Transcript
AlphaID – For In Vitro Diagnostic Use
Informed consent reminder:
To get started, explain the need for screening to the patient. Provide the included Informed Consent Card and ensure that the patient’s questions are addressed.
AlphaID is designed for the collection of DNA through saliva samples. The DNA will be tested for 14 variants of the gene related to alpha-1-antitrypsin deficiency.
Instructions for sample collection:
Donor should not eat, drink, smoke, or chew gum for 30 minutes before collecting oral sample.
Open package and remove collector without touching sponge tip.
Ensure the sponge tip does not come into contact with any surface prior to collection.
Place sponge as far back in the mouth as comfortable...
...and rub along the lower gums in a back and forth motion.
Gently rub the gums 10 times.
If possible, avoid rubbing the teeth.
Gently repeat rubbing motion on the opposite side of the mouth along the lower gums.
Hold the tube upright to prevent the liquid inside the tube from spilling.
Unscrew the blue cap from the collection tube without touching the sponge.
Turn the cap upside down, insert the sponge into the tube...
...and close the cap tightly.
Invert the capped tube and shake vigorously 15 times.
Warning and precautions
Storage: 15/25 °C
Choking hazard.
Caution should be used when inserting sponge into the mouth.
Wash with water if liquid comes in contact with eyes or skin.
Do NOT ingest.
See material safety data sheet (MSDT) at www.dnagenotek.com
AlphaID is a self-collection kit that provides the materials and instructions for collecting human oral samples.
AlphaID – Next steps after sample collection
Three steps for sample shipping:
- Write the patient’s initials and date of birth in the white space on the swab label. Seal the swap sample within the provided specimen bag.
- Complete and sign the Requisition Form. Send the top copy with the cheek swap sample and retain the other copy for your records.
- Enclose the Requisition Form and the specimen bag in the shipping box, then seal the box and ship via USPS (prepaid shipping label is on the back).
Sample processing:
- AlphaID is processed at an independent, CLIA-certified laboratory that values and adheres to strict privacy and confidentiality standards.
- Results will be processed within 5 business days from the time the lab receives the package.
Reviewing results:
- Results will be available via fax or online at MyAlphaID.com.
- Results are strictly confidential and only ordering clinicians and designated office staff can access the results.
Ruling out alpha-1 is fast, easy, and completely free with AlphaID.
Alpha-1 expert clinicians are available for personal consultation to discuss abnormal results.
Contact your Grifols representative or visit AlphaID.com to obtain screening kits.
US-PRL-2400110
