GWU COVID-19 Test Home Collection Kit User Guide

June 6, 2024
GWU

THE GEORGE WASHINGTON UNIVERSITY
WASHINGTON, DC

The George Washington University Public Health Laboratory
GWU COVID-19 Test Home Collection Kit
For in vitro diagnostic use under EUA only. For prescription use only. For use by individuals 16 years of age and older.

Instructions for Use
Please read all instructions before collecting your sample

KIT COMPONENTS

Make sure to:

  • Activate your kit via the online form
  • Return sample on the day of collection
  • Collect and return on a weekday

STEP ONE: KIT ACTIVATION

  • On the day you are going to collect your sample, click on the link in the email that was sent to you from phl@gwu.edu with the subject GWU COVID-19 Home Test Kit Activation Link
  • Verify that your name is correct and that the barcode on record matches the kit in your possession. If the barcodes do not match, enter the barcode on your kit into the online Sample Collection form.
  • Record the date and time of your sample collection in the online form.
  • Open your kit, unpack the components, and place them on a clean surface.
  • With a pen or permanent marker, fill out the provided sample label with your GWID, date of birth, and collection date/time.
  • Affix the sample label onto the tube over the manufacturer’s label, so that the barcode runs along the length of the tube.
  • Ensure the online sample collection information you entered matches the information on the label and press “Submit.”

STEP TWO: SAMPLE COLLECTION

Please follow all instructions carefully to ensure acceptable sample collection. Failure to do so may result in incorrect results or the rejection of your sample.

  1. Wash your hands thoroughly with soap and water.
  2. Remove the swab from its package, being careful not to touch the tip of the swab to your hands or any other surfaces.
  3. Insert swab into one nostril approximately one inch, about to where the tip is no longer visible; do not force the swab into your nostril any deeper.
  4. Firmly rotate the swab around the walls of your nostril for 10-15 seconds.
  5. Repeat steps 3 and 4 in your other nostril using the same swab.
  6. Remove the cap of your sample tube.
  7. Without touching the swab tip, place the swab tip down in your sample tube.
  8. Find the breakpoint on the stick of the swab and snap it against the side of the tube.
  9. Replace the cap on the tube and close it firmly.
  10. Place your sample tube inside of the biohazard bag with the absorbent pad; seal the bag. Do NOT remove the absorbent pad.
  11. Place the sealed bag containing your sample into the cardboard box.
  12. Close the box securely.
  13. Wash your hands thoroughly with soap and water.
  14. Place the box in the envelope and seal.
  15. Return your sealed sample kit on the same day that you collected the sample to your designated drop-off location or directly to the lab. If you are unsure of where to drop off your kit, please contact the lab at phl@gwu.edu.

COLLECTION CHECKLIST

Before returning your sample, please check the following:

  • You have activated your kit online and submitted the online form with the correct collection date and time.
  • You have completed the sample label with your GWID, DOB, and collection date/time and affixed it to your sample tube.
  • The swab is sealed inside the sample bag, the sample bag is inside the closed box, and the box is sealed inside the envelope.

QUESTIONS?

If you have any questions about the collection process, please contact the Public Health Lab at phl@gwu.edu.
Your results should be available on your myCHC online portal within 24-48 hours of receipt in the lab.
If at any point you feel any pain or discomfort, please stop collecting immediately and contact the PHL.

This product (collection kit in combination with the authorized test) has not been FDA cleared or approved, but has been authorized for emergency use by FDA under a EUA for use by the authorized laboratory.
This product (collection kit in combination with the authorized test) has been authorized only for the detection of nucleic acid from SARS-COV-2, not for any other viruses or pathogens.
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 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.

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>

Related Manuals