By Bill Galluccio
Jan 8, 2021
The agency said that three FDA-approved tests, MesaBiotech Accula, TaqPath Covid-19 Combo Kit, and Linea Covid-19 Assay Kit, may be impacted by the new coronavirus strains but said the impact on testing accuracy is low. If a patient is exhibiting symptoms of COVID-19 and tests negative, the FDA advised them to undergo a different test to confirm the results. The FDA will continue to monitor SARS-CoV-2 genetic, viral variants to ensure authorized tests continue to provide accurate results for patients, FDA Commissioner
Stephen M. Hahn, M.D. said in a statement. While these efforts continue, we are working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants.
The U.S. new cases 7-day rolling average is 22.8 % HIGHER than the 7-day rolling average one week ago. U.S. hospitalizations due to COVID-19 are now 4.8 %
HIGHER than the rolling average one week ago. U.S. deaths due to coronavirus are now 16.6 %
HIGHER than the rolling average one week ago. Today s posts include:
U.S. Coronavirus New Cases are at an elevated 274,703
U.S. Coronavirus hospitalizations are at an elevated 132,370 (for the next 4 days this is the number to watch as new cases and deaths will not be accurately reported)
U.S. Coronavirus deaths are at a record 4,085
U.S. Coronavirus immunizations have been administered to 1.8 % of the population
Former CDC Director Dr. Tom Frieden says the new strain increases the urgency for vaccines and wearing masks.
The Food and Drug Administration (FDA) on Friday issued an alert about the impact viral mutations of the coronavirus may have, including the potential to result in false negative tests. The variant, B.1.1.7 was first discovered in the U.K. several weeks ago, and has been confirmed in over 50 cases in the U.S. so far. The Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs on the part of the virus’s genome assessed by that test, the FDA said. The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic
US passes 4,000 Covid-19 deaths in one day for the first time
A temporary hospital set up to treat Covid-19 patients in Los Angeles. (Photo / CNN)
US passes 4,000 Covid-19 deaths in one day for the first time Sat, 9 Jan 2021, 10:00AM
The US reported more Covid-19 cases and deaths in the last week than any previous seven days during the pandemic, data showed Friday morning.
And more than 4,080 US coronavirus deaths were reported on Thursday alone the most ever reported in a single day during the pandemic and the first time the daily tally rose above 4,000, Johns Hopkins University (JHU) data showed.