Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing

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 a laboratory is 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 which will determine what action to take against the offending laboratory.

The guidelines make four key points with regard to actual testing standards.

1. Eligibility Criteria for Testing Laboratories

Panel tests may be performed only by laboratories that are CDC qualified, and, CLIA certified for high complexity tests.

2. Testing Must Meet CLIA Standards

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, which a laboratory must be to perform the Panel, does not exempt the laboratory from the need to comply with CLIA requirements.

3. Laboratories Must Follow Manufacturer’s Instructions

CDC qualified laboratories must also follow any and all applicable Manufacturer’s Instructions (MI) in performing the Panel assays.

4. Laboratories Must Verify Performance Specifications

Upon receipt of the Panel assay, CDC qualified laboratories must verify assay performance specifications in their own laboratory as per the MI. Test laboratories are required to use the CDC kits and reagents but are permitted to use their own RT-PCR equipment and extraction kits.

Takeaway

If your laboratory is qualified to perform the new CDC Panel, be sure that you are aware of and strictly adhere to CLIA and the other requirements specified in the CMS guidelines. Also keep in mind that while similar eligibility and performance standards are likely to apply to other coronavirus detection tests if and when they receive EUA from the FDA, each test will come with its own MI.