For use under Emergency Use Authorization (EUA) only. 

Carefully read instructions before performing test. 

Failure to follow the instructions may result in 

inaccurate test results.

An anterior nasal swab can be self-collected by an 

individual age 14 years and older. Children ages 2 to 13 years should be tested by an adult.

In vitro diagnostic use only.

A. PREPARE FOR TEST

B. COLLECT NASAL SAMPLE C. TEST PROCEDURE D. TEST INTERPRETATION

1 Swab 1 Cassette

in Packaging

1 Solution

Vial

1 Wash or sanitize your hands. Make sure they

are dry before starting the test.

2 Check your kit contents. Use only 1 of each

of the following for each test. 

Check expiration date on the test cassette 

pouch.

Timer

(not included)

3 When you are ready to proceed with the test,

open the foil pouch of the cassette. 

Locate the circular sample well.

Note: Testing should commence immediately after 

opening the sealed pouch.

4 Locate the vial. Open the vial and place on

flat surface.

Result window

Do not touch the 

result window

Sample well

5 Open the swab

packaging at the 

stick end, not 

the swab end. 

Do not touch 

the swab tip.

6 Swab both nostrils as shown.

Check: Did you swab 

both nostrils?

A false negative may 

occur if the nasal swab is 

not properly collected.

a Insert up to 3/4 of

an inch.

b At least 5 big circles.

c At least 5 big circles.

Gently insert the entire 

soft tip of the swab into 

a nostril (usually 1/2-3/4 

of an inch). 

Using medium pressure, 

rub the swab against all 

of the inside walls of 

your nostril.

Using the same swab, 

repeat step 6 in the 

second nostril.

en, 

be 

Make at least 5 big circles, taking 

at least 15 seconds per nostril. 

Do not just spin the swab.

7 After swabbing each nostril,

immediately place swab into 

the vial and slowly move up 

and down for 10 seconds.

8 Push swab all the way to the bottom of the vial

and leave for 1 minute. Following this, dispose 

of the swab.

9 Place test cassette with the sample well facing

up on a flat level surface and CAREFULLY pour 

ALL of the liquid content GENTLY into sample 

well to avoid spilling. 

It is normal for a minimal amount of the liquid 

to remain in the bottom of the vial.

10 Start your timer for 20 minutes.

Read the result 

at 20 minutes.

Do not read the result 

before 20 minutes or 

after 30 minutes.

Wait 20 

minutes

Read

between

20-30 minutes

Note: A false negative or false positive result may 

occur if the test result is read before 20 minutes or 

after 30 minutes.

Do NOT pour into 

the rectangular well

Report your test result(s) at MakeMyTestCount.Org - this 

voluntary and anonymous reporting helps public health teams 

understand COVID-19 spread in your area and across the 

country and informs public health decisions.

COVID-19 Positive (+)

C

T

You do not need to go 

deeper. With young childr

the swab may not need to 

inserted so far.

Repeat testing is needed to improve test accuracy. Please follow the 

table below when interpreting test results for COVID-19.

Status on First Second Third 

First Day of TestingResult 

Day 1

Result 

Day 3

Result 

Day 5 Interpretation

With 

Symptoms

Positive N/A N/A Positive for COVID-19

Negative Positive N/A Positive for COVID-19

Negative Negative N/A Negative for COVID-19

Without 

Positive N/A N/A Positive for COVID-19

Negative Positive N/A Positive for COVID-19

Symptoms Negative Negative Positive Positive for COVID-19

Negative Negative Negative Negative for COVID-19

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.

If the Control (C) line and the Test (T) line are visible, 

the test is positive. Any faint visible pink/purple test 

(T) line with the control line (C) should be read as

positive.

You do not need to perform repeat testing if you 

have a positive result at any time.

A positive test result means that the virus that causes 

COVID-19 was detected in your sample and it is very 

likely that you have COVID-19 and are contagious. 

Please contact your doctor/primary care physician or 

your local health authority immediately and adhere to 

the local guidelines regarding self-isolation. There is 

a very small chance that this test can give a positive 

result that is incorrect (a false positive).

COVID-19 Negative (-)

If the Control (C) line is visible, but the Test (T) line is 

not visible, the test is negative.

To increase the chance that the negative result for 

COVID-19 is accurate, you should:

• Test again in 48 hours if you have symptoms on

the first day of testing.

• Test 2 more times at least 48 hours apart if you

do not have symptoms on the first day of testing.

A negative test result indicates that the virus that causes COVID-19 

was not detected in your sample. A negative result is presumptive, 

meaning it is not certain that you do not have COVID-19. You may 

still have COVID-19 and you may still be contagious. There is a higher 

chance of false negative results with antigen tests compared to 

laboratory-based tests such as PCR. If you test negative and continue 

to experience COVID-19-like symptoms, (e.g., fever, cough, and/or 

shortness of breath) you should seek follow up care with your health 

care provider.

Invalid

If the Control (C) line is not visible, the test 

is invalid. Re-test with a new swab and new 

test device.

C

T
ASSURE-100 Rapid COVID-19 Home Test

Instructions for Use

For Use Under an Emergency Use Authorization (EUA) Only.

For In Vitro Diagnostic Use (IVD) Only.

INTENDED USE

The ASSURE-100 Rapid COVID-19 Home Test is a lateral flow 

assay intended for the qualitative detection of nucleocapsid protein 

antigen from the SARS-CoV-2 virus.

This test is authorized for non-prescription home use with selfcollected anterior nasal (nares) swab samples from individuals aged 

14 years or older, or adult-collected anterior nasal (nares) swab 

samples from individuals aged 2 years or older, with symptoms of 

COVID-19 within the first 7 days of symptom onset when tested at 

least twice over three days with at least 48 hours between tests and 

for individuals without symptoms or other epidemiological reasons 

to suspect COVID-19, when tested at least three times over five 

days with at least 48 hours between tests.

The ASSURE-100 Rapid COVID-19 Home Test does not 

differentiate between SARS-CoV and SARS-CoV-2.

Results are for the identification of the SARS-CoV-2 nucleocapsid 

protein antigen, which is generally detectable in anterior nasal swab 

specimens during the acute phase of infection. Positive results 

indicate the presence of viral antigens, 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, and agent 

detected may not be the definite cause of disease. Individuals who 

test positive with the ASSURE-100 Rapid COVID-19 Home Test 

should self-isolate and seek follow-up care with their physician or 

healthcare provider as additional testing may be necessary.

All negative results are presumptive and confirmation with a 

molecular assay, if necessary for patient management, may be 

performed. Negative results do not rule out SARS-CoV-2 infection 

and should not be used as the sole basis for treatment of patient 

management decisions, 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. 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 CDC.

The ASSURE-100 Rapid COVID-19 Home Test is intended for 

non-prescription self-use and/or, as applicable for an adult lay user 

testing another person aged 2 years or older in a non-laboratory 

setting.

The ASSURE-100 Rapid COVID-19 Home Test is only for use under 

the Food and Drug Administration’s Emergency Use Authorization. 

This product has not been FDA cleared or approved.

HOW TO USE THIS TEST

• Serial testing should be performed in all individuals with

negative results; individuals with symptoms of COVID-19 and

initial negative results should be tested again after 48 hours.

Individuals without symptoms of COVID-19, and with initial

negative results, should be tested again after 48 hours and,

if the 2nd test is also negative, a 3rd time after an additional 48

hours. You may need to purchase additional tests to perform this 

serial (repeat) testing.

• If you test negative but continue to have symptoms of

COVID-19, and both your first and second tests are negative,

you may not have COVID-19, however you should follow-up with

your healthcare provider.

• If your test is positive, then proteins from the virus that causes

COVID-19 have been found in your sample and you likely have

COVID-19.

FREQUENTLY ASKED QUESTIONS (FAQ)

What are the known and potential risks and benefits of this test?

Potential risks include: 

• Possible discomfort during sample collection.

• Possible incorrect test results (see Warnings and Result

Interpretation sections for more information).

Potential benefits include: 

• The results, along with other information, can help you and your

healthcare provider make informed recommendations about your

care.

• The results of this test may help limit the spread of COVID-19 to

your family and others in your community.

For more information on EUAs go here: https://www.fda.gov/

emergency-preparedness-and-response/mcm-legal-regulatory-andpolicy-framework/emergency-us-authorization

What is the difference between an antigen and molecular test?

There are different kinds of tests for the SARS-CoV-2 virus that 

causes COVID-19. Molecular tests detect genetic material from the 

virus. Antigen tests, such as ASSURE-100 Rapid COVID-19 Home 

Test, detect proteins from the virus. Due to the lower sensitivity of 

antigen tests, there is a higher chance this test will give you a false 

negative result when you have COVID-19 than a molecular test 

would.

How accurate is this test?

Clinical studies have shown that antigen tests more accurately 

determine whether you are infected with the virus that causes 

COVID-19 when taken multiple times across several days. Repeat 

testing improves test accuracy. This serial testing approach is 

recommended to minimize the risk of incorrect results. For more 

information on the performance of the test and how the performance 

may apply to you, please refer to the performance data in the 

Healthcare Provider Instructions for Use (IFU), available at www.

assure-test.com.

What if I have a positive test result?

A positive result means that it is very likely you have COVID-19 

because proteins from the virus that causes COVID-19 were found 

in your sample. You should self-isolate from others and contact a 

healthcare provider for medical advice about your positive result.

What if I have a negative test result?

A negative test result indicates that antigens from the virus that 

causes COVID-19 were not detected in your sample. However, if 

you have symptoms of COVID-19, and your first test is negative, 

you should test again in 48 hours since antigen tests are not as 

sensitive as molecular tests. If you do not have symptoms and 

received a negative result, you should test at least two more times 

with 48 hours in between tests for a total of three tests. If you have 

a negative result, it does not rule out SARS-CoV-2 infection; you 

may still be infected and you may still infect others. It is important 

that you work with your healthcare provider to help you understand 

the next steps you should take.

What does an invalid test result mean?

An invalid result means the test was not able to tell if you have 

COVID-19 or not. If the test is invalid, a new swab should be used 

to collect a new nasal specimen and you should test again with a 

new test.

Important

Do not use this test as the only guide to manage your illness. 

Consult your healthcare provider if your symptoms persist or 

become more severe.

Individuals should provide all results obtained with this product to 

their healthcare provider.

WARNINGS, PRECAUTIONS AND SAFETY INFORMATION

• Read all instructions carefully before performing the test. Failure

to follow the instructions may result in inaccurate test results.

• In the USA, this product has not been FDA cleared or approved,

but has been authorized by FDA under an Emergency Use

Authorization. This product has been authorized only for the

detection of proteins 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.

• Serial testing should be performed in individuals with

negative results at least twice over three days (with 48

hours between tests) for symptomatic individuals and three

times over five days (with at least 48 hours between tests)

for asymptomatic individuals. You may need to purchase

additional tests to perform this serial (repeat) testing.

• If you have had symptoms longer than 7 days you should

consider testing at least three times over five days with at

least 48 hours between tests.

• An anterior nasal swab sample can be self-collected by an

individual age 14 years and older. Children age 2 to 13 years

should be tested by an adult.

• Do not use on anyone under 2 years of age.

• Wear a safety mask or other face-covering when collecting a

specimen from a child or another individual.

• Do not use if any of the test kit contents or packaging is

damaged.

• Test components are single-use. Do not re-use.

• Do not use kit past its expiration date.

• Do not touch the swab tip.

• Once opened, the test card should be used within 60 minutes.

• Do not read test results before 20 minutes or after 30 minutes.

Results read before 20 minutes or after 30 minutes may lead to

a false positive, false negative, or invalid result.

• Keep testing kit and kit components away from children and pets

before and after use. Avoid contact with your skin, eyes, nose, or

mouth. Do not ingest any kit components. The reagent solution

contains harmful chemicals (see table below). If the solution

contacts your skin, eyes, nose, or mouth, flush with large

amounts of water. If irritation persists, seek medical advice.

If irritation persists, seek medical advice:

https://www.poisonhelp.org or 1-800-222-1222.

Chemical 

Name

Harms (GHS) code for each 

ingredient Concentration

Triton X-100

Harmful if swallowed (H302) 

Cause skin irritation (H315) 

Causes serious eye damage 

(H318)

1%

Sodium Azide

Harmful if swallowed (H300) 

Cause skin irritation (H310), 

Causes serious eye irritation 

(H319)

Aquatic hazard (H400, H410)

0.09%

EDTAdisodium salt

Causes mild skin irritation 

(H316), Causes serious eye 

irritation (H319)

1.5%

Sodium 

Chloride

Causes serious eye irritation 

(H319) 1.5%

• For more information on EUAs please visit:

https://www.fda.gov/emergencypreparedness-and-response/

mcm-legal-regulatory-and-policy-framework/emergencyuseauthorization

• For the most up to date information on COVID-19, please visit:

www.cdc.gov/COVID19

LIMITATIONS

• There is a higher chance of false negative results with antigen

tests than with laboratory-based molecular tests due to the

sensitivity of the test technology. This means that there is a

higher chance this test will give a false negative result in an

individual with COVID-19 as compared to a molecular test,

especially in samples with low viral load.

• The performance of this test was established based on the

evaluation of a limited number of clinical specimens collected

between March 2022 and May 2022. The clinical performance

has not been established in all circulating variants but is

anticipated to be reflective of the prevalent variants in circulation

at the time and location of the clinical evaluation. Performance

at the time of testing may vary depending on the variants

circulating, including newly emerging strains of SARS-CoV-2 and

their prevalence, which change over time.

• All COVID-19 antigen test negative results are presumptive and

confirmation with a molecular assay may be necessary. If you

continue to have symptoms of COVID-19, and both your first

and second tests are negative, you may not have COVID-19,

however you should follow-up with a healthcare provider.

• If the test is positive, then proteins from the virus that causes

COVID-19 have been found in the sample and you likely have

COVID-19.

• This test is read visually and has not been validated for use by

those with impaired vision or color-impaired vision.

• Incorrect test results may occur if a specimen is incorrectly

collected or handled.

STABILITY AND STORAGE

Store the kit at room temperature 65-86°F (18-30°C) and protect 

from direct sunlight. Do not use past the expiration date. For 

information about current expiration dates for at-home OTC 

COVID-19 diagnostic tests, visit http://www.fda.gov/covid-tests.

Manufactured for Oceanit Foundry, LLC

828 Fort Street Mall, Suite 600

Honolulu, HI 96816, USA

Made in S. Korea

Date of last revision: 12/22/22
Rapid COVID-19 Home Test

531-101 1 2 36 F 86 F

1

Test

epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.when tested at least twice over three days with at least 48 hours between tests, and for those without symptoms or other antigen from SARS-CoV-2 in anterior nasal swabs from those with symptoms of COVID-19 within the first 7 days of symptom onset, The ASSURE-100 Rapid COVID-19 Home Test is a lateral flow immunoassay intended for the detection of nucleocapsid protein 

• For Emergency Use Authorization (EUA) only.• For in vitro diagnostic use.• For use in ages two (2) years and up.• In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.•

revoked sooner.the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the 

•

testing. This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test.Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) 

• This test does NOT determine if you had COVID-19 in the past or if you have immunity.•

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#listFor up-to-date test kit expiration dating please visit:

1 Instructions for Use1 Solution Vial1 Nasal Swab1 Test Cassette

Rapid COVID-19 Home Test

Rapid COVID-19 Home Test

1

Test

531-101

2 36 F

1 86 F

Rapid COVID-19 Home Test

1

Test

Rapid COVID-19 Home Test Simple. Fast. Accurate.
Rapid COVID-19 Home Test

531-102 2 2 36 F 86 F

2

Tests

1 Instructions for Use2 Solution Vials2 Nasal Swabs2 Test Cassettes

Rapid COVID-19 Home Test

Rapid COVID-19 Home Test

2

Tests

531-102

2 36 F

2 86 F

Rapid COVID-19 Home Test

2

Tests

Rapid COVID-19 Home Test Simple. Fast. Accurate.

epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.when tested at least twice over three days with at least 48 hours between tests, and for those without symptoms or other antigen from SARS-CoV-2 in anterior nasal swabs from those with symptoms of COVID-19 within the first 7 days of symptom onset, The ASSURE-100 Rapid COVID-19 Home Test is a lateral flow immunoassay intended for the detection of nucleocapsid protein 

• For Emergency Use Authorization (EUA) only.• For in vitro diagnostic use.• For use in ages two (2) years and up.• In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.•

authorization is revoked sooner.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 the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying 

•

testing. This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test.Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) 

• This test does NOT determine if you had COVID-19 in the past or if you have immunity.•

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#listFor up-to-date test kit expiration dating please visit:
Rapid COVID-19 Home Test

Rapid COVID-19 Home Test

531-125

25 Test Cassettes

25 Nasal Swabs

25 Solution Vials

1 Instructions for Use

Rapid COVID-19 Home Test Rapid COVID-19 Home Test

Rapid COVID-19 Home Test

25 

Tests

531-125 2 36 F 25

86 F

531-125 25 36 F 2 86 F

25 

Tests

The ASSURE-100 Rapid COVID-19 Home Test is a lateral flow immunoassay intended for the detection of nucleocapsid protein 

antigen from SARS-CoV-2 in anterior nasal swabs from those with symptoms of COVID-19 within the first 7 days of symptom onset, 

when tested at least twice over three days with at least 48 hours between tests, and for those without symptoms or other 

epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.

• For Emergency Use Authorization (EUA) only.

• For in vitro diagnostic use.

• For use in ages two (2) years and up.

• In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.

• This product has been authorized only for the detection of proteins 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.

• Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) 

testing. This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test.

• This test does NOT determine if you had COVID-19 in the past or if you have immunity.

• For up-to-date test kit expiration dating please visit:

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list