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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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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. |
format | Online Article Text |
id | pubmed-10340693 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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