Risk interpretation based on Coriell’s CYP2D6/Codeine Response Genotype Translation Version 1 (January 2015).
Interpretation
This individual is expected to be a
Codeine Extensive Metabolizer
based on the Combined Genetic Result:
CYP2D6*1/*1
Individuals who are extensive metabolizers have normal CYP2D6 enzymatic function and are expected to respond to codeine.
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 CYP2D6 gene that are not included in this test, that influence the response to codeine. 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. Ten nanogram of DNA from each sample was used in the CYP2D6 copy number assay (Taqman Copy Number Assay, ThermoFisher, Hs00010001). Data analysis was performed using CopyCaller V2.1 software (ThermoFisher). Risk interpretation was based on Coriell’s CYP2D6/Codeine Response Genotype Translation Version 1.