COVID-19 Antigen Pen Home Test

Quick Reference Instructions

For Emergency Use Authorization (EUA) use only.

In vitro diagnostic use.

Carefully read the instructions before performing the test. Failure to 

follow the instructions may result in inaccurate test results.

Kit Contents

Instructions 

for Use

Foil Package 

(Containing Test Pen and Base)

Timer 

(not included)

Storage and Stability

Store the kit at 2‐30°C / 36‐86°F 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

• For information about current expiration dates for at‐home OTC 

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

• The test should be used at room temperature.

• Make sure that all packaging is intact. Do not use the test if the 

foil packaging is visibly damaged.

• Do not open the foil package until you are ready to perform the 

test. Use the test within 1 hour of opening.

• Ensure you have a flat surface area, such as a 

table top.

• Wash your hands with soap and water 

for 20 seconds or use hand sanitizer.

Note

Do not use this test on children under 2 years of age. 

Children between 2 and 14 years of age must be aided or 

supervised by an adult when carrying out the test. 

How to Use This Test

• Serial testing should be performed on 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 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 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

Test Procedure

1 Remove the Test Pen 

and the Base from the 

packaging.

USE THE TEST 

WITHIN 1 HOUR 

OF OPENING.

CC

COVCOV COV

COV

COV

TT

Base

Test Pen

2 Remove 

Swab Cap 

from the 

Test Pen. 

CC

COVCOV COV

COV

COV

TT

Trash

Discard the 

Swab Cap.

3 Gently insert the Swab end of the Pen in 

one nostril about 1/2 ‐ 3/4 of an inch.

Firmly rub the swab at least 5 times 

against the inside walls of the nostril in a 

circular motion. Do not just spin the swab.

Make sure you have removed 

the swab cap (see step 2).

CC

COVCOV COV COV

COV TT

5x 4 Repeat the process with 

CC

COVCOV COV COV

COV TT

5x

Did you swab both 

nostrils? If not, 

inaccurate results can 

occur.

Instructions for swabbing children: 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 hold the child’s head while swabbing.

5a Place the Base on a flat 

surface. Place the swab end 

of the Pen into the base. 

CCCOVCOV COV COV COV

CCCOVCOV COV COV COV

TT

CCCOVCOV COV COV COV

TT

TT

TT

Locate 

orange band 

on the pen.

5b Press firmly on the test pen to insert it all 

the way into the base so that the orange 

band is completely covered by the base. 

CCCOVCOV COV COV COV

TT

CCCOVCOV COV COV COV

TT

Orange band 

covered

Orange band 

is still partially 

visible COV COV

COV COV

COV

COVCOVCOV

COVCOV

TT TT

TT

Orange band is 

still completely

visible

WARNING: Failure to insert the test pen all the 

way into the base can lead to inaccurate results.

6 Leaving the test upright, set 

a timer and read the results at 

15 minutes.

CCCOVCOV COV COV COV

TT

Results 

Window

15 Minutes

WARNING: Do not read 

results earlier than 15 

minutes. Do not read the 

results after 30 minutes.

After test is completed, 

dispose of used materials 

in trash.

Read and Interpret Your Results

WARNING: Do not read results earlier than 15 minutes. 

Do not read the results after 30 minutes. Inaccurate 

test interpretations may occur.

Locate the letters CC and TT at the top and bottom of the results 

window. After the 15 minutes has elapsed, a pink line should always 

appear at the control (CC) region; this is a control line and signals 

that the test is working properly.

CCCOVCOV COV

TT

CCCOVCOV COV

TT

C

T

C

T

< COVID-19 Positive (+)

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

are visible, the test is positive. Any faint 

visible line in the test (TT) region with 

a line in the control (CC) region 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).

CCCOVCOV COV

TT

CCCOVCOV COV

TT

C

T

C

T

< 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 the individual has symptoms on 

the first day of testing.

• Test 2 more times at least 48 hours apart if the individual 

does 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 the sample. A negative result does not rule 

out COVID‐19. There is a higher chance of false negative results 

with antigen tests compared to laboratory‐based tests such as 

PCR tests. If the test is negative but COVID‐19‐like symptoms, 

e.g., fever, cough, and/or shortness of breath continue, follow up 

testing for SARS‐CoV‐2 with a molecular test or testing for other 

respiratory disease should be considered. If applicable, seek follow 

up care with the primary health care provider.

CCCOVCOV COV

TT

CCCOVCOV COV

TT

C

T

C

T

< 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-1

Negative Positive N/A Positive for 

COVID-1

Negative Negative N/A Negative for 

COVID-1

Without Symptoms

Positive N/A N/A Positive for 

COVID-1

Negative Positive N/A Positive for 

COVID-1

Negative Negative Positive Positive for 

COVID-1

Negative Negative Negative Negative for 

COVID-1

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.

Intended Use

The Fastep COVID-19 Antigen Pen 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 years or older or adult collected anterior nasal (nares) swab samples from individuals 

aged two (2) years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 6 

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 Fastep COVID‐19 Antigen Pen 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 definitive cause of disease. Individuals who test positive with the Fastep 

COVID‐19 Antigen Pen 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 Fastep COVID‐19 Antigen Pen Home Test is intended for non‐prescription self‐use and/or as applicable, 

for an adult lay user testing another person 2 years of age or older in a non‐laboratory setting. The Fastep 

COVID‐19 Antigen Pen 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.

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.

Warnings, Precautions, and Safety Information Cont’d)

• 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 6 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.

• Ensure that there is sufficient lighting for testing and interpretation

• 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-us

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

Sodium Azide/

26628-22

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 August 24, 2022 and January 5, 2023. 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.

• These test results are shown as lines of color. Because these lines can be very faint, users with conditions 

affecting their vision ‐ such as far‐sightedness, glaucoma, or color blindness ‐ are encouraged to seek assistance 

to interpret results accurately (e.g., reading glasses, additional light source, or another person).

• 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.

For more information on EUAs go here: https://www.fda.gov/emergency‐preparedness‐and‐response/

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

Frequently Asked Questions, Cont’d)

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 Pen 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 Pen Home Test Letter of Authorization, authorized Fact Sheet, and authorized labeling are 

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

Glossary of 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

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: AB‐US‐REC‐DHF‐0002 R.6 Effective Date: 14 April 2023
Box Contents: 

1 × Instruction for use 

Items necessary to use the test but not provided in the test kit: 

* 

1 × Test Pen 1 × Base 

Timer 

C CCOV COV COV

T T

C CCOVCOV COV

T T

COVCOV COV

COVID-19

ANTIGEN PEN HOME TEST

Quick results

in 15 minutes 

Easy to use 

Self –Test 

For use under the FDA Emergency

Use Authorization (EUA) only. 

For ages 2 and up 

50mm

25mm

180mm

C

T

COVID-19 ANTIGEN PEN 

HOME TEST 

COVID-19

ANTIGEN PEN 

HOME TEST 

1 Test

Store between36-86

°F(2-30

°C)

until use 

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 https://www.fda.gov/covid-tests 

UDI Label SAMPLE

5x 5x 

T

C

T

T T

Orange band

covered 

C

T

C C

T T

Results 

Window 

1 Swab both nostrils

3 

15 Minutes 

2 

For symbol glossary, refer to Instructions for Use 

1 

C

T

T T

T T

Azure Biotech, Inc. 

10400 Main Street 

Houston, TX 77025 

United States 

hometest@azure.bio 

1-800-281-9867 

6 952804 807276

SAMPLE 

180*50*25mm 

2023-4-6 
Box Contents: 

1 × Instruction for use 

Items necessary 

to use the test 

but not provided 

in the 

test kit: 

* 

20 × Bases 20 × Test Pens 

Timer 

COV

COV COV

COVCOV COV

2023-4-6 

106mm

6 952804 807276

SAMPLE 

Self –Test 

Quick results in 15 minutes Easy to use 

COVID-19 ANTIGEN PEN 

HOME TEST

COVID-19 ANTIGEN PEN HOME TEST 

COVID-19 

ANTIGEN PEN HOME TEST 

Tests 20 For use under the FDA Emergency Use Authorization (EUA) only. For ages 2 and up 

For symbol glossary, refer to Instructions for Use 

20 

UDI Label SAMPLE 

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 

Azure Biotech, Inc. diagnostic tests, visit https://www.fda.gov/covid-tests 10400 Main Street 

Houston, TX 77025 

United States 

hometest@azure.bio 

1-800-281-9867 

Store between 36-86°F(2-30°C)until use 

T T

C C

T

C

5x 5x 

T

C

T

C C

T T

T T

Orange band

covered 

C

T

C CCOV COV

T T

Results 

Window 

1 Swab both nostrils

3 

15 Minutes 

2 

C

T

T T

T T

COV

185*135*106mm 

185mm 135mm 185mm 135mm