Symbiotica & InTeleLabs: at-home sampling - YouTube
Instructions for FDA models including: COVID-19 Self-Collected Antibody Test System Collection Kit
Collection Kit Instructions for Use. For in vitro diagnostic only ... Video instructions are available at https://youtu.be/6 BDCiFwb8A. Prep your area first.
Collection Kit Instructions for Use For in vitro diagnostic only For prescription use only For Emergency Authorization Use Only For use by individual s age 18 years or older or by adults ...
File Info : application/pdf, 1 Pages, 139.86KB
DocumentDocumentPrep your area first Lay out the contents of the kit in front of you. COVID-19 Self-Collected Antibody Test System Collection Kit Instructions for Use For in vitro diagnostic only For prescription use only For Emergency Authorization 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 usable for testing. Video instructions are available at https://youtu.be/6_BDCiFwb8A Dried blood spot (DBS) card Clearly label the card with your full name and today's date. Alcohol wipes Open packages and place wipes on the table. 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. Open the dried blood spot card. Lay it vertical with the spots in the direction of the hand you will collect from. 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 at least 15 seconds. Sterile gauze Open packages and place gauze on the table. Adhesive bandage Open packages and place bandages on the table. Pressureactivated 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. Place the red end of lancet on either side of your fingertip. Apply gently steady pressure against the fingertip to activate lancet mechanism. You will hear a click and then it will automatically retract afterwards. Set the safety lancet down. 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 flap. 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. 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. 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 usable for testing. Mail samples same day as collection. On the same day you collect your sample: 1. Close the card and place in the provided biohazard bag with desiccant packet. 2. Place in the return mailer with the pre-paid label. 3. Drop in the nearest USPS mailbox. · 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 an 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 · 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 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 info@symbioticalabs.com or call (818) 808-9192. TEST-19-ATT-A, v3.0