{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,13]],"date-time":"2026-09-13T17:55:15Z","timestamp":1789322115814,"version":"build-2803163510"},"reference-count":22,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,12,7]],"date-time":"2020-12-07T00:00:00Z","timestamp":1607299200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Although a diagnosis of infectious diseases is essential for timely treatment, the performance of diagnostic tests has been hardly evaluated due to variable results that are influenced by multiple factors in different conditions. In the present study, the performance of the Alinity i system, which is a newly developed immunoassay to diagnose infectious diseases, was evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We evaluated the precision, linearity, correlation, and carryover of 16 analytes (HAV Ab IgG, HBsAg, HBeAg, anti\u2010HBc, anti\u2010HBe, anti\u2010HBs, anti\u2010HCV, HIV Ag\/Ab, EBV VCA IgM, EBV VCA IgG, EBV EBNA IgG, CMV IgM, CMV IgG, Toxoplasma IgG, Rubella IgG, and Syphilis TP) of Alinity i by comparison with ARCHITECT i2000<jats:sub>SR<\/jats:sub> system following the rationale of the Clinical and Laboratory Standards Institute (CLSI).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>For quantitative tests, the coefficients of variation (CV) % of repeatability and intermediate precision were between 0% and 4.18%. The coefficients of the linearity (<jats:italic>r<\/jats:italic><jats:sup>2<\/jats:sup>) over a widely tested analytical range were\u00a0\u2265\u00a00.990 and the correlation between Alinity i and the ARCHITECT i2000<jats:sub>SR<\/jats:sub> system was strong (<jats:italic>r<\/jats:italic>\u00a0\u2265\u00a00.994). For qualitative tests, the agreement between Alinity i and the ARCHITECT i2000<jats:sub>SR<\/jats:sub> system was excellent (kappa coefficient 1) with 100% sensitivity and specificity. Carryover rates for all analytes were less than 1.0% (\u22120.11%\u00a0~\u00a00.21%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The Alinity i system showed good analytical performance and favorable comparability with the ARCHITECT i2000<jats:sub>SR.<\/jats:sub> It could be suitable as a routine immunoassay analyzer for screening and diagnosis of infectious disease.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.23671","type":"journal-article","created":{"date-parts":[[2020,12,7]],"date-time":"2020-12-07T09:53:12Z","timestamp":1607334792000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Performance evaluation of immunoassay for infectious diseases on the Alinity i system"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3542-3487","authenticated-orcid":false,"given":"Minjeong","family":"Nam","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine, Seoul National University Hospital Seoul National University College of Medicine  Seoul Korea"},{"name":"Department of Laboratory Medicine Konkuk University Medical Center  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Da Young","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Seoul National University Hospital Seoul National University College of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang Hoon","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Seoul National University Hospital Seoul National University College of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eun Youn","family":"Roh","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University Boramae Medical Center  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sue","family":"Shin","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University Boramae Medical Center  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyoung Un","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University Bundang Hospital  Seongnam Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1286-9611","authenticated-orcid":false,"given":"Eun Young","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Seoul National University Hospital Seoul National University College of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,12,7]]},"reference":[{"issue":"12","key":"e_1_2_7_2_1","first-page":"S17","article-title":"Evaluation of diagnostic tests for infectious diseases: general principles","volume":"8","author":"TDR Diagnostics Evaluation Expert Panel","year":"2010","journal-title":"Nat Rev Microbiol"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cit578"},{"issue":"4","key":"e_1_2_7_4_1","first-page":"227","article-title":"Factors affecting the antigen\u2010antibody reaction","volume":"5","author":"Reverberi R","year":"2007","journal-title":"Blood Transfus"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1872-2040(11)60518-5"},{"key":"e_1_2_7_6_1","first-page":"247","article-title":"Verification\/validation of the performances of analytical method","volume":"68","author":"Vassault A","year":"2010","journal-title":"Ann Biol Clin (Paris)"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00769-002-0556-x"},{"issue":"4","key":"e_1_2_7_8_1","first-page":"S1","article-title":"AACB Uncertainty of Measurement Working Group. Uncertainty of measurement in quantitative medical testing: a laboratory implementation guide","volume":"25","author":"White GH","year":"2004","journal-title":"Clin Biochem Rev"},{"key":"e_1_2_7_9_1","volume-title":"User verification of precision and estimation of bias; approved guideline\u2010third edition","author":"CLSI","year":"2014"},{"key":"e_1_2_7_10_1","unstructured":"CLSI.Evaluation of precision of quantitative measurement procedures; approved guideline\u2010third edition.Wayne PA.Clinical and Laboratory Standards Institute.2018. CLSI document EP05\u2010A3E."},{"key":"e_1_2_7_11_1","unstructured":"CLSI.Evaluation of the linearity of quantitative measurement procedures: astatistical approach; approved guideline\u2010second edition.Wayne PA:Clinical and Laboratory Standards Institute;2003. CLSI document EP06\u2010A3."},{"key":"e_1_2_7_12_1","unstructured":"CLSI.Measurement procedure comparison and bias estimation using patient samples; approved guideline\u2010third edition.Wayne PA:Clinical and Laboratory Standards Institute;2013. CLSI document EP09\u2010A3."},{"key":"e_1_2_7_13_1","volume-title":"User protocol for evaluation of qualitative test performance; approved guideline\u2010second edition","author":"CLSI","year":"2008"},{"key":"e_1_2_7_14_1","volume-title":"Preliminary evaluation of quantitative clinical laboratory methods; approved guideline\u2010third edition","author":"CLSI","year":"2019"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1155\/S1463924684000201"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1155\/2018\/8509127"},{"issue":"1","key":"e_1_2_7_17_1","first-page":"S5","article-title":"Analytical dquality \u2013 What should we be aiming for?","volume":"29","author":"Sikaris K","year":"2008","journal-title":"Clin Biochem Rev"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02430-07"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.4103\/2277-9175.133178"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01603-08"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.03486-13"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.3343\/alm.2018.38.5.458"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/2047-783X-15-2-66"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.23671","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.23671","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.23671","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,2]],"date-time":"2023-09-02T02:59:54Z","timestamp":1693623594000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.23671"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,7]]},"references-count":22,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["10.1002\/jcla.23671"],"URL":"https:\/\/doi.org\/10.1002\/jcla.23671","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,7]]},"assertion":[{"value":"2020-08-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-17","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-07","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e23671"}}