{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,12]],"date-time":"2025-12-12T13:39:35Z","timestamp":1765546775822,"version":"3.37.3"},"reference-count":13,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2021,8,12]],"date-time":"2021-08-12T00:00:00Z","timestamp":1628726400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A high\u2010throughput, fully automated antigen detection test for SARS\u2010CoV\u20102 is a viable alternative to reverse\u2010transcription polymerase chain reaction (RT\u2010qPCR) for mass screening during outbreaks. In this study, we compared RT\u2010qPCR for viral load and the VITROS\u00ae SARS\u2010CoV\u20102 Antigen Test with reference to the results of the LUMIPULSE\u00ae SARS\u2010CoV\u20102 Ag Test. Of 128 nasopharyngeal swab specimens taken from patients suspected of being infected with SARS\u2010CoV\u20102, 49 were positive and 79 were negative according to RT\u2010qPCR. Consistent dose\u2010dependent detection with VITROS\u00ae assay was successfully achieved when using nasopharyngeal swab specimens with Ct values of 32.0 or lesser, whereas the CLEIA\u2010based LUMIPULSE\u00ae assay was able to detect lower viral loads compared with the VITROS\u00ae assay. Our results show that the performance of the VITROS\u00ae assay was satisfactory for the diagnosis of contagious COVID\u201019 patients in the clinical setting.<\/jats:p><jats:p><jats:bold>Highlights<\/jats:bold> The performance of the VITROS\u00ae SARS\u2010CoV\u20102 Antigen Test was sufficient for the diagnosis of contagious COVID\u201019. This test showed high sensitivity and specificity in the detection of SARS\u2010CoV\u20102 in samples with a Ct value of 32 or less.<\/jats:p>","DOI":"10.1002\/jmv.27153","type":"journal-article","created":{"date-parts":[[2021,6,25]],"date-time":"2021-06-25T15:51:32Z","timestamp":1624636292000},"page":"6778-6781","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Evaluation of a chemiluminescent enzyme immunoassay\u2010based high\u2010throughput SARS\u2010CoV\u20102 antigen assay for the diagnosis of COVID\u201019: The VITROS\u00ae SARS\u2010CoV\u20102 Antigen Test"],"prefix":"10.1002","volume":"93","author":[{"given":"Nanako","family":"Matsuzaki","sequence":"first","affiliation":[{"name":"Department of Clinical Laboratory Saitama Medical University Hospital  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuta","family":"Orihara","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Saitama Medical University Hospital  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Kodana","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Saitama Medical University Hospital  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaro","family":"Kitagawa","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Saitama Medical University Hospital  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masaru","family":"Matsuoka","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Saitama Medical University Hospital  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rieko","family":"Kawamura","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Saitama Medical University Hospital  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinichi","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Saitama Medical University Hospital  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8416-7371","authenticated-orcid":false,"given":"Kazuo","family":"Imai","sequence":"additional","affiliation":[{"name":"Department of Infectious Disease and Infection Control Saitama Medical University  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norihito","family":"Tarumoto","sequence":"additional","affiliation":[{"name":"Department of Infectious Disease and Infection Control Saitama Medical University  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shigefumi","family":"Maesaki","sequence":"additional","affiliation":[{"name":"Department of Infectious Disease and Infection Control Saitama Medical University  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0912-4643","authenticated-orcid":false,"given":"Takuya","family":"Maeda","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Saitama Medical University Hospital  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,8,12]]},"reference":[{"key":"e_1_2_9_2_1","first-page":"1","article-title":"Evaluating the clinical utility and sensitivity of SARS\u2010CoV\u20102 antigen testing in relation to RT\u2010PCR Ct values","volume":"13","author":"Lanser L","year":"2020","journal-title":"Infection"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1101\/2020.12.21.20248640"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.26997"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines9030282"},{"key":"e_1_2_9_6_1","unstructured":"Centers for Disease Control and Prevention. 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