March 4 LOCS (CDC) Email

Audience: Clinical Laboratory Professionals
Subject: COVID-19 Public Health Reporting for Laboratories that Develop or Use Laboratory Developed Tests with Intent to Obtain EUA
Level: Laboratory Alert

On February 29, 2020, the Food and Drug Administration (FDA) issued new guidance that indicated laboratories could develop novel coronavirus (COVID-19) molecular diagnostics tests and begin to use them before obtaining Emergency Use Authorization (EUA).

CDC joins the Council of State and Territorial Epidemiologists and the Association of Public Health Laboratories in strongly encouraging clinical laboratories that are developing and implementing their own tests for COVID-19 to contact their state public health department as early as possible in the process, even before receipt of any test orders or patient specimens. Taking this step will help ensure that there will be rapid reporting of information necessary to support case investigations. Early notification will also help state public health departments provide the capacity needed for confirmation of the initial testing results in support of the FDA guidance.

All state and local public health departments have laws that mandate reporting of diseases and conditions of public health significance. Any provider (laboratory or clinician) who fails to notify public health of COVID-19 test results or orders may be violating local or state public health laws or regulations.

Laboratories should be prepared to submit positive specimens (all or a subset) to public health for additional testing. Before discarding specimens, laboratories should contact the state health department to ensure the coordination of any additional public health specimen referral or testing. Electronic laboratory reporting of results via standard messaging for COVID-19 (positive, negative, inconclusive) is mandated by many state and local public health departments.

We ask that laboratories help federal and state partners to ensure the most robust response to protecting the nation’s health by communicating early about your COVID-19 testing or EUA-related activities.

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