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May 28, 2020

US FDA sets up reference panel for Covid-19 diagnostic test evaluation

The US Food and Drug Administration (FDA) has launched SARS-CoV-2 reference panel to support its evaluation of Covid-19 diagnostic tests.

The US Food and Drug Administration (FDA) has launched SARS-CoV-2 reference panel to support its evaluation of Covid-19 diagnostic tests.

The FDA panel will work as an additional step to assure the quality of the Covid-19 tests, validation of new assays, test calibration and monitoring of assay performance.

It will offer ‘well-characterised’ reagents to test developers to analyse the performance of different molecular diagnostic tests under the same conditions.

The panel is available to commercial and laboratory developers who are interacting with the agency through the pre-emergency use authorisation (EUA) process.

FDA Center for Devices and Radiological Health (CDRH) director Jeffrey Shuren said: “The FDA has taken many steps during this pandemic to ensure that Americans have access to trustworthy diagnostic tests.

“We are continuously 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.”

In the past, the agency has offered similar tools to help the industry in developing tests for other infectious diseases, including Zika.

At that time, the FDA launched a Zika reference panel for molecular-based diagnostic tests and later rolled out a panel of human plasma samples to support the regulatory evaluation of serological tests.

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, the FDA noted.

Earlier this month, the agency published a list of antibody tests removed from the ‘notification list’ of tests to be offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

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