COVID-19 Antigen Home Test

Quick Reference Instructions

 COV-S23010H1

 COV-S23010H2

 COV-S23010H4

 COV-S23010H5

 COV-S23010H25

For Emergency Use Authorization (EUA) Only. For in vitro diagnostic use

Carefully read the instructions before performing the test. Failure 

to follow the instructions may result in inaccurate test results.

Package Contents

Test Device Individually 

wrapped swab

Extraction 

buffer tube

Instructions for Use

Tube holder 

(perforation 

on box)

Needed but not 

provided: Clock

Storage and Stability

Store the kit at 2-30°C / 36-86°F until use and protect from direct 

sunlight. The expiration date of the materials is indicated on the 

external packaging. Do not freeze the kit.

Prepare for the Test

• All test materials must be at room temperature before use

• Exposure to humidity may decrease the stability of the test.

The test should be performed immediately after removing it

from the pouch.

1. Check expiration date printed on test.*

2. Wash your hands

thoroughly.

3. Open the pouch and

place the test cassette

on a flat surface. 

4. Peel off the aluminum

foil cover of the

extraction buffer.

5. Insert the extraction buffer

into the tube holder by

punching through

the perforation on

the box.

* Do not use kit past its expiration date. For information about current expiration dates 

for at-home OTC COVID-19 diagnostic tests, visit “At-Home OTC COVID-19 Diagnostic 

Tests”: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/

home-otc-covid-19-diagnostic-tests

Note 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. Wear a face mask if swabbing others.

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.

Test Procedure

1. Open the swab packaging. Remove

the swab from the stem.

Be careful not to touch 

the soft, fabric tip of the 

swab.

2. Insert the swab about 1⁄2 to 3⁄4 inch into

the nostril. (Collect the anterior nasal

swab specimen).

3. Circle the swab against the nasal wall

5 times.

Do not just spin the swab.

4. Pull the swab out of the nose while

rubbing it against the walls and

repeat the process with the same

swab in the other nostril.

WARNING: Inaccurate test 

results may occur if the nasal 

swab specimen is not properly 

collected. Collect specimen and 

immediately perform test according 

to instructions.

Note: With children, the maximum depth of insertion 

into the nostril may be less than 3⁄4 of an inch, and 

you may need to have a second person to hold the 

child’s head while swabbing.

5. Place swab into the tube that

you previously placed in the

tube holder.

6. Remove the tube from the tube

holder. Rotate the swab while

squeezing the lower part of the tube

10-15 times so that a slight pressure

is exerted on the tip of the swab.

WARNING: Failure to rotate the 

swab 10-15 times may lead to 

incorrect results.

WARNING: Failure to squeeze the 

tube can lead to incorrect results due 

to excess buffer in the swab.

7. Remove the swab while squeezing

the sides of the tube to extract the

liquid from the swab.

8. Secure the dropper cap onto

the buffer tube.

9. Invert the tube and add 3 drops of the

solution to the sample well by gently

squeezing the tube.

Do not add test sample to the

rectangular results window. Do not

touch the sample well with dropper tip.

WARNING: Do not hold the dropper tube

more than 1⁄4” above sample well.

WARNING: Adding other than the recommended

number of drops may result in inaccurate results.

10. Set a timer and read the

results at 15 minutes.

15 Minutes

WARNING: Do not read the result before 15 

minutes or after 30 minutes. 

After test is completed, dispose of used

materials in trash.

Read and Interpret Your Results

WARNING: Do not read the result before 15 minutes or after 30 

minutes. Inaccurate test interpretations may occur.

Look at the result window and locate the letters C and T on the side of the 

window. A red line should always appear at the C position; this is a control 

line and signals that the test is working properly.

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

below when interpreting test results 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.

< Negative result

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.

< Positive result 

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

visible, the test is positive. Any faint visible 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 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).

< Invalid result

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

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

device.

WARNING: The control line may show up within a few minutes of 

starting the test. It may take up to 15 minutes for the test line to 

show up.
Read and Interpret Your Results (Cont’d)

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.

For more information on EUAs please visit: www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatoryand-policy-framework/emergency-use-authorization.

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

Intended Use

The Fastep COVID-19 Antigen Home Test is lateral flow immunoassay intended for the qualitative detection of 

nucleocapsid antigen from SARS-CoV-2. 

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 is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom 

onset when tested 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 Fastep COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2.

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

nasal (nares) 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. The agent 

detected may not be the definite cause of disease. Individuals who test positive with the Fastep 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 from 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 HYPERLINK “https://www.cdc.

gov/csels/dls/sars-cov-2-livd-codes.html” Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 

Tests provided by the CDC. 

The Fastep COVID-19 Antigen Home Test is intended for non-prescription self-use and/or as applicable an adult lay 

user testing another person 2 years of age or older in a non-laboratory setting. The Fastep COVID-19 Antigen 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.

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 SARSCoV-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 five 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. For information about current expiration dates for at-home OTC COVID-19 

diagnostic tests, visit “At-Home OTC COVID-19 Diagnostic Tests”: https://www.fda.gov/medical-devices/

coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

• Do not touch the swab tip.

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

• If applicable: 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/CAS GHS Code for applicable ingredient Concentration (%)

Sodium Azide/

26628-22-8

Acute Tox. 2 (Oral), H300

Acute Tox. 1 (Dermal), H310 0.02%

For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/

mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

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 July 5, 2022 and July 25, 2022. 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 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.

Frequently Asked Questions

WHAT ARE THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF THE TEST? 

Potential risks include:

• Possible discomfort during sample collection.

• Possible incorrect test result (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 potential spread of COVID-19 to your family and others

in your community.

Frequently Asked Questions, Continued

For more information on EUAs go here: https://www.fda.gov/emergency-preparedness-and-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 SARS-CoV-2 virus that causes COVID-19. Molecular tests detect genetic 

material from the virus. Antigen tests, such as the Fastep 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 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 fastep.azure.bio. 

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.

Support

For questions, or to report a problem, please call 1-800-281-9867 or email hometest@azure.bio. Additional information 

is also available for you and your healthcare provider at fastep.azure.bio. The User Instructions, Quick Reference 

Guide, Fact Sheet for Health Care Provider and Health Care Provider Instructions for Use are also available at fastep.

azure.bio. The Fastep COVID-19 Antigen Home Test Letter of Authorization, authorized Fact Sheet, and authorized 

labeling are available on the FDA website and fastep.azure.bio.

Glossary of Symbols

Azure Biotech, Inc.

10400 Main Street

Houston, TX 77025 

United States

hometest@azure.bio

www.azure.bio

Customer Service Phone: 1-800-281-9867

Service Hours: Monday through Friday 9:00 AM to 5:00 PM CST

Number: 082316 Effective Date: 2022-11

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
1

Self –Test

Quick results in 15 minutes Easy to use 

 Antigen Home Test

COVID-19 

Antigen Home Test

COVID-19 

6 952804 807276

SAMPLE

Insert tube here

1Test Test

For symbol glossary, refer to Instructions for Use 

UDI Label

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

Contents: Store between 

36-86°F(2-30°C)

until use

1 × Test Device 1 × Individually wrapped swab 1 × Extraction buffer tube 1 × Instructions for use

For ages 2 and up

Azure Biotech, Inc.

10400 Main Street

Houston, TX 77025 

United States

hometest@azure.bio

1-800-281-9867

For Emergency Use Authorization (EUA) only.

For in vitro diagnostic use.

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.

For information about current expiration dates for at-home OTC COVID-19 

diagnostic tests, visit "At-Home OTC COVID-19 Diagnostic Tests"

15 minutes

5x

3x

1

3 4

Swab both nostrils 2

Test See your result

Extraction

Items necessary 

to use the test 

but not provided 

in the 

test kit: 

*

Timer

126mm

72mm

19mm
 Antigen Home Test

COVID-19 

2

Self –Test

Quick results in 15 minutes Easy to use 

Antigen Home Test

COVID-19 

Insert tube here

2

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

Tests

6 952804 807276

SAMPLE

For symbol glossary, refer to Instructions for Use 

2

Contents: Store between 

36-86°F(2-30°C)

until use

2 × Test Devices 2 × Individually wrapped swabs 2 × Extraction buffer tubes 1 × Instructions for use

For ages 2 and up

Items necessary 

to use the test 

but not provided 

in the 

test kit: 

*

Timer

UDI Label

Azure Biotech, Inc.

10400 Main Street

Houston, TX 77025 

United States

hometest@azure.bio

1-800-281-9867

For Emergency Use Authorization (EUA) only.

For in vitro diagnostic use.

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.

For information about current expiration dates for at-home OTC COVID-19 

diagnostic tests, visit "At-Home OTC COVID-19 Diagnostic Tests"

15 minutes

5x

3x

1

3 4

Swab both nostrils 2

Test See your result

Extraction

126mm

72mm

24mm
4

Self –Test

Antigen Home Test

COVID-19 

Insert tube here

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

Tests

UDI Label

Antigen Home Test

COVID-19 

6 952804 807276

SAMPLE

For symbol glossary, refer to Instructions for Use 

4

4 × Test Devices 4 × Individually wrapped swabs

4 × Extraction 

buffer tubes

1 × Instructions for use

Easy to use Quick results in 15 minutes

For ages 2 and up

Contents:

Store between 

36-86°F(2-30°C)

until use

Azure Biotech, Inc.

10400 Main Street

Houston, TX 77025 

United States

hometest@azure.bio

1-800-281-9867

Items necessary 

to use the test 

but not provided 

in the 

test kit: 

*

Timer

For Emergency Use Authorization (EUA) only.

For in vitro diagnostic use.

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.

For information about current expiration dates for at-home OTC COVID-19 diagnostic 

tests, visit "At-Home OTC COVID-19 Diagnostic Tests"

15 minutes

5x

3x

1

3 4

Swab both nostrils 2

Test See your result

Extraction

125mm

45mm

80mm
UDI Label

Antigen Home Test

COVID-19 

6 952804 807276

SAMPLE

Contents:

5 × Test Devices 5 × Individually wrapped swabs

5 × Extraction 

buffer tubes

1 × Instructions for use

For symbol glossary, refer to Instructions for Use 

5

5

Self –Test

Easy to use Quick results in 15 minutes

Antigen Home Test

COVID-19 

5

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

Tests

Store between 

36-86°F(2-30°C)

until use

Insert tube here

Azure Biotech, Inc.

10400 Main Street

Houston, TX 77025 

United States

hometest@azure.bio

1-800-281-9867

Items necessary 

to use the test 

but not provided 

in the 

test kit: 

*

Timer

For Emergency Use Authorization (EUA) only.

For in vitro diagnostic use.

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.

For information about current expiration dates for at-home OTC COVID-19 

diagnostic tests, visit "At-Home OTC COVID-19 Diagnostic Tests"

15 minutes

5x

3x

1

3 4

Swab both nostrils 2

Test See your result

Extraction

125mm

50mm

80mm

For ages 2 and up
25

Antigen Home Test

COVID-19 

Self –Test

Insert tube here

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

Tests

UDI Label Antigen Home Test

COVID-19 

6 952804 807276

SAMPLE

For symbol glossary, refer to Instructions for Use 

25

25 × Test Devices 25 × Individually wrapped swabs

25 × Extraction 

buffer tubes

1 × Instructions for use Store between 

36-86°F(2-30°C)

until use

Easy to use Quick results in 15 minutes

Contents:

For ages 2 and up

Azure Biotech, Inc.

10400 Main Street

Houston, TX 77025 

United States

hometest@azure.bio

1-800-281-9867

15 minutes

5x

3x

1

3 4

Swab both nostrils 2

Test See your result

Extraction

Items necessary 

to use the test 

but not provided 

in the 

test kit: 

*

Timer

210mm

81mm

122mm

For Emergency Use Authorization (EUA) only.

For in vitro diagnostic use.

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.

For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, 

visit "At-Home OTC COVID-19 Diagnostic Tests"