FlowFlex Product Documentation

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.

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 manufacturer's instructional video.

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

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.

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.

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

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

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

Insert the swab 1/2 to 3/4 inches inside your nostril. With children, the maximum depth of insertion into the nostril may be less than 3/4 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.

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

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.

Please contact the manufacturer's customer service line at (800) 838-9502.

Do not use the test and contact the manufacturer's customer service line at (800) 838-9502.

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.

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

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

Results are available in 15 minutes.

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.

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

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.

A negative test result indicates no antigens for COVID-19 were detected. It is possible for this test to give a negative result that is incorrect (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 possibly 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 to determine if you have contracted the virus causing COVID-19. If you are concerned about your COVID-19 infection status after testing or think you may need follow-up testing, please contact your healthcare provider.

An invalid test result indicates that not enough specimen volume was collected or incorrect test operation are the likely reasons for an invalid result. Please review the instructions again and repeat the test with a new cassette. If the problem persists, call the manufacturer's customer service line at (800) 838-9502 for assistance.

A false positive is a test result that indicates a person has a specific disease or condition when the person actually 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.

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.

The type of testing and documentation required for international/air travel may be different based on the travel destination, airline, and state requirements. Therefore, we recommend that you contact your airline carrier, visit the CDC/TSA website, and your local health department’s website for the latest requirements on the type of acceptable testing and documentation for your travel destination.

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.

For more information on the different kinds of COVID-19 tests, please visit: https://www.fda.gov/consumers/consumerupdates/coronavirus-disease-2019-testing-basics

Please see the manufacturer's website for Self-Guided Support documentation.

The FlowFlex™ COVID-19 Antigen Home Test is FSA and HSA eligible.

You can use the funds from your FSA/HSA either with an FSA/HSA debit card provided by your employer, or by submitting paper receipts for reimbursement. Using an FSA/HSA debit card will often mean you don't have to submit receipts to your administrator, but it's always a good idea to hold onto your receipts just in case they're needed for any reason

Shipping and handling fees to obtain an eligible item are reimbursable if the fees are required for the legal procurement of that item. In those circumstances, shipping and handling fees are eligible for reimbursement with a flexible spending account (FSA), health savings account (HSA) or a health reimbursement arrangement (HRA)

Shipping and handling fees reimbursement is not eligible with a dependent care flexible spending account (DCFSA).

Purchases of at-home over-the-counter COVID-19 diagnostic tests authorized by the U.S. Food and Drug Administration (FDA) must now be reimbursed by health insurance companies under new rules. Each covered family member is entitled to up to eight tests every 30 days.

To file a claim for reimbursement, save the PDF receipt from your QuickShipCovidTests purchase and submit it according to your health insurance provider's claim submission process. Your level of reimbursement will be determined by your health insurance provider.

PLEASE NOTE: Shipping fees to procure allotted tests may not be eligible for reimbursement under this mandate. Please call the number on the back of your health insurance card for details specific to your health insurance plan and provider.

We guarantee your order will ship within 24 hours of purchase.

During the checkout process, you may choose from a variety of shipping options to suit your desired timing and needs. Once your order is shipped, you will receive tracking information from your chosen shipping carrier.

Unfortunately, because we fulfill orders so quickly, we are unable to process cancellations once your purchase has been confirmed.

Due to the sensitive nature of this product, we cannot accept returns nor issue refunds. All sales are final.

If you find that anything is missing from your test kit, experience an error while testing that renders the kit unusable, or encounter any other trouble while testing, please contact the manufacturer directly via their customer service line: (800) 838-9502