{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T20:15:26Z","timestamp":1775333726853,"version":"3.50.1"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2020,7,27]],"date-time":"2020-07-27T00:00:00Z","timestamp":1595808000000},"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":[[2020,11,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Little is known about the performance of the Roche novel severe acute respiratory syndrome coronavirus 2 antibody (anti-SARS-CoV-2) assay. We provide an extensive evaluation of this fully automated assay on Cobas e801\/e602 immunoassay analyzers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We assessed the linearity, precision, and throughput of the Roche anti-SARS-CoV-2 assay. Sensitivity was calculated from 349 SARS-CoV-2 polymerase chain reaction (PCR) positive samples; specificity was determined from 715 coronavirus disease 2019 (COVID-19)-naive samples. We examined cross-reactivity against other antibody positive samples [syphilis, rheumatoid factor (RF), antinuclear antibody (ANA), double-stranded DNA (ds-DNA), influenza, dengue, hepatitis B (HBV), hepatitis C (HCV)] and the anti-SARS-CoV-2 kinetics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The assay cut-off index (COI) was linear up to 90.8. The interassay precision was 2.9% for a negative control (COI\u2009=\u20090.1) and 5.1% for a positive control (COI\u2009=\u20093.0). Assay time is 18\u2009min and results are available 1\u2009min later; throughput for 300 samples was 76\u2009min. Only 1 case positive for HBsAg tested falsely positive; specificity was 99.9%. The assay has a sensitivity of 97.1% 14\u2009days after PCR positivity (POS) and 100% at \u226521\u2009days POS; 48.2% of cases had anti-SARS-CoV-2 within 6\u2009days POS. In 11 patients in whom serum was available prior to a positive antibody signal (COI \u22651.0) the interval between the last negative and first positive COI (time to \u201cseroconversion\u201d) on average is 3\u2009days (range 1\u20136\u2009days) and 4 more days (range 1\u20137) for the anti-SARS-CoV-2 to plateau.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The Roche anti-SARS-CoV-2 assay shows excellent performance with minimal cross-reactivity from other viral and confounding antibodies. Antibody development and seroconversion appears quite early.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jalm\/jfaa134","type":"journal-article","created":{"date-parts":[[2020,7,25]],"date-time":"2020-07-25T15:08:57Z","timestamp":1595689737000},"page":"1313-1323","source":"Crossref","is-referenced-by-count":25,"title":["Evaluation of an Electrochemiluminescent SARS-CoV-2 Antibody Assay"],"prefix":"10.1093","volume":"5","author":[{"given":"C S","family":"Lau","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine, Changi General Hospital, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S P","family":"Hoo","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Changi General Hospital, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S F","family":"Yew","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Changi General Hospital, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S K","family":"Ong","sequence":"additional","affiliation":[{"name":"Department of Pathology, Sengkang General Hospital, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L T","family":"Lum","sequence":"additional","affiliation":[{"name":"Department of Pathology, Sengkang General Hospital, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P Y","family":"Heng","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Khoo Teck Puat Hospital, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J G","family":"Tan","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Khoo Teck Puat Hospital, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M S","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Khoo Teck Puat Hospital, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T C","family":"Aw","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Changi General Hospital, Singapore"},{"name":"Department of Pathology, Sengkang General Hospital, Singapore"},{"name":"Department of Medicine, National University of Singapore, Singapore"},{"name":"Academic Pathology Program, Duke-NUS Medical School, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2020,7,27]]},"reference":[{"key":"2020110800224572100_jfaa134-B1","doi-asserted-by":"crossref","DOI":"10.1056\/NEJMcp2009249","article-title":"Mild or moderate Covid-19","author":"Gandhi","year":"2020","journal-title":"N Engl J Med"},{"key":"2020110800224572100_jfaa134-B2","doi-asserted-by":"crossref","DOI":"10.1056\/NEJMcp2009575","article-title":"Severe Covid-19","author":"Berlin","year":"2020","journal-title":"N Engl J 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