COVID-19 FDA Fact vs. Fiction
During this unprecedented pandemic, governments, communities and individuals worldwide have had to make drastic changes to confront the Coronavirus and the resulting respiratory illness, COVID-19. We have seen different measures employed around the world such as social-distancing, mass-testing, self-quarantining and even the reduction of red tape by regulatory bodies around the globe.
The United States is one of those countries that has taken the step of lessening or eliminating red tape to help confront everything from nursing scope of practice laws, to certificate of need reform to empowering the private sector to address the testing shortage being felt nationwide.
That testing shortage is where these screens come in. Below is a few frequently asked questions about the Coronavirus / COVID-19 rapid test. AllSource wants to present the facts as transparently as possible.
What is the accuracy of this test?
How long does it take to render “rapid” results?
2 to 10 minutes.
Are Coronavirus / COVID-19 rapid tests allowed for sale in the United States?
Yes, but only authorized tests. The FDA has issued an Emergency Use Authorization (EUA) for both of our covid-19 antibody tests, those being AssureTech's Ecotest and Healgen's Rapid Antibody Test.
Are these Coronavirus / COVID-19 rapid tests currently being used around the world?
Yes. Millions of these screens have been dispensed and used around the world as an effort to identify who has or has had the virus, thus enabling people to take precautions and consult with their doctors for the next step.
Has the FDA approved this screen in the United States?
The FDA has issued an Emergency Use Authorization (EUA) for both of our covid-19 antibody tests, those being AssureTech's Ecotest and Healgen's Rapid Antibody Test.
Does this screen have any international certifications?
Yes. This screen has a CE certification, permitting its sale in all EU countries.
What exactly is this screen testing for?
This screen is testing for the amount of antibodies that are in your system for Coronavirus. These antibodies present themselves in the bloodstream in response to viral infection. If the antibodies are present in your system, that indicates that the individual has, or has had the virus.