A Blood Collection Device

for AlphaTest®

A test for Alpha-1 Antitrypsin Deficiency

PurposeThis convenient kit is designed to facilitate sampling and shipping of blood to permit AlphaTest®, the full-spectrum testing process for making the diagnosis of alpha1-antitrypsin deficiency. Blood collected from a finger stick should be dried onto the filter paper, then shipped for testing.

In the AlphaTest® process, specific protein- and molecular-based tests diagnose alpha1-antitrypsin deficiency. The first test (an immunoassay) determines the concentration of alpha1-antitrypsin (AAT) in the specimen. Additional testing, when appropriate, determines the phenotype of the alpha1-antitrypsin by isoelectric focusing of the proteins in the specimen or the genotype by DNA-based molecular methods.

Materials Provided• Filter paper with imprinted circles and attached form (filter paper kit)

• Pre-addressed return envelope

• Lancet device for obtaining a blood sample by finger stick

• Antiseptic swab

• Plastic bandages

Materials Required But Not Provided• Gauze pads

• Gloves

Storage and StabilityPrior to use, the filter paper kit should be kept in its pre-addressed envelope. After removal of the filter paper kit from its envelope, care must be taken to keep the filter paper clean and dry until it is used.

After the blood has completely dried onto the filter paper (see detailed instructions in this brochure), the filter paper kit should be returned to its protective envelope. The envelope should be sealed, kept dry at room temperature, and protected from extreme temperatures. It should be mailed as soon as possible (within three days).

Get Ready• Enter all of the requested information including:

• Patient’s name, birth date and family history of AATD

• Physician’s name, full address, phone and FAX numbers

• Date blood drawn

• Tear out the second sheet of paper from the filter paper kit (the “Physician Copy”), and save for your records. This will expose the circles on the filter paper. The other two copies (“Alpha1Center Copy” and “Laboratory Copy”) are sent with the blood specimen.

Please read the following instructions carefully and gather all of the necessary materials.

The IncisionTo increase the local circulation, have the patient wash his/her hands in warm water, or gently massage the entire length of the finger.

• Clean the incision site and surrounding area with the enclosed alcohol pad. To avoid hemolysis, let the skin dry completely before proceeding.

• Remove the lancet device from the plastic packet. Twist off tab to break the seal and discard tab.

• Again, gently massage the lower portion of the finger while avoiding the fingertip incision site. Firmly grasp the lower portion of the finger to restrict return circulation. Firmly position the lancet device at the incision site and depress the trigger. Do not worry about penetrating too deeply. The lancet is designed to penetrate the skin to the proper depth.

• After triggering, immediately remove the device from the patient’s finger. When blood begins to flow, wipe the first drop away with a gauze pad. Apply gentle pressure to the finger to encourage blood flow. Do not squeeze or “milk” the finger.

The LancetThe lancet device is engineered to penetrate the skin to the proper depth.

When the device is held and pressed against the target incision area of the skin, it will trigger and a surgical steel blade swiftly projects. It produces a nearly painless incision in only the uppermost vasculature of the finger, and then automatically retracts.

Recommended Incision Area• The middle and fourth

fingers are preferred for virtually pain-free skin incisions, because they are not as sensitive to pain as the index finger. The index finger should be avoided if possible. The middle portion of any fingertip should be avoided, because this area has greater sensitivity to pain and yields less robust bleeding.

• The incision should be made on the lateral aspect of the fingertip, approximately 3 mm to 5 mm from the nail bed, at the point where the finger begins to curve. This area of the finger is highly vascularized, yet relatively insensitive to pain.

Collecting Blood from the Finger

Apply Drop of Blood to Filter Paper• Touch a filter paper circle to the

blood drop.

• Fill the first circle completely before going to the next one. Make sure the entire circle is soaked all the way through to the back of the filter paper.

• Fill the circles from just the front side. Do not turn the filter paper over to apply blood.

• Take care not to make direct contact between the wound and the filter paper.

• If you are not able to get at least one circle completely filled, you will need to start again with a second lancet. Go through the procedures carefully again, starting with an unused circle.

Valid Specimen Invalid Specimen

After the circles have been filled, the finger should be elevated, and pressure should be applied with a gauze pad or cotton until the bleeding stops.

Allow the Paper to Dry• Do not rest the filter paper on

a flat surface.

• Place it over the edge of a book or a table to dry.

• Let the filter paper dry at room temperature for at least one to four hours—or overnight if necessary— until completely dry.

• Remember, do not refrigerate.

Prepare the Kit for TestingAfter the blood is completely dry, return the filter paper kit to the

protective return envelope and seal it. Mail it as soon as possible (within three days).

Send the Filter Paper Kit in the Enclosed Protective Envelope for Testing to:Alpha1Center 1060 E. 100 South, Suite 109 Salt Lake City, UT 84102

If you have any trouble understanding the instructions, or if you have difficulty with the procedure, you may contact the Alpha1Center through the website at www.alpha1center.com or call us toll-free for assistance at (888) 401-1400.

Applying Blood to the Filter Paper

Circle is properly filled with blood and saturated through to back of filter paper

One good circle is better than several

partially filled circles!

Let dry at least

1-4 hours

Specimen quantity insufficient for testing; circle not properly filled to line

Specimen not saturated through to back of filter paper

FRONT FRONT FRONT

BACK BACK BACK

HYL2515C 051631

To order additional AlphaTest Kits, please call 1-888-926-6099

or order online at www.alpha1health.com

AlphaTest® Kit

Fingerstick Blood Collection Device for Detection of Alpha1-Antitrypsin Deficiency (AATD)