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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 |
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- Birth
date |
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- Date blood
drawn |
| Physician's |
- Name and
full address |
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- 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
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