{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T06:10:51Z","timestamp":1790662251523,"version":"4.1.0"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2020,5,19]],"date-time":"2020-05-19T00:00:00Z","timestamp":1589846400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a novel beta-coronavirus that has recently emerged as the cause of the 2019 coronavirus pandemic (COVID-19). Polymerase chain reaction (PCR) based tests are optimal and recommended for the diagnosis of an acute SARS-CoV-2 infection. Serology tests for viral antibodies provide an important tool to diagnose previous exposure to the virus. Here we evaluate the analytical performance parameters of the Diazyme SARS-CoV-2 IgM\/IgG serology assays and describe the kinetics of IgM and IgG seroconversion observed in patients with PCR-confirmed COVID-19 who were admitted to our hospital.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We validated the performance of the Diazyme assay in 235 presumed SARS-CoV-2 negative subjects to determine specificity. Subsequently, we evaluated the SARS-CoV-2 IgM and IgG seroconversion of 54 PCR-confirmed COVID-19 patients and determined sensitivity of the assay at three different timeframes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Result<\/jats:title><jats:p>Sensitivity and specificity for detecting seropositivity at \u226515\u2009days following a positive SARS-CoV-2 PCR result, was 100.0% and 98.7% when assaying for the panel of IgM and IgG. The median time to seropositivity observed for a reactive IgM and IgG result from the date of a positive PCR was 5\u2009days (IQR: 2.75\u20139\u2009days) and 4\u2009days (IQR: 2.75\u20136.75\u2009days), respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our data demonstrate that the Diazyme IgM\/IgG assays are suited for the purpose of detecting SARS-CoV-2 IgG and IgM in patients with suspected SARS-CoV-2 infections. For the first time, we report longitudinal data showing the evolution of seroconversion for both IgG and IgM in a cohort of acutely ill patients in the United States. We also demonstrate a low false positive rate in patients who were presumed to be disease free.<\/jats:p><\/jats:sec>","DOI":"10.1093\/jalm\/jfaa079","type":"journal-article","created":{"date-parts":[[2020,5,12]],"date-time":"2020-05-12T19:09:03Z","timestamp":1589310543000},"page":"908-920","source":"Crossref","is-referenced-by-count":102,"title":["Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19"],"prefix":"10.1093","volume":"5","author":[{"given":"Raymond T","family":"Suhandynata","sequence":"first","affiliation":[{"name":"Department of Pathology UC, San Diego Health, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa A","family":"Hoffman","sequence":"additional","affiliation":[{"name":"Department of Pathology UC, San Diego Health, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J","family":"Kelner","sequence":"additional","affiliation":[{"name":"Department of Pathology UC, San Diego Health, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald W","family":"McLawhon","sequence":"additional","affiliation":[{"name":"Department of Pathology UC, San Diego Health, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon L","family":"Reed","sequence":"additional","affiliation":[{"name":"Department of Pathology UC, San Diego Health, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert L","family":"Fitzgerald","sequence":"additional","affiliation":[{"name":"Department of Pathology UC, San Diego Health, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,5,19]]},"reference":[{"key":"2021013020055136400_jfaa079-B1","first-page":"389","volume-title":"Human coronavirus 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