EasyManua.ls Logo

Amazon COVID-19 Test Collection Kit - User Manual

Amazon COVID-19 Test Collection Kit
4 pages
Save Page as PDF
Print Icon
To Next Page IconTo Next Page
To Next Page IconTo Next Page
Loading...
Important: Read all instructions thoroughly before you start.
Your test kit includes a biohazard bag, test tube and nasal swab. If
you run into problems with your test kit, wipe down the area and
discard kit in the waste bin at check-in station. Get a new kit.
Put on gloves. Wipe the station
with disinfecting wipes. Then use
hand sanitizer.
Remove the lid from the tube.
Place the tube in the holder.
Do not spill the fluid in the tube!
Open the swab pouch and remove
from the package. Hold at the bottom.
Do not touch the soft tip!
Lower mask below your nose.
Keep your mouth covered.
Swab first nostril.
Insert the soft end of the swab 1 inch.
Rub the swab slowly against the inside
walls of your nostril at least 4 times.
This should take about 15 seconds.
Repeat in other nostril.
Place swab into the tube. Break
at the indicator line by bending
back and forth against the tube.
Tightly recap the tube.
Then place mask to cover your
nose.
Place the tube into bag.
Remove air and seal the bag.
Wipe the station and chair
with disinfecting wipes.
Put gloves and trash in the
waste bin at your station. Keep
your sample.
Put your sample in the
collection bin as you exit.
Do not spill the fluid in the tube!
Amazon COVID-19 Collection Kit | Questions: covid19testing@amazon.com
For use under emergency use authorization only. For prescription use only. For in vitro diagnostic use. For use by individuals 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 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 Cosmetics Act,
21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Question and Answer IconNeed help?

Do you have a question about the Amazon COVID-19 Test Collection Kit and is the answer not in the manual?

Summary

COVID-19 Test Collection Procedure

Prepare Testing Station and Personal Protective Equipment

Don gloves, wipe the station with wipes, and use hand sanitizer before starting.

Prepare Collection Tube and Swab

Remove tube lid, place tube in holder, open swab pouch, avoid touching soft tip.

Nasal Swabbing Technique

Lower mask, swab first nostril 1 inch, then repeat in the other nostril.

Prepare Sample for Transport

Place swab in tube, break handle, recap, seal tube in bag, and clean station.

Kit Contents and Important Reminders

Included Items

Overview of kit components: Instructions, Nasal swab, Collection tube with saline, Plastic bag.

Key Reminders for Sample Collection

Register kit, wash hands, return sample within 24 hours, collection takes <10 min.

Registering and Collecting Your Sample

Register Your Kit Online

Visit amazondx.com or scan QR code to sign in or create an account.

Confirm Test Details

Verify name and date of birth, enter collection tube ID for confirmation.

Collect Sample

Read instructions, seat yourself, avoid touching swab tip or fluid.

Swabbing Instructions

Open swab pouch, swab each nostril 1/2-3/4 inch with circular motion for 15 seconds.

Finalizing Sample and Returning Kit

Secure Swab and Tube

Place swab in tube, break handle, recap tightly, and ensure no fluid spills.

Prepare Tube for Bag

Place sealed tube inside the plastic bag, remove excess air, and seal the bag.

Return Your Sample

Drop off sealed bag at worksite within 24 hours for processing.

Summary

COVID-19 Test Collection Procedure

Prepare Testing Station and Personal Protective Equipment

Don gloves, wipe the station with wipes, and use hand sanitizer before starting.

Prepare Collection Tube and Swab

Remove tube lid, place tube in holder, open swab pouch, avoid touching soft tip.

Nasal Swabbing Technique

Lower mask, swab first nostril 1 inch, then repeat in the other nostril.

Prepare Sample for Transport

Place swab in tube, break handle, recap, seal tube in bag, and clean station.

Kit Contents and Important Reminders

Included Items

Overview of kit components: Instructions, Nasal swab, Collection tube with saline, Plastic bag.

Key Reminders for Sample Collection

Register kit, wash hands, return sample within 24 hours, collection takes <10 min.

Registering and Collecting Your Sample

Register Your Kit Online

Visit amazondx.com or scan QR code to sign in or create an account.

Confirm Test Details

Verify name and date of birth, enter collection tube ID for confirmation.

Collect Sample

Read instructions, seat yourself, avoid touching swab tip or fluid.

Swabbing Instructions

Open swab pouch, swab each nostril 1/2-3/4 inch with circular motion for 15 seconds.

Finalizing Sample and Returning Kit

Secure Swab and Tube

Place swab in tube, break handle, recap tightly, and ensure no fluid spills.

Prepare Tube for Bag

Place sealed tube inside the plastic bag, remove excess air, and seal the bag.

Return Your Sample

Drop off sealed bag at worksite within 24 hours for processing.

Overview

  1. Function Description
  2. Usage Features
  3. Preparation and Safety
  4. Sample Collection Process (On-Site Supervised)
  5. Sample Collection Process (Self-Collection)
  6. Important Reminders for Self-Collection
  7. Maintenance Features

This document outlines the procedures for using the Amazon COVID-19 Test Collection Kit, designed for on-site sample collection. It provides instructions for both supervised collection at a testing station and self-collection, emphasizing safety, accuracy, and proper handling of the kit components.

Function Description

The Amazon COVID-19 Test Collection Kit is an in vitro diagnostic device intended for the collection of nasal swab samples to detect nucleic acid from SARS-CoV-2. It is authorized for emergency use by the FDA for individuals 18 years of age or older. The primary function of the kit is to enable individuals to collect their own nasal swab sample, which is then processed by authorized laboratories to determine the presence of the virus. The kit includes a nasal swab, a collection tube with saline solution, and a biohazard bag for safe transport of the collected sample.

Usage Features

The kit is designed for user-friendly operation, with clear, step-by-step instructions to guide the user through the collection process.

Preparation and Safety:

  • Initial Setup: Before starting, users are instructed to carefully read all instructions. At a testing station, this includes putting on gloves, wiping down the station with disinfecting wipes, and using hand sanitizer. For self-collection, users must wash and dry their hands thoroughly with soap and warm water for 20 seconds, and clean the collection surface.
  • Kit Components: The kit includes a nasal swab, a collection tube with saline, and a biohazard bag. Users are warned not to touch or drink the fluid in the tube and to rinse with water if it comes into contact with eyes or skin.
  • Mask Usage: During on-site collection, users are reminded to keep their mask on, covering their mouth at all times, and to lower it only below the nose when swabbing. For self-collection, the mask should remain on, covering the mouth, when the face mask is lowered below the nose for swabbing.
  • Handling Precautions: A critical safety feature is the instruction not to touch the soft tip of the nasal swab. If the swab tip touches any surface other than the inside of the nostril, the kit must be discarded, the area cleaned, and a new kit requested. Similarly, if the fluid in the collection tube is spilled, the area must be cleaned, the kit discarded, and a new one obtained.

Sample Collection Process (On-Site Supervised):

  1. Read Instructions: Users begin by reading all instructions.
  2. Sanitize Station: Put on gloves, wipe the station with disinfecting wipes, and use hand sanitizer.
  3. Prepare Tube: Remove the lid from the collection tube and place the tube in its holder. Users are explicitly warned not to spill the fluid.
  4. Open Swab: Open the swab pouch from the handle end, remove the swab, and hold it by the bottom. The soft tip must not be touched.
  5. Lower Mask: Lower the mask below the nose, keeping the mouth covered.
  6. Swab First Nostril: Insert the soft end of the swab 1 inch into the nostril. Rub the swab slowly against the inside walls of the nostril at least 4 times, taking approximately 15 seconds.
  7. Swab Second Nostril: Repeat the swabbing process in the other nostril using the same swab. After swabbing both nostrils, the mask should be placed back to cover the nose.
  8. Place Swab in Tube: Insert the swab into the collection tube. Break the swab handle at the indicator line by bending it back and forth against the tube until it breaks. Tightly recap the tube, ensuring no fluid spills.
  9. Seal Sample: Place the capped tube into the biohazard bag, remove excess air, and seal the bag.
  10. Dispose of Waste: Wipe the station and chair with disinfecting wipes. Put gloves and all trash into the waste bin at the station.
  11. Submit Sample: Place the sealed sample bag into the designated collection bin upon exiting.

Sample Collection Process (Self-Collection):

  1. Register Kit Online: Users must register their kit online at amazondx.com or by scanning a QR code. This step is crucial for receiving results.
  2. Confirm Details: Verify personal details and enter the collection tube ID.
  3. Press "Register Kit": Confirm registration. Sample collection should occur immediately after registration, ideally within 10 minutes.
  4. Wash Hands: Wash hands thoroughly with soap and warm water for 20 seconds and clean the collection surface. Hand sanitizer can be used if a sink is unavailable.
  5. Open Swab Pouch: Peel back the tab on the handle end to remove the nasal swab. Hold by the handle, avoiding contact with the soft tip. Discard the pouch.
  6. Swab First Nostril: Insert the soft tip of the swab 1/2 - 3/4 inch into the nostril. Rub in a slow circular motion against the inside walls at least 4 times, for about 15 seconds.
  7. Swab Second Nostril: Repeat the previous step in the other nostril using the same swab.
  8. Place Swab in Tube: While holding the swab, open the collection tube. Place the tube cap with the flat top down on a clean surface. Insert the swab, soft tip down, into the tube. Do not spill the fluid.
  9. Break Swab Handle: Hold the tube firmly. Bend the swab handle at the indicator line back and forth against the collection tube until it breaks. Discard the broken swab handle.
  10. Recap Tube: Tightly recap the tube, ensuring no fluid spills. Wash hands or use hand sanitizer.
  11. Seal Sample: Place the sealed tube inside the plastic bag. Release excess air and seal it shut. Clean the surface area with a disinfectant.
  12. Checklist: Before returning the bag, users must confirm they have registered the kit, collected a sample from both nostrils, ensured the nasal swab only touched nostrils, and did not spill fluid. If any box is unchecked, the test cannot be processed, and the kit must be discarded for a new one.
  13. Drop Off Sample: Drop off the sealed bag at the designated worksite within 24 hours of collection. Updates will be received via email/SMS.

Important Reminders for Self-Collection:

  • Registration is Mandatory: Results cannot be obtained without kit registration.
  • Hand Hygiene: Hands must be washed or sanitized before collection.
  • Timely Return: The sample kit must be returned to the worksite within 24 hours of collection; late samples cannot be processed.
  • Collection Time: Sample collection should take less than 10 minutes.
  • Support: For questions, users can visit amazondx.com/testing-faq or email covid19testing@amazon.com.

Maintenance Features

The kit itself is a single-use device, so there are no ongoing maintenance requirements for the kit components. However, the instructions emphasize cleanliness and proper disposal, which can be considered maintenance of the testing environment and overall process integrity:

  • Disinfection: Disinfecting wipes are provided or recommended for cleaning the testing station and chair before and after use. This ensures a sterile environment for sample collection and prevents cross-contamination.
  • Waste Disposal: All used gloves, disinfecting wipes, and other trash (e.g., swab pouch, broken swab handle) must be placed in a designated waste bin. This ensures proper disposal of potentially contaminated materials.
  • Kit Integrity: Users are instructed to discard the entire kit and request a new one if the swab tip touches any surface other than the nostril, or if the fluid in the collection tube is spilled. This maintains the integrity of the sample and prevents inaccurate results.
  • Storage: While not explicitly stated as a maintenance feature, the implicit instruction to return the sample within 24 hours suggests that the kit components and collected sample are designed for short-term stability under typical environmental conditions until laboratory processing.

In summary, the Amazon COVID-19 Test Collection Kit is a comprehensive system designed for efficient and safe self-collection or supervised collection of nasal swab samples for SARS-CoV-2 detection. Its usage features prioritize user safety, sample integrity, and clear procedural guidance, while its maintenance aspects focus on environmental hygiene and proper disposal of materials.

Amazon COVID-19 Test Collection Kit Specifications

General IconGeneral
Prescription RequiredNo
FDA AuthorizationEmergency Use Authorization (EUA)
Sample TypeNasal swab
Test TypePCR
Results TurnaroundResults typically within 24-48 hours from the lab receiving your sample
Age Requirement18 years and older
ComponentsNasal swab, instructions, prepaid shipping label
Intended UseThe Amazon COVID-19 Test Collection Kit is intended for self-collection of nasal swab specimens at home or in a healthcare setting from individuals 18 years of age and older with symptoms of COVID-19, or who have been exposed to someone with COVID-19.