{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,25]],"date-time":"2025-10-25T12:39:26Z","timestamp":1761395966005,"version":"3.41.2"},"reference-count":23,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,2,19]],"date-time":"2021-02-19T00:00:00Z","timestamp":1613692800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS\u2010CoV\u20102) has generated a pandemic with alarming rates of fatality worldwide. This situation has had a major impact on clinical laboratories that have attempted to answer the urgent need for diagnostic tools, since the identification of coronavirus disease 2019 (COVID\u201019). Development of a reliable serological diagnostic immunoassay, with high levels of sensitivity and specificity to detect SARS\u2010CoV\u20102 antibodies with improved differential diagnosis from other circulating viruses, is mandatory.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>An enzyme\u2010linked immunosorbent assay (ELISA) using whole inactivated virus cultured <jats:italic>in vitro<\/jats:italic>, was developed to detect viral antigens. WB and ELISA investigations were carried out with sera of convalescent patients and negative sera samples. Both analyses were concurrently performed with recombinant MABs to verify the findings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Preliminary data from 10 sera (5 patients with COVID\u201019, and 5 healthy controls) using this immunoassay are very promising, successfully identifying all of the confirmed SARS\u2010CoV\u20102\u2010positive individuals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This ELISA appears to be a specific and reliable method for detecting COVID\u201019 antibodies (IgG, IgM, and IgA), and a useful tool for identifying individuals which have developed immunity to the virus.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.23735","type":"journal-article","created":{"date-parts":[[2021,2,21]],"date-time":"2021-02-21T02:34:09Z","timestamp":1613874849000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Large scale production and characterization of SARS\u2010CoV\u20102 whole antigen for serological test development"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3424-7725","authenticated-orcid":false,"given":"Helena","family":"Cerutti","sequence":"first","affiliation":[{"name":"R&amp;D Site: Via Fiorentina 1\u2010 c\/o Toscana Life Sciences Siena Italy"},{"name":"Diesse Diagnostica Senese SpA Siena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veronica","family":"Ricci","sequence":"additional","affiliation":[{"name":"Diesse Diagnostica Senese SpA Siena Italy"},{"name":"Production Site: Via delle Rose Monteriggioni Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giulia","family":"Tesi","sequence":"additional","affiliation":[{"name":"R&amp;D Site: Via Fiorentina 1\u2010 c\/o Toscana Life Sciences Siena Italy"},{"name":"Diesse Diagnostica Senese SpA Siena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Soldatini","sequence":"additional","affiliation":[{"name":"R&amp;D Site: Via Fiorentina 1\u2010 c\/o Toscana Life Sciences Siena Italy"},{"name":"Diesse Diagnostica Senese SpA Siena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marinunzia","family":"Castria","sequence":"additional","affiliation":[{"name":"R&amp;D Site: Via Fiorentina 1\u2010 c\/o Toscana Life Sciences Siena Italy"},{"name":"Diesse Diagnostica Senese SpA Siena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco Natale","family":"Vaccaro","sequence":"additional","affiliation":[{"name":"Diesse Diagnostica Senese SpA Siena Italy"},{"name":"Production Site: Via delle Rose Monteriggioni Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefania","family":"Tornesi","sequence":"additional","affiliation":[{"name":"Diesse Diagnostica Senese SpA Siena Italy"},{"name":"Production Site: Via delle Rose Monteriggioni Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simona","family":"Toppi","sequence":"additional","affiliation":[{"name":"Diesse Diagnostica Senese SpA Siena Italy"},{"name":"Production Site: Via delle Rose Monteriggioni Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvana","family":"Verdiani","sequence":"additional","affiliation":[{"name":"Diesse Diagnostica Senese SpA Siena Italy"},{"name":"Production Site: Via delle Rose Monteriggioni Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alessandra","family":"Brogi","sequence":"additional","affiliation":[{"name":"R&amp;D Site: Via Fiorentina 1\u2010 c\/o Toscana Life Sciences Siena Italy"},{"name":"Diesse Diagnostica Senese SpA Siena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,2,19]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"World Health Organization.Laboratory testing of human suspected cases of novel coronavirus (nCoV) infection[published online ahead of print January 21 2020].https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/330374\/WHO\u20102019\u2010nCoV\u2010laboratory\u20102020.1\u2010eng.pdf. 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