CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing

On Feb. 6, CMS issued guidance to labs and other providers on how to use the newly approved Centers for Disease Control and Prevention (CDC) test for coronavirus. Here are the key takeaways.

The CDC Test

As with other infectious illness outbreaks, coronavirus caught regulators, test makers and labs off guard. The only test for it currently available in the US is the real-time reverse transcription polymerase chain reaction panel, aka, the 2019-nCoV Real-Time RT-PCR Diagnostic Panel developed by the CDC using sequencing information made public by Chinese authorities. The FDA issued emergency use authorization (EUA) for the Panel on Feb. 4.

The Panel, which is capable of detecting coronavirus from respiratory and blood serum samples, including nasal or oral swabs. Test labs must use the kits and reagents supplied by the CDC to public health agencies in all 50 states but are allowed to use their RT-PCR equipment and extraction kits.

The CMS Guidelines

Two days after the test received EUA from the FDA, CMS published the guidelines telling state regulators in charge of enforcing the CLIA laws how to police use of the Panel by labs. The guidelines make four key points.

  1. Which Labs Can Perform

Only labs that are CDC qualified, and, CLIA certified for high complexity tests may perform the tests.

  1. CLIA Applies

As with other assays that have received EUA from the FDA, use of the CDC panel and corresponding protocols remains subject to CLIA regulations. In other words, being CDC qualified doesn’t exempt the lab from the need to meet CLIA requirements.

  1. Need to Follow Manufacturer’s Instructions (MI)

CDC qualified labs must also follow any and all applicable MI.

  1. Need to Verify Performance Specifications

Upon receipt of the Panel assay and corresponding MI, CDC qualified labs must verify assay performance specifications in their lab per the manufacturer’s instructions.

The guidance also instructs regulators to notify their CMS Location if they discover a lab using an assay without an EUA that is testing for the same agent for which the emergency has been declared, or a modified EUA assay. The CMS location will then relay the notification to CMS headquarters in Baltimore.

 

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