Flow flex COVID-19 antigen home tests

Flow flex 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 symptoms onset or without symptoms or other epidemiolocal reasons to suspect COVID-19.

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 flow-flex COVID 19 antigen home test does not differentiate between SARS-COV and SARS-COV-2

Result is not the identification of SARS-coV-2 nucleocapsid protein antigen. This antigen is generally found in anterior nasal swab during the acute phase of infection.

Positive result indicates the presence of viral antigen, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive result does not rule out bacteria infection or co-infection with other viruses. The agent detected may not be the define causes of disease.

The flow flex COVID-19 Antigen home test is intended for self-use or lay user testing another in a non-laboratory setting.  The flow flex COVIDD-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 B genus. COVID-19 is an acute respiratory infection 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 infection 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 diarrhoea are found in a few cases.

Warning, precaution and safety information

• Read the flow flex COVID-19 Antigen home test package insert carefully before performing a test. Failure to follow direction 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 result 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 age 2 or 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 after the expiration date shown on the test cassette pouch.

FREQUENTLY ASKED QUESTIONNS

WHAT IS COVID-19?

COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in human causing a contagious respiratory illness. COVID -19 can present with mild to serve 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 condition have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death.

 

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 RISK AND BENEFITS OF THIS TEST?

Potential risk include:

• Possible discomfort during sample collection.
• Possible incorrect test result

Potential benefits include

• The result along with other information, can help you and your healthcare provider make informed decisions about your care.
• The result of this test may help limit the spread of COVID-19 to your family and others your community.

WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST?

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 flow flex COVID-19 antigen home test, detect proteins from 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 is necessary and if you should discuss with your healthcare provider whether an additional test is necessary and if you should continue isolation at home.

WHAT ID YOU TEST POSITIVE?

A positive result means that if I 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 health care provider will work with you to determine how best to care for you based on your test result, medical history, and symptoms.

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WHAT IF YOU TEST NEGATIVE?

A negative test result indicates that antigen from the virus that causes COVID-19 were not found in your sample. If you have symptoms, you likely do not have COVID-19. However, negative result does not rule out SARS-Cov-2infection.

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 the test should be run again, using a new test cassette and extraction buffer tube.

IMPORTANT

A 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 flow flex web App or provide all results obtained with this product to their healthcare provider for public health reporting.