Flowflex SARS-CoV-2 COVID-19 Antigen Home Test Instruction Manual

Flowflex SARS-CoV-2 COVID-19 Antigen Home Test

KIT CONTENTS

PREPARATION

Wash or sanitize your hands. Make sure they are dry before starting the test. Read the instructions. Check your kit contents and make sure you have everything. Check the expiration date printed on the cassette foil pouch. Do not use if the pouch is damaged or open. Open the pouch and lay the cassette on a clean, flat surface. Locate the Result Window and Sample Well on the cassette.
SPECIMEN COLLECTION
SELF COLLECTION
COLLECTION BY AN ADULT A nasal swab sample can be self-collected by an individual aged 14 years and older. Children aged 2 to 13 years should be tested by an adult.
The Flow flex Web App allows you to track and report your COVID-19 test results

• The Web App is optional and not required to run a COVID-19 test. It will assist you in interpreting your visual test result and report your result to local health authorities.
• Ensure you have an internet connection and scan the Flowflex QR code or go to www.flowflexcovid.com prior to starting the test.
• Ensure you are using a compatible web browser (Chrome, Firefox, Edge, or Safari) and your electronic device has a camera.
•  Click on “Report Your Test Result”.
•  Create an account.

To perform a COVID-19 test

1. Log in to the Flow flex Web App – Ensure you are connected to the internet during your test.
2. Answer a few questions on the Web App.
3. Follow step-by-step instructions for your test.
4. Read result.

TEST PROCEDURE

1. Remove the foil from the top of the extraction buffer tube.

2. Punch through the perforated circle on the kit box to form a tube holder. Place the tube in the tube holder. For 25 test quantity kit box the tube holder is provided.

3. Open the swab packaging at the stick end, not the swab tip. Do not touch the swab tip.

4. Gently insert the entire absorbent tip of the swab into 1 nostril (½ to ¾ of an inch). 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. Note: A false negative result may occur if the nasal swab specimen is not properly collected.

5. Firmly rub the swab in a circular motion around the inside wall of the nostril 5 times. Take approximately 15 seconds to collect the specimen. Be sure to collect any nasal drainage that may be present onto the swab. Repeat this in the other nostril.

6. Remove the swab from the nostril and immediately place into the extraction buffer tube. Note: Test samples immediately after collection, and no more than one hour after the swab is added to the reagent solution, if stored at room temperature.

7. Immediately place the swab into the tube and swirl for 30 seconds. Note: A false negative result may occur if the swab is not swirled at least 30 seconds.

8. Rotate the swab 5 times while squeezing the tube. Note: A false negative result may occur if the swab is not rotated five times.

9. Remove the swab while squeezing the tube. Dispose of the swab in the trash.

10. Attach the dropper tip firmly onto the tube. Mix thoroughly by swirling or flicking the bottom of the tube.

11. Gently squeeze the tube and dispense 4 drops of solution into the Sample Well. Dispose the tube in the trash. Note: A false negative or invalid result may occur if less than 4 drops of fluid are added to the Sample Well.
    

12. Set the timer for 15 minutes. Result should be read at 15 minutes. Do not read after 30 minutes. Dispose the test cassette in the trash. Note: A false negative or false positive result may occur if the test result is read before 15 minutes or after 30 minutes.

RESULT INTERPRETATION

• Negative

  • Only the control line (C) and no test line (T) appears. This means that no SARS-CoV-2 antigen was detected.
  • A negative test result indicates that antigens from the virus that causes COVID-19 were not detected from the specimen. A negative result does not rule out COVID-19.
  • There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests.
  • This means that there is a higher chance this test will give you a negative result when you have COVID-19. If you test negative and continue to experience COVID-19 like symptoms of fever, cough, and/or shortness of breath you should seek follow up care with your healthcare provider.
  • If you do not have symptoms, you should test again in 24 hours (but not more than 48 hours).

• Positive

  • Both the control line (C) and test line (T) appear. This means that SARS-CoV-2 antigen was detected.
    NOTE: Any faint red or pink line in the test line region (T) should be considered positive.

  • 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).

  • Your healthcare provider will work with you to determine how best to care for you based on your test results along with medical history and your symptoms.

• Invalid

  • Control line (C) fails to appear. If a control (C) line is not visible, the test is invalid. Re-test with a new swab and new test cassette.
  • If the problem persists, call 800-838-9502 for assistance.

FOR FDA EMERGENCY USE AUTHORIZATION (EUA) ONLY

• 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 IVDs 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.

• 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

• For detailed instructions, please visit: www.flowflexcovid.com

INTENDED USE

• The Flowflex COVID-19 Antigen Home Test is a rapid lateral flow immunoassay intended for the qualitative detection of the nucleocapsid protein 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 with symptoms of COVID-19 within 7 days of symptom onset.
• This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
• This test is also 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 swab samples from individuals aged 2 or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
• The Flowflex 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. Antigen is generally detectable in nasal (nares) samples during the acute phase of infection.
• Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease.
• Individuals who test positive with the Flowflex COVID-19 Antigen Home Test should self-isolate and consult their physician or healthcare provider as additional testing may be necessary.
• 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 decisions. 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. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection. 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 healthcare provider.
• Individuals should provide all results obtained with this product to their healthcare provider for public health reporting. Healthcare providers will report all test results they received 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 Flowflex COVID-19 Antigen Home Test is intended for non-prescription self-use and/or as applicable an adult lay user testing another aged 2 or older. The Flowflex COVID-19 Antigen Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION

• Read the Flowflex COVID-19 Antigen Home Test Package Insert carefully before performing a test. Failure to follow directions may produce inaccurate test results.
• The Test is intended to aid in the diagnosis of active COVID-19. Please consult a healthcare professional to discuss your results and if any additional testing is required.
• Keep test kit and materials out of the reach of children and pets before and after use.
• Do not use on anyone under two years of age.
• Children aged 2 to 13 years of age should be tested by an adult.
• Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
• Leave the test cassette sealed in its pouch until just before use. Once opened, the test cassette should be used within 60 minutes.
• Do not use the test after the expiration date shown on the test cassette pouch.
• Do not use if any of the test kit contents or packaging is damaged or open.
• Test components are single use. Do not re-use. Do not use with multiple specimens.
• Make sure there is sufficient light when testing.
• Do not use nasal sprays for at least 30 minutes before collecting a nasal sample.
• Remove any piercings from the nose before starting the test.
• Do not use on anyone who is prone to nosebleeds or has had facial injuries or head injuries/surgery in the past six months.
• False negative test results may occur if a specimen is incorrectly collected or handled.
• Do not touch the swab tip when handling the swab.
• The test is intended to be read at 15 minutes. If the test is read before 15 minutes or after 30 minutes, false negative or false positive results may occur, and the test should be repeated with a new test cassette.
• Do not ingest any kit components.
• Avoid exposure of your skin, eyes, nose, or mouth to the solution in the extraction tube.
• The Reagent Solution contains a harmful chemical
  Hazard Category (mixture)| Hazard Statement for mixture| Labeling of Harm(s)
  ---|---|---
  Not classified| Acute oral or dermal toxicity| None
  Category 2| Eye irritation| May cause eye irritation
  Category 3| Skin irritation| Causes mild skin irritation
• If the reagent solution contacts the skin or eye, flush with plenty of water. If irritation persists, seek medical advice. https://www.poisonhelp.org or 1-800-222-1222
• If you have symptoms of COVID-19 that started within the last 7 days, you can use a single test.
• For serial testing, if your first test result is negative, you should test again with a new test in 24 to 48 hours.
• Testing for asymptomatic individuals should be performed at least twice over two to three days, with at least twenty-four hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.
• There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have a COVID-19.
• Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms.
• If your first or second test is positive, then proteins from the virus that causes COVID-19 have been found in your sample and you likely have COVID-19.
• If both your first and second tests are negative, you may not have COVID-19, however you should follow-up with your healthcare provider if you are at high risk for COVID-19.

STORAGE AND STABILITY

• Store Flowflex COVID-19 Antigen Home Test between 2-30°C (36-86°F) until use.
• Ensure all kit component are at room temperature before use.
• Kit contents are stable until the expiration date printed on the outer packaging.
• Do not use beyond the expiration date.

FREQUENTLY ASKED QUESTIONS

Q: WHAT IS COVID-19?
A: COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A full list of symptoms of COVID-19 can be found at the following link: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
Q: WILL THIS TEST HURT?
A: No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from your healthcare provider.
Q: WHAT ARE THE KNOWN POTENTIAL RISKS AND BENEFITS OF THIS TEST?
A: Potential risks include:

• Possible discomfort during sample collection.

• Possible incorrect test results (see Warnings and Result Interpretation section).
  Potential benefits include:

• The results, along with other information, can help you and your healthcare provider make informed decisions about your care.

• The results of this test may help limit the spread of COVID-19 to your family and others in your community.

Q: WHAT IS SERIAL TESTING?
A: Serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. Serial testing (i.e. testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms. Testing for asymptomatic individuals should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.
Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST?
A: There are different kinds of tests for the virus that causes COVID-19. Molecular tests detect genetic material from the virus. Antigen tests, such as the Flowflex COVID-19 Antigen Home Test, detect proteins from the virus. Antigen tests are very specific for the SARS-CoV-2 virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional test is necessary and if you should continue isolating at home. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19 than a molecular test would.
Q: HOW ACCURATE IS THIS TEST?
A: The performance of Flowflex COVID-19 Antigen Home Test was established in an all-comers clinical study conducted between March 2021 and May 2021 with 172 nasal swabs self-collected or pair-collected by another study participant from 108 individual symptomatic patients (within 7 days of onset) suspected of COVID-19. The Flowflex COVID-19 Antigen Home Test was compared to an FDA authorized molecular SARS-CoV-2 test. The Flowflex COVID-19 Antigen Home Test correctly identified 93% of positive specimens and 100% of negative specimens in that study.
Q: WHAT IF YOU TEST POSITIVE?
A: 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. Your healthcare provider will work with you to determine how best to care for you based on your test result, medical history, and symptoms.
Q: WHAT IF YOU TEST NEGATIVE?
A: A negative test result indicates that antigens from the virus that causes COVID-19 were not found in your sample. If you have symptoms, you likely do not have COVID-19. If you do not have symptoms and you receive a second negative result 24 to 48 hours after your first negative result, then you are likely not infected with COVID-19. However, negative results do not rule out SARS-CoV-2 infection. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. For example, you may get a false negative result if you did not perform the test correctly or if the level of antigen from the virus causing COVID-19 was below the test limits. The amount of antigen in a sample may decrease the longer you have symptoms of infection. If you test negative and continue to experience symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. It is important that you work with your healthcare provider to help you understand the next steps you should take.
Q: WHAT DOES AN INVALID TEST RESULT MEAN?
A: 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 the test should be run again, using a new test cassette and extraction buffer tube.
IMPORTANT
This test is intended to be used as an aid in the clinical diagnosis of active COVID-19. Do not use this test as the only guide to manage your illness. Please consult your healthcare provider if your symptoms persist or become more severe, or if you are concerned at any time.
Individuals should report the test result through the Flowflex Web App or provide all results obtained with this product to their healthcare provider for public health reporting.

HEALTHCARE PROVIDERS

Please visit www.flowflexcovid.com to obtain the complete instructions for use and fact sheet for healthcare providers.
Index of Symbols

| Do not reuse

References

• Flowflex COVID-19 Antigen Home Test - Flowflexcovid.com
• Coronavirus Disease 2019 (COVID-19) | CDC
• Flowflex COVID-19 Antigen Home Test - Flowflexcovid.com
• Symptoms of COVID-19 | CDC
• 800-222-1222" class="nturl" > Poison Control | Call Poison Help Centers Now 1-800-222-1222

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