{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T05:10:19Z","timestamp":1791263419124,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2013,1,10]],"date-time":"2013-01-10T00:00:00Z","timestamp":1357776000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2013,9]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Identifying antibodies to <jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content> (anti\u2010<jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content>) by solid\u2010phase assays is used to screen blood donors to mitigate transfusion\u2010related acute lung injury risk. Various cutoffs for detection assays have been proposed in the literature; however, these do not take into consideration lot\u2010to\u2010lot variability of commercially available assays.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>Samples from 93 nontransfused males were tested using five different lots of a multiplex bead\u2010based anti\u2010<jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content> detection kit. A subset of 17 samples was tested on 5\u2009days using a single lot. An additional 96 samples from donations with varied anti\u2010<jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content> levels were tested using kits from two different lots. Results were reported as a normalized background (<jats:styled-content style=\"fixed-case\">NBG<\/jats:styled-content>) ratio.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>For the 93 nontransfused donors, <jats:styled-content style=\"fixed-case\">NBG<\/jats:styled-content> values generated using the reference lot were significantly higher than those obtained with three of the four comparator lots. However, for the 96 samples with low\u2010, moderate\u2010, and higher\u2010level anti\u2010<jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content>, Class\u2009I (CL\u2010I) values were 1.4 times lower and Class\u2009II (CL\u2010II) values were 1.2 times lower using the reference versus comparator lot. For CL\u2010I antibodies the between\u2010lot standard deviation (<jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content>) was 1.36 (95% confidence interval [<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>], 1.19\u20101.60), while the between\u2010day <jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content> was 1.27 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 1.08\u20101.52). Similarly, for CL\u2010II antibodies the between\u2010lot <jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content> was 0.81 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 0.70\u20100.95), while the between\u2010day <jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content> was 0.50 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 0.43\u20100.60).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>There is interlot variability in the tested <jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content> detection assay as well as significant bias between lots. It may be reasonable to develop a new cutoff when a new lot is obtained.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.12064","type":"journal-article","created":{"date-parts":[[2013,1,11]],"date-time":"2013-01-11T02:37:37Z","timestamp":1357871857000},"page":"1940-1947","source":"Crossref","is-referenced-by-count":20,"title":["Lot\u2010to\u2010lot variability in <scp>HLA<\/scp> antibody screening using a multiplexed bead\u2010based assay"],"prefix":"10.1111","volume":"53","author":[{"given":"Manish J.","family":"Gandhi","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine and Pathology Department of Biomedical Statistics &amp; Informatics Department of Anesthesiology Division of Transfusion Medicine Mayo Clinic  Rochester Minnesota"},{"name":"Westat, Inc.  Rockville Maryland"},{"name":"One Lambda, Inc.  Canoga Park California"},{"name":"Deparment of Laboratory Medicine University of California at San Francisco Blood Systems Research Institute  San Francisco California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle M.","family":"Carrick","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology Department of Biomedical Statistics &amp; Informatics Department of Anesthesiology Division of Transfusion Medicine Mayo Clinic  Rochester Minnesota"},{"name":"Westat, Inc.  Rockville Maryland"},{"name":"One Lambda, Inc.  Canoga Park California"},{"name":"Deparment of Laboratory Medicine University of California at San Francisco Blood Systems Research Institute  San Francisco California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Jenkins","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology Department of Biomedical Statistics &amp; Informatics Department of Anesthesiology Division of Transfusion Medicine Mayo Clinic  Rochester Minnesota"},{"name":"Westat, Inc.  Rockville Maryland"},{"name":"One Lambda, Inc.  Canoga Park California"},{"name":"Deparment of Laboratory Medicine University of California at San Francisco Blood Systems Research Institute  San Francisco California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"De Goey","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology Department of Biomedical Statistics &amp; Informatics Department of Anesthesiology Division of Transfusion Medicine Mayo Clinic  Rochester Minnesota"},{"name":"Westat, Inc.  Rockville Maryland"},{"name":"One Lambda, Inc.  Canoga Park California"},{"name":"Deparment of Laboratory Medicine University of California at San Francisco Blood Systems Research Institute  San Francisco California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy A.","family":"Ploeger","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology Department of Biomedical Statistics &amp; Informatics Department of Anesthesiology Division of Transfusion Medicine Mayo Clinic  Rochester Minnesota"},{"name":"Westat, Inc.  Rockville Maryland"},{"name":"One Lambda, Inc.  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