{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T14:11:16Z","timestamp":1760710276586,"version":"3.41.2"},"reference-count":23,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,6,5]],"date-time":"2020-06-05T00:00:00Z","timestamp":1591315200000},"content-version":"vor","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81521001","81870182"],"award-info":[{"award-number":["81521001","81870182"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical &amp; Translational Med"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The pandemic of novel coronavirus disease 2019 (COVID\u201019) seriously threatened the public health all over the world. A colloidal gold immunochromatography assay for IgM\/IgG antibodies against the receptor\u2010binding domain of severe acute respiratory syndrome coronavirus 2 (SARS\u2010CoV\u20102) S1 protein was established to assess its rapid diagnostic value. We first designed and manufactured all contents of the test cassette of SARS\u2010CoV\u20102 rapid test kit: the colloidal gold\u2010labeled mouse\u2010antihuman lgM\/lgG antibody, the recombinant SARS\u2010CoV\u20102 antigen, the nitrocellulose membrane control line, and specimen diluents. Furthermore, reverse transcription\u2010polymerase chain reaction (RT\u2010PCR) assay, colloidal gold immunochromatography assay, serological validation of cross reaction with other common viruses, and clinical validation were performed. The kit was finally evaluated by 75 serum\/plasma samples of SARS\u2010CoV\u20102 infection cases and 139 healthy samples as control, with the result of that the sensitivity, specificity, and accuracy for IgM were 90.67%, 97.84%, and 95.33%, whereas for IgG were 69.33%, 99.28%, and 88.79%, respectively; the combination of IgM and IgG could improve the value: 92.00%, 97.12%, and 95.33%, respectively. Therefore, the rapid detection kit has high sensitivity and specificity, especially for IgM&amp;IgG, showing a critical value in clinical application and epidemic control of COVID\u201019.<\/jats:p>","DOI":"10.1002\/ctm2.90","type":"journal-article","created":{"date-parts":[[2020,6,8]],"date-time":"2020-06-08T14:55:09Z","timestamp":1591628109000},"source":"Crossref","is-referenced-by-count":15,"title":["A new and rapid approach for detecting COVID\u201019 based on S1 protein fragments"],"prefix":"10.1002","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9644-6768","authenticated-orcid":false,"given":"Hua","family":"Li","sequence":"first","affiliation":[{"name":"Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Shanghai Xuhui District Central Hospital &amp; Zhongshan\u2010xuhui Hospital, Zhongshan Hospital Fudan University  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhe","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Medicine BestNovo (Beijing) Medical Technology Co., Ltd  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yue","family":"He","sequence":"additional","affiliation":[{"name":"Department of Cardiology Shanghai Xuhui District Central Hospital &amp; Zhongshan\u2010xuhui Hospital  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yingjie","family":"Qi","sequence":"additional","affiliation":[{"name":"Division of Life Sciences and Medicine The First Affiliated Hospital of USTC, University of Science and Technology of China  Hefei 230000 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jie","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine  Shanghai Xuhui District Central Hospital &amp; Zhongshan\u2010xuhui Hospital  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuanyuan","family":"Ma","sequence":"additional","affiliation":[{"name":"Shanghai Public Health Clinical Center Clinical Trial Institution  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fujia","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Medicine BestNovo (Beijing) Medical Technology Co., Ltd  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaisheng","family":"Lai","sequence":"additional","affiliation":[{"name":"Department of Medicine BestNovo (Beijing) Medical Technology Co., Ltd  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yong","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Medicine BestNovo (Beijing) Medical Technology Co., Ltd  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liu","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Medicine BestNovo (Beijing) Medical Technology Co., Ltd  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiangdong","family":"Wang","sequence":"additional","affiliation":[{"name":"Institute of Clinical Science, Zhongshan Hospital Fudan University  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junbo","family":"Ge","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Shanghai Xuhui District Central Hospital &amp; Zhongshan\u2010xuhui Hospital, Zhongshan Hospital Fudan University  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,6,5]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2001017"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30251-8"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.meegid.2020.104212"},{"key":"e_1_2_5_5_1","doi-asserted-by":"crossref","unstructured":"World Health Organization (WHO).Clinical Management of Severe Acute Respiratory Infection When Novel Coronavirus (nCoV) Infection is Suspected.Geneva Switzerland:WHO;2020.","DOI":"10.15557\/PiMR.2020.0003"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.25727"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/22221751.2020.1729071"},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1084\/jem.20200678"},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/jcmm.15275"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30788-1"},{"key":"e_1_2_5_11_1","first-page":"13","article-title":"Diagnostic performance of COVID\u201019 serology assays","volume":"42","author":"Zainol Rashid Z","year":"2020","journal-title":"Malays J Pathol"},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.imlet.2009.06.003"},{"key":"e_1_2_5_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa344"},{"key":"e_1_2_5_14_1","article-title":"Scientific research progress of COVID\u201019\/ SARS\u2010CoV\u20102 in the first five months","author":"Li H","year":"2020","journal-title":"J Cell Mol Med"},{"key":"e_1_2_5_15_1","article-title":"Longitudinal change of SARS\u2010Cov2 antibodies in patients with COVID\u201019","author":"Zhang G","year":"2020","journal-title":"J Infect Dis"},{"key":"e_1_2_5_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/22221751.2020.1762515"},{"key":"e_1_2_5_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(20)30196-1"},{"key":"e_1_2_5_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/22221751.2020.1756699"},{"key":"e_1_2_5_19_1","first-page":"1","volume-title":"Diagnosis and treatment Guideline for Novel Coronavirus Pneumonia","author":"National Health Commission of the PRC","year":"2020"},{"key":"e_1_2_5_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.25674"},{"key":"e_1_2_5_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpmc.100"},{"key":"e_1_2_5_22_1","first-page":"1348","article-title":"Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS\u2010Cov\u20102 IgM\/IgG","volume":"12","author":"Shen B","year":"2020","journal-title":"Am J Transl Res"},{"key":"e_1_2_5_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.2783"},{"key":"e_1_2_5_24_1","article-title":"Application of the technology of serum specific antibody in detecting 2019 novel coronavirus","volume":"11","author":"Ning Y","year":"2020","journal-title":"Med J PUMCH"}],"container-title":["Clinical and Translational Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fctm2.90","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ctm2.90","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ctm2.90","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ctm2.90","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,5]],"date-time":"2023-09-05T11:51:30Z","timestamp":1693914690000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ctm2.90"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,6]]},"references-count":23,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,6]]}},"alternative-id":["10.1002\/ctm2.90"],"URL":"https:\/\/doi.org\/10.1002\/ctm2.90","archive":["Portico"],"relation":{},"ISSN":["2001-1326","2001-1326"],"issn-type":[{"type":"print","value":"2001-1326"},{"type":"electronic","value":"2001-1326"}],"subject":[],"published":{"date-parts":[[2020,6]]},"article-number":"e90"}}