{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T17:52:24Z","timestamp":1782841944212,"version":"3.54.5"},"reference-count":16,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Public Health Surveill"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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 \u201cready-to-test\u201d scenarios in which samples were collected on site and tested immediately, and samples from 503 cases were obtained from a \u201cfreeze-thaw test\u201d scenario in which samples were collected, frozen, and thawed for testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Pluslife SARS-CoV-2 rapid testing of samples from the \u201cready-to-test\u201d 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 \u201cfreeze-thaw test\u201d 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 \u201cready-to-test\u201d 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/48107","type":"journal-article","created":{"date-parts":[[2023,10,17]],"date-time":"2023-10-17T00:07:37Z","timestamp":1697501257000},"page":"e48107","source":"Crossref","is-referenced-by-count":2,"title":["Trial of the Pluslife SARS-CoV-2 Nucleic Acid Rapid Test Kit: Prospective Cohort Study"],"prefix":"10.2196","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-7783-9950","authenticated-orcid":false,"given":"Dandan","family":"Zhu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3587-2370","authenticated-orcid":false,"given":"Jing","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5802-1694","authenticated-orcid":false,"given":"Bei","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3100-4752","authenticated-orcid":false,"given":"Donglin","family":"Cao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8717-1651","authenticated-orcid":false,"given":"Dingqiang","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6581-7535","authenticated-orcid":false,"given":"Xinqiang","family":"Song","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5070-0887","authenticated-orcid":false,"given":"Jialing","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-5626-3999","authenticated-orcid":false,"given":"Hao","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-4352-4182","authenticated-orcid":false,"given":"Aiqun","family":"Cen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8765-9339","authenticated-orcid":false,"given":"Tieying","family":"Hou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2023,11,14]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-020-2012-7"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2020.25.3.2000045"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.3864"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1080\/22221751.2020.1756698"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.3389\/fcimb.2020.00331"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2020.04.001"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1038\/s41587-020-0513-4"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1080\/07388551.2022.2030295"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2020.1757437"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104433"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00512-20"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104412"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMcp2009575"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00977-20"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1038\/d41587-020-00010-2"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104455"}],"container-title":["JMIR 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