A TEST FOR ALPH1-ANTITRYPSIN DEFICIENCY

 

 

 

 

 

 

 

 

 

 

 

 

 

 


One good circle is
better than several
partially filled ones!


Valid Example


Invalid Examples

Purpose
This 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, specified 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.

Material 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 by not provided
Sterile gauze pads
Sterile gloves

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

When the device is held against the target incision area of the skin and triggered, 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 cure. This area of the finger is highly vascularized, yet relatively insensitive to pain.

The Incision
To 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 its plastic packet, taking care not to touch or contaminate the blade-slot surface or contoured end of the device.

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 sterile gauze pad. Apply gentle pressure to the finger to encourage blood flow. Do not squeeze or "mild" 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.
Fill the circles from just the front side.
Note that the blood should soak completely through the filter paper. 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.

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

Valid Specimen
Circle is properly filled with blood

Invalid Specimen
Specimen quantity insufficient for testing

Specimen appears supersaturated

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 hour, or until completely dry.
Remember, do NOT refrigerate.

Prepare the Kit for Testing
After 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 3 days).

Storage and Stability
Prior to use, the filter paper kit should be kept in its preaddressed 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, 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.

Get Ready
Enter all of the requested information:

Patient's - Name
- Birth date
- Date blood drawn
Physician's - Name and full address
- Phone and FAX numbers

Fill out the back page.

Tear out the second sheet of paper from the filter paper kit (the "Physician's Office Copy"), and save for your records. This will expose the circles on the filter paper.

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

 


© 2005, Alpha1Center and HerediLab, Inc. All rights reserved.