{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T11:43:02Z","timestamp":1768822982227,"version":"3.49.0"},"reference-count":20,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2021,11,6]],"date-time":"2021-11-06T00:00:00Z","timestamp":1636156800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Severe acute respiratory syndrome coronavirus 2 (SARS\u2010CoV\u20102) is a highly infectious and concealed virus that causes pneumonia, severe acute respiratory syndrome, and even death. Although the epidemic has been controlled since the development of vaccines and quarantine measures, many people are still infected, particularly in third\u2010world countries. Several methods have been developed for detection of SARS\u2010CoV\u20102, but owing to its price and efficiency, the immune strip could be a better method for the third\u2010world countries.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this study, two antibodies were linked to latex microspheres, using 1\u2010(3\u2010dimethylaminopropyl)\u20103\u2010ethylcarbodiimide hydrochloride and N\u2010hydroxysuccinimide, as the bridge to decrease the cost further and improve the detection performance. The specificity of the lateral flow immunoassay strip (LFIA) was tested by several common viruses and respiratory bacterial infections. Besides, the reproducibility and stability of the LFIAs were tested on the same batch of test strips. Under optimal conditions, the sensitivity of LFIA was determined by testing different dilutions of the positive specimens.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The proposed LFIAs were highly specific, and the limit of detection was as low as 25 ng\/mL for SARS\u2010CoV\u20102 antigens. The clinical applicability was evaluated with 659 samples (230 positive and 429 negative samples) by using both LFIA and rRT\u2010PCR. Youden\u2019s index (J) was used to assess the performance of these diagnostic tests. The sensitivity and specificity were 98.22% and 97.93%, respectively, and J is 0.9615. The sensitivity and specificity were 98.22% and 97.93%, respectively, and J is 0.9615. In addition, the consistency of our proposed LFIA was analyzed using Cohen's kappa coefficient (\u03ba = 0.9620).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We found disease stage, age, gender, and clinical manifestations have only a slight influence on the diagnosis. Therefore, the lateral flow immunoassay SARS\u2010CoV\u20102 antigen test strip is suitable for point\u2010of\u2010care detection and provides a great application for SARS\u2010CoV\u20102 epidemic control in the third\u2010world countries.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24091","type":"journal-article","created":{"date-parts":[[2021,11,6]],"date-time":"2021-11-06T07:03:20Z","timestamp":1636182200000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["A rapid lateral flow immunoassay strip for detection of SARS\u2010CoV\u20102 antigen using latex microspheres"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1462-276X","authenticated-orcid":false,"given":"Lin","family":"Shen","sequence":"first","affiliation":[{"name":"School of Life and Environmental Sciences Guilin University of Electronic Technology Guilin 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