By CDC.gov | March 2, 2019 | Source: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html
Revisions were made on February 27, 2020, to reflect the following:
- Information updated in the “Criteria to Guide Evaluation of PUI for COVID-19” section.
CDC Q/A: Should I be testing all patients for COVID-19?
At this time, CDC only recommends diagnostic testing of patients who meet the clinical criteria for a COVID-19 person under investigation (PUI), per Interim Guidelines for Collecting, Handling and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19).
- People who have been in close contact with a confirmed COVID-19 patient, and people who live in or recently traveled from an area with sustained transmission, are at elevated risk of COVID-19.
- For more information about interpreting test results, see section labeled “Interpretation of test results from CDC 2019 novel coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel.”
What safety equipment should labs use when using the diagnostic tool?
Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of being infected with COVID-19 as outlined in the CDC Interim Guidelines for Collecting, Handling and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19).
How can my lab get the virus?
The National Institute of Health (NIH)’s Biodefense and Emerging Infections Research Resources Repositoryexternal icon (BEI Resources) will provide laboratories with COVID-19.
CDC has developed a new laboratory test kit for use in testing patient specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The test kit is called the “Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.” It is intended for use with the Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS 1.4 software. This test is intended for use with upper and lower respiratory specimens collected from persons who meet CDC criteria for COVID-19 testing. CDC’s test kit is intended for use by laboratories designated by CDC as qualified, and in the United States, certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. The test kits also will be shipped to qualified international laboratories, such as World Health Organization (WHO) Global Influenza Surveillance Response System (GISRS) laboratories. The test will not be available in U.S. hospitals or other primary care settings. The kits will be distributed through the International Reagent Resourceexternal icon (IRR)
What other equipment will labs need to perform tests using the diagnostic panel?
The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel also requires the use of additional authorized materials and authorized ancillary reagents that are not included with the test but are commonly used in clinical laboratories and are described in the authorized CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel Instructions for Use Package Insert.
The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel requires the following control materials, or other authorized control materials; all controls listed below must generate expected results for a test to be considered valid, as outlined in the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel Instructions for Use:
- Human Specimen Control (HSC): A human cell culture preparation used as an extraction control and positive control for the RNase P primer and probe set that is extracted and tested concurrently with each specimen extraction run.
- Positive Control for COVID-19 (nCoVPC): Run with each batch of specimens. Monitors for failures of rRT-PCR reagents and reaction conditions.
- No Template Control (NTC): Nuclease-free water included in each run. Monitors for reagent and system contamination.
SOURCES: https://www.cdc.gov/coronavirus/2019-ncov/about/testing.html; CDC Page last reviewed: February 25, 2020; Page last reviewed: March 1, 2020