P23 LABS At-Home COVID-19 Test Collection Kit Instructions
- June 6, 2024
- P23 LABS
Table of Contents
P23 LABS At-Home COVID-19 Test Collection Kit
INSTRUCTIONS FOR PATIENTS
Complete COVID-19 Medical Questionnaire and obtain a prescription for the P23 At-Home Covid-19 Test Collection Kit
The process starts with the Healthcare Professional (HCP) ordering the P23 At- Home Covid-19 Test Collection Kit for you and scheduling an appointment for your specimen collection. The HCP ordering the P23 At-Home Covid-19 Test Collection Kit will initiate one of two options:
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The HCP will provide a P23 At-Home Covid-19 Test Collection Kit and shipping supplies directly to you.
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P23 Lab will ship a P23 At-Home Covid-19 Test Collection Kit overnight directly to your home after you authenticate your order (Step 2 below). A valid email address will be required.
Authenticate your order
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Go to P23 Lab’s website at www.P23Labs/covid19
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Verify your identity by uploading your driver license or a current photo of yourself.
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You will be prompted for a response to the following question:
Did you elect to receive a P23 At-Home Covid-19 Test Collection Kit via the HCP’s office?- If the answer is yes, do you have a scheduled appointment for your supervised specimen collection? The specimen collection and packaging must be supervised by a HCP.
- If the answer is no, contact your HCP to schedule your specimen collection appointment.
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If payment is required, you will be asked to pay at this time.
Receive your P23 At-Home Covid-19 Test Collection Kit
Once you have received your P23 At-Home Covid-19 Test Collection Kit, initiate the following steps.
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Go to P23 Lab’s website at www.P23Labs/register
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Inspect your P23 At-Home Covid-19 Test Collection Kit to ensure all components are included.
- Locate your unique 14-digit barcode on the collection tube and register your P23 At-Home Covid-19 Test Collection Kit by entering the barcode on the secure patient portal.
IMPORTANT
Follow all directions carefully to ensure an adequate specimen is collected
for testing.
Do not collect your specimen until your scheduled appointment with your HCP.
Do NOT eat, drink, smoke or chew gum for 30 minutes before giving your saliva
specimen. Do not remove the plastic film on the tube’s funnel.
For questions at any time, please call the laboratory help line at
901-341-6464. Our professionals are
available to guide you.
www.p23labs.com P23 Labs, 500 S. University Ave., Suite 504, Little Rock, AR 72205.
IMPORTANT
Do NOT eat, drink, smoke or chew gum for 30 minutes before giving a saliva
specimen. Healthcare Professionals (HCP) trained according to 49CFR 172.700
can find additional guidance at:
Collection steps: https://www.dnagenotek.com/US/support/collection-
instructions/omnigene-oral/om-505.html Collection video:
https://www.youtube.com/watch?v=l0bkXhjPVlU
Collection appointment
Under the supervision of your HCP during your appointment, you will collect
your saliva specimen.
Note: This may be done in person at the HCP office or via online
Telemedicine.
Specimen collection
Complete the specimen collection with your HCP’s guidance.
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IMPORTANT: Wash your hands thoroughly for 20 seconds then dry your hands before starting the collection.
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Open your P23 At-Home Covid-19 Test Collection Kit and place all of the contents on a clean, dry surface.
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Remove the saliva collection device from its packaging and collect your specimen.
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IMPORTANT: Wash your hands thoroughly for 20 seconds again, then dry your hands after completing the collection.
Specimen shipping preparation with your HCP
- Make sure the cap on your specimen tube is tightly closed. Do not return the funnel.
- Place specimen into the bio hazard bag and press firmly across the closure to securely zip.
- Follow HCP instructions for placing the bagged specimen onto the protective bubble wrap in the shipping box. Place the absorbent sheet on top and close the shipping box lid.
- IMPORTANT: Wash your hands thoroughly for 20 seconds again, then dry your hands after completing the shipping preparation.
- The shipping box goes into the labeled return overpack, remove the adhesive liner and seal the overpack closed.
- Drop off the sealed return overpack containing your specimen at the closest Fedex or UPS depot as determined by the shipping label with P23 Lab’s address. IMPORTANT: Drop off the return overpack at the shipping depot within 24 hours of specimen collection.
Results are ready within 72 hours
Your HCP will contact you when your results are available. For questions at any time, please call the laboratory help line at 901-341-6464. Our professionals are available to guide you.
www.p23labs.com P23 Labs, 500 S. University Ave., Suite 504, Little Rock, AR 72205.
This product has not been FDA cleared or approved, but has been authorized for
emergency use by FDA under an EUA; This product has been authorized only for
the home collection and maintenance of saliva specimens as an aid in detection
of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and,
The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of medical devices 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.
PD-PR-00995 Issue 3/2021-03