HODL & Earn Crypto with Miny! - Earn passive income by holding Bitcoin, Litecoin and Ethereum in a smart wallet that leverages funds to secure AI powered mining hardware! The easiest way to make money in crypto, period.

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
An additional extraction instrument and associated reagents
A new process that can be used in place of the extraction method when materials for the current method are limited
How to order the Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel
The International Reagent Resource (IRR)external icon is distributing the diagnostic panel and supplies to registered state and local public health laboratories so they can perform SARS-CoV-2 testing.

Herd immunity and why social distancing won't prevent the spread ...

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
CDC lab test kit
CDC’s laboratory test kit for the SARS-CoV-2 virus.

The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel contains four reagents:

Three primer-probe mixes for:
2019-nCoV_N1: targets virus nucleocapsid (N) gene for specific detection of SARS-CoV-2
2019-nCoV_N2: targets virus nucleocapsid (N) gene for specific detection of SARS-CoV-2
RP: targets human RNase P gene for detection of human nucleic acids; control for sample integrity
nCoVPC: noninfectious positive control material; yields a positive result in each assay included in the panel
If the diagnostic panel is not available, see the updated instructions for useexternal icon for acceptable alternatives.

Other materials labs will need to perform the diagnostic panel
The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel requires the use of additional authorized materials that are not included with the test. These materials include PCR reagents and items that are commonly used in clinical laboratories, such as a microfuge, microcentrifuge tubes, pipettes, and pipette tips. They are described starting on page 6 in the authorized CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel Instructions for Useexternal icon package insert. Two control materials are also required but not provided; these materials must produce expected results in order for a test to be considered valid, as outlined in the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel Instructions for Useexternal icon. The controls are:

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.
No Template Control (NTC): Nuclease-free water included in each run. Monitors for reagent and system contamination.
More Resources on the CDC Diagnostic Panel

List of Acceptable Commercial Primers and Probespdf icon
Processing of Sputum Specimens for Nucleic Acid Extractionpdf icon
Research Use Only RT-PCR Primers and Probes
Fact Sheets for CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

Patient Fact Sheetpdf icon
Healthcare Provider Fact Sheetpdf icon
More Resources for Diagnostic Testing

Request 2019-nCoV grown in cell culture at NIH’s BEI Resources Repositoryexternal icon
Information about COVID-19 diagnostic tests under FDA Emergency Use Authorizationexternal icon
FDA Diagnostic Testing FAQsexternal icon

Readmore: COVID-19 Test Kit

Also See: Rt Pcr, Pcr Diagnostic, Diagnostic Panel, 2019 Ncov, Testing, Rt, Real

Singing Superstar Karaoke Experience
Singing Superstar is a fully fledged Karaoke system that harnesses the power of your PC. You can test your skills with real time golden notes, line bonus' and popup's as you sing along with your favorite song.
Advanced Guitar with Express Guitar Volume 2 - The Advancing Guitarist
Get ready for a Major Upgrade with your guitar skills, accuracy and musicianship!

CryptoTab Browser - Easy way for Bitcoin Mining | CryptoTab Browser
CryptoTab Browser is the world's first web browser with built-in mining features. Familiar Chrome user interface is perfectly combined with extremely fast mining speed. Mine and browse at the same time!

WordPress Plugins and Themes - WP Marketer Tools
WordPress Themes and Plugins To Help Grow Your Online Business and Make It More Efficient.

Advertise Here