{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T10:12:31Z","timestamp":1784628751506,"version":"3.55.0"},"reference-count":21,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,11,29]],"date-time":"2019-11-29T00:00:00Z","timestamp":1574985600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["RO1HL092173"],"award-info":[{"award-number":["RO1HL092173"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["K24HL133373"],"award-info":[{"award-number":["K24HL133373"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:p>The antiplatelet agent clopidogrel, a prodrug that requires bioactivation through the cytochrome P450 2C19 (CYP2C19) enzyme, is commonly prescribed post\u2010percutaneous coronary intervention (PCI). Genetic variation in <jats:italic>CYP2C19<\/jats:italic> contributes to individual variability in clopidogrel response, and can lead to adverse cardiovascular events. Incorporating <jats:italic>CYP2C19<\/jats:italic> testing during routine clinical care helps identify high\u2010risk patients, and provides the opportunity for pharmacotherapeutic interventions in the early post\u2010PCI period. The Spartan RX <jats:italic>CYP2C19<\/jats:italic> System has emerged as an optimal genotyping assay for use in clinical care due to ease of use, utilization of buccal swabs, and rapid turnaround time. However, workflow constraints related to sample collection and processing, storage, time, and personnel were encountered when integrating testing into clinical care. To improve clinical workflow and successfully implement <jats:italic>CYP2C19<\/jats:italic> genotyping at our institution, we validated the Spartan RX System to return genotype utilizing blood samples. Our Molecular Diagnostic Laboratory tested 26 known reference materials and both blood and buccal swab samples from 23 patients and volunteers using the Spartan RX Assay. Genotype results were 100% concordant between DNA from blood and buccal swabs for all patients or volunteers, and consistent with expected results for the 26 reference materials. For reproducibility, three samples were tested in at least four separate runs, with all resulting genotypes in agreement between runs. Post\u2010validation, the laboratory began offering <jats:italic>CYP2C19<\/jats:italic> testing during clinical care. DNA extracted from blood can serve as a genomic DNA source for the Spartan RX Assay. Alteration of the methodology allowed for clinical implementation to support genotype\u2010guided therapy.<\/jats:p>","DOI":"10.1111\/cts.12714","type":"journal-article","created":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T15:26:30Z","timestamp":1572449190000},"page":"260-264","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Validation of the Spartan RX<i>CYP2C19<\/i> Genotyping Assay Utilizing Blood Samples"],"prefix":"10.1111","volume":"13","author":[{"given":"Brittney H.","family":"Davis","sequence":"first","affiliation":[{"name":"Department of Neurology University of Alabama at Birmingham Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gina","family":"DeFrank","sequence":"additional","affiliation":[{"name":"Department of Pathology University of Alabama at Birmingham Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nita A.","family":"Limdi","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Alabama at Birmingham Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuko","family":"Harada","sequence":"additional","affiliation":[{"name":"Department of Pathology University of Alabama at Birmingham Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,11,29]]},"reference":[{"key":"e_1_2_10_1_1","first-page":"667","article-title":"Contemporary prescription patterns of adenosine diphosphate receptor inhibitors in acute coronary syndrome","volume":"43","author":"Yin E.B.","year":"2018","journal-title":"P T"},{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2010.1543"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2008.11.048"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.1232"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.11.068"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2010.05.007"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2013.105"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9258(17)40694-6"},{"key":"e_1_2_10_9_1","first-page":"738","article-title":"Comparison of two point\u2010of\u2010care","volume":"47","author":"Zhou Y.","year":"2017","journal-title":"Ann. Clin. Lab. Sci."},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2017.07.022"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1161\/ATVBAHA.118.311963"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.631"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1006"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.12.004"},{"key":"e_1_2_10_15_1","unstructured":"US Food and Drug Administration.FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug. <https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/fda-drug-safety-communication-reduced-effectiveness-plavix-clopidogrel-patients-who-are-poor> (2017). Accessed June 13 2019."},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60161-5"},{"key":"e_1_2_10_17_1","unstructured":"US Food and Drug Administration.Spartan RX CYP2C19 System 510(k) Summary. <https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf12\/K123891> (2013). Accessed June 12 2019."},{"key":"e_1_2_10_18_1","unstructured":"Centers for Disease Control and Prevention.Clinical Laboratory Improvement Amendments (CLIA) Test Complexities. <https:\/\/www.cdc.gov\/clia\/test-complexities.html> (2018). Accessed August 20 2019."},{"key":"e_1_2_10_19_1","volume-title":"CLIA\u2010Clinical Laboratory Improvement Amendments Database","year":"2013"},{"key":"e_1_2_10_20_1","unstructured":"American Academy of Family Physicians.CLIA Requirements for Lab Personnel<https:\/\/www.aafp.org\/practice-management\/regulatory\/clia\/personnel.html> (2019). Accessed August 20 2019."},{"key":"e_1_2_10_21_1","unstructured":"College of American Pathologists.CAP Personnel Requirements by Testing Complexity<https:\/\/documents.cap.org\/documents\/CAP-personnel-requirements-by-test-complexity.pdf> (2018). Accessed August 20 2019."}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fcts.12714","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.12714","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cts.12714","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.12714","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T09:17:39Z","timestamp":1694078259000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.12714"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,29]]},"references-count":21,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,3]]}},"alternative-id":["10.1111\/cts.12714"],"URL":"https:\/\/doi.org\/10.1111\/cts.12714","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,11,29]]},"assertion":[{"value":"2019-08-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-09-27","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-29","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}