COVID-19 is a disease caused by a new strain of coronavirus. ‘CO’ stands for corona, ‘VI’ for virus, and ‘D’ for disease. Formerly, this disease was referred to as ‘2019 novel coronavirus’ or ‘2019-nCoV.’
The COVID-19 virus is a new virus linked to the same family of viruses as Severe Acute Respiratory Syndrome (SARS) and some types of common cold.
The Flowflex™ COVID-19 Antigen Home Test offers quick results in showing if somebody is carrying the COVID-19 virus. It is easy to use, very affordable and accurate. The nasal swab provides results within 20 minutes and is extremely suitable for testing large groups of people by professionals.
The Flowflex™ COVID-19 Antigen Home Test is an antigen test that will show if you have antigens for an active COVID-19 infection. The COVID-19 Antigen Rapid Swab Test is developed to find proteins from the virus that causes COVID-19 via nasal swabs. The test is easy to perform and gives accurate information on whether someone is actively infected with the COVID-19 virus.
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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.
• To determine your family’s Covid-19 status, whether symptoms are present or not.
• Easy and Affordable
• Highly Accurate Nasal Swab Test
• Quick Results in 15 minutes
• Safe for children as young as 2 years old
• For use with and without symptoms
Insert the swab into the nostril. Gently rub and roll the swab and leave it in place for several seconds to absorb the specimen. Then slowly remove it while rotating the swab. Repeat for both nostrils.
Put the sample into the tube and rotate it. Squeeze the bottom of the tube while the sample is inside. Close the tube.
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Wait 15 minutes before checking the results. You can check the results by holding your device close to your smartphone.
Do not wait longer than 20 minutes before checking!
The Flowflex™ COVID-19 Antigen Home Test device offers all the benefits of a rapid test. The sensitivity, specificity and accuracy for SARS-VoV-2 Antigen Rapid Test meet the acceptance criteria.
• Results in 15 minutes
• Visual results
• Everything necessary in one package
• Easy to use instructions for using the test
• Clear results
• Sensitivity: 97,1%
• Specificity: 99,6%
• Accuracy: 99.3%
Every set exists out of all the parts that are necessary to take the COVID-19 Antigen Rapid Swab Test:
• Test Cassette(s)
• Package Insert
• Extraction Buffer Tube(s)
• Nasal Swab(s)
• External Tube Holder - Package of 25 tests
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
