VIVERA + OMECARE

HOME SPECIMEN COLLECTION KIT
FOR IN VITRO DIAGNOSTIC USE

BEFORE YOU START

PLEASE READ ALL OF THE INSTRUCTIONS BEFORE BEGINNING COLLECTION

DO NOT USE TEST IF THE BOX SEAL IS BROKEN

• You will need access to a device and Internet to retrieve results •

1 Your box contains everything you need to collect your sample and return the sample to the lab for processing. Do not dispose of the blue COVx-HT box. You will use this box to return your sample to the lab.

2 Wash and dry your hands. Open the COVx-HT box and remove the swab package, specimen bag, and collection tube. Place the items on a clean dry surface. Set the COVx-HT box to the side.

3 Take one of the sterile swabs out of the package. Hold the swab by the stem, and do not touch the ends of the swab. Set the package of swabs to the side.

4 Using your other hand, gently unscrew the cap from the collection tube. Hold the tube in your hand. Do not spill the liquid. Do not drink the liquid.

5 Insert the tip of the swab in your right nostril until the cotton is not visible. Rotate the swab in a circle against the inside of your right nostril at least 4 times. Take the swab out of your nostril.

6 Using the same side of the swab insert the swab into your left nostril and repeat Step 4. A damp sample is required. NOTE: If your sinuses are unusually dry, you may need to try collecting the sample again with a new swab, repeating Step 4 and Step 5.

7 Place the swab into the collection tube with the side that went into your nose placed into the liquid. Screw the tube cap back on to reseal the collection tube. Be sure to tighten the cap securely.

8 Carefully set down the tube. Wash and dry your hands. Insert the collection tube into the specimen bag. Seal the specimen bag by removing the protective strip and folding the bag over onto the adhesive.

9 Remove the envelope from the COVx-HT box. Place the sealed specimen bag in the COVx-HT box and close the lid. Place the box inside the envelope, remove the adhesive cover strip, and seal the envelope closed.

10   Return your sample the same day, but no later than 24 hours after you have collected your sample. Please double check your carrier prior to drop off and obtain a receipt.
11 You will receive a confirmation email once your sample arrives at the lab. General processing times are within 48-72 hours from intake.

12When your test results are ready you will receive a secure download link via email. Simply visit the link, provide the required authentication information, and download your report.

THE KIT INCLUDES:

  • 1 Collection Tube Filled with Saline
  • 1 Pack of Five Sterile Cotton Swabs
  • 1 Biohazardous Specimen Bag
  • 1 COVx-HT Package
  • 1 Return Envelope
  • 1 Instructions For Use

Distributed by

Vivera Pharmaceuticals, Inc

26021 Pala Drive, Suite A

Mission Viejo, CA 92691

This home collection kit has not been FDA cleared or approved.
This home collection kit has been authorized only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
This home collection kit in combination with the authorized test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/ or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner