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Topic: COVID-19 Test

FDA Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 Coronavirus diagnostic test for self-testing at home and that provides rapid results.

The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 Coronavirus.

Coronavirus

Coronavirus

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President Donald Trump on the Right Side of History in Confronting Latin America’s Dictators

 

The White HouseWashington, D.C. – “The brutal regimes in Venezuela, Cuba and Nicaragua pose a grave threat to our country’s national security interests.”

“We must continue to consistently deny funds to these regimes, which work together to oppress their people, wreak havoc in our hemisphere and oppose U.S. interests,” Representative Mario Díaz-Balart (R-FL) writes in the Miami Herald.

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BioGX recieves FDA Emergency Use Authorization Submission of Extraction-Free Direct RT-PCR Test for COVID-19

 

BioGXBirmingham, ALBioGX, a molecular diagnostics solutions company, announced  FDA Emergency Use Authorization (EUA) submission of an extraction-free, direct sample addition RT-PCR test for detection of SARS-CoV-2 viral RNA in patients suspected of COVID-19 Coornavirus. 

The Xfree® COVID-19 Direct RT-PCR test (“Xfree COVID-19″) is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready format.  The user would simply Just Add Water, the patient sample, and run the test on a validated real-time PCR instrument. 

World's Simplest High Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week

World’s Simplest High Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week

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Lamar Alexander says Vaccine Program on Track to be an Unprecedented Sprint to Success

 

U.S. SenateWashington, D.C. – “The Donald Trump Administration’s program to develop and deploy a vaccine that will protect against COVID-19 Coronavirus is on track to be an unprecedented sprint to success,” the Chairman of the United States Senate health committee said today. “The program, called Operation Warp Speed, will save lives without cutting corners on safety and efficacy,” he said.

Chairman Lamar Alexander (R-Tenn.) said “The secret to this success is that the government — in partnership with private industry — is for the first time developing and manufacturing a vaccine in parallel.”

U.S. Senator Lamar Alexander

U.S. Senator Lamar Alexander

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FDA Coronavirus (COVID-19) Update: September 19th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:

The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test.

Coronavirus.

Coronavirus.

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FDA Authorizes First Diagnostic Test Where COVID-19 Results Can Be Read Directly From Testing Card

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.

This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer.

Coronavirus

Coronavirus

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Lamar Alexander says Tennessee Could Receive Up to One Million New Rapid, Reliable $5 COVID-19 Tests during October

 

U.S. SenateMaryville, TN – United States Senator Lamar Alexander (R-Tenn.) released the following statement Friday, August 28th, 2020:

“The Donald Trump Administration has announced that during the next three months the federal government will help make available 150 million new Abbott COVID-19 antigen diagnostic tests costing $5.00 each that deliver rapid results in 15 minutes.”

“This could mean as many as one million additional tests just during October for use in Tennessee hospitals, doctors’ offices and other health care settings to help schools, colleges, child care centers and workplaces continue to safely reopen.”

U.S. Senator Lamar Alexander

U.S. Senator Lamar Alexander

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Tennessee’s Community Colleges launch Fall Semester with a focus on Health, Safety

 

Tennessee Board of Regents - TBRNashville, TN – Tennessee’s community colleges are welcoming students back for fall semester, in a variety of class modalities and with a focus on keeping them healthy and safe as they continue their studies.

Eleven of the 13 community colleges start fall classes Monday (August 24th, 2020).  Northeast State Community College and Roane State Community College began classes this past week.

Students arrive at Roane State Community College for their first day of classes.

Students arrive at Roane State Community College for their first day of classes.

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FDA Coronavirus (COVID-19) Update: August 20th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

The FDA issued the third Emergency Use Authorization (EUA) for a COVID-19 Coronavirus antigen test. 

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: August 17th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

The FDA issued Yale School of Public Health an emergency use authorization (EUA) for its SalivaDirect COVID-19 Coronavirus diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 Coronavirus.

Coronavirus

Coronavirus

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