Alimetrix COVID-19 Home Collection Kit Instructions
- June 6, 2024
- Alimetrix
Table of Contents
ALIMETRIX COVID-19 HOME COLLECTION KIT
SAMPLE COLLECTION INSTRUCTIONS
CONTENTS
Prepare
- Read and understand the instructions prior to beginning the collection process.
- It is important to follow these instructions so that your test result is accurate.
- Open your kit and place all the contents on a clean, dry surface.
Label collection tube
- IMPORTANT: Write PATIENT NAME, DATE OF BIRTH, & DATE OF COLLECTION on Kit ID barcode label. (fig A)
- Place label on sample collection tube, the barcode should go along the length of tube. (fig A)
Ready the swab
- Wash and dry your hands.
- Open swab packaging (fig B); leave the swab in the packaging.
- Remove the cap from the collection tube and place cap upright on the counter.
- While continuing to hold the collection tube, grasp the handle of the swab with the other hand and remove it from its packaging. (fig C)
- Do not touch the tip of the swab.
- The tube contains liquid. Take care not to splash, spill, or drink the liquid.
Collect your sample
- Tilt head back, insert swab until resistance is felt and no more than one inch, do not force the swab or injury may occur.
- Rotate the swab in a circle around the entire inside edge of your nostril at least 5 times. (fig D)
- Remove the swab and repeat using the same swab in the other nostril. (fig E)
- Place the swab directly into the tube. Take care to not touch the swab to anything in the environment. (fig F)
- Rotate swab 5 or more times in the solution. (fig F)
- Carefully snap off the handle of the swab at the narrow breakpoint line against the tube wall. (fig G)
- Discard the snapped-off handle.
- Reapply cap to the collection tube with a swab inside. (fig H)
- Seal tube cap tightly to avoid leaking during transport.
- Wash and dry your hands
Return your sample
- Wrap sample collection tube in the absorbent pad and place wrapped sample collection tube into the biohazard bag and seal bag.
- Place the biohazard bag containing the collection tube into the Alimetrix kit box; close box.
- You will be instructed to either return kit box to your provider or to ship the kit box with FedEx (see step 6 on back).
- Return sample on the same day of collection.
FedEx shipping instructions
If instructed by your medical provider to ship with FedEx:
- Ship samples on the same day of collection.
- Place kit box in the pre-paid FedEx pak provided to you by your medical provider.
- Seal FedEx shipping pak.
- Ship sample using FedEx Express.
For In Vitro Diagnostic Use Only.
For Prescription Use Only.
For Use Under an Emergency Use Authorization (EUA) Only.
For Use by 18 Years of Age or Older.
This product has not been FDA cleared or approved but has been authorized for
emergency use by FDA under a EUA;
This product has been authorized only for the home collection and maintenance
of mid-turbinate nasal swab 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.
QUESTIONS?
alimetrix.com
Email: [email protected]
Toll-Free: 1-844-443-6663
800 Hudson Way
Huntsville, AL 35806