Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab

The STANDARD™ M10 severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) assay (M10 assay) (SD Biosensor Inc., Suwon, Korea) is a rapid, fully-automated, cartridge-type molecular diagnostic assay that detects SARS-CoV-2 RNA using primers and probes for each target gene (ORF1ab gene, E gene). T...

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Autores principales: Ham, Sin Young, Jeong, Hyeonju, Jung, Jongtak, Kim, Eu Suk, Park, Kyoung Un, Kim, Hong Bin, Park, Jeong Su, Song, Kyoung-Ho
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Society of Infectious Diseases; Korean Society for Antimicrobial Therapy; The Korean Society for AIDS 2022
Materias:
Brief Communication
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9259922/
https://www.ncbi.nlm.nih.gov/pubmed/35706076
http://dx.doi.org/10.3947/ic.2022.0047
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author Ham, Sin Young
Jeong, Hyeonju
Jung, Jongtak
Kim, Eu Suk
Park, Kyoung Un
Kim, Hong Bin
Park, Jeong Su
Song, Kyoung-Ho
author_facet Ham, Sin Young
Jeong, Hyeonju
Jung, Jongtak
Kim, Eu Suk
Park, Kyoung Un
Kim, Hong Bin
Park, Jeong Su
Song, Kyoung-Ho
author_sort Ham, Sin Young
collection PubMed
description The STANDARD™ M10 severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) assay (M10 assay) (SD Biosensor Inc., Suwon, Korea) is a rapid, fully-automated, cartridge-type molecular diagnostic assay that detects SARS-CoV-2 RNA using primers and probes for each target gene (ORF1ab gene, E gene). This study evaluated its performance by assessing its concordance with the approved SARS-CoV-2 real-time PCR assay. Tests were performed on 80 nasopharyngeal samples. The sensitivity and specificity of the M10 assay were 100%. The M10 assay effectively diagnosed SARS-CoV-2 infection, and it was comparable to the approved SARS-CoV-2 real-time PCR assay. It is a viable point-of-care test due to its short turnaround time.
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spelling pubmed-92599222022-07-18 Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab Ham, Sin Young Jeong, Hyeonju Jung, Jongtak Kim, Eu Suk Park, Kyoung Un Kim, Hong Bin Park, Jeong Su Song, Kyoung-Ho Infect Chemother Brief Communication The STANDARD™ M10 severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) assay (M10 assay) (SD Biosensor Inc., Suwon, Korea) is a rapid, fully-automated, cartridge-type molecular diagnostic assay that detects SARS-CoV-2 RNA using primers and probes for each target gene (ORF1ab gene, E gene). This study evaluated its performance by assessing its concordance with the approved SARS-CoV-2 real-time PCR assay. Tests were performed on 80 nasopharyngeal samples. The sensitivity and specificity of the M10 assay were 100%. The M10 assay effectively diagnosed SARS-CoV-2 infection, and it was comparable to the approved SARS-CoV-2 real-time PCR assay. It is a viable point-of-care test due to its short turnaround time. The Korean Society of Infectious Diseases; Korean Society for Antimicrobial Therapy; The Korean Society for AIDS 2022-06 2022-05-13 /pmc/articles/PMC9259922/ /pubmed/35706076 http://dx.doi.org/10.3947/ic.2022.0047 Text en Copyright © 2022 by The Korean Society of Infectious Diseases, Korean Society for Antimicrobial Therapy, and The Korean Society for AIDS https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Brief Communication
Ham, Sin Young
Jeong, Hyeonju
Jung, Jongtak
Kim, Eu Suk
Park, Kyoung Un
Kim, Hong Bin
Park, Jeong Su
Song, Kyoung-Ho
Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab
title Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab
title_full Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab
title_fullStr Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab
title_full_unstemmed Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab
title_short Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab
title_sort performance of standard™ m10 sars-cov-2 assay for the diagnosis of covid-19 from a nasopharyngeal swab
topic Brief Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9259922/
https://www.ncbi.nlm.nih.gov/pubmed/35706076
http://dx.doi.org/10.3947/ic.2022.0047
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