Phosphorus Covid-19 Test Home Collection Kit DTC Instructions

Phosphorus Covid-19 Test Home Collection Kit DTC Instructions

For In Vitro Diagnostic Use and For Use Under Emergency Use Authorization Only. Must be 18+ to use.

Read and follow these instructions carefully for your COVID-19 test to be properly completed.

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. Follow directions for use. Keep out of reach of children. Avoid contact with skin and eyes. Wash with water if stabilizing liquid  comes in contact with eyes or skin. If irritation persists, seek medical advice. Do NOT ingest stabilizing liquid. It is recommended to use eyewear when performing the collection procedure.

REGISTER YOUR KIT

Please scan this QR code or visit covid-19.phosphorus.com/register to complete the registration process. The lab cannot process your sample if this step is missed. The medical information you provide will be reviewed by an independent physician.

DO NOT eat, drink (including water), smoke, or chew gum for 30 minutes before giving a saliva sample.

To ensure timely receipt of your kit and sample, drop off your completed test kit with FedEx on the same day you collect your sample.

Samples received more than 56 hours after collection cannot be processed.

COLLECTION KIT CONTENTS

• Phosphorus Kit Box
  

• FedEx Clinical Pak
  

• Biohazard Bag and Absorbent Pouch
  

• DNA Genotek OGD-510 Saliva Collection Device
  

• At-Home Step-By-Step Instructions
  

• Fact Sheet for Individuals
  

REGISTER YOUR KIT

You must register your kit at covid-19.phosphorus.com/register before you collect your saliva sample. The lab cannot process your COVID-19 test if this step is not completed.

The 14-digit bar code on your sample collection tube must be entered online to begin the registration process.

COMPLETE MEDICAL QUESTIONNAIRE

Complete the medical questionnaire, record your sample collection time, and finalize your kit registration. You must complete the registration process and record the date and time of sample collection.

COLLECT YOUR SAMPLE

Once you have completed the online registration process, you may collect your sample using the provided saliva collection device.

First wash your hands for 20 seconds with soap, and follow the instructions provided with the saliva collection device. After collecting your sample, wash your hands again for 20 seconds with soap.

PLACE IN BIOHAZARD BAG

Place your filled sample tube into the absorbent pouch, and then place the assembled pouch into the biohazard bag and seal the bag. Place the sealed biohazard bag, containing the tube and pouch, into the Phosphorus kit box.

Wash your hands for 20 seconds with soap after placing the sample in the pouch. Ensure the Phosphorus kit box contains the biohazard bag with the saliva sample inside.

SHIP WITH FedEx

Place the kit within the included FedEx Clinical Pak and drop off or schedule a FedEx pickup to mail your COVID-19 test to Phosphorus.

Drop your package at the nearest FedEx store or call 1.800.463.3339 to schedule a same-day pickup with FedEx.

WE PROCESS YOUR SAMPLE

Once your test kit arrives at our lab in Secaucus, NJ, our technicians begin processing your saliva sample. Your results will be ready within 72 hours of the lab receiving your sample, and a member of our clinical team will notify you of your result.

Should you have any questions about your results, you will have the option to speak with the physician who reviewed your online registration. If positive, inconclusive, or invalid results are generated, you will receive a follow-up phone call by our independent physician network for a recommended course of care and appropriate follow-up action.

What’s Included

• Fact Sheet for Individuals

• At-Home Step-By-Step Instructions

• DNA Genotek OGD-510 Saliva Collection Device

• Absorbent Pouch

• Biohazard Bag

• FedEx Clinical Pak

Support

Questions about collecting your specimen?

Please get in touch.
www.phosphorus.com
support@phosphorus.com
855.746.7423

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