{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T21:01:50Z","timestamp":1785877310810,"version":"3.56.0"},"reference-count":47,"publisher":"Walter de Gruyter GmbH","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,5,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>We provide here a pooled analysis of accuracy of Fujirebio Lumipulse SARS-CoV-2 Antigen chemiluminescent immunoassay for diagnosing acute SARS-CoV-2 infections. An electronic search was conducted in Scopus and Medline with the keywords \u201cLumipulse\u201d AND \u201cantigen\u201d AND \u201cSARS-CoV-2\u201d or \u201cCOVID-19\u201d, up to January 21, 2022, for identifying clinical investigations (minimum sample size\u00a0\u2265100) where diagnostic accuracy of Lumipulse G SARS-CoV-2 Ag was tested against reference molecular techniques. All studies which allowed to construct a 2\u00a0\u00d7\u00a02 table were included in a pooled analysis. A final number of 21 studies, totalling 17,648 nasopharyngeal and 8538 saliva specimens, were finally included. The pooled diagnostic sensitivity and specificity in nasopharyngeal swabs were 0.80 (95%CI, 0.78\u20130.81) and 0.98 (95%CI, 0.97\u20130.98), respectively, whilst the area under the curve and agreement were 0.980 (95%CI, 0.973\u20130.986) and 94.9%, respectively. In the twelve studies which used the fixed 1.34\u00a0pg\/mL currently recommended manufacturer\u2019s threshold, the diagnostic accuracy remained unvaried. In saliva samples, the pooled diagnostic sensitivity and specificity were 0.75 (95%CI, 0.71\u20130.75) and 1.00 (95%CI, 0.99\u20131.00), respectively, whilst the area under the curve and were 0.976 (95%CI, 0.969\u20130.984) and 98.4%, respectively. In the five studies which used the fixed 0.67\u00a0pg\/mL currently recommended manufacturer\u2019s threshold, the diagnostic accuracy remained unvaried. In conclusion, Lumipulse G SARS-CoV-2 Ag assay demonstrates good diagnostic sensitivity and specificity, thus representing a valuable complementary and integrative option to molecular testing for SARS-CoV-2 in the current pandemic.<\/jats:p>","DOI":"10.1515\/dx-2022-0021","type":"journal-article","created":{"date-parts":[[2022,3,15]],"date-time":"2022-03-15T11:27:18Z","timestamp":1647343638000},"page":"149-156","source":"Crossref","is-referenced-by-count":15,"title":["Fujirebio Lumipulse SARS-CoV-2 antigen immunoassay: pooled analysis of diagnostic accuracy"],"prefix":"10.1515","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9523-9054","authenticated-orcid":false,"given":"Giuseppe","family":"Lippi","sequence":"first","affiliation":[{"name":"IFCC Task Force on COVID-19 , Milan , Italy"},{"name":"Section of Clinical Biochemistry, University of Verona , Verona , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brandon M.","family":"Henry","sequence":"additional","affiliation":[{"name":"IFCC Task Force on COVID-19 , Milan , Italy"},{"name":"Clinical Laboratory, Division of Nephorlogy and Hypertension, Cincinnati Children\u2019s Hospital Medical Center , Cincinnati , OH , USA"},{"name":"Disease Intervention & Prevention and Population Health Programs, Texas Biomedical Research Institute , San Antonio , TX , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khosrow","family":"Adeli","sequence":"additional","affiliation":[{"name":"IFCC Task Force on COVID-19 , Milan , Italy"},{"name":"Laboratory Medicine and Pathobiology, University of Toronto , Toronto , ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0270-1711","authenticated-orcid":false,"given":"Mario","family":"Plebani","sequence":"additional","affiliation":[{"name":"Department of Medicine-DIMED, University of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2022,3,15]]},"reference":[{"key":"2025121206441109459_j_dx-2022-0021_ref_001","doi-asserted-by":"crossref","unstructured":"Sampath, S, Khedr, A, Qamar, S, Tekin, A, Singh, R, Green, R, et al.. 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