FaStep COV-S23010H1 COVID-19 Antigen Home Test Instruction Manual

COV-S23010H1 COVID-19 Antigen Home Test
Instruction Manu
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

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.

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.

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 ½ to ¾ 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 ¾ 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 ¼” 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.
    WARNING: Do not read the result before 15 minutes or after 30 minutes.
    After test is completed, dispose of used materials in trash.

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.

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| NIA| Positive for
Negative| Positive| NIA| Positive for COVID-19
Negative| Negative| NIA| Negative for
Without Symptoms| Positive| N/A| NIA| Positive for
Negative| Positive| N/A| Positive forCOVID-19
Negative| Negative| Positive| Positive forCOVID-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-regulatory-and-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: 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), I-1310| 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.

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.

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

References

• Coronavirus Disease 2019 (COVID-19) | CDC
• Emergency Preparedness and Response | FDA
• Medical Devices | FDA
• 800-222-1222" class="nturl" > Poison Control | Call Poison Help Centers Now 1-800-222-1222

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