FLOWFLEX COVID-19 RAPID HOME TEST

FLOWFLEX COVID-19 RAPID HOME TEST

The Flowflex COVID-19 Rapid Home Test offers a quick solution to to determine your family’s COVID-19 status.

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.

FEATURES

• Kit contains everything you need to perform a test
• No prescription needed
• Easy-to-use nasal swab test
• Requires just 1 test*
• Can be used to test children as young as 2 years old
• For use with and without COVID-19 symptoms
• Accurate results in 15 minutes
• No need to send off to a lab to obtain results
• Compact packaging for “On-The-Go” testing

*Other COVID-19 antigen home tests may require a 2nd test 2-3 days after the first.

TEST PROCEDURE

This test procedure overview does not replace the package insert. Before you begin the test, it is important to read and follow the detailed instructions in the package insert.

INTENDED USE

The Flowflex COVID-19 Antigen Home Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is authorized for non-prescription home use with self-
collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older. 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. This antigen is generally found in anterior nasal swabs 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. The agent detected may not be the definite cause of disease.

Individuals who test positive should self-isolate and consult their healthcare provider as additional testing may be necessary and for public health reporting. 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.

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 self-use or lay user testing another in a non-laboratory setting.

The Flowflex COVID-19 Antigen Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

FREQUENTLY ASKED QUESTIONS

• WILL THIS TEST HURT? 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.
• WHAT ARE THE KNOWN 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.
• WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST? 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.
• HOW ACCURATE IS THIS TEST? 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 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.
• WHAT IF YOU TEST POSITIVE? A positive test result means that antigens from COVID-19 were detected and it is very likely you currently have COVID-19 disease. 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) along with your medical history, and your symptoms.
• WHAT IF YOU TEST NEGATIVE? 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 (false negative) in some people with COVID-19, and 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.

RESOURCES

• FlowFlex Home Test Quick Reference Instructions
• FlowFlex COVID-19 Home Test Consumer Package Insert