Test for Active/Current Infection with this Rapid Antigen Test.
- For self-testing use.
- Easy-to-use nasal swab test.
- Compact packaging for “On-The-Go” testing.
- 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
- FDA Authorized (EUA)
- Long shelf-life
Flowflex COVID-19 Antigen Home Test (Package Insert)
Flowflex COVID-19 Antigen Home Test (Prospecto - Español)
Flowflex Instructions for Health Care Providers
Flowflex Fact Sheet for Health Care Providers
Flowflex Emergency Use Authorization
Flowflex Quick Reference Guide
Frequently Asked Questions
SUMMARY & EXPLANATION
A rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.
With Flowflex, there is no necessary follow-up test, unless new symptoms appear.
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.
MATERIALS PROVIDED:
20 test cassettes
20 extraction buffer tubes
20 specimen collection swabs
1 package insert
- 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-use-authorization
- For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19