title: The Diagnostic Utility of the Point-of-Care CYP2C19 Genotyping Assay in Patients with Acute Coronary Syndrome Dosing Clopidogrel: Comparison with Platelet Function Test and SNP Genotyping.
abstract: BACKGROUND
  Clopidogrel is a widely used antiplatelet agent for dual antiplatelet therapy and metabolized by CYP2C19. The polymorphism of CYP2C19 is associated with the therapeutic effect of clopidogrel.
  
  
  METHODS
  A total of 119 patients diagnosed with acute coronary syndrome (ACS) and underwent percutaneous coronary intervention (PCI) with drug-eluting stents was enrolled. Polymorphisms of CYP2C19 *2,*3,*17 were determined by the Spartan RX CYP2C19 and confirmed by SNP genotyping assay. Genotype was grouped as ultra-rapid metabolizer, extensive metabolizer, intermediate metabolizer, and poor metabolizer. The degree of platelet inhibition was assessed by the VerifyNow P2Y12 system (Accumetrics, USA).
  
  
  RESULTS
  The CYP2C19 genotypes were distributed as 4 (3.3%) for UM, 39 (32.8%) for EM, 54 (45.4%) for IM, 22 (18.5%) for PM by evaluation with Spartan RX CYP2C19. The numbers of patients with the *1/*17, *1/*1, *1/*2, *1/*3, *3/*17, *2/*2, *2/*3, and *3/*3 genotype were 4 (3.3%), 39 (32.8%), 40 (33.6%), 13 (10.9%), 1 (0.9%), 11 (9.2%), 10 (8.4%), 1 (0.9%), respectively. The genotyping results between Spartan RX CYP2C19 and SNP genotyping assay showed discrepancy in 2 patients. The discrepancy appeared in *17 allele analysis in both patients as false-positive result.
  
  
  CONCLUSIONS
  The false-positive *17 allele couldn't affect IM or PM group associated with thrombotic events, but it could affect UM group associated with bleeding events, which is relatively less investigated. Although the supplement of *17 allele detection should be accomplished, this novel point-of-care CYP2C19 genotyping instrument could determine the response to the clopidogrel and support the appropriate treatment of ACS patients.
authors.affiliation: Department of Laboratory Medicine, Seegene Medical Foundation, Busan, Korea.
authors.forename: Jae-Lim
authors.initials: JL
authors.lastname: Choi
authors.affiliation: Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Korea.
authors.forename: Bo-Ram
authors.initials: BR
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Korea.
authors.forename: Kwang-Sook
authors.initials: KS
authors.lastname: Woo
authors.affiliation: Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Korea.
authors.forename: Kyeong-Hee
authors.initials: KH
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Korea.
authors.forename: Jeong-Man
authors.initials: JM
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
authors.forename: Moo-Hyun
authors.initials: MH
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Korea jyhan@dau.ac.kr.
authors.forename: Jin-Yeong
authors.initials: JY
authors.lastname: Han
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis* / Q000188:drug therapy / Q000201:enzymology / Q000235:genetics*; D000077144:Clopidogrel; D065731:Cytochrome P-450 CYP2C19 / Q000235:genetics*; D004305:Dose-Response Relationship, Drug; D005260:Female; D060005:Genotyping Techniques / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D010979:Platelet Function Tests; D019095:Point-of-Care Systems; D020641:Polymorphism, Single Nucleotide / Q000235:genetics*; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D065731:Cytochrome P-450 CYP2C19; D013988:Ticlopidine
keywords: CYP2C19 genotyping; clopidogrel; point-of-care