MEDNA is CLIA certified

2020-05-27

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.


Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role in assuring quality laboratory testing.


MEDNA is a CLIA certified laboratory and dedicated to the development and production of a robust Quantitative Binding Antibody Test for SARS-CoV-2.  With our test result reporting, you are getting more than just a positive or negative answer.  We go a few steps further and evaluate your test results based on an effective concentration analysis and a known set of positive and negative control data points.