3EO HEALTH COVID-19 Test Medical Countermeasures User Guide

3EO HEALTH COVID-19 Test Medical Countermeasures

Product Information

Specifications:

• Product: COVID-19 Test Kit
• Manufacturer: 3EO HealthTM Inc.
• For use under Emergency Use Authorization (EUA) only
• For in vitro diagnostic use
• For over-the-counter (OTC) use
• Intended for use by individuals with signs and symptoms of Respiratory Tract Infection

Product Usage Instructions

Watch How-to-Test Video:
Before starting the test, watch the instructional video available at 3EOhealth.com/test or scan the QR code provided in the kit.

Your Test Items Overview:
Do not use the test kit beyond the expiration date. Open pouches only when instructed. The kit includes a 3EO Cube, 3EO Key, and 3EO Swab.

Prepare to Test:
Handle the Key and Swab as instructed. Access the eIFU (Instructions For Use) at 3EOHealth.com/eIFU.

Begin Test:

• Step 1: Activate Key
  Wash or sanitize your hands. Activate the Key by swinging it down once with the end facing away from you.

• Step 2: Insert Key
  Insert the Key handle first.

• Step 3: Swab Both Nostrils
  Swab both nostrils gently without exerting excessive force. Ensure the tip does not touch any surfaces.

• Step 4: Remove the Guard from the Swab
  Remove the guard from the Swab and discard it. Hold the Swab by the handle without allowing the tip to contact surfaces.

FAQ

• Q: Can I reuse the test kit?
  A: No, the test kit is for one-time use only. Do not reuse any components.

• Q: What should I do if I encounter difficulties during testing?
  A: If you face any issues during testing, refer to the complete Instructions For Use available at 3EOhealth.com/test or seek assistance from healthcare professionals.

FEATURING

• A HELPFUL VIDEO
  showing you how to test – before you test!

• EASY TO FOLLOW
  step-by-step instructions

• EASY TO USE
  swab, test and reusable reader

• For use under an Emergency Use Authorization (EUA) only.
• For in vitro diagnostic use.
• For over-the-counter (OTC) use.
• For use by Individuals with signs and symptoms of Respiratory Tract Infection.

Hi there!
We know you are eager to dive in and get started!

Before you do, please take a moment to:

• Watch our helpful how-to-test video in its entirety, before you begin testing
• After watching the whole video, follow these instructions step by step
• If you are unable to watch the video, read through this entire Quick Start guide in whole before starting your test
• While following these instructions, pay close attention to the stop warnings – they ensure you don’t miss critical steps in the 3EO testing process

NOW

Watch this video BEFORE you test.
We’ll give you directions on how to scan this QR code on the next page. If you are unable to watch the video.

NEXT

Follow this guide step-by-step to test.

Pay attention to STOP warnings.
STOP warnings ask you to double-check important steps – they are there to help you perform the steps correctly.

Find our complete Instructions For Use and Fact Sheet for Individuals at: https://3EOhealth.com/test.

WATCH OUR HOW-TO-TEST VIDEO

Before you test, watch how it’s done!

• We made a quick video to demonstrate each step of the 3EO testing process. Watch the entire video, then follow these instructions to take the test step by step.
• Please resist the urge to do the test while watching the video for the first time! You will have the best testing experience if you watch first, and then test step-by-step.

To watch the video:

• Go to 3EOhealth.com/test
• Text “TEST” to205-973-2550 to recieve a one-time text with a link to watch the video

SCAN THIS QR CODE

• Open the camera app on your mobile phone
• Hold the camera directly in front of the QR code
• Your camera will “read” the QR code – you won’t take a picture
• Tap the “qr.go3eo.com” link that appears on your screen
• You will be brought to our video located at: 3EOhealth.com/test.

Unable to watch the video?
Continue to the next page.

YOUR TEST ITEMS OVERVIEW

• Your 3EO test has three items that you will use to take your test. Below are the important details for each to help you become familiar before you test.

• Don’t worry – you won’t have to remember these details! We will remind you later, at the correct step on the following pages.

• STOP
  Do not use the test kit beyond the expiration date.

• STOP
  Do not open the Key or Swab pouches until the instructions tell you to do so at the correct step.

3EO Cube

• Place on a clear, clean, flat surface
• Needs to be plugged in to operate
• The power adapter is included

3EO Key

• Once you take the Key out of the pouch, you will hold the Key by its handle
• You will then activate the Key
• Once activated, you will plug the Key into the Cube

3EO Swab

• You will hold the Swab by its handle
• Remove the swab guard only after swabbing
• You will plug the Swab into the Key immediately after removing the guard

PREPARE TO TEST

• Place Cube on a clear, clean, flat surface.
• Plug Cube in.
• All lights will come on.
• Place the Key and Swab
• pouches next to the Cube.
• Put this Quick Start Guide flat in front of you.

You must run the 3EO Health COVID-19 Test at room temperature (between 59°F (15°C) to 86°F (30°C)

BEGIN TEST

STEP 1: ACTIVATE KEY

• Be sure to wash or sanitize your hands before and after testing.
• There is liquid inside the Key. This step helps to ensure proper liquid placement.

To activate Key:

Remove the Key from the pouch when ready to begin testing

• Hold the Key with a pointed end facing away from you.
• Swing arm quickly with force down one time only.
• Do not swing your arm back up.
• Keep the Key pointed down.
• Do not shake the key.

Start

• Hold the Key with a pointed end facing away from you.
• Swing arm quickly with force down one time only.
• Do not swing your arm back up.
• Keep the Key pointed down.
• Do not shake the Key.

STOP
Are you keeping your Key pointed down?

STEP 2: INSERT KEY

• Keep the pointed end of the Key down.
• Line up the handle with the arrow on the Cube.
• Insert the pointed end of the Key into the hole in the Cube.
• Push the Key down firmly until only the READY light glows steady GREEN.
• If the READY light does not glow steady GREEN, check that the Key is inserted fully into the Cube.

STEP 3: SWAB BOTH NOSTRILS

Blow your nose before swabbing to clear excess mucus.

• Peel the pouch to remove the 3EO Swab.
• Remove the Swab, holding it upright by its handle.
• Do not touch Swab on any surface.
• Do not remove the swab guard – you will remove it after swabbing.
• Hold the swab upright by its handle only.
• Be sure the tip of the swab is visible and fingers are not touching Guard.
• Insert Swab 3/4 of an inch in each nostril (1/2 inch if swabbing a child).
• Do 5 circles around the wall of each nostril.
• Make sure the Swab tip touches the inside walls of the nose.

Do not exert excessive force while swabbing or insert the swab beyond the recommended depth.

STEP 4: REMOVE THE GUARD FROM SWAB

• A. Remove the guard from the Swab. Discard guard.
• B. Continue to hold the Swab by the handle.

Do not set the Swab down or allow the Swab tip to come in contact with other surfaces before or after you swab your nose.

STEP 5: INSERT SWAB INTO KEY IMMEDIATELY

• Insert the Swab into the top of the Key immediately after sample collection and remove the Swab Guard.
• Do not attempt to insert a Swab that still has the guard attached.
• Press the Swab firmly down until flat.
• Ensure the Swab is even with the top of Key

STOP
Did you push the swab down flat?

STEP 6: START TEST

• A. Double-check to make sure the top of the Swab is flat and even with the top of the Key.
• B. Press and hold the GREEN button until the READY light starts flashing. If the READY light does not begin flashing, press and hold the GREEN button again.

If you forget to press the GREEN button within 60 minutes of inserting the Swab into the Key, you will need to retest. Remove the Key and Swab from the Cube. Start a new test with a new Key and a new Swab.

STEP 7: GET TEST RESULT

• Your test will take approximately 30 minutes to display a result.
• The GREEN READY light will flash until your result is ready.
• Once ready, your result will be displayed via a steady light on the top of the Cube.
• If you have waited more than 35 minutes and lights are flashing on the top of the Cube, you will need to retest. Go to page 9 for more details.

POSITIVE RESULT

Steady RED light next to POSITIVE

• You likely have COVID-19 and it is important to be under the care of a healthcare provider.
• A positive result means that SARS-CoV-2, the virus that causes COVID-19, has been detected in your sample.
• Consult your healthcare provider for treatment.
• Continue to the next page for more details.

NEGATIVE RESULT

Steady GREEN light next to NEGATIVE

• A Negative Result means that SARS-CoV-2, the virus that causes COVID-19, was not detected in your sample.
• Negative results should be taken within the context of possible exposure and symptoms. A negative result in no way indicates the absence of other respiratory or non-respiratory viruses or other infections.
• Continue to the next page for more details.

POSITIVE RESULT DETAILS

POSITIVE RESULT:
Steady RED light next to POSITIVE

• You likely have COVID-19 and it is important to be under the care of a healthcare provider.
• A positive result means that SARS-CoV-2, the virus that causes COVID-19, has been detected in your sample. Consult your healthcare provider for treatment.
• Those with difficulty breathing or other serious symptoms should seek emergency care immediately. Your healthcare provider will work with you to determine how best to care for you based on your test results medical history and your symptoms.

NEGATIVE RESULT DETAILS

NEGATIVE RESULT:
Steady GREEN light next to NEGATIVE

• A Negative Result means that SARS-CoV-2, the virus that causes COVID-19, was not detected in your sample.
• Negative results should be taken within the context of possible exposure and symptoms. A negative result in no way indicates the absence of other respiratory or non-respiratory viruses or other infections.
• This test can give an incorrect negative result (a false negative) in some people with COVID-19. This means you could still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider your overall health and history to decide how to care for you.
• You must work with your healthcare provider to help you understand the next steps you should take.

Test results should be reported to: https://makemytestcount.com.

WHEN TO RETEST

INVALID RESULT
RED AND GREEN LIGHTS FLASH: The test is invalid

• If both the Positive and Negative lights flash, your test is invalid and must be repeated.
• Unplug the Cube and plug it back in.
• Remove the Key from the Cube.
• Start a new test with a new Key and new Swab, or seek testing by an alternative method.

TEST ERROR
AND LIGHTS FLASH: The test has an error.

• If, at any time, all lights flash, there has been a testing error.
• Unplug the Cube and plug it back in.
• Remove the Key from the Cube.
• Start a new test with a new Key and new Swab, or seek testing by an alternative method.

Find more information on Troubleshooting and Frequently Asked Questions in our Instructions For Use at: https://3EOhealth.com/test.

TEST DISPOSAL

DO NOT BREAK OPEN KEY

THROW KEY AWAY

• After the test is complete, remove the used Key with the contained Swab. Dispose of in a household trash can or per local regulation.
• Care must be taken in disposing of the Key and Swab to not contaminate other surfaces with samples or internal components, for example by forcing open or breaking the Key. Treat all biological samples as capable of transmitting infectious agents.

After each use, wipe the outer surfaces of the Cube with germicidal wipes containing 0.55% sodium hypochlorite as the active ingredient.

INTENDED USE

The 3EO Health COVID-19 Test is a single-use molecular in vitro diagnostic test intended for the qualitative detection of SARS-CoV-2 nucleic acid directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 (i.e., symptomatic). This test is authorized for non- prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal (nares) swab samples from individuals aged two years or older. This test utilizes nucleic acid amplification technology, similar to PCR, for the detection of SARS-CoV-2 RNA, which is generally detectable in anterior nasal swab samples during the acute phase of infection.

Positive results indicate the presence of SARS-CoV-2 RNA, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definitive cause of the disease. Individuals who test positive with the 3EO Health COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or management decisions for the individual, including infection control measures such as isolating from others and wearing masks. Negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19. Individuals who test negative and continue to experience COVID-19-like symptoms of fever, cough, and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow-up care with their physician or healthcare provider.

Individuals should provide all results obtained with this product to their healthcare provider for public health reporting and to receive appropriate healthcare. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities by local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by the CDC. The 3EO Health COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

SUMMARY AND EXPLANATION

• The 3EO Health COVID-19 Test™ is an in-vitro diagnostic molecular test for the qualitative detection of the SARS-CoV-2 virus that causes the COVID-19 disease.
• Samples from anterior nasal swabs are analyzed and results are available within approximately 30 minutes. Each 3EO Health COVID-19 Test Kit contains all components necessary to test for SARS-CoV-2.

WARNING AND PRECAUTIONS

Warnings and Precautions include, but are not limited to:

• Follow directions for use.
• Do not ingest.
• Keep out of reach of children.
• Children aged 2 to 13 years of age should be tested by an adult.
• Do not use it on anyone under 2 years of age.
• Avoid contact with skin and eyes. If contact with the body occurs, rinse with water. If irritation persists, seek medical advice.
• Do not use if packaging is opened or damaged before use.
• Do not use any components with visible damage.
• Do not use the 3EO Key past the expiration date
• Key and Swab are one-time-use items.
• Nasal sprays, gels, or creams should not be used before collecting a sample.
• Avoid eating or drinking 30 minutes prior or smoking 60 minutes before specimen collection.
• Do not move or tilt the Cube during operation. Doing so could lead to false results.
• Do not place the 3EO Cube in direct sunlight.
• Store and use the Key within the below temperature ranges:
  • Storage: between 59°F (15°C) and 86°F (30°C)
  • Use: between 59°F (15°C) to 86°F (30°C)
• Performance of the 3EO Health COVID-19 Test has only been established using the sample types, acquisition, and protocol described here.
• Risks of sample collection include irritation, bleeding, and infection inside the nose.
• This device was not validated for use by individuals with color-impaired vision, including individuals with red/green vision impairment.

1. This product has not been FDA-cleared or approved but has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA).
2. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
3. 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. §360bb-3(b)(1) unless the declaration is terminated or authorization is revoked sooner.

3EO Health™ Inc.
48 Dunham Ridge Rd. Suite 4350 Beverly, MA 01915
+1-844-538-7336 3EOHealth.com.
TM/MC/MR: 3EO Health.

References

• 3EO Health
• MakeMyTestCount

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