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SARS-CoV-2 Emergency Use Authorization (EUA)-authorized molecular assays are important tools for the diagnostic testing of SARS-CoV-2 in clinical microbiology and public health laboratories. The demand for sensitive and specific SARS-CoV-2 diagnostic testing is high. Labs need to start testing with commercial assays receiving FDA EUA, but the process of verifying these molecular tests is complex. Each EUA test is unique, with different characteristics and limitations, and clear guidance is needed to ensure tests are performing properly before diagnostic data can be collected and accurately interpreted. Numerous molecular SARS-COV-2 assays are receiving EUA from the FDA. These include direct sample to answer and “point of care” devices, as well as high-complexity batched-based testing.
 
The American Society for Microbiology has developed step-by-step verification procedures to help labs develop efficient and effective verification protocols for these assays. These guidelines identify necessary supplies, quality control standards, safety requirements and limitations of cartridge-style and batch format assays.
 
These procedures will help with the verification process, allowing tests to not only be made available faster, but also ensuring that the data is accurate.

Contact Information

Vaishali Dharmarha, clinmicro@asmusa.org