{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T13:37:29Z","timestamp":1785245849293,"version":"3.55.0"},"reference-count":12,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2023,8,7]],"date-time":"2023-08-07T00:00:00Z","timestamp":1691366400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Quidel Diagnostics"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,12,1]]},"abstract":"Abstract<\/jats:title>\n \n Objectives<\/jats:title>\n Recently modified 2-tier testing (MTTT) algorithms using 2 enzyme immunoassays (EIAs) as opposed to an EIA followed by immunoblot have been approved by the US Food and Drug Administration (FDA) for the screening and confirmation of Lyme disease. The Quidel Sofia Lyme fluorescent immunoassay is a rapid lateral-flow method that can be performed in real time, permitting on-demand testing. We evaluated the performance of the Sofia assay as a first-tier test in an MTTT algorithm.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We compared the Sofia Lyme test with the Zeus ELISA Borrelia VlsE1\/pepC10 lgG\/IgM test, followed by the Zeus monovalent IgM\/IgG EIA as the confirmatory test.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n When used as a first-tier test compared with a standard Zeus MTTT assay, the positive percentage agreement was 91.4%% (95% CI, 77.6%-97.0%). The negative percentage agreement was 100% (95% CI, 94.0%-100%). The overall agreement was 98.3% (95% CI, 94.2%-99.4%). \u03ba\u2009=\u20090.945, indicating \u201calmost perfect agreement.\u201d<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The Sofia Lyme test performs well compared with an FDA-approved MTTT.<\/jats:p>\n <\/jats:sec>","DOI":"10.1093\/ajcp\/aqad094","type":"journal-article","created":{"date-parts":[[2023,8,7]],"date-time":"2023-08-07T17:03:21Z","timestamp":1691427801000},"page":"599-602","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of the rapid Quidel Sofia Lyme fluorescent immunoassay as a first-tier test in a modified 2-tier testing algorithm for Lyme disease: A comparison with the Zeus ELISA Borrelia<\/i> VlsE1\/pepC10 lgG\/IgM assay followed by the Zeus monovalent IgM\/IgG confirmatory assay"],"prefix":"10.1093","volume":"160","author":[{"given":"Elizabeth","family":"Lee-Lewandrowski","sequence":"first","affiliation":[{"name":"Department of Pathology, Division of Clinical Laboratories and Molecular Medicine, Massachusetts General Hospital"},{"name":"Harvard Medical School , Boston, MA , US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Turbett","sequence":"additional","affiliation":[{"name":"Department of Pathology, Division of Clinical Laboratories and Molecular Medicine, Massachusetts General Hospital"},{"name":"Harvard Medical School , Boston, MA , US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John A","family":"Branda","sequence":"additional","affiliation":[{"name":"Department of Pathology, Division of Clinical Laboratories and Molecular Medicine, Massachusetts General Hospital"},{"name":"Harvard Medical School , Boston, MA , US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kent","family":"Lewandrowski","sequence":"additional","affiliation":[{"name":"Department of Pathology, Division of Clinical Laboratories and Molecular Medicine, Massachusetts General Hospital"},{"name":"Harvard Medical School , Boston, MA , US"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,8,7]]},"reference":[{"key":"2023120112205093200_CIT0001"},{"key":"2023120112205093200_CIT0002","first-page":"139","article-title":"Laboratory blood-based testing for non-Lyme disease tick-borne infections at a national reference laboratory","volume-title":"Am J Clin Pathol.","author":"Lee-Lewandrowski","year":"2020"},{"key":"2023120112205093200_CIT0003","first-page":"1169","article-title":"Current guidelines, common pitfalls and future directions for laboratory diagnosis on Lyme disease, United States","volume-title":"Emerg Infect Dis.","author":"Moore","year":"2016"},{"key":"2023120112205093200_CIT0004","first-page":"e0252821","article-title":"Multicenter clinical evaluation of modified two-tiered testing algorithms for disease using Zeus Scientific commercial assays","volume-title":"J Clin Microbiol.","author":"Sfeir","year":"2022"},{"key":"2023120112205093200_CIT0005","first-page":"115837","article-title":"Clinical evaluation of Borrelia modified two-tier testing (MTTT) shows increased sensitivity for Borrelia burgdorferi but not other endemic Borrelia species in a high incidence region for Lyme disease in Wisconsin","volume-title":"Diag Microbiol Infect Dis.","author":"Sabin","year":"2023"},{"key":"2023120112205093200_CIT0006","first-page":"125","article-title":"Modified two-tiered testing algorithm for Lyme disease serology: the Canadian context","volume-title":"Can Commun Dis Rep.","year":"2020"},{"key":"2023120112205093200_CIT0007","first-page":"1074","article-title":"Evaluation of modified two-tier serodiagnostic testing algorithms for early Lyme disease","volume-title":"Clin Infect Dis.","author":"Branda","year":"2017"},{"key":"2023120112205093200_CIT0008","first-page":"e00547-19","article-title":"Evaluation of the modified two-tier testing method for diagnosis of Lyme disease in children","volume-title":"J Clin Microbiol.","author":"Lipsett","year":"2019"},{"key":"2023120112205093200_CIT0009","first-page":"ofac272","article-title":"Modified two-tier testing enzyme immunoassay algorithm for serologic diagnosis of Lyme disease","volume-title":"Open Forum Infect Dis.","author":"Khan","year":"2022"},{"key":"2023120112205093200_CIT0010","first-page":"58","article-title":"Evaluation of the rapid Quidel Sofia Lyme immunoassay as a first-tier test in a two-tier testing algorithm for Lyme disease: comparison to the Zeus ELISA Borrelia VlsE1\/pepC10 lgG\/IgM assay followed by immunoblot","volume-title":"Am J Clin Pathol.","author":"Lee-Lewandrowski","year":"2023"},{"key":"2023120112205093200_CIT0011","first-page":"159","article-title":"The measurement of observer agreement for categorical data","volume-title":"Biometrics.","author":"Landis","year":"1977"},{"key":"2023120112205093200_CIT0012","first-page":"703","article-title":"Updated CDC recommendation for serologic diagnosis of Lyme disease","volume-title":"MMWR Morb Mortal Wkly Rep.","author":"Mead","year":"2019"}],"container-title":["American Journal of Clinical Pathology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ajcp\/article-pdf\/160\/6\/599\/53932551\/aqad094.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ajcp\/article-pdf\/160\/6\/599\/53932551\/aqad094.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T12:22:00Z","timestamp":1701433320000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ajcp\/article\/160\/6\/599\/7238251"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,7]]},"references-count":12,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2023,8,7]]},"published-print":{"date-parts":[[2023,12,1]]}},"URL":"https:\/\/doi.org\/10.1093\/ajcp\/aqad094","relation":{},"ISSN":["0002-9173","1943-7722"],"issn-type":[{"value":"0002-9173","type":"print"},{"value":"1943-7722","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,12,1]]},"published":{"date-parts":[[2023,8,7]]}}}