MaximBio

COVID-19

Antigen Home Test

User Instructions

For Emergency Use Authorization (EUA) Only.

In vitro diagnostic use only.

Carefully read the instructions prior to starting test. It is 

recommended that gloves (not provided) be used during testing.

Required testing components:

1 Swab

1 Test Strip 

in Pouch

1 Tube of 

Sample Buffer

Timer

(not included)

Check printed 

Expiration Date

STOP

Note: This kit comes in 1, 2, 4, and 25 test quantities. The number of 

items supplied in the kit will vary depending on which kit is purchased.

Check the test expiration ( ) printed on the kit box. 

Wash or sanitize your hands. Make sure they are dry 

before starting. Ensure space is clean prior to testing.

Place the tube upright in the tube

holder/stand.

Remove cap - DO NOT discard. 

Save the cap for use in Step 9.

emove Cap

Gently insert the swab tip into one 

nostril about 1⁄2 to 3⁄4 of an inch. Do not 

insert the swab any farther if you feel 

any resistance.

Using medium pressure, rub the swab tip 

inside wall of the one nostril.

Make at least 5 large circles (about 15 sec

Do not just spin the swab.

against the 

onds). 

Using the same swab, repeat Step 4 in the other nostril.

Note: Both nostrils must be swabbed to ensure 

accurate results. Note: If you are swabbing others, 

please wear a face mask. With children, you may not 

need to insert the swab as far into the nostril. For 

very young children, you may need another person to 

steady the child’s head while swabbing.

Completely submerge swab 

tip into the liquid inside the 

tube and set a 30 second 

timer. Repeatedly plunge for

30 seconds (approximately 

30-60 plunges) or more. Mix

by firmly pressing the swab

tip to the bottom of the tube

with each down motion.

Note: this step is very 

important, do not mix for 

less than 30 seconds.

Repeat for 

30 seconds

(30-60 plunges)

Firmly press to 

bottom of tube

Note: Incorrect or invalid 

results may occur if the mix 

time is too short.

Make sure the swab tip is in the 

liquid inside of the tube. While 

using one hand to securely hold 

the tube down, use the other 

hand to carefully break the swab 

handle against the side of the 

tube. Discard the swab handle 

and leave the broken swab tip in 

the tube.

Open the test strip pouch carefully at

notch and hold the test strip as show

Hold the “MaximBio 

COVID-19” side of the test strip 

and carefully place it into the 

tube, facing outwards, so the 

results window is clearly visible.

 tear 

n.

R

Wi

Hold 

Here

DO NOT 

Touch

esults 

ndow

Note: If test strip is inserted upside 

down, discard all test components 

and restart from Step 1. Do not 

touch results window as it can 

cause false results.

Make sure the test strip touches the bottom of 

the tube. While keeping the tube upright, secure 

the cap on the tube. 

DO NOT disturb tube during this time.

Read results at 15 minutes with good lighting. Do not read results 

before 15 minutes or after 30 minutes. If tube is disturbed prior to 

or during the 15 minute wait time, restart test from Step 1.

Wait

15 Min.

15 Min.

Read

15 - 30 Min.

Note: False results may occur if the test is read outside the 

recommended time period. When reading test results, remove the 

test strip from the tube if necessary. 

COVID-19 Positive (+)

If the Control (C) line and the Test (T)

line are visible, the test is positive. Any

CONTROL faint visible reddish pink test (T) line 

with the control line (C) should be 

TEST 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 Look very closely! causes COVID-19 was detected in 

Even a very faint, pink your sample and it is very likely you Test Line and Control have COVID-19 and are contagious. Line is a POSITIVE result. Please contact your doctor/primary Any red/pink line here is 

positive. 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

CONTROL for COVID-19 is accurate, you should:

No Line •	 Test again in 48 hours if you have 

TEST 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 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 experienc

shortness of 

care provider

Invalid

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

breath) you should seek follow up care with your health 

.

No Line

CONTROL No Lines 

Present

TEST

If the control (C) line 

is not visible, the test is 

invalid. Re-test with a 

new swab and new test 

device.

All used components should be disposed of in 

household trash.

Kit Contents

Prepare for Test

Test Procedure

1 Stand Up Tube & R

2 Open Swab

Do not touch the swab tip

Open the swab packaging at stick 

end. Take out swab.

Test Procedure (Cont’d)

3 Swab Both Nostrils

4 Swab Other Nostril

5 Insert Swab Into Tube & Mix

6 Break Swab

9 Wait 15 Minutes

8 Securely Cap the Tube

Keep tube UPRIGHT during entire test.

7 Insert Test Strip

Interpret the Results

Dispose In Trash
MaximBio

COVID-19 

Antigen Home Test

User Instructions 

For Emergency Use Authorization (EUA) Only. 

In vitro diagnostic use only.

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

interpreting test results for COVID-19.

Status on First 

Day of Testing

First Result 

Day 1

Second Result 

Day 3

Third 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 

Symptoms

Positive N/A N/A Positive for 

COVID-19

Negative Positive N/A Positive for 

COVID-19

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. 

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.

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.

How to Use This Test (Cont’d)

•	 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.

Intended Use

The MaximBio ClearDetectTM COVID-19 Antigen Home Test is a lateral flow 

immunoassay device 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 self-collected anterior nasal 

(nares) swab samples from individuals aged 14 or older or adult collected anterior nasal 

(nares) swab samples from individuals aged 2 years or older. This test is authorized 

for individuals with symptoms of COVID-19 within the first 5 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 MaximBio ClearDetectTM COVID-19 Antigen Home Test does not differentiate 

between SARS-CoV or SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is 

generally detectable in anterior nasal (nares) samples during the acute phase of infection. 

Positive results indicate the presence of viral antigens, but clinical correlation with patient 

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 

the agent detected may not be the definitive cause of disease. Individuals who test positive 

with the MaximBio ClearDetect COVID-19 Antigen 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 or 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 and to receive appropriate medical care. 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 MaximBio ClearDetectTM COVID-19 Antigen Home Test is intended for nonprescription self-use and/or as applicable, for an adult lay user testing another aged 2 years 

or older in a non-laboratory setting. The MaximBio ClearDetectTM COVID-19 Antigen 

Home Test is only for in vitro diagnostic use under the Food and Drug Administration’s 

Emergency Use Authorization. This product has not been FDA cleared or approved.

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 October, 2021 and December, 

2021. The clinical performance has not been established for 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 SARSCoV-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.

Warnings, Precautions and Safety

•	 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 5 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 strip should be used within 5 minutes.

•	 Do not read test results before 15 minutes or after 30 minutes. Results read before 15 

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

Chemical Name GHS Code for each Ingredient Concentrations

Microcide III H317, May cause an allergic skin reaction

H320 , Causes eye irritation

H316, Causes mild skin irritation

0.2%

Tris Base H320 , Causes eye irritation

H316, Causes mild skin irritation

0.242%

Sodium chloride H320 , Causes eye irritation 1.75%

Tris-HCl H320 , Causes eye irritation

H316, Causes mild skin irritation

0.314%

NP-40 H316, Causes mild skin irritation 0.6%

•	 For more information on EUAs please visit: https://www.fda.gov/emergencypreparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergencyuse-authorization

•	 For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

Frequently Asked Questions

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 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-preparednessand-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

What is the difference between an antigen and molecular test?

There are different kinds of tests for the virus that causes COVID-19. Molecular tests 

detect genetic material from the virus. Antigen tests, such as the MaximBio ClearDetectTM

COVID-19 Antigen 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 negative result 

when you have COVID-19 than a molecular test would.

Frequently Asked Questions (Cont’d)

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.maximbio.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.

Storage and Stability

Store the MaximBio ClearDetect

TM COVID-19 Antigen Home Test Kit between 4-30°C 

(39.2-86°F). Ensure all kit contents are at room temperature before use. Kit contents are 

stable until the expiration date printed on the outer packaging. Do not use beyond the 

expiration date. The Test Strip must remain in the sealed pouch until use. For the most 

current expiration dates of this test, please refer to: http//www.fda.gov/covid-tests.

Symbols

Catalog Number In vitro diagnostic 

use only

Lot Number (Batch Code) Tests Per Kit

Use by (Expiration Date) Manufacturer

Temperature Limitations 

(Storage Temperature)

Date of Manufacture

One Time Use (Single Use 

Only)

Consult Instructions 

for Use

Maxim Biomedical, Inc. For technical support:

1500 East Gude Drive (P) 301-251-0800 

Rockville, MD 20850 cleardetect@maximbio.com

www.maximbio.com

Available hours: 

Mon. to Fri.: 

9 a.m. – 4 p.m. EST

Number: LN-20615.10 Effective Date: 2023-09

Interpret the Results (Cont’d)
30°C FPO

4°C

1

94311

The emergency use of this product is only authorized for the duration of the declaration that other viruses or pathogens; andThis product has been authorized only for the detection of proteins from SARS-CoV-2, not for any http://www.fda.gov/covid-tests.under EUA. For more information on expiration dating for COVID-19 antigen tests, please refer to In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA have COVID-19 than a lab-based molecular test.perform serial (repeat) testing. This test is more likely to give you a false negative result when you Determining a negative result requires multiple tests. You may need to purchase additional tests to least three times over five days with at least 48 hours between tests.individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at onset when tested at least twice over three days with at least 48 hours between tests, and for This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom For in vitro diagnostic use.microfilm, without permission in writing from either ISO at the address.utilized in any form or by any means, electronic or mechanical, including photocopying and All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or 21 U.S.C § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, circumstances exists justifying the authorization of emergency use of in vitro diagnostics for detection 

COVID-19

Antigen Home Test

• Contents:

1 Nasal Swab

• 1 User Instructions• 1 Sample Buffer Tube• 1 Test Strip

Maxim Biomedical, Inc.301-251-0800www.maximbio.comRockville, MD 20850 USA1500 East Gude Drive, Suite A

COVID-19

Antigen Home Test

1

Test

EASYNasal Swab TestFASTResults in 15 min

COVID-19 Antigen Home Test Test

1

COVID-19 Antigen Home Test

For Emergency Use Authorization (EUA) only

For Emergency Use Authorization (EUA) only

For symbol glossary, please refer to Instructions for Use

TM

TM

TM

TM

0 0000 0000 0

Ages 2 and up

• Timernot included:Items necessary but 

15:00 Results

COVID-19

EASYNasal Swab TestFASTResults in 15 min
30°C

4°C

2

95677

15:00 Results

EASYNasal Swab TestFASTResults in 15 min

The emergency use of this product is only authorized for the duration of the declaration that other viruses or pathogens; andThis product has been authorized only for the detection of proteins from SARS-CoV-2, not for any http://www.fda.gov/covid-tests.under EUA. For more information on expiration dating for COVID-19 antigen tests, please refer to In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA have COVID-19 than a lab-based molecular test.perform serial (repeat) testing. This test is more likely to give you a false negative result when you Determining a negative result requires multiple tests. You may need to purchase additional tests to least three times over five days with at least 48 hours between tests.individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at onset when tested at least twice over three days with at least 48 hours between tests, and for This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom For in vitro diagnostic use.microfilm, without permission in writing from either ISO at the address.utilized in any form or by any means, electronic or mechanical, including photocopying and All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or 21 U.S.C § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, circumstances exists justifying the authorization of emergency use of in vitro diagnostics for detection 

COVID-19

Antigen Home Test

• Contents:

2 Nasal Swabs

• 1 User Instructions• 2 Sample Buffer Tubes• 2 Test Strips

Maxim Biomedical, Inc.301-251-0800www.maximbio.comRockville, MD 20850 USA1500 East Gude Drive, Suite A

COVID-19

Antigen Home Test

2

Tests

EASYNasal Swab TestFASTResults in 15 min

COVID-19 Antigen Home Test

2

Tests

COVID-19 Antigen Home Test

For Emergency Use Authorization (EUA) only

For Emergency Use Authorization (EUA) only

For symbol glossary, please refer to Instructions for Use

TM

TM

TM

TM

Ages 2 and up

• Timernot included:Items necessary but 

COVID-19
30°C

4°C

4

97382

The emergency use of this product is only authorized for the duration of the declaration that other viruses or pathogens; andThis product has been authorized only for the detection of proteins from SARS-CoV-2, not for any http://www.fda.gov/covid-tests.under EUA. For more information on expiration dating for COVID-19 antigen tests, please refer to In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA have COVID-19 than a lab-based molecular test.perform serial (repeat) testing. This test is more likely to give you a false negative result when you Determining a negative result requires multiple tests. You may need to purchase additional tests to least three times over five days with at least 48 hours between tests.individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at onset when tested at least twice over three days with at least 48 hours between tests, and for This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom For in vitro diagnostic use.microfilm, without permission in writing from either ISO at the address.utilized in any form or by any means, electronic or mechanical, including photocopying and All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or 21 U.S.C § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, circumstances exists justifying the authorization of emergency use of in vitro diagnostics for detection 

COVID-19

Antigen Home Test

• Contents:

4 Nasal Swabs

• 1 User Instructions• 4 Sample Buffer Tubes• 4 Test Strips

Maxim Biomedical, Inc.301-251-0800www.maximbio.comRockville, MD 20850 USA1500 East Gude Drive, Suite A

COVID-19

Antigen Home Test

4

Tests

EASYNasal Swab TestFASTResults in 15 min

COVID-19 Antigen Home Test

4

Tests

COVID-19 Antigen Home Test

For Emergency Use Authorization (EUA) only

For Emergency Use Authorization (EUA) only

For symbol glossary, please refer to Instructions for Use

TM

TM

TM

TM

Ages 2 and up

• Timernot included:Items necessary but 

15:00 Results

COVID-19

EASYNasal Swab TestFASTResults in 15 min
9" 5.625” 9" 5.625”

3.75”

30°C

4°C

25

92020

52

Tests

COVID-19

Antigen Home Test

ASY E

Nasal Swab Test

AST F

min 15 Results in 

25

Tests

COVID-19

Antigen Home Test Contents:

Maxim Biomedical, Inc.

1500 East Gude Drive, Suite A

Rockville, MD 20850 USA

www.maximbio.com

301-251-0800

Ages 2 and up

25

Tests

COVID-19

Antigen Home Test

• 25 Nasal Swabs

• 25 Test Strips

• 25 Sample Buffer Tubes

• 1 User Instructions

25

Tests

52

Tests

In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under EUA. For more information on

expiration dating for COVID-19 antigen tests, please refer to http://www.fda.gov/covid-tests.

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic 

or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address.

For in vitro diagnostic use.

This test is authorized for individuals with symptoms of COVID-19 within the first 5 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.

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.

For symbol glossary, please refer to Instructions for Use

COVID-19

For Emergency Use Authorization (EUA) only For Emergency Use Authorization (EUA) only

Items necessary but 

not included:

• Timer

Antigen Home Test

For use under the FDA Emergency Use Authorization (EUA) only.

15:00

Results