FaStep COVID-19 Antigen Pen Home Test User Guide

User Guide for FaStep models including: COVID-19 Antigen Pen Home Test, COVID-19, Antigen Pen Home Test, Pen Home Test, Home Test

FaStep COVID-19 Antigen Pen Home Test - Instructions for Use (Home Test)

FaStep

Fastep COVID-19 Antigen Pen Home Test - FDA

prieš 5 dienas — For information about current expiration dates for at‑home OTC. COVID‑19 diagnostic tests, visit http://www.fda.gov/covid‑tests.

Fastep 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 ...

Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.

File Info : application/pdf, 4 Pages, 5.20MB

EUA-Azure-FaStep-PenOTC-ifuHT

COVID-19 Antigen Pen Home Test
Quick Reference Instructions

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 COVID19, however you should followup with your healthcare provider.
· If the test is positive, then proteins from the virus that causes COVID19 have been found in the sample and you likely have COVID19

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 230°C / 3686°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 athome OTC COVID19 diagnostic tests, visit http://www.fda.gov/covidtests
· 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.

Test Procedure

1 Remove the Test Pen and the Base from the packaging.
USE THE TEST WITHIN 1 HOUR OF OPENING.

CC TT

2 Remove Swab Cap from the Test Pen.
Base Test Pen

COV COV COV COV
COV
COV COV COV COV
COV

CC 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.

CC TT

COV COV COV

COV COV

Make sure you have removed the swab cap (see step 2).

CC TT

COV COV

COVCOV COV

4 Repeat the process with

the same swab in the

other nostril.

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.

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.

6 Leaving the test upright, set a timer and read the results at 15 minutes.

COV CO COV
COV CO

COV CO COV
COV CO COV CO
COV COV CO

TT TT
CC
Locate
TT
orange band CC on the pen. TT

CC
Results

Window

15 Minutes

Orange band covered

TT
Orange band is still partially
visible

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.

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.

CC < 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

COVID19 was detected in your sample and it is very likely you

have COVID19 and are contagious. Please contact your doctor/

primary care physician or your local health authority immediately

and adhere to the local guidelines regarding selfisolation. There

is a very small chance that this test can give a positive result that

is incorrect (a false positive).

CC < 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 COVID19 was not detected in the sample. A negative result does not rule out COVID19. There is a higher chance of false negative results with antigen tests compared to laboratorybased tests such as PCR tests. If the test is negative but COVID19like symptoms, e.g., fever, cough, and/or shortness of breath continue, follow up testing for SARSCoV2 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.

COV

CC < Invalid result

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

is invalid. Retest 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 COVID19.

Status on First Day First Result

of Testing

Day 1

With Symptoms

Positive Negative

Negative

Positive

Without Symptoms

Negative Negative

Negative

Second Result Day 3 N/A Positive Negative N/A Positive Negative Negative

Third Result Day 5 N/A N/A N/A N/A N/A Positive Negative

Interpretation
Positive for COVID19
Positive for COVID19
Negative for COVID19
Positive for COVID19
Positive for COVID19
Positive for COVID19
Negative for COVID19

Results should be considered in the context of an individual's recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID19.
Report your test result(s) at MakeMyTestCount.Org this voluntary and anonymous reporting helps public health teams understand COVID19 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 SARSCoV2 virus.
This test is authorized for nonprescription 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 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 COVID19, when tested at least three times over five days with at least 48 hours between tests.
The Fastep COVID19 Antigen Pen Home Test does not differentiate between SARSCoV and SARSCoV2.
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 coinfection with other viruses. The agent detected may not be the definitive cause of disease. Individuals who test positive with the Fastep COVID19 Antigen Pen Home Test should selfisolate and seek followup 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 SARSCoV2 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 COVID19.
Individuals who test negative and continue to experience COVID19 like symptoms of fever, cough and/or shortness of breath may still have SARSCoV2 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 SARSCoV2 Tests provided by CDC.
The Fastep COVID19 Antigen Pen Home Test is intended for nonprescription selfuse and/or as applicable, for an adult lay user testing another person 2 years of age or older in a nonlaboratory setting. The Fastep COVID19 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 CoV2, 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 COVID19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(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 selfcollected 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 facecovering 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 singleuse. Do not reuse.
· 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
Sodium Azide/ 26628228

GHS Code for applicable ingredient
Acute Tox. 2 (Oral), H300 Acute Tox. 1 (Dermal), H310

Concentration (%) 0.02%

For more information on EUAs please visit: https://www.fda.gov/emergencypreparednessandresponse/ mcmlegalregulatoryandpolicyframework/emergencyuseauthorization.
For the most up to date information on COVID19, please visit: www.cdc.gov/COVID19.

Limitations
· There is a higher chance of false negative results with antigen tests than with laboratorybased 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 COVID19 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 SARSCoV2 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 COVID19, however you should followup with a healthcare provider.
· If the test is positive, then proteins from the virus that causes COVID19 have been found in the sample and you likely have COVID19.
· These test results are shown as lines of color. Because these lines can be very faint, users with conditions affecting their vision such as farsightedness, 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 COVID19 to your family and others in your
community. For more information on EUAs go here: https://www.fda.gov/emergencypreparednessandresponse/ mcmlegalregulatoryandpolicyframework/emergencyuseauthorization.

Frequently Asked Questions, Cont'd)
WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST? There are different kinds of tests for the SARSCoV2 virus that causes COVID19. Molecular tests detect genetic material from the virus. Antigen tests, such as the Fastep COVID19 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 COVID19 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 COVID19 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 COVID19 because proteins from the virus that causes COVID19 were found in your sample. You should selfisolate 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 COVID19 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 SARSCoV2 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 COVID19 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 COVID19 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 Lot Number (Batch Code) Use by (Expiration Date)

In vitro diagnostic use only Tests Per Kit Manufacturer

Temperature Limitations (Storage Temperature)
One Time Use (Single Use Only)

Date of Manufacture 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: ABUSRECDHF0002 R.6 Effective Date: 14 April 2023

COVID-19 ANTIGEN PEN HOME TEST

COVID-19
ANTIGEN PEN HOME TEST

Store between 36-86c2-30 until use

COVID-19
ANTIGEN PEN HOME TEST
Self Test
Quick results in 15 minutes
C T

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

1 × Instruction for 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

1 × Test Pen

Easy to use

1 Swab both nostrils

Box Contents:

1 × Base

T T

T T T

TT
C T

Results

Window

Orange band covered

15 Minutes

U SDIAMLPaLEbel

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

1 For symbol glossary, refer to Instructions for Use
Azure Biotech, Inc. 10400 Main Street Houston, TX 77025 United States hometest@azure.bio 1-800-281-9867
SAMPLE
6 952804 807276

2023-4-6

For ages 2 and up

For use under the FDA Emergency Use Authorization (EUA) only. 20 Tests

COVID-19
ANTIGEN PEN HOME TEST
Self Test
Easy to use Quick results in 15 minutes

SAMPLE
6 952804 807276

Azure Biotech, Inc. 10400 Main Street Houston, TX 77025 United States
hometest@azure.bio 1-800-281-9867

UDSAI MLPaLbE el

COVID-19 ANTIGEN PEN HOME TEST

T T T

1 Swab both nostrils
5x

TT
CC C T
TT

CC C T
TT

Orange band covered

COV COV
COV

T T

5x
Results Window
15 Minutes

20 For symbol glossary, refer to Instructions for Use

COVID-19 ANTIGEN PEN HOME TEST

Box Contents:

CC C T
TT

20 × Bases

20 × Test Pens

1 × Instruction for use

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

Store between 36-86c2-30until use

References

Adobe Acrobat Pro (32-bit) 23.1.20064