FDA COVID-19 Self-Collected Antibody Test System Collection Kit Instructions
- June 6, 2024
- FDA
Table of Contents
COVID-19 Self-Collected Antibody Test System
Collection Kit Instructions for Use
For prescription use only
For use by individuals age 18 years or older or by adults collecting specimens
from individuals 5 years of age and older
Poorly collected blood samples may not be used for testing.
Video instructions are available at https://youtu.be/6_BDCiFwb8A
Prep your area first
Layout the contents of the kit in front of you.
Dried blood spot (DBS) card Clearly label the card with your full name
and today’s date.
Alcohol wipes Open packages and places wipe on the table.
Sterile gauze
Open packages and place gauze on the table.
Adhesive bandage
Open packages and place bandages on the table.
Pressure activated lancets
Remove the clear cap from one safety lancet.
Biohazard bag
Open the bag and keep the desiccant package inside.
Return envelope
Place on table in preparation for Step 9.
Step 1
We recommend the following steps be completed before collection:
In preparation:
– Drink plenty of water
– Wash hands with soap and warm water.
– Rub hands together to warm hands or windmill arm 5-10 times.
Step 2
Open the dried blood spot card.
Lay it vertical with the spots in the direction of the hand you will collect
from.
Step 3
Use the middle or ring finger.
Disinfect the sides on the tip of the finger with the provided alcohol wipe
and allow it to dry for at least 15 seconds.
Step 4
Place the red end of the lancet on either side of your fingertip.
Apply gently steady pressure against the fingertip to activate the lancet
mechanism.
You will hear a click and then it will automatically retract afterward. Set
the safety lancet down.
Step 5
Allow full drop of blood to collect on the finger. Use provided gauze pad to
wipe away the first drop.
Allow blood to collect, and lightly touch the card with the blood.
Note: Do not press your finger onto the card.
Step: 6
Completely fill 2 circles only.
If you do not have enough blood from the first fingerstick, use the additional
lancet and a different finger to collect another sample, if necessary.
Step 7
When finished, hold the gauze on the fingertip to stop the bleeding.
Use the provided bandage.
Leave the card open and allow 30 minutes to dry before closing the flap.
Step 8
Dispose of used material in the trash.
Samples must be completely dry before proceeding to step 9.
Samples that do not completely fill the circles (as shown on the right) or are
not dry may not be used for testing.
Step 9
Mail samples same day as collection.
On the same day you collect your sample:
- Close the card and place in the provided biohazard bag with a desiccant packet.
- Place in the return mailer with the pre-paid label.
- Drop in the nearest USPS mailbox.
Testing services performed by Symbiotica, Inc. elicity® is a registered trademark of InTeleLabs, Inc.
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This self-collection kit is used as part of a test system. This test system has not been FDA cleared or approved but has been
authorized for emergency use by FDA under a EUA for use by Symbiotica Inc., located at 1350 Burton Drive, Vacaville, CA 95687; -
This test system has been authorized only for detecting IgG antibodies to SARS-CoV-2, not for any other viruses or pathogens; and
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The emergency use of this test system is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Questions or Concerns? Contact Symbiotica, Inc. at [email protected] or call 818-808-9192.
TEST-19-ATT-A, v3.0