Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies

BACKGROUND: Several qPCR kits are available for SARS-CoV-2 diagnosis, mostly lacking of evaluation due to covid19 emergency. OBJECTIVE: We evaluated nCoV-QS (MiCo BioMed) kit using CDC kit as gold standard. RESULTS: We found limitations for nCoV-QS: 1) lower sensitivity 2) lack of RNA quality contro...

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Autores principales: Freire-Paspuel, Byron, Vega-Mariño, Patricio, Velez, Alberto, Castillo, Paulina, Cruz, Marilyn, Garcia-Bereguiain, Miguel Angel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier B.V. 2020
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7243755/
https://www.ncbi.nlm.nih.gov/pubmed/32485473
http://dx.doi.org/10.1016/j.jcv.2020.104454
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author Freire-Paspuel, Byron
Vega-Mariño, Patricio
Velez, Alberto
Castillo, Paulina
Cruz, Marilyn
Garcia-Bereguiain, Miguel Angel
author_facet Freire-Paspuel, Byron
Vega-Mariño, Patricio
Velez, Alberto
Castillo, Paulina
Cruz, Marilyn
Garcia-Bereguiain, Miguel Angel
author_sort Freire-Paspuel, Byron
collection PubMed
description BACKGROUND: Several qPCR kits are available for SARS-CoV-2 diagnosis, mostly lacking of evaluation due to covid19 emergency. OBJECTIVE: We evaluated nCoV-QS (MiCo BioMed) kit using CDC kit as gold standard. RESULTS: We found limitations for nCoV-QS: 1) lower sensitivity 2) lack of RNA quality control probe. CONCLUSIONS: Validation studies should be implemented for any SARS-CoV-2 RT-qPCR commercial kit to prevent unreliable diagnosis.
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spelling pubmed-72437552020-05-22 Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies Freire-Paspuel, Byron Vega-Mariño, Patricio Velez, Alberto Castillo, Paulina Cruz, Marilyn Garcia-Bereguiain, Miguel Angel J Clin Virol Article BACKGROUND: Several qPCR kits are available for SARS-CoV-2 diagnosis, mostly lacking of evaluation due to covid19 emergency. OBJECTIVE: We evaluated nCoV-QS (MiCo BioMed) kit using CDC kit as gold standard. RESULTS: We found limitations for nCoV-QS: 1) lower sensitivity 2) lack of RNA quality control probe. CONCLUSIONS: Validation studies should be implemented for any SARS-CoV-2 RT-qPCR commercial kit to prevent unreliable diagnosis. Elsevier B.V. 2020-07 2020-05-22 /pmc/articles/PMC7243755/ /pubmed/32485473 http://dx.doi.org/10.1016/j.jcv.2020.104454 Text en © 2020 Elsevier B.V. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Freire-Paspuel, Byron
Vega-Mariño, Patricio
Velez, Alberto
Castillo, Paulina
Cruz, Marilyn
Garcia-Bereguiain, Miguel Angel
Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies
title Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies
title_full Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies
title_fullStr Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies
title_full_unstemmed Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies
title_short Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies
title_sort evaluation of ncov-qs (mico biomed) for rt-qpcr detection of sars-cov-2 from nasopharyngeal samples using cdc fda eua qpcr kit as a gold standard: an example of the need of validation studies
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7243755/
https://www.ncbi.nlm.nih.gov/pubmed/32485473
http://dx.doi.org/10.1016/j.jcv.2020.104454
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