12/10/2020: Lab Advisory: CMS Guidance for the Use of Expired SARS-CoV-2 Tests

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

To address the concern about SARS-CoV-2 testing reagents and swab supply shortages during the COVID-19 public health emergency, the Centers for Medicare & Medicaid Services (CMS) will allow laboratories and testing sites to use expired SARS-CoV-2 test kits, reagents, and swabs—unless doing so deviates from the test manufacturer’s authorized instructions for use.

The Clinical Laboratory Improvement Amendments (CLIA) Interpretive Guidelines state that “when in-date reagents are unavailable, it may become necessary to frame written policies for their temporary use beyond their expiration dates until non-expired supplies become available. Under no circumstances, however, should a laboratory adopt policies that would allow for the regular use of expired reagents.”

According to these guidelines, laboratories and testing sites may use expired supplies until non-expired supplies become available, provided that there are policies and procedures in place to ensure that reagents are performing as expected. For example, any expired supplies must pass quality control tests with each assay run.

For more information about this issue (and other topics related to CLIA certification and testing for SARS-CoV-2), refer to the CMS Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency.

Online Resources:

For questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)