Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

FDA new step to support the evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. Reference panels are needed to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance.

On May 27, 2020, the U.S. Food and Drug Administration took a new step to support the agency’s evaluation of diagnostic tests for Covid-19, by providing a SARS-CoV-2 reference panel. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance. These types of reference panels have proven to be an invaluable resource in the development of accurate, reliable, and validated diagnostic tests for detecting infectious diseases. Jeffrey Shuren, M.D., J.D., and director of the FDA’s Center for Devices and Radiological Health highlighted the FDA”s continued dedication to “evaluating our policies and approaches on diagnostic tests during this pandemic, including addressing poorly performing tests. We are committed to remaining flexible and providing more resources to developers as necessary, based on our regulatory expertise, real-world experience, and data, in order to protect and promote public health.”