{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T08:36:03Z","timestamp":1782462963181,"version":"3.54.5"},"reference-count":34,"publisher":"Walter de Gruyter GmbH","issue":"3","license":[{"start":{"date-parts":[[2022,12,9]],"date-time":"2022-12-09T00:00:00Z","timestamp":1670544000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,2,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_cclm-2022-0661_abs_001\">\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Various comorbidities associated with COVID-19 add up in severity of the disease and obviously prolonged the time for viral clearance. This study investigated a novel ultrasensitive MAGLUMI<jats:sup>\u00ae<\/jats:sup> SARS-CoV-2 Ag chemiluminescent immunoassay assay (MAG-CLIA) for diagnosis and monitoring the infectivity of COVID-19 patients with comorbid conditions during the pandemic of 2022 Shanghai.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2022-0661_abs_002\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Analytical performances of the MAG-CLIA were evaluated, including precision, limit of quantitation, linearity and specificity. Nasopharyngeal specimens from 232 hospitalized patients who were SARS-CoV-2 RT-qPCR positive and from 477 healthy donors were included. The longitudinal studies were performed by monitoring antigen concentrations alongside with RT-qPCR results in 14 COVID-19 comorbid participants for up to 22\u00a0days. The critical antigen concentration in determining virus infectivity was evaluated at the reference cycle threshold (Ct) of 35.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2022-0661_abs_003\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>COVID-19 patients were well-identified using an optimal threshold of 0.64\u00a0ng\/L antigen concentration, with sensitivity and specificity of 95.7% (95% CI: 92.2\u201397.9%) and 98.3% (95% CI: 96.7\u201399.3%), respectively, while the Wondfo LFT exhibited those of 34.9% (95% CI: 28.8\u201341.4%) and 100% (95% CI: 99.23\u2013100%), respectively. The sensitivity of MAG-CLIA remained 91.46% (95% CI: 83.14\u201395.8%) for the samples with Ct values between 35 and 40. Close dynamic consistence was observed between MAG-CLIA and viral load time series in the longitudinal studies. The critical value of 8.82\u00a0ng\/L antigen showed adequate sensitivity and specificity in evaluating the infectivity of hospitalized convalescent patients with comorbidities.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2022-0661_abs_004\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The MAG-CLIA SARS-CoV-2 Ag detection is an effective and alternative approach for rapid diagnosis and enables us to evaluate the infectivity of hospitalized convalescent patients with comorbidities.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/cclm-2022-0661","type":"journal-article","created":{"date-parts":[[2022,12,8]],"date-time":"2022-12-08T17:50:36Z","timestamp":1670521836000},"page":"510-520","source":"Crossref","is-referenced-by-count":6,"title":["Application of ultrasensitive assay for SARS-CoV-2 antigen in nasopharynx in the management of COVID-19 patients with comorbidities during the peak of 2022 Shanghai epidemics in a tertiary hospital"],"prefix":"10.1515","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0565-2484","authenticated-orcid":false,"given":"Di","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine , Huashan Hospital, Fudan University , Shanghai , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hailong","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Huashan Hospital, Fudan University , Shanghai , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaju","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Huashan Hospital, Fudan University , Shanghai , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiazhen","family":"Shen","sequence":"additional","affiliation":[{"name":"Research & Development Department , Shenzhen New Industries Biomedical Engineering Co., Ltd. , Shenzhen , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangjie","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Huashan Hospital, Fudan University , Shanghai , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin","family":"Xiang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Huashan Hospital, Fudan University , Shanghai , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huanhuan","family":"Qin","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Huashan Hospital, Fudan University , Shanghai , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming","family":"Guan","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Huashan Hospital, Fudan University , Shanghai , P.R. China"},{"name":"Shanghai Huashen Institute of Microbes and Infections , Shanghai , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2022,12,9]]},"reference":[{"key":"2023013019295634425_j_cclm-2022-0661_ref_001","doi-asserted-by":"crossref","unstructured":"Zhang, X, Zhang, W, Chen, S. Shanghai\u2019s life-saving efforts against the current omicron wave of the COVID-19 pandemic. Lancet 2022;399:2011\u20132. https:\/\/doi.org\/10.1016\/s0140-6736(22)00838-8.","DOI":"10.1016\/S0140-6736(22)00838-8"},{"key":"2023013019295634425_j_cclm-2022-0661_ref_002","doi-asserted-by":"crossref","unstructured":"Loconsole, D, Centrone, F, Sallustio, A, Accogli, M, Casulli, D, Sacco, D, et al.. Characteristics of the first 284 patients infected with the SARS-CoV-2 omicron BA.2 subvariant at a single center in the Apulia region of Italy, January\u2013March 2022. 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