COVID-19 TEST

QUICK START GUIDE

FEATURING:

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.

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
Hi there!

DURING

Scan with your phone 

to watch this video 

before you test

3EOHealth.com/test

If unable to watch, see 

included instructions or visit:

qr.go3eo.com

3EOHealth.com/test

Pay attention to 

STOP warnings.

Find our complete Instructions For Use and 

Fact Sheet for Individuals at: 

https://3EOhealth.com/test

STOP

QUICK

START

GUIDE

A

B

C

STOP warnings ask you to 

double check important steps – 

they are there to help you 

perform the steps correctly.

1

• 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

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

NOW

Watch this video 

BEFORE you test.

We’ll give you directions how to 

scan this QR code on the next 

page. If you are unable to watch 

the video, turn to page 3.

NEXT

Follow this guide 

step-by-step to test.
Tap the “qr.go3eo.com” link 

that appears on your 

screen

Before you test, watch how its done!

Unable to watch the video?

Continue to the next page.

2

WATCH OUR HOW-TO-TEST VIDEO

Go to 3EOhealth.com/test

Text “TEST” to (205) 973-2550

to recieve a one-time text with a link to watch the video

OR

OR

Open the camera app A on your mobile phone

SCAN THIS QR CODE

Scan with your phone 

to watch this video 

before you test

3EOHealth.com/test

If unable to watch, see 

included instructions or vis

qr.go3e

3EOHealth.com/test

qr.go3eo.com

B

C

D

E

To watch the video:

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, then test 

step-by-step. 

Hold the camera directly 

in front of the QR code

Your camera will “read” 

the QR code – you won’t 

take a picture

You will be brought to 

our video located at: 

3EOhealth.com/test
STOP

PREPARE TO TEST

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.

You must run the 3EO Health COVID-19 Test at room 

temperature (between 59°F (15°C) to 86°F (30°C)

YOUR TEST ITEMS OVERVIEW

• Place on clear, clean, 

flat surface

• Needs to be plugged 

in to operate

• Power adapter

is included

3

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

Do not open Key or Swab pouches until the 

instructions tell you to do so at the correct step.

• 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

• 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

• Place Cube on clear, 

clean, flat surface.

• Plug Cube in. 

• All lights will come on.

• Place Key and Swab 

• pouches next to Cube.

• Put this Quick Start Guide 

flat in front of you.

3EO Cube 3EO Key 3EO Swab

Arrow

KEY

Handle

Pointed

End

SWAB

Handle

Guard

Tip

B

20-00024 v00

eIFU is available at 

3EOHealth.com/eIFU

KEY Pouch contents: (1) Key

Scan me 

to start 20-00007

For Use Under Emergency 

Use Authorization (EUA) Only

3EO HealthTM Inc.

Beverly, MA 01915 USA

3EOHealth.com

SWAB

3EO HealthTM Inc.

Beverly, MA 01915 USA

3EOHealth.com

20-00023 v00

For Use Under Emergency 

Use Authorization (EUA) Only

Pouch contents: (1) Swab

20-00006

Scan me 

to start

A
To activate Key:

4

STEP 1: ACTIVATE KEY

BEGIN TEST

A

B

Start

• Hold Key with pointed 

end facing away from 

you.

• Swing arm quickly with 

force down one time only.

• Do not swing arm back 

up.

• Keep Key pointed down.

• Do not shake Key.

Start

Stop

Swing down 

one time 

only!

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.

• Remove Key from pouch when ready to begin testing

• Hold Key with pointed end facing away from you.

• Swing arm quickly with force down one time only. 

• Do not swing arm back up.

• Keep Key pointed down.

• Do not shake key.

STOP Are you keeping your 

Key pointed down?
Did you swab

both nostrils?

STOP

5

• 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. 

STEP 2: INSERT KEY

STEP 3: SWAB BOTH NOSTRILS

A

Handle

Pointed

end

• Push the Key down firmly 

until only the READY light 

glows steady GREEN.

• If READY light does not 

glow steady GREEN, check 

that the Key is inserted 

fully into the Cube. 

Blow your nose before swabbing to clear excess mucus.

• Peel pouch to remove 

3EO Swab.

• Remove Swab, holding 

upright by its handle.

• Do not touch Swab to 

any surface.

• Do not remove swab 

guard - you will remove it 

after swabbing.

• Hold swab upright by its 

handle only.

• Be sure tip of 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 Swab tip 

touches inside walls of 

nose.

Do not exert excessive force while 

swabbing or insert the swab beyond 

the recommended depth.

A

B

B

Handle

Guard

Tip

A
6

Remove guard from Swab.

Discard guard.

STEP 4: REMOVE GUARD FROM SWAB

STEP 5: INSERT SWAB INTO KEY IMMEDIATELY

A

• Insert the Swab into top 

of Key immediately after 

sample collection and 

removing the Swab 

Guard.

• Do not attempt to insert 

a Swab that still has the 

guard attached.

• Press Swab firmly 

down until flat.

A

B

Continue to hold 

Swab by handle.

• Ensure Swab is even 

with top of Key

C STOP Did you push the 

swab down flat?

B

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. 

C
B

7

Double-check to make sure top 

of Swab is flat and even with 

top of Key.

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 6: START TEST

Press and hold GREEN button 

until the READY light starts 

flashing. 

If READY light does not begin flashing, 

press and hold GREEN button again.

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 there are lights 

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

• It is very likely you 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.

• 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 contexts 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.

Steady GREEN light 

next to NEGATIVE

NEGATIVE RESULT

A
8

POSITIVE RESULT DETAILS

NEGATIVE RESULT DETAILS

POSITIVE RESULT:

Steady RED light

next to POSITIVE

NEGATIVE RESULT: 

Steady GREEN light 

next to NEGATIVE

• It is very likely you have COVID-19 and 

it is important to be under the care of 

a healthcare provider. 

• A positive result means that SARSCoV-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 along with 

medical history and your symptoms. 

• 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 contexts of possible exposure and 

symptoms. A negative result in no way 

indicates the absence of other 

respiratory or non-respiratory viruses or 

other infections. 

• It is possible for this test to give a 

negative result that is incorrect (a false 

negative) in some people with 

COVID-19. This means you could 

possibly 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. 

• It is important you work with your 

healthcare provider to help you 

understand the next steps you should 

take.

Test results should be reported to:

https://makemytestcount.com
9

WHEN TO RETEST

TEST DISPOSAL

RED AND GREEN LIGHTS 

FLASH: Test is invalid

After each use, wipe the outer surfaces of the Cube with 

germicidal wipes containing 0.55% sodium hypochlorite as the 

active ingredient.

(blinking)

INVALID RESULT

AND LIGHTS FLASH: 

Test has an error.

TEST ERROR

• If both of the Positive and 

Negative lights flash, your test 

is invalid and must be

repeated.

• Unplug the Cube and plug 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.

• If, at any time, all lights flash,

there has been a testing error. 

• Unplug the Cube and plug 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.

• 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.

Find more information on Troubleshooting and Frequently Asked 

Questions in our Instructions For Use at: 

https://3EOhealth.com/test

DO NOT BREAK OPEN KEY

THROW KEY AWAY
10

INTENDED USE

The 3EO Health COVID-19 Test is a single-use molecular in vitro 

diagnostic test intended for the qualitative detection of SARSCoV-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 adultcollected 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 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 in 

accordance with 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.
11

SUMMARY AND EXPLANTION

The 3EO Health COVID-19 TestTM is an in-vitro diagnostic 

molecular test for the qualitative detection of 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

The 3EO Health COVID-19 TestTM is an in-vitro diagnostic 

molecular test for the qualitative detection of 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.

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 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 cream should not be used before 

collecting a sample. 

• Avoid eating or drinking 30 minutes prior or smoking 60 

minutes prior to 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. 
12

This product has not been FDA cleared or approved, but has been authorized for emergency 

use by FDA under an Emergency Use Authorization (EUA).

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. §360bb-3(b)(1), unless the declaration is terminated or authorization is 

revoked sooner.
3EO Health

TM Inc.

48 Dunham Ridge Rd.

Suite 4350

Beverly, MA 01915

+1-844-538-7336

3EOHealth.com

TM/MC/MR: 3EO Health 20-00046-0