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Pain Management, CYP450 3A4/3A5 Genotype, Qualitative
Test Code91597
CPT Codes
81230, 81231
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: ACD solution A (yellow-top) tube or ACD solution B (yellow-top) tube • Saliva collected in DNA Genotek Oragene-Dx kit • Buccal swab collected in Celera/Copan DNA collection kit
Instructions
Whole blood (preferred): Normal phlebotomy procedure; specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.
Saliva (acceptable): Use only DNA Genotek Oragene-Dx (OGD-510) kit. Follow instructions. Store and ship room temperature or refrigerated. Do not freeze.
Buccal swab (acceptable): Use only Celera/Copan DNA collection kit (Celera part# 5002737). Store and ship room temperature only. Do not refrigerate or freeze.
Saliva (acceptable): Use only DNA Genotek Oragene-Dx (OGD-510) kit. Follow instructions. Store and ship room temperature or refrigerated. Do not freeze.
Buccal swab (acceptable): Use only Celera/Copan DNA collection kit (Celera part# 5002737). Store and ship room temperature only. Do not refrigerate or freeze.
Transport Temperature
Room temperature
Specimen Stability
Whole blood
Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable
Saliva
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Buccal swab
Room temperature: 14 days
Refrigerated: Unacceptable
Frozen: Unacceptable
Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable
Saliva
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Buccal swab
Room temperature: 14 days
Refrigerated: Unacceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Incorrect collection device • Liquid has leaked from container • No liquid present • Blood sample received frozen • Buccal swabs received refrigerated or frozen
Methodology
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.
Setup Schedule
A.M. Sets up 1 day a week.
Report Available
Reports in 8 days.
Clinical Significance
CYP3A4 and CYP3A5 are liver enzymes that are responsible for metabolizing approximatley 50% of small molecule drugs, and their induction often causes unwanted drug-drug interactions and potential toxicities. Variants of CYP3A4/3A5 are associated with significant phenotypic variations that alter the rate of drug metabolism and may cause increased or decreased drug efficacy or adverse drug reactions. Detecting genetic predisposition to altered CYP3A4/3A5 metabolism may help avoid drug toxicity and can assist the physician with optimizing therapeutic strategies for maximum efficacy and minimal adverse effects.
