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Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System

The emergence of COVID-19 has caused unprecedented impacts on global public health and many other aspects. Meanwhile, many types of methods have been developed to detect the causative agent, SARS-CoV-2; this has greatly advanced the technologies in the diagnostic field. Here, we describe the develop...

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Autores principales: Zhu, Jin-Hui, Tai, Chia-Hsing, Ping, Chia-Fong, Chou, Pin-Hsing, Tsai, Yun-Long, Chung, Simon, Bradner, Laura, Pentella, Michael, Gauger, Phillip, Zhang, Jianqiang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10340693/
https://www.ncbi.nlm.nih.gov/pubmed/37443612
http://dx.doi.org/10.3390/diagnostics13132219
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author Zhu, Jin-Hui
Tai, Chia-Hsing
Ping, Chia-Fong
Chou, Pin-Hsing
Tsai, Yun-Long
Chung, Simon
Bradner, Laura
Pentella, Michael
Gauger, Phillip
Zhang, Jianqiang
author_facet Zhu, Jin-Hui
Tai, Chia-Hsing
Ping, Chia-Fong
Chou, Pin-Hsing
Tsai, Yun-Long
Chung, Simon
Bradner, Laura
Pentella, Michael
Gauger, Phillip
Zhang, Jianqiang
author_sort Zhu, Jin-Hui
collection PubMed
description The emergence of COVID-19 has caused unprecedented impacts on global public health and many other aspects. Meanwhile, many types of methods have been developed to detect the causative agent, SARS-CoV-2; this has greatly advanced the technologies in the diagnostic field. Here, we describe the development and validation of a sample-in-result-out POCKIT Central SARS-CoV-2 PCR system for detecting SARS-CoV-2 in comparison with a commercial reference real-time RT-PCR assay (TaqPath COVID-19 Combo Kit). Both assays were specific and did not cross-react with non-SARS-CoV-2 agents. Both assays were able to detect various SARS-CoV-2 strains including some variants. Based on testing serial dilutions of SARS-CoV-2 USA-WA1/2020 isolate, the limit of detection was 0.8 TCID(50)/mL (1.87 × 10(3) genomic copies/mL) for POCKIT Central SARS-CoV-2 PCR and 0.16 TCID(50)/mL (3.75 × 10(2) genomic copies/mL) for the reference PCR. Subsequently, 183 clinical samples were tested by both assays and the diagnostic sensitivity, specificity, and agreement of the POCKIT Central SARS-CoV-2 PCR were 91.7%, 100%, and 94.0%, respectively, when compared to the reference PCR. The compact sample-to-result POCKIT Central SARS-CoV-2 PCR system is a simplified and efficient point-of-care tool for SARS-CoV-2 detection. In addition, this platform can be readily adapted to detect other human and animal viruses.
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spelling pubmed-103406932023-07-14 Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System Zhu, Jin-Hui Tai, Chia-Hsing Ping, Chia-Fong Chou, Pin-Hsing Tsai, Yun-Long Chung, Simon Bradner, Laura Pentella, Michael Gauger, Phillip Zhang, Jianqiang Diagnostics (Basel) Article The emergence of COVID-19 has caused unprecedented impacts on global public health and many other aspects. Meanwhile, many types of methods have been developed to detect the causative agent, SARS-CoV-2; this has greatly advanced the technologies in the diagnostic field. Here, we describe the development and validation of a sample-in-result-out POCKIT Central SARS-CoV-2 PCR system for detecting SARS-CoV-2 in comparison with a commercial reference real-time RT-PCR assay (TaqPath COVID-19 Combo Kit). Both assays were specific and did not cross-react with non-SARS-CoV-2 agents. Both assays were able to detect various SARS-CoV-2 strains including some variants. Based on testing serial dilutions of SARS-CoV-2 USA-WA1/2020 isolate, the limit of detection was 0.8 TCID(50)/mL (1.87 × 10(3) genomic copies/mL) for POCKIT Central SARS-CoV-2 PCR and 0.16 TCID(50)/mL (3.75 × 10(2) genomic copies/mL) for the reference PCR. Subsequently, 183 clinical samples were tested by both assays and the diagnostic sensitivity, specificity, and agreement of the POCKIT Central SARS-CoV-2 PCR were 91.7%, 100%, and 94.0%, respectively, when compared to the reference PCR. The compact sample-to-result POCKIT Central SARS-CoV-2 PCR system is a simplified and efficient point-of-care tool for SARS-CoV-2 detection. In addition, this platform can be readily adapted to detect other human and animal viruses. MDPI 2023-06-29 /pmc/articles/PMC10340693/ /pubmed/37443612 http://dx.doi.org/10.3390/diagnostics13132219 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Zhu, Jin-Hui
Tai, Chia-Hsing
Ping, Chia-Fong
Chou, Pin-Hsing
Tsai, Yun-Long
Chung, Simon
Bradner, Laura
Pentella, Michael
Gauger, Phillip
Zhang, Jianqiang
Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System
title Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System
title_full Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System
title_fullStr Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System
title_full_unstemmed Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System
title_short Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System
title_sort evaluation of a sample-to-result pockit central sars-cov-2 pcr system
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10340693/
https://www.ncbi.nlm.nih.gov/pubmed/37443612
http://dx.doi.org/10.3390/diagnostics13132219
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