The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization ...
On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic. The Agency did this by updating (and superseding) previous ...
QUANTITATIVE serologic tests for syphilis have become more widely used in recent years following the introduction of intensive methods of syphilotherapy. These tests not only are useful in methods of ...
In January 2020, the Food and Drug Administration (FDA) began considering the U.S. response to Covid-19. On February 4, after the declaration of a public health emergency, we began authorizing tests ...
The Families First Coronavirus Response Act (FFCRA) was passed by Congress on March 18 and mandated that Medicare, Medicaid, and private insurance plans cover COVID-19 testing and administration costs ...
Against a backdrop of dynamic federal regulations and a quickly expanding commercial landscape, labs are facing unusual obstacles in validating serology testing for COVID-19. Issues with test accuracy ...
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