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Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing

INTRODUCTION: The gold standard for COVID-19 diagnosis is currently a real-time reverse transcriptase polymerase chain reaction (RT-PCR) to detect SARS-CoV-2. This is most commonly performed on respiratory secretions obtained via a nasopharyngeal swab. Due to supply chain limitations and high demand...

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Autores principales: Tay, Joshua K., Cross, Gail B., Sun, Louisa, Chia, Alfred, Chee, Jeremy, Loh, Jerold, Lim, Zhen Yu, Ngiam, Nicholas, Khang, Wen Pang, Yeap, Stephanie, Goh, Han Lee, Siow, Chor Hiang, Loh, Woei Shyang, Loh, Kwok Seng, Lee, Chun Kiat, Yan, Benedict, Chow, Vincent T. K., Wang, De Yun, Boey, Freddy, Wong, John E. L., Allen, David M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7799401/
https://www.ncbi.nlm.nih.gov/pubmed/33432534
http://dx.doi.org/10.1007/s40121-020-00391-6
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author Tay, Joshua K.
Cross, Gail B.
Sun, Louisa
Chia, Alfred
Chee, Jeremy
Loh, Jerold
Lim, Zhen Yu
Ngiam, Nicholas
Khang, Wen Pang
Yeap, Stephanie
Goh, Han Lee
Siow, Chor Hiang
Loh, Woei Shyang
Loh, Kwok Seng
Lee, Chun Kiat
Yan, Benedict
Chow, Vincent T. K.
Wang, De Yun
Boey, Freddy
Wong, John E. L.
Allen, David M.
author_facet Tay, Joshua K.
Cross, Gail B.
Sun, Louisa
Chia, Alfred
Chee, Jeremy
Loh, Jerold
Lim, Zhen Yu
Ngiam, Nicholas
Khang, Wen Pang
Yeap, Stephanie
Goh, Han Lee
Siow, Chor Hiang
Loh, Woei Shyang
Loh, Kwok Seng
Lee, Chun Kiat
Yan, Benedict
Chow, Vincent T. K.
Wang, De Yun
Boey, Freddy
Wong, John E. L.
Allen, David M.
author_sort Tay, Joshua K.
collection PubMed
description INTRODUCTION: The gold standard for COVID-19 diagnosis is currently a real-time reverse transcriptase polymerase chain reaction (RT-PCR) to detect SARS-CoV-2. This is most commonly performed on respiratory secretions obtained via a nasopharyngeal swab. Due to supply chain limitations and high demand worldwide because of the COVID-19 pandemic, access to commercial nasopharyngeal swabs has not been assured. 3D printing methods have been used to meet the shortfall. For longer-term considerations, 3D printing may not compare well with injection molding as a production method due to the challenging scalability and greater production costs of 3D printing. METHODS: To secure sufficient nasopharyngeal swab availability for our national healthcare system, we designed a novel injection molded nasopharyngeal swab (the IM2 swab). We performed a clinical diagnostic study comparing the IM2 swab to the Copan FLOQSwab. Forty patients with a known diagnosis of COVID-19 and 10 healthy controls were recruited. Paired nasopharyngeal swabs were obtained from the same nostril of each participant and tested for SARS-CoV-2 by RT-PCR. RESULTS: When compared to the Copan FLOQswab, results from the IM2 swab displayed excellent overall agreement and positive percent agreement of 96.0% and 94.9%, respectively. There was no significant difference in mean RT-PCR cycle threshold values for the ORF1ab (28.05 vs. 28.03, p = 0.97) and E-gene (29.72 vs. 29.37, p = 0.64) targets, respectively. We did not observe any significant adverse events and there was no significant difference in patient-reported pain. CONCLUSION: In summary, the IM2 nasopharyngeal swab is a clinically safe, highly accurate option to commercial nasopharyngeal swabs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-020-00391-6.
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spelling pubmed-77994012021-01-12 Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing Tay, Joshua K. Cross, Gail B. Sun, Louisa Chia, Alfred Chee, Jeremy Loh, Jerold Lim, Zhen Yu Ngiam, Nicholas Khang, Wen Pang Yeap, Stephanie Goh, Han Lee Siow, Chor Hiang Loh, Woei Shyang Loh, Kwok Seng Lee, Chun Kiat Yan, Benedict Chow, Vincent T. K. Wang, De Yun Boey, Freddy Wong, John E. L. Allen, David M. Infect Dis Ther Brief Report INTRODUCTION: The gold standard for COVID-19 diagnosis is currently a real-time reverse transcriptase polymerase chain reaction (RT-PCR) to detect SARS-CoV-2. This is most commonly performed on respiratory secretions obtained via a nasopharyngeal swab. Due to supply chain limitations and high demand worldwide because of the COVID-19 pandemic, access to commercial nasopharyngeal swabs has not been assured. 3D printing methods have been used to meet the shortfall. For longer-term considerations, 3D printing may not compare well with injection molding as a production method due to the challenging scalability and greater production costs of 3D printing. METHODS: To secure sufficient nasopharyngeal swab availability for our national healthcare system, we designed a novel injection molded nasopharyngeal swab (the IM2 swab). We performed a clinical diagnostic study comparing the IM2 swab to the Copan FLOQSwab. Forty patients with a known diagnosis of COVID-19 and 10 healthy controls were recruited. Paired nasopharyngeal swabs were obtained from the same nostril of each participant and tested for SARS-CoV-2 by RT-PCR. RESULTS: When compared to the Copan FLOQswab, results from the IM2 swab displayed excellent overall agreement and positive percent agreement of 96.0% and 94.9%, respectively. There was no significant difference in mean RT-PCR cycle threshold values for the ORF1ab (28.05 vs. 28.03, p = 0.97) and E-gene (29.72 vs. 29.37, p = 0.64) targets, respectively. We did not observe any significant adverse events and there was no significant difference in patient-reported pain. CONCLUSION: In summary, the IM2 nasopharyngeal swab is a clinically safe, highly accurate option to commercial nasopharyngeal swabs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-020-00391-6. Springer Healthcare 2021-01-11 2021-06 /pmc/articles/PMC7799401/ /pubmed/33432534 http://dx.doi.org/10.1007/s40121-020-00391-6 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Brief Report
Tay, Joshua K.
Cross, Gail B.
Sun, Louisa
Chia, Alfred
Chee, Jeremy
Loh, Jerold
Lim, Zhen Yu
Ngiam, Nicholas
Khang, Wen Pang
Yeap, Stephanie
Goh, Han Lee
Siow, Chor Hiang
Loh, Woei Shyang
Loh, Kwok Seng
Lee, Chun Kiat
Yan, Benedict
Chow, Vincent T. K.
Wang, De Yun
Boey, Freddy
Wong, John E. L.
Allen, David M.
Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing
title Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing
title_full Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing
title_fullStr Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing
title_full_unstemmed Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing
title_short Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing
title_sort clinical diagnostic study of a novel injection molded swab for sars-cov-2 testing
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7799401/
https://www.ncbi.nlm.nih.gov/pubmed/33432534
http://dx.doi.org/10.1007/s40121-020-00391-6
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