CDC LOCS Lab Advisory: Updated Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19)

Publication Date: Mar 16, 2020

This LOCS message is to inform clinical laboratories that perform testing for SARS-CoV-2 (the agent of coronavirus disease 2019 [COVID-19])with the CDC Emergency Use Authorization (EUA) COVID-19 real-time PCR assay, CDC recommends collecting only the upper respiratory nasopharyngeal (NP) swab. Collection of an oropharyngeal (OP) specimen is a lower priority, and, if collected, should be combined in the same tube as the NP swab.

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

For more information, see updated Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19).

Clinical laboratories should contact their state health departments for guidance if they have a suspected 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.

Learn more by reading the full CDC Laboratory Outreach Communication System (LOCS) Lab Update here. Check out the CDC LOCS website and Coronavirus Disease 2019 (COVID-19) Information for Laboratories website for the latest information.

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