Ordering Recommendation

Assesses genetic risk of abnormal drug metabolism for substrates of CYP3A4 and/or CYP3A5. May aid in drug selection and dose planning for drugs metabolized by CYP3A4 and/or CYP3A5.

Methodology

Polymerase Chain Reaction (PCR)/Fluorescence Monitoring

Performed

Varies

Reported

5-10 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation
Collect

Lavender (EDTA), Pink (K2EDTA), or Yellow (ACD Solution A or B).

Specimen Preparation

Transport 3 mL whole blood. (Min: 1 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma or serum. Specimens collected in sodium heparin or lithium heparin. Frozen specimens in glass collection tubes.

Remarks
Stability

Ambient: 72 hours; Refrigerated: 1 week; Frozen: 1 month

Reference Interval

By report

Interpretive Data

Refer to report

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online.

Compliance Category

Laboratory Developed Test (LDT)

Note

Whole blood is the preferred specimen. Saliva samples that yield inadequate DNA quality and/or quantity will be reported as inconclusive if test performance does not meet laboratory-determined criteria for reporting.

Hotline History

N/A

CPT Codes

81230; 81231

Components

Component Test Code* Component Chart Name LOINC
3001519 3A4/3A5 Specimen 31208-2
3001520 CYP3A4 Genotype 81139-8
3001521 CYP3A5 Genotype 81140-6
3001522 3A4/3A5 Interpretation 50398-7
3004504 CYP3A4 Phenotype 81145-5
3004505 CYP3A5 Phenotype 79717-5
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • 3A4
  • 3A5
  • CYP3A4
  • CYP3A5
  • Cytochrome P450 3A4
  • Cytochrome P450 3A5
  • fentanyl
  • tacrolimus
CYP3A4 and CYP3A5