March 17 LOCS (CDC) Email

Audience: Clinical Laboratory Professionals
Subject: Change to Result Interpretation for CDC EUA Assay
Level: Laboratory Alert

This message is to inform clinical laboratories using the CDC 2019-nCoV Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel Emergency Use Authorization (EUA) that the presumptive positive result interpretation has been revised. Positive results generated by any laboratory testing under the CDC EUA may be interpreted as positive instead of presumptive. No confirmation of positive results is required. Please review the CDC EUA Instructions for Use and Letter of Authorization for other changes.

Clinical laboratories that use CDC primers and probes purchased from Integrated DNA Technologies (IDT) or Biosearch Technologies must follow the CDC EUA precisely. Laboratories that use a test that modifies the CDC EUA need to submit their assay information to the Food and Drug Administration (FDA) for emergency use authorization.

Clinical laboratories should contact their state health departments for guidance if they have a suspected coronavirus disease 2019 (COVID-19) case specimen. Clinical laboratories should NOT attempt viral isolation from specimens collected from COVID-19 persons under investigation unless this is performed in a BSL3 laboratory.

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