CMS issues guidance ensuring Americans with health insurance have coverage for IgM/IgG antibody testing performed by their physician at no cost! Here is the policy.

PreventCare Presents The FaStep Corona Virus COVID-19 IgM/IgG Antibodies Test Kit For Healthcare Professionals

In the midst of a nationally declared public healthcare emergency and extremely limited testing options available on the market, the FaStep Antibody Test Kit brings a quick and easy-to-use clinically validated solution to inform your patient population and office staff on the presence of antibodies in response to exposure from the novel corona virus, and ease the burden on emergency healthcare services around the country. ​ 

This testing kit has been registered with the FDA under Policy D of the March 16, 2020 guidance for sale to licensed medical professionals in compliance with CMS/CLIA requirements. Assure Tech has submitted for an Emergency Use Authorization with the FDA for the FaStep Antibody Test (EUA200487).

​This testing kit has not been reviewed by the FDA but at PreventCare, quality is our foremost priority. These antibody test kits are designed and manufactured by Assure Tech, with nearly eight years of history with the FDA bringing products to the US market for both point-of-care and over the counter use. To date, Assure Tech has successfully earned 71 approvals for lateral flow chromatographic immunoassays and other products. Assure Tech’s FDA registered owner/operator number is 10040710 and its registered establishment number is 3009585529.

This antibody kit has been internally validated by the manufacturer and by PreventCare. Further, we are currently conducting two additional independent validation studies in the United States. Please find the results of both studies performed as of 5/10/20 below: 

COVID-19 Antibody Serology Rapid Test Kit

Results in 15 minutes

No laboratory equipment necessary 

97.7% IgM accuracy*

98.7% IgG accuracy*

*See the manufacturer validation here for further information

This internally validated qualitative antibody test kit was designed for the rapid detection of SARS/COV-2 antibodies. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. This test cannot be used as the sole basis for diagnosis.  ​  

Provides peace of mind and evidence-based empirical information on the presence of corona virus exposure antibodies for medical professionals and their patients. Keep your medical staff and patients alike informed and safe.

EC DECLARATION OF CONFORMITY: 

ce-mark_edited.png

Utilize FaStep COVID-19 Antibody Test Kit to identify patients that carry SARS/COV-2 antibodies as the quarantines requirements begin to loosen around the country

See the approvals, FDA manufacturer registration and validation studies

Answers to your questions about administering the corona virus COVID-19 Antibody Test

Contact Us

Your questions and comments are very important to us. Please use this form to contact us and we will respond in a time-sensitive manner!

FDA Policy for COVID-19 Diagnostic Tests during the Public Health Emergency. Here is the policy.

 

Terms & Conditions


© 2020 PreventCare. All Rights Reserved.