FlowFlex OTC Rapid Antigen Test

Flowflex COVID-19 Antigen Home Test Kit

EXP DATE: June 2025

Flowflex FDA Extension Letter

The FlowFlex™ COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2, not for any other viruses or pathogens. Flowflex at home COVID test kit additional information.

• For use with direct anterior nasal and nasopharyngeal swab specimens, non-invasive test procedures
• Detects Active COVID-19 Infection - This test detects multiple COVID-19 variants including the Omicron and Delta variants.
• Accuracy:
  • Nasal Swab: 98.8% (95% CI: 97.6%-99.5%) 95% Confidence Intervals
  • Saliva: 97.1% (95% CI: 94.6%-98.5%) 95% Confidence Intervals
• Variant-ready solution. Detects Omricon Variant
• Instructions for Use at Home
• Healthcare Provider Instructions for Use
• Fact Sheet for Healthcare Providers
• Rapid results within 15 minutes
• Read about the difference between Antigen tests and Antibody tests
• Expiration Date: If you receive a box that has an expiration date that has passed, please do not be concerned. The state department has granted an extended expiration life of 12 months from the expiration date printed on the back of the box for these tests.

Please call us at 1-877-597-3224 or e-mail us at sales@peachmedical.com for wholesale pricing. We are more than happy to provide references in theatre, government, banking, education, fortune 500 companies, and more. Over 50,000+ orders of test kits sold over the past year.

• NO PRESCRIPTION REQUIRED - Authorized for home use.
• TRUSTED TECHNOLOGY - Identical to health professional test used.
• DETECTS COVID-19 INFECTION including variants.
• NO SYMPTOMS NECESSARY – Test with or without COVID-19 symptoms.
• QUICK-TO-TEST – Effortless test with easy-to-read results in 15 minutes.
• EASY-TO-USE - Simple instructions and all components included.

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

DISCLAIMER

Please note that all Peach Medical shipments do not require a signature upon delivery. Since most test kits should be stored between 35.6 and 86 degrees F range, we strongly recommend that you track your order and anticipate its delivery. However, if the test is stored outside the temperature range for a relatively short period of time – for a couple of hours up to a day or two – it will be fine to use as long as the test and its components are used at room temperature. Peach Medical is not responsible if the test kits are left outside in extreme temperatures for longer than the recommended time frame after delivery.

FAQ

1. What is the Flowflex COVID-19 Antigen Home Test?

The Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal

specimens. It is intended for self-testing use. For use under an Emergency Use Authorization (EUA) only.

2. How does this test work?

This test uses a nasal swab sample to determine the presence or absence of COVID-19 antigens in nasal samples. For a demonstration on how this test works, watch the instructional video.

3. What is serial testing? Do I have to serial test with the Flowflex COVID-19 Antigen Home Test?

Serial testing is a process in which a user must test themselves twice within a two-to-three-day period. The Flowflex

COVID-19 Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms.

4. What is the age range for this test?

This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older.

6. Will this test work if I do not have COVID-19 symptoms?

This test is intended for individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.

7. How many tests come with the test package?

This test is available in 2-test, 5-test, and 25-test packages.

8. Can I swab my throat/ear instead of my nose?

Please do not swab your throat/ear. Please only swab your nose to collect samples and follow instructions on the package insert.

9. I lost my swab, can I use a Q-tip instead of the swab?

Please only use the swab that is provided with the test. Contact customer service at (800) 838-9502 for assistance.

Customer Service hours are 8 a.m. to 5 p.m. (Pacific Time), Monday - Friday.

10. How deep should I insert the swab into my nose?

Insert the swab ½ to ¾ inches inside your nostril. 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 hold the child’s head while swabbing.

Note: A false-negative result may occur if the nasal swab specimen is not properly collected.

11. Should I swab my left or right nostril?

Please use the swab to collect specimens from both of your nostrils to ensure sufficient sample collection to generate an accurate result.

12. For how long do I have to swab my nostril?

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 on the swab. Repeat this in the other nostril.

15. After nasal specimen collection, how long do I need to swirl the nasal swab in the buffer tube?

Place the swab into the buffer tube and swirl for 30 seconds. Rotate the swab 5 times while squeezing the tube.

Remove the swab while squeezing the tube to extract as much liquid as possible. Attach the dropper tip firmly onto the tube. Mix thoroughly by swirling or flicking the bottom of the tube. Then gently squeeze the tube and dispense 4 drops of solution into the Sample Well.

16. How many drops should I put in the cassette well? Can I put in all the buffer solutions?

You should dispense 4 drops of solution into the cassette sample well. Please do not overuse the buffer solution.

17. Where should I dispense the solution on the cassette?

You should dispense 4 drops of solution into the cassette Sample Well marked with an “S”.

18. How long does it take to obtain results with FlowFlex?

Results are available in 15 minutes.

19. Will this test cause any pain?

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.

Do not use this test on children under two years of age. Do not use this test on anyone who is prone to nosebleeds or has had facial injuries or head injuries/surgery in the past six months.

20. What are the known and potential risks and benefits of this test?

Potential risks include:

• Possible discomfort during sample collection.

• Possible incorrect test results (see 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.

23. Is the test result still valid if I see a pinkish color on the test strip after applying the sample to the test cassette sample well?

Pinkish background color on the test strip will not affect the result of your test.

24. What is the difference between Antigen, Molecular, and Antibody tests?

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR 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 COVID-19 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 molecular test is necessary and if you should continue isolating at home.

Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been produced by your immune system in response to a previous COVID-19 infection or vaccination. Antibody tests are not suitable for diagnosing an active COVID-19 infection.

25. What do the two red lines on the cassette mean after I complete the test?

If both the control line (C) and test line (T) appear, even if the line on the test line (T) is very faint, this means that you have a positive test result because antigens from COVID-19 were detected, and it is very likely you currently have COVID-19. Please refer to the package insert for more information.

26. What does it mean if I have a positive test result?

A positive test result means that antigens from COVID-19 were detected and it is very likely you currently have COVID-19. There is a very small chance that this test can give a positive result that is wrong (a false-positive result). If you test positive you should self-isolate at home per CDC recommendations to stop spreading the virus to others.

Please consult the CDC recommendations regarding self-isolation at www.cdc.gov/coronavirus. Seek follow-up care with your healthcare provider immediately. Your healthcare provider will work with you to determine how best to care for you based on your test result(s), medical history, and symptoms.

27. What does it mean if I have a negative test result?

A negative test result indicates no antigens for COVID-19 were detected. This test can give an incorrect negative result (a false-negative result) in some people with COVID-19. Negative results are presumptive and may need to be confirmed with a molecular test. This means that you could still have COVID-19 even though the test is negative.

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 immediately. Your healthcare provider may suggest you need another test.

28. What if I have an invalid result?

An invalid test result indicates that not enough specimen volume was collected or incorrect test operation is the likely reasons for an invalid result. Please review the instructions again and repeat the test with a new cassette.

29. What is a false-positive and a false-negative test result?

A false positive is a test result that indicates a person has a specific disease or condition when the person does not have the disease or condition. A false-negative test result indicates a person does not have a specific disease or condition when the person actually does have the disease or condition. Incorrect specimen collection and sample preparation can result in false-negative and false-positive test results. Therefore, before you begin the test, it is very important to read the package insert provided in the test package and follow the instructions.

30. How accurate is this test?

The performance of the 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 and 64 asymptomatic patients. All subjects were screened for the presence or absence of COVID-19 symptoms within two weeks of study enrollment. 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.

For more information on EUAs please visit: FDA Website For EUA Information

Product Documents

FDA EXTENSION LETTER

Shipping and Returns

How Long Does It Take For My Item(s) To Ship?

Items are shipped Monday - Friday from our warehouse. 1-2 Day Processing Time.

For B2B accounts, please contact us at sales@pechmedical.com for urgent order requests.

Please feel free to contact support@peachmedical.com if you have any questions.

What Shipping Methods Do You Offer?

At Peach Medical we use UPS (most orders ship via UPS but some may ship via USPS) as our logistic and Shipping partners. We currently offer the following services:

UPS Next Day Air

UPS 2nd Day Air

UPS Ground (3-5 Day Delivery)

When Will I Receive My Tracking Number?

Our system updates clients every evening with tracking numbers for their orders. This will be sent via e-mail with an additional copy of your receipt.

Incorrect Address

Please verify your address when ordering, we are unable to fix an incorrect shipping address on an order once it is in transit. If your order is in transit with an incorrect address, please reach out to your carrier to reroute the package. Peach Medical cannot have packages rerouted or contact the carrier on your behalf.

Refunds will not be issued for packages that were shipped to an incorrect address but it may be possible for a replacement package to be sent, please get in touch with the customer service team to see if you are eligible.

Return Policy and Cancellation Policy

All sales are final. If items are found defective, the customer has 7 Business Days to request a return label. We are not responsible for any delays caused by shipping companies, ie: UPS, FedEx, DHL, or Freight.

If a customer chooses a 3rd party receiver who is not the purchaser, Peach Medical is not responsible for any goods once they leave our warehouse and when tracking is provided. I.e Gifts, International Shipping Services.

Note: If Peach Medical has not shipped your item within 7 business days, cancellations will be honored.