FaStep® Rapid Diagnostic Test for
COVID-19
Assure has developed the first and only FDA approved rapid point-of-care lateral flow immunoassays to aid in the diagnosis of coronavirus infection. The test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary) or venous whole blood, serum, and plasma samples.
The COVID-19 IgM/IgG Rapid Test demonstrates a combined sensitivity and specificity of 100% and ~99% respectively, making it one of the most accurate and reliable tests in the world.
FaStep COVID-19 IgG/IgM Rapid Test Device Demonstration
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Purchasing Information
PHONE:
+1 (702) 620-9756
EMAIL:
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NON-MEMBERS:
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PLEASE NOTE THIS IS NOT FOR INDIVIDUAL PURCHASE OR USE. THIS IS STRICTLY FOR BUSINESSES AND GOVERNMENTAL ORGANIZATIONS.
Any orders shipped to a personal address or non-medical business address will be voided and refunded.
Downloads
Resources
Authorized by
The U.S. Food and Drug Administration
“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,”
– FDA Commissioner Stephen M. Hahn, M.D.
FaStep® Rapid Diagnostic Test Product Documents
Product Information + Instructions
Instructions for Use: Fastep® COVID-19 IgG/IgM Rapid Test
Click to view or download
Brochure: Fastep® COVID-19 IgG/IgM Rapid Test
Click to view or download
Point-of-Care (POC) Quick Reference Card
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Authorization, Certification + Clinical Studies
FDA EUA: Letter of Authorization
Click to view or download
EC Declaration of Conformity
Click to view or download
Policy for Coronavirus Tests
Click to view or download
Serology Test Evaluation Report
Click to view or download
Fact + Data Sheets
Healthcare Providers Fact Sheet
Click to view or download
Recipients Fact Sheet
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Safety Data Sheet for Rapid Test
Click to view or download
CPT Coding/Reporting + Reimbursements
CPT Coding/Reporting for COVID-19 Testing
Click to view or download
United Healthcare: COVID-19 Provider Billing Guidance
Click to view or download
Medicare Administrative Contractor (MAC) Test Pricing
Click to view or download
CMS Reimbursement Ruling CMS-2020-01-R
Click to view or download