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In an effort to guarantee reliable community\u2010based <jats:italic><jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content>\u2010B*15:02<\/jats:italic> testing throughout China, a <jats:italic><jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content>\u2010B*15:02<\/jats:italic> genotyping external quality assessment (<jats:styled-content style=\"fixed-case\">EQA<\/jats:styled-content>) program was set up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In 2016, 10 genomic <jats:styled-content style=\"fixed-case\">DNA<\/jats:styled-content> samples with known <jats:italic><jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content>\u2010B*15:02<\/jats:italic> allele status were sent to 37 laboratories from 16 provinces with a request for routine <jats:italic><jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content>\u2010B*15:02<\/jats:italic> screening. The samples were validated using Sanger sequencing by a reference laboratory. Both genotyping results and clinical written reports were evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty\u2010six of the participating laboratories correctly identified the <jats:italic><jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content>\u2010B*15:02<\/jats:italic> allele status for all <jats:styled-content style=\"fixed-case\">EQA<\/jats:styled-content> samples. However, one lab failed to identify any positive challenges. The overall analytical sensitivity was 97.3% (180\/185 challenges; 95% confidence interval: 93.8%\u201099.1%) and the analytic specificity was 100% (185\/185; 95% confidence interval: 98.0%\u2010100%). A review of the written reports showed that the clinical reporting for <jats:italic><jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content>\u2010B*15:02<\/jats:italic> detection should be improved. Some essential information was missing, most notably laboratory information\/contact, therapeutic recommendations, and methodology.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>External quality assessment is valuable in assessing and improving the quality of laboratory testing of <jats:italic><jats:styled-content style=\"fixed-case\">HLA<\/jats:styled-content>\u2010B*15:02<\/jats:italic> allele.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.22242","type":"journal-article","created":{"date-parts":[[2017,4,25]],"date-time":"2017-04-25T10:53:39Z","timestamp":1493117619000},"source":"Crossref","is-referenced-by-count":2,"title":["External quality assessment for laboratory testing of <i><scp>HLA<\/scp>\u2010B*15:02<\/i> allele in relation to carbamazepine therapy"],"prefix":"10.1002","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0406-9078","authenticated-orcid":false,"given":"Guigao","family":"Lin","sequence":"first","affiliation":[{"name":"National Center for Clinical Laboratories Beijing Hospital National Center of Gerontology Beijing China"},{"name":"Beijing Engineering Research Center of Laboratory Medicine Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kuo","family":"Zhang","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories Beijing Hospital National Center of Gerontology Beijing China"},{"name":"Beijing Engineering Research Center of Laboratory Medicine Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanxi","family":"Han","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories Beijing Hospital National Center of Gerontology Beijing China"},{"name":"Beijing Engineering Research Center of Laboratory Medicine Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiehong","family":"Xie","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories Beijing Hospital National Center of Gerontology Beijing China"},{"name":"Beijing Engineering Research Center of Laboratory Medicine Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinming","family":"Li","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories Beijing Hospital National Center of Gerontology Beijing China"},{"name":"Beijing Engineering Research Center of Laboratory Medicine Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,4,25]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/428486a"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199411103311906"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2013.103"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2007.06.017"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.fpc.0000199500.46842.4a"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.tpj.6500356"},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2007.01022.x"},{"key":"e_1_2_5_9_1","unstructured":"US Food and Drug Administration.Information for Healthcare Professionals: Dangerous or Even Fatal Skin Reactions\u2014Carbamazepine (marketed as Carbatrol Equetro Tegretol and generics).2007.http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketdrugsafetyinformationforPatientsandProviders\/ucm124718.htm. 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