How to Get CDC’s COVID-19 Diagnostic Test and Supplies
Posted by luaestrelas on June 24th, 2020
The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)–PCR Diagnostic Panel detects the SARS-CoV-2 virus in upper and lower respiratory specimens. It is designed to be used with an existing RT-PCR testing instrument commonly used to test for seasonal influenza virus.
The U.S. Food and Drug Administration (FDA) gave Emergency Use Authorization (EUA) for this test on February 4, 2020. The diagnostic panel’s FDA-authorized Instructions for Useexternal icon contain information about the test, its intended use, the test procedure, and performance characteristics. The EUA websiteexternal icon has published the FDA Letter of Authorizationexternal icon for the diagnostic panel. The letter defines the authorized use and the conditions of authorization that apply to CDC and to testing laboratories that use this test.
On June 12, 2020, FDA granted an amendmentexternal icon to the EUA for the CDC diagnostic test to address global shortages of materials needed to perform the test. This amendment provides alternativesexternal icon for processing the test:
Four additional extraction reagents that can be used in the existing extraction methods
During the SARS-CoV-2 pandemic, state public health laboratories can authorize county or city laboratories in each state to perform testing. These laboratories must be certified under the Clinical Laboratory Improvement Amendment (CLIA) to perform high-complexity tests, have appropriate laboratory equipment and training, and demonstrate testing proficiency under their state laboratory’s stewardship to maintain their status as an IRR-registered laboratory. The IRR does not supply clinicians, hospitals, or healthcare professionals with testing kits directly. Clinicians, hospitals, and healthcare professionals should refer to the list of commercially available lots of primers and probespdf icon that are acceptable alternatives to the CDC-provided reagents. The list begins on page 7 in the authorized CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel Instructions for Useexternal icon Package Insert.
Materials included in the diagnostic panel
The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel contains four reagents:
Three primer-probe mixes for:
Other materials labs will need to perform the diagnostic panel
Human Specimen Control (HSC): A human cell culture preparation used as an extraction procedural control to demonstrate successful recovery of nucleic acid, as well as extraction reagent integrity. Acceptable alternatives to HSC are listed in the package insert.
List of Acceptable Commercial Primers and Probespdf icon
Patient Fact Sheetpdf icon
Request 2019-nCoV grown in cell culture at NIH’s BEI Resources Repositoryexternal icon
Readmore: COVID-19 Test KitAlso See: Rt Pcr, Pcr Diagnostic, Diagnostic Panel, 2019 Ncov, Testing, Rt, Real
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