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Trial of the Pluslife SARS-CoV-2 Nucleic Acid Rapid Test Kit: Prospective Cohort Study

BACKGROUND: In response to the SARS-CoV-2 epidemic, a convenient, rapid, and sensitive diagnostic method for detecting COVID-19 is crucial for patient control and timely treatment. OBJECTIVE: This study aimed to validate the detection of SARS-CoV-2 with the Pluslife SARS-CoV-2 rapid test kit develop...

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Autores principales: Zhu, Dandan, Huang, Jing, Hu, Bei, Cao, Donglin, Chen, Dingqiang, Song, Xinqiang, Chen, Jialing, Zhou, Hao, Cen, Aiqun, Hou, Tieying
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10650960/
https://www.ncbi.nlm.nih.gov/pubmed/37962934
http://dx.doi.org/10.2196/48107
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author Zhu, Dandan
Huang, Jing
Hu, Bei
Cao, Donglin
Chen, Dingqiang
Song, Xinqiang
Chen, Jialing
Zhou, Hao
Cen, Aiqun
Hou, Tieying
author_facet Zhu, Dandan
Huang, Jing
Hu, Bei
Cao, Donglin
Chen, Dingqiang
Song, Xinqiang
Chen, Jialing
Zhou, Hao
Cen, Aiqun
Hou, Tieying
author_sort Zhu, Dandan
collection PubMed
description BACKGROUND: In response to the SARS-CoV-2 epidemic, a convenient, rapid, and sensitive diagnostic method for detecting COVID-19 is crucial for patient control and timely treatment. OBJECTIVE: This study aimed to validate the detection of SARS-CoV-2 with the Pluslife SARS-CoV-2 rapid test kit developed based on a novel thermostatic amplification technique called RNase hybridization-assisted amplification. METHODS: From November 25 to December 8, 2022, patients with suspected or confirmed COVID-19, close contacts, and health care workers at high risk of exposure were recruited from 3 hospitals and 1 university. Respiratory specimens were collected for testing with the Pluslife SARS-CoV-2 rapid test kit and compared with reverse transcription-quantitative polymerase chain reaction (RT-qPCR) and a commercial antigen assay kit. Samples from 1447 cases were obtained from 3 “ready-to-test” scenarios in which samples were collected on site and tested immediately, and samples from 503 cases were obtained from a “freeze-thaw test” scenario in which samples were collected, frozen, and thawed for testing. RESULTS: Pluslife SARS-CoV-2 rapid testing of samples from the “ready-to-test” scenario was found to be accurate (overall sensitivity and specificity of 98.3% and 99.3%, respectively) and diagnostically useful (positive and negative likelihood ratios of 145.45 and 0.02, respectively). Pluslife SARS-CoV-2 rapid testing of samples from the “freeze-thaw test” scenario was also found to be accurate (overall sensitivity and specificity of 71.2% and 98.6%, respectively) and diagnostically useful (positive and negative likelihood ratios of 51.01 and 0.67, respectively). Our findings demonstrated that the time efficiency and accuracy of the results in a “ready-to-test” scenario were better. The time required from sample preparation to the seeing the result of the Pluslife SARS-CoV-2 rapid test was 10 to 38 minutes, which was substantially shorter than that of RT-qPCR (at least 90 minutes). In addition, the diagnostic efficacy of the Pluslife SARS-CoV-2 rapid test was better than that of a commercial antigen assay kit. CONCLUSIONS: The developed RNase hybridization-assisted amplification assay provided rapid, sensitive, and convenient detection of SARS-CoV-2 infection and may be useful for enhanced detection of COVID-19 in homes, high-risk industries, and hospitals.
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spelling pubmed-106509602023-11-14 Trial of the Pluslife SARS-CoV-2 Nucleic Acid Rapid Test Kit: Prospective Cohort Study Zhu, Dandan Huang, Jing Hu, Bei Cao, Donglin Chen, Dingqiang Song, Xinqiang Chen, Jialing Zhou, Hao Cen, Aiqun Hou, Tieying JMIR Public Health Surveill Original Paper BACKGROUND: In response to the SARS-CoV-2 epidemic, a convenient, rapid, and sensitive diagnostic method for detecting COVID-19 is crucial for patient control and timely treatment. OBJECTIVE: This study aimed to validate the detection of SARS-CoV-2 with the Pluslife SARS-CoV-2 rapid test kit developed based on a novel thermostatic amplification technique called RNase hybridization-assisted amplification. METHODS: From November 25 to December 8, 2022, patients with suspected or confirmed COVID-19, close contacts, and health care workers at high risk of exposure were recruited from 3 hospitals and 1 university. Respiratory specimens were collected for testing with the Pluslife SARS-CoV-2 rapid test kit and compared with reverse transcription-quantitative polymerase chain reaction (RT-qPCR) and a commercial antigen assay kit. Samples from 1447 cases were obtained from 3 “ready-to-test” scenarios in which samples were collected on site and tested immediately, and samples from 503 cases were obtained from a “freeze-thaw test” scenario in which samples were collected, frozen, and thawed for testing. RESULTS: Pluslife SARS-CoV-2 rapid testing of samples from the “ready-to-test” scenario was found to be accurate (overall sensitivity and specificity of 98.3% and 99.3%, respectively) and diagnostically useful (positive and negative likelihood ratios of 145.45 and 0.02, respectively). Pluslife SARS-CoV-2 rapid testing of samples from the “freeze-thaw test” scenario was also found to be accurate (overall sensitivity and specificity of 71.2% and 98.6%, respectively) and diagnostically useful (positive and negative likelihood ratios of 51.01 and 0.67, respectively). Our findings demonstrated that the time efficiency and accuracy of the results in a “ready-to-test” scenario were better. The time required from sample preparation to the seeing the result of the Pluslife SARS-CoV-2 rapid test was 10 to 38 minutes, which was substantially shorter than that of RT-qPCR (at least 90 minutes). In addition, the diagnostic efficacy of the Pluslife SARS-CoV-2 rapid test was better than that of a commercial antigen assay kit. CONCLUSIONS: The developed RNase hybridization-assisted amplification assay provided rapid, sensitive, and convenient detection of SARS-CoV-2 infection and may be useful for enhanced detection of COVID-19 in homes, high-risk industries, and hospitals. JMIR Publications 2023-11-14 /pmc/articles/PMC10650960/ /pubmed/37962934 http://dx.doi.org/10.2196/48107 Text en ©Dandan Zhu, Jing Huang, Bei Hu, Donglin Cao, Dingqiang Chen, Xinqiang Song, Jialing Chen, Hao Zhou, Aiqun Cen, Tieying Hou. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 14.11.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Public Health and Surveillance, is properly cited. The complete bibliographic information, a link to the original publication on https://publichealth.jmir.org, as well as this copyright and license information must be included.
spellingShingle Original Paper
Zhu, Dandan
Huang, Jing
Hu, Bei
Cao, Donglin
Chen, Dingqiang
Song, Xinqiang
Chen, Jialing
Zhou, Hao
Cen, Aiqun
Hou, Tieying
Trial of the Pluslife SARS-CoV-2 Nucleic Acid Rapid Test Kit: Prospective Cohort Study
title Trial of the Pluslife SARS-CoV-2 Nucleic Acid Rapid Test Kit: Prospective Cohort Study
title_full Trial of the Pluslife SARS-CoV-2 Nucleic Acid Rapid Test Kit: Prospective Cohort Study
title_fullStr Trial of the Pluslife SARS-CoV-2 Nucleic Acid Rapid Test Kit: Prospective Cohort Study
title_full_unstemmed Trial of the Pluslife SARS-CoV-2 Nucleic Acid Rapid Test Kit: Prospective Cohort Study
title_short Trial of the Pluslife SARS-CoV-2 Nucleic Acid Rapid Test Kit: Prospective Cohort Study
title_sort trial of the pluslife sars-cov-2 nucleic acid rapid test kit: prospective cohort study
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10650960/
https://www.ncbi.nlm.nih.gov/pubmed/37962934
http://dx.doi.org/10.2196/48107
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