{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T17:03:14Z","timestamp":1787677394960,"version":"build-2784847793"},"reference-count":9,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2019,5,1]],"date-time":"2019-05-01T00:00:00Z","timestamp":1556668800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100011234","name":"Bio-Rad Laboratories","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011234","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Toxoplasmosis is routinely diagnosed through detection of Toxoplasma gondii\u2013specific antibodies. However, the imperfect specificity of T. gondii serologic assays is a well-recognized limitation. The new BioPlex 2200 (Bio-Rad Laboratories) T. gondii, rubella, and cytomegalovirus (ToRC) IgM multiplex flow immunoassay (MFI) received FDA clearance in May 2017. We evaluated the clinical performance of the new T. gondii IgM and existing IgG portion of this MFI.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Three hundred prospectively collected consecutive, residual sera, submitted for T. gondii serologic testing as part of routine clinical care, and an archived set of 52 residual sera previously positive for anti\u2013T. gondii IgM and IgG with the predicate ADVIA Centaur Toxoplasma IgM and IgG assays (Siemens) were evaluated. Performance of the BioPlex 2200 T. gondii IgM and IgG MFIs was assessed by calculating positive (PPA) and negative percent agreement (NPA) compared to the Centaur tests.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among prospective specimens, the BioPlex 2200 T. gondii IgM and IgG MFIs demonstrated a PPA of 0% (0\/7) and 82.3% (28\/34) and NPA of 99.3% (288\/290) and 95.8% (251\/262), respectively, with the Centaur assays. Chart review of the 7 Centaur T. gondii IgM-positive samples revealed that these were likely falsely positive. Among archived samples, the BioPlex 2200 T. gondii IgM and IgG MFIs showed PPAs of 90.4% (47\/52) and 100% (52\/52), respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The BioPlex 2200 T. gondii IgM and IgG MFIs demonstrated excellent concordance with the Centaur assays. The T. gondii IgM MFI may provide higher specificity in low-prevalence populations.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1373\/jalm.2018.026906","type":"journal-article","created":{"date-parts":[[2018,8,13]],"date-time":"2018-08-13T17:55:29Z","timestamp":1534182929000},"page":"1022-1027","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of the Bio-Rad BioPlex 2200 <i>Toxoplasma gondii<\/i> IgM Multiplex Flow Immunoassay"],"prefix":"10.1093","volume":"3","author":[{"given":"Elitza S","family":"Theel","sequence":"first","affiliation":[{"name":"Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie L","family":"Yarbrough","sequence":"additional","affiliation":[{"name":"Department of Pathology and Immunology, Washington University School of Medicine, Saint Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Hilgart","sequence":"additional","affiliation":[{"name":"Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann M","family":"Gronowski","sequence":"additional","affiliation":[{"name":"Department of Pathology and Immunology, Washington University School of Medicine, Saint Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,5,1]]},"reference":[{"key":"2022020118533220400_B1","first-page":"363","article-title":"Toxoplasmosis Lancet","volume":"12","author":"Montoya","year":"2004"},{"key":"2022020118533220400_B2","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1128\/CMR.05013-11","article-title":"Epidemiology of and diagnostic strategies for toxoplasmosis","volume":"25","author":"Robert-Gangneaux","year":"2012","journal-title":"Clin Micro"},{"key":"2022020118533220400_B3","article-title":"FDA public health advisory: limitations of toxoplasma IgM commercial test kits","author":"U.S. Food and Drug Administration","year":"1997"},{"key":"2022020118533220400_B4","article-title":"Clinical use and interpretation of serologic tests for Toxoplasma gondii; approved guideline","volume-title":"M36-A","author":"Clinical and Laboratory Standards Institute","year":"2004"},{"key":"2022020118533220400_B5","doi-asserted-by":"crossref","first-page":"757","DOI":"10.1093\/infdis\/142.5.757","article-title":"An enzyme-linked immunosorbent assay for detection of IgM antibodies to Toxoplasma gondii: use for diagnosis of acute acquired toxoplasmosis","volume":"142","author":"Naot","year":"1980","journal-title":"J Infect Dis"},{"key":"2022020118533220400_B6","doi-asserted-by":"crossref","first-page":"660","DOI":"10.1126\/science.108.2815.660","article-title":"Dyes as microchemical indicators of a new immunity phenomenon affecting a protozoan parasite (Toxoplasma)","volume":"108","author":"Sabin","year":"1948","journal-title":"Science"},{"key":"2022020118533220400_B7","doi-asserted-by":"crossref","first-page":"551","DOI":"10.4269\/ajtmh.17-0677","article-title":"Toxoplasma gondii infection in the United States, 2011\u20132014","volume":"98","author":"Jones","year":"2018","journal-title":"Am J Trop Med Hyg"},{"key":"2022020118533220400_B8","doi-asserted-by":"crossref","first-page":"496","DOI":"10.1128\/CVI.00624-13","article-title":"Performance of the BioPlex 2200 flow immunoassay in critical cases of serodiagnosis of toxoplasmosis","volume":"21","author":"Guigue","year":"2014","journal-title":"Clin Vaccine Immunol"},{"key":"2022020118533220400_B9","article-title":"BioPlex 2220 System ToRC IgM Instructions for use","author":"Bio-Rad Laboratories","year":"2017"}],"container-title":["The Journal of Applied Laboratory Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/3\/6\/1022\/42354154\/3_3_6_1022.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/3\/6\/1022\/42354154\/3_3_6_1022.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,1]],"date-time":"2022-02-01T19:05:02Z","timestamp":1643742302000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jalm\/article\/3\/6\/1022\/5603093"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,5,1]]},"references-count":9,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2019,5,1]]},"published-print":{"date-parts":[[2019,5,1]]}},"URL":"https:\/\/doi.org\/10.1373\/jalm.2018.026906","relation":{},"ISSN":["2576-9456","2475-7241"],"issn-type":[{"value":"2576-9456","type":"print"},{"value":"2475-7241","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2019,5,1]]},"published":{"date-parts":[[2019,5,1]]}}}