A new test that boasts nearly 100% accuracy has recently been approved, but debate still surrounds how useful such tests might be for both populations and individuals. Dale Smith is a former Associate ...

As more and more COVID-19 data are collected, the clearer our picture of the novel disease becomes. One of the most important pieces of the puzzle (though we stress that it is nevertheless only one ...

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 ...

With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable ...

At the root of almost every plan to restart society is a new kind of coronavirus test that searches not for the virus itself, but the remnants floating in people’s blood of the battle between their ...

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 ...

Autoantibody assays may have significant differences due to the heterogeneity of autoantibodies, including epitope specificity, isotype, and affinity/avidity. This makes it challenging for clinical ...