Hyderabad: The U.S. Food and Drug Administration (FDA) have set up a SARS-CoV-2 reference panel to support its evaluation of diagnostic tests for COVID-19.
The panel launched by FDA will works as an additional step to assure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance.
The FDA’s research panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process.
FDA’s 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. Today’s reference panel will provide test developers with well-characterized reagents to compare the performance of different molecular diagnostic tests under the same conditions.”
“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,” Shuren added.
Earlier, FDA has offered similar tools to assist industry in developing tests for other infectious diseases.
In 2015 during Zika outbreak, the FDA launched reference panel for molecular-based diagnostic tests, and then a panel was rolled out of human plasma samples to support the regulatory evaluation of serological tests to detect recent Zika virus infection.
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 continues its public health mandate in combating this pandemic by providing this new tool to aid in the evaluation of diagnostic tests for SARS-CoV-2.
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