Predicine SARS-CoV-2 RT-PCR COVID-19 Collection Kit Instructions

: June 4, 2024
: Predicine

Table of Contents

COVID-19 Collection Kit Instructions (Individual)
COVID-19 Collection Kit Instructions (Bulk)
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Predicine SARS-CoV-2 RT-PCR COVID-19 Collection Kit

COVID-19 Collection Kit Instructions (Individual)

Thank you
for taking your frst step in
being safe with us!

This collection kit is suitable for the following individuals:
For Use by Individuals 18 Years of Age and Older When Self-collected
For Use by Individuals 14-17 Years of Age when Self-collected Under Adult Supervision
For Use by Individuals 2-13 Years of Age when Collected with Adult Assistance
FOR Rx USE ONLY | FOR IVD USE | FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY

Step 1: Inspect Your Test Kit

Please read these instructions carefully before you start to collect the sample

IMPORTANT: Drop of your sample within the same day of your collection. Do NOT register, collect, or drop of your sample on a Saturday or Sunday.

Inspect your test kit to ensure all components are included:

****Nasal swab

| Collection tube| Biohazard bag|

Specimen Return Instruction
(provided by facilitor of your testing program)

---|---|---|---

Step 2: Register Your Test Kit

Before collecting your sample, use your personal device to the sample register at https://covid19-test.predicine.com/activate or scan the QR code below with you camera app.
If registration is successful, a comfrmation email will be sent. If you do not receive a comfrmation email please contact us at covid19-test@predicine.com

If you have any questions, contact us at:
covid19-test@predicine.com or 650-300-2188
You can also check out our FAQ page at: https://covid19.predicine.com/#FAQ

Step 3: Collect Your Sample

IMPORTANT: Before collecting your sample: 1. Thoroughly wash and dry your hands & 2. Do not rinse your nasal cavity.

Warning:

Small cap may pose choking hazard; keep out of reach of children when not in use.
You may experience sneezing, coughing or tearing during the sample collection.
The tip can ONLY touch the inside of the nostril.

Take out nasal swab

Pull out the nasal swab from the wrapper by pulling the two ends of the wrapper apart (like you would to open a band-aid). Be careful to only touch the handle, not the t ip.

Swab nose

Gently insert the entire soft tip of the swab into one nostril until you feel a bit of resistance and rub it in a circle around your nostril 4-5 t imes. Repeat in other nostril.

Break off swab handle at the notched breakpoint on the handle

Open the collection tube. Place the swab, tip first, into the collection tube. Break off the swab tip at the notched breakpoint by bending back and forth at the top of the tube.
The broken off handle can be discarded. Seal the collection tube using the same cap. Do not over-tighten the cap.

Step 4: Pack and Drop Of Your Sample

IMPORTANT: After collecting your sample: Thoroughly wash and dry your hands.

Place tube in biohazard bag

Place the sealed tube into the biohazard bag and seal the bag

Drop-of specimen (See Specimen Return Instructions)

Drop-of the specimen at a drop-of location ideally the same day that the specimen was collected – but no later than 24 hours after collecting the specimen. DO NOT drop-of the specimen if the drop-of location is closed. See the Specimen Return Instructions provided by the facilitator of the testing program.

Step 5: Checklist

IMPORTANT: If you cannot check all of the boxes below, your sample cannot be processed

IMPORTANT: Results are expected to be delivered within 48 hours after sample receipt. Please contact us if you do not receive results within this time period.
Results will be delivered electronically by text or email with a link to view your report. A text or phone call is made for all positive, invalid, or rejected specimens.
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product 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 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.

COVID-19 Collection Kit Instructions (Bulk)

Thank you
for taking your frst step in
being safe with us!
This collection kit is suitable for the following individuals:
For Use by Individuals 18 Years of Age and Older When Self-collected
For Use by Individuals 14-17 Years of Age when Self-collected Under Adult Supervision
For Use by Individuals 2-13 Years of Age when Collected with Adult Assistance
FOR Rx USE ONLY | FOR IVD USE | FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY