March 15 LOCS (CDC) Email

Audience: Clinical Laboratory Professionals
Subject: Lab Advisory: Updated Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19)
Level: Laboratory Advisory

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.

Online Resources:

• CDC 2019 Novel Coronavirus Laboratory Biosafety
• CDC Information for Laboratories: COVID-19
• CDC 2019 Novel Coronavirus
• International Air Transport Association (IATA) Dangerous Goods Regulation
• IATA Packing Instructions 650
• Register for CDC Health Alert Network (HAN) notifications, including updates about the 2019 Novel Coronavirus. Enter your email address, search for HAN, and sign-up

If you have any questions, please contact us at LOCS@cdc.gov.