Risk interpretation based on Coriell's CYP2C19 Clopidogrel Metabolizer Type Genotype Translation Version 1 (March 2011)
Test Limitations
DNA-based testing is highly accurate, however there are many sources of potential
error including: mis-identification of samples, rare technical errors, trace contamination
of PCR reactions, and rare genetic variants that interfere with analysis. There
may be other variants in the CYP2C19 gene, not included in this test, that influence
metabolizer status. This test or one or more of its components was developed and
its performance characteristics determined by the Coriell Institute for Medical
Research. It has not been approved by the Food and Drug Administration (FDA). The
FDA has determined that such approval is not necessary. The Coriell Institute is
regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 as
qualified to perform high-complexity testing.
Test Methodology
Saliva samples were collected using Oragene DNA Collection Kits (DNA Genotek) and
DNA was extracted manually according to the manufacturer’s instructions or automatically
using a DNAdvance Kit (Agencourt). Purified DNA was quantified using UV absorbance
at 260 nm. One microgram of the resulting DNA from each sample was used as template
in the Affymetrix DMET Plus GeneChip assay. Data analysis was performed using Affymetrix
DMET Console software.