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Approach to Assessment of New Swabs and Viral Transport Media for SARS-CoV-2 Testing
In light of the present pandemic of novel coronavirus disease 2019 (COVID-19) and the unprecedented high demand for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing worldwide, there are shortages of established specimen collection devices for respiratory viral testing for diagnos...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Society for Microbiology
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091853/ https://www.ncbi.nlm.nih.gov/pubmed/33139423 http://dx.doi.org/10.1128/JCM.01562-20 |
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author | Locher, Kerstin Velapatino, Billie Caza, Mélissa Li, Lisa Porter, Charlene Charles, Marthe |
author_facet | Locher, Kerstin Velapatino, Billie Caza, Mélissa Li, Lisa Porter, Charlene Charles, Marthe |
author_sort | Locher, Kerstin |
collection | PubMed |
description | In light of the present pandemic of novel coronavirus disease 2019 (COVID-19) and the unprecedented high demand for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing worldwide, there are shortages of established specimen collection devices for respiratory viral testing for diagnostic microbiology laboratories. This creates the need to validate unverified collection devices from manufacturers that may not be a registered supplier for medical devices. As clinical laboratories do not routinely perform quality control of established collection devices, there is a need to have a systematic, robust approach to the assessment of substitute unregistered collection swabs and viral transport media (VTM). A discussion of the aspects requiring consideration when determining the suitability and implementation of new collection devices is presented. These specific assessment criteria include an inspection of device integrity, determination of swab and VTM sterility and in vitro performance, VTM stability, and examination of the clinical performance of the device. This method was used in a front-line medical microbiology laboratory on swabs and VTM from an unregistered manufacturer, with suboptimal results that precluded implementation. As the pandemic continues, it will be important for diagnostic laboratories to adopt a flexible and streamlined approach to maintaining adequate supply chains for testing reagents and materials. |
format | Online Article Text |
id | pubmed-8091853 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | American Society for Microbiology |
record_format | MEDLINE/PubMed |
spelling | pubmed-80918532021-05-18 Approach to Assessment of New Swabs and Viral Transport Media for SARS-CoV-2 Testing Locher, Kerstin Velapatino, Billie Caza, Mélissa Li, Lisa Porter, Charlene Charles, Marthe J Clin Microbiol Commentary In light of the present pandemic of novel coronavirus disease 2019 (COVID-19) and the unprecedented high demand for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing worldwide, there are shortages of established specimen collection devices for respiratory viral testing for diagnostic microbiology laboratories. This creates the need to validate unverified collection devices from manufacturers that may not be a registered supplier for medical devices. As clinical laboratories do not routinely perform quality control of established collection devices, there is a need to have a systematic, robust approach to the assessment of substitute unregistered collection swabs and viral transport media (VTM). A discussion of the aspects requiring consideration when determining the suitability and implementation of new collection devices is presented. These specific assessment criteria include an inspection of device integrity, determination of swab and VTM sterility and in vitro performance, VTM stability, and examination of the clinical performance of the device. This method was used in a front-line medical microbiology laboratory on swabs and VTM from an unregistered manufacturer, with suboptimal results that precluded implementation. As the pandemic continues, it will be important for diagnostic laboratories to adopt a flexible and streamlined approach to maintaining adequate supply chains for testing reagents and materials. American Society for Microbiology 2021-04-20 /pmc/articles/PMC8091853/ /pubmed/33139423 http://dx.doi.org/10.1128/JCM.01562-20 Text en Copyright © 2021 American Society for Microbiology. https://doi.org/10.1128/ASMCopyrightv2All Rights Reserved (https://doi.org/10.1128/ASMCopyrightv2) . https://doi.org/10.1128/ASMCopyrightv2This article is made available via the PMC Open Access Subset for unrestricted noncommercial re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. |
spellingShingle | Commentary Locher, Kerstin Velapatino, Billie Caza, Mélissa Li, Lisa Porter, Charlene Charles, Marthe Approach to Assessment of New Swabs and Viral Transport Media for SARS-CoV-2 Testing |
title | Approach to Assessment of New Swabs and Viral Transport Media for SARS-CoV-2 Testing |
title_full | Approach to Assessment of New Swabs and Viral Transport Media for SARS-CoV-2 Testing |
title_fullStr | Approach to Assessment of New Swabs and Viral Transport Media for SARS-CoV-2 Testing |
title_full_unstemmed | Approach to Assessment of New Swabs and Viral Transport Media for SARS-CoV-2 Testing |
title_short | Approach to Assessment of New Swabs and Viral Transport Media for SARS-CoV-2 Testing |
title_sort | approach to assessment of new swabs and viral transport media for sars-cov-2 testing |
topic | Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091853/ https://www.ncbi.nlm.nih.gov/pubmed/33139423 http://dx.doi.org/10.1128/JCM.01562-20 |
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