(1) Purpose of the test: Sequence determination of genes involved in pharmacogenetic interactions in humans.

(2) Specimen type: Buccal swabs (cheek/buccal mucosa tissue).

(3) Collection and handling procedures: Client MD and Nurses collect buccal swab samples from patients on- or off-site. Use Catch-All™ Sample Collection Swabs:

Explain to the patient that his/her healthcare provider is requesting a genetic drug sensitivity test in order to measure how efficiently he/she metabolizes different drugs. This will help the physician identify the optimal drug and dosage for that individual patient. The metabolic profile will classify his/her ability to metabolize a given drug as poor, intermediate, extensive (normal) or ultra-rapid.

Purpose of Test:
Cytochrome P450 Drug Metabolism: This panel is useful in estimating a patient’s unique, personal drug metabolism pattern. A patient’s unique array of genetic variants can indicate how certain drugs will be metabolized by that patient, which is useful in predicting drug interactions and drug efficacy for that individual.

The healthcare provider must complete and sign the Alcala Test Requisition form.

1. The treating physician must sign, enter the NPI number and check what panels should be tested (boxed items in requisition form).
2. The patient must consent to the Pharmacogenetic Testing and sign the requisition form with the date.
3. Prepare patient information sheet including health insurance information to return with swabs. All applicable ICD-10 codes must be checked, or written in the blank space.
4. OPTIONAL:  Please include a reconciled medication list for patient being tested.

COLLECTION: Use 4 swabs (2 for each cheek)!

1. Thoroughly rinse out the subject’s mouth twice with water. It is recommended that subjects do not drink or eat for 30 minutes before tissue collection.
2. Collect tissue by rolling the Catch-All sample collection swab firmly on the inside of the cheek, approximately 20 times on each side, making certain to move the brush over the entire cheek.

SHIPPING:

1. Return the swab into the small envelope provided and seal.
2. Write Patient Name and Date on the small envelope. Pack both swab envelope and paperwork, including requisition form and medication list into large envelope provided.
3. Ship right away in UPS envelope with provided label or Store at 4°C or -20°C for up to one week before returning to Alcala (please return as soon as possible).

NOTE: do not use any other type of swab. Alcala provides synthetic, non-cotton swabs with each requisition form.

Criteria for rejection: Rejection of Buccal swab samples and request for new specimens occurs when the buccal swab itself or its labeled biohazard bag show contamination or evidence of corruption.

• Requisition form
• Four sterile swabs
• Sealable paper swab collection envelope
• Sealable outer envelope
• UPS shipping pouch
• UPS Label
• FAQ patient insert
• Final Step-By-Step Checklist

Ship samples to:

Alcala Testing and Analysis Services
Accessioning
3703 Camino del Rio South
Suite 100-A
San Diego, CA 92108