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 require serial testing.
Easy to use anterior nasal swab specimens, results within 15 minutes.
Excellent performance when compared to an FDA authorized molecular SARS-CoV-2 test.
Provides peace of mind for individuals with and without COVID-19 symptoms.
Sample self-collection for ages 14 or older. For children ages, 2 to 13 sample collection by an adult is required.
Flowflex™ Clinical Performance
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’s Included In The Box
The Flowflex™ COVID-19 Antigen Home Test includes the following;
Test cassette(s)
Package insert
Extraction buffer tube(s)
Nasal swab(s)
External tube holder
Testing Procedure And Interpretation
Step 1 Swab
Step 2 Swirl
Step 3 Drop
Step 4 See Results
Test Results Negative
Test Results Positive
Test REsults Invalid
*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.
Order Your COVID Rapid Tests Now
Rapid testing solutions from Sanalife are here to help organizations in the US with COVID-19 response. Minimum order quantities start at 300 units, please fill out the form and a member of our team will contact you to fulfill your order.
Minimum 300 Order Quantity
Important Product Documentation
Below you will find the pertinent documentation on the FlowFlex™ Covid-19 Antigen Home Test. To download any documents below, click on the link, and the file will automatically download.
This product has a 12-month shelf life and must be stored between 36° to 86° F.
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-preparednessand-response/mcm-legal-regulatory-and-policy-framework/emergency-useauthorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
For detailed instructions, please visit: www.aconlabs.com
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