techniques allowing careful preservation of pathogens are improved. Dove Medical Press 2014-01-23 /pmc/articles/PMC3904809/ /pubmed/24489460 http://dx.doi.org/10.2147/DDDT.S52446 Text en © 2014 Dollow and Green. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Review
Dollow, Joshua M
Green, Justin A
Significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics
title Significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics
title_full Significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics
title_fullStr Significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics
title_full_unstemmed Significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics
title_short Significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics
title_sort significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3904809/
https://www.ncbi.nlm.nih.gov/pubmed/24489460
http://dx.doi.org/10.2147/DDDT.S52446
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