Important update: Healthcare facilities

CDC has updated select ways to operate healthcare systems effectively in response to COVID-19 vaccination. Learn more

Find the latest information:
Aquatics FAQs
Recommendations for Fully Vaccinated People
COVID-19 Homepage

UPDATE

Given new evidence on the B.1.617.2 (Delta) variant, CDC has updated the guidance for fully vaccinated people. CDC recommends universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Children should return to full-time in-person learning in the fall with layered prevention strategies in place.

UPDATE

The White House announced that vaccines will be required for international travelers coming into the United States, with an effective date of November 8, 2021. For purposes of entry into the United States, vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. More information is available here.

UPDATE

Travel requirements to enter the United States are changing, starting November 8, 2021. More information is available here.

FAQ: CDC Distribution of COVID-19 Assays

Updated Oct. 6, 2021

At this time, CDC distributes both the 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel and the Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. After September 30, 2021, CDC will no longer distribute the 2019-nCoV Real-Time RT-PCR Diagnostic Panel, and laboratories should transition away from the Diagnostic Panel by the end of 2021.

No, CDC does not manufacture either the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel or the Flu SC2 Multiplex Assay for use by hospital, community, or commercial laboratories.
CDC provides both the 2019-nCoV Real-Time RT-PCR Diagnostic Panel and Flu SC2 Multiplex Assay for use in designated state, tribal, local, and territorial government-supported public health laboratories. For more information, check with your health department.
CDC encourages commercial manufacturers to use the CDC-published assay designs for the 2019-nCoV Real-Time RT-PCR Diagnostic Panel or the Flu SC2 Multiplex Assay to pursue their own Emergency Use Authorization (EUA). Laboratories also can use the published assay designs to create a laboratory-developed test (LDT).

Yes, however, the manufacturer must pursue its own EUA.
CDC is offering developers the right of reference to both the 2019-nCoV Real-Time RT-PCR Diagnostic Panel and the Flu SC2 Multiplex Assay. The right of reference allows developers seeking EUA to use the performance data already submitted to FDA as part of the 2019-nCoV Real-Time RT-PCR Diagnostic Panelexternal icon(FDA submission number EUA200001) or CDC EUA request for the Flu SC2 Multiplex Assayexternal icon (FDA submission number EUA201781). This approach will help developers bring tests to the market more quickly. Tests that use right of reference will not be affected by the discontinuation of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.

Yes, however, the laboratory will need to manufacture the primers and probes or purchase them from a commercial vendor using the published designs for the 2019-nCoV Real-Time RT-PCR Diagnostic Panel or the Flu SC2 Multiplex Assay.
The laboratory will need to perform testing to meet all appropriate Clinical Laboratory Improvement Amendment (CLIA) regulations prior to reporting diagnostic results.
LDTs created using CDC’s design would not be authorized under the CDC 2019-nCoV Diagnostic Panel or Flu SC2 Multiplex Assay EUA.

CDC provides:
- Technical specifications for Flu SC2 Multiplex Assay primers and probes
- Right of reference to the performance data submitted to FDA as part of the CDC Flu SC2 Multiplex Assay EUA request
CDC does not provide:
- Quality control testing
- Positive controls – refer to the CDC Flu SC2 Multiplex Assay Instructions for Useexternal icon for additional information
- Validation panels
  - Exclusivity panels
  - Limit of Detection panels
- A CDC-manufactured kit to use for comparison or validation purposes

No license or agreement is necessary to use the CDC-published 2019-nCoV Real-Time RT-PCR Diagnostic Panel or the Flu SC2 Multiplex Assay primer and probe sequences. CDC has published these sequences to allow manufacturers and test developers to use this information for creation and/or distribution of their own test or components.
The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel and the Flu SC2 Multiplex Assay use proprietary components from other companies. Developers of commercial tests will need to obtain licenses from the manufacturers of these proprietary components or qualify alternative materials to use in their test.