On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US Centers for Disease Control and Prevention (CDC) using sequencing information made public by Chinese authorities, the 2019-nCoV Real-Time RT-PCR Diagnostic Panel (Panel) is a real-time reverse transcription polymerase chain reaction panel capable of detecting coronavirus from respiratory and blood serum samples, including nasal or oral swabs. The CDC has created and distributed kits containing the Panel to public health agencies in all 50 states. On Feb. 6, two days after the FDA granted the Panel emergency clearance, the Centers for Medicare and Medicaid Services (CMS) issued guidelines laying out the standards laboratories must follow in performing the assay. Here are the four things testing laboratories need to know about the guidelines. The CMS Guidelines Technically, the CMS guidelines are addressed not directly to the testing laboratories but to the state regulators in charge of enforcing the Clinical Laboratory Improvement Amendment (CLIA) who are charged with policing the performance of Panel testing within their jurisdiction. The guidelines also instruct regulators to notify their CMS Location if they discover that […]