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AccuType® CP, Clopidogrel CYP2C19 Genotype (NY)
Test Code16925
CPT Codes
81225<br /> **This test is not available for non-New York patient testing. For non-NY patient testing, use test code 16924.**
Physician Attestation of Informed Consent
This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.
Preferred Specimen
4 mL whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
2 mL whole blood • 1 mL saliva
Other Acceptable Specimens
Whole blood collected in: Sodium heparin (green-top) tube, ACD-A (yellow-top) tube or EDTA (lavender-top) pediatric tube • 1 mL saliva collected in an Oragene DNA self-collection kit
Instructions
Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship immediately.
Saliva: Saliva collection kits require patient to rinse mouth prior to spitting into Oragene collection kit. See Oragene product insert for further details.
Saliva: Saliva collection kits require patient to rinse mouth prior to spitting into Oragene collection kit. See Oragene product insert for further details.
Transport Temperature
Room temperature
Specimen Stability
Whole blood
Room temperature: 8 days
Refrigerated: 30 days
Frozen: 49 days
Saliva
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Room temperature: 8 days
Refrigerated: 30 days
Frozen: 49 days
Saliva
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Methodology
Real-time Polymerase Chain Reaction (PCR) • Single Nucleotide Primer Extension
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
This test is performed pursuant to a license agreement with Orchid Biosciences, Inc.
Setup Schedule
Night; P.M. Sets up 7 days a week.
Clinical Significance
The cytochrome P450 gene products are responsible for metabolizing a large number of widely prescribed drugs. Clopidogrel (Plavix®) is metabolized by cytochrome P450 2C19 (CYP2C19, S-mephenytoin 4-prime-hydroxylase) to its active form. Poor metabolizers (PM) will require increased dosage to obtain therapeutic levels, while ultra-extensive metabolizers (UM) will require a decreased dosage due to higher than normal rates of drug metabolism. CYP2C19 catalyzes the hydroxylation of a number of clinically important drugs, including omeprazole, proguanil, hexobarbital, imipramine and to a lesser extent, propranolol and diazepam. CYP2C19 loss-of-function alleles were shown to be associated with a higher rate of subsequent cardiovascular events among patients with an acute myocardial infarction and were receiving clopidogrel treatment (N Engl J Med. 2009; 360: 363-375).
