Connect with us


FDA announces CDC’s PCR test failed review, will have Emergency Use Authorization revoked



The Centers for Disease Control and Prevention (CDC) announced this week that its PCR test has failed its full review and will have its Emergency Use Authorization (EUA) revoked by the Food and Drug Administration (FDA).

The Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the CDC’s benchmark COVID-19 diagnostic testing system, will be withdrawn for Emergency Use by the end of 2021 due to an inordinate frequency of false positive and negative results.

“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the FDA stated on its website.

“Labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests,” the FDA’s website read. “The performance characteristics of the test have not been adequately established, presenting a risk of false results.”

The FDA goes on to explain the risks associated with false positives and negatives:

False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause patient harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when presumed negative patients are grouped into cohorts in health care, long-term care, and other facilities based on false test results.

False-positive results could lead to a delay in the correct diagnosis and the initiation of an appropriate treatment for the actual cause of patient illness, which could be another life-threatening disease that is not SARS-CoV-2. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive patients are grouped into cohorts based on false test results.

In April, the Innova Medical Group sent an Urgent Medical Device Recall letter to all affected device users.

“Do not use these tests to screen for or diagnose COVID-19,” the letter states.

“Either destroy the tests by placing them in the trash or return the tests using the FedEx return label that was included with the letter Innova sent to its customers.”

The CDC released a statement in response to the FDA’s recall, urging clinics to abandon the PCR test in favor of an “FDA-authorized” alternative.

“After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only,” the CDC website states.

“CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.”

Continue Reading
Click to comment

Leave a Reply


More police brutality in Australia as orange vest protests continue against COVID-19 restrictions



There were more examples of police brutality in Australia as construction workers continued to protest against the shut down of their industry and mandatory COVID-19 vaccinations.

Constructions workers in the state of Victoria were told by their union they’d be forced to get the coronavirus jab or face being fired, prompting major unrest in Melbourne.

In another slap to the face, the government then announced a two week shut down of construction work to punish the protesters.

Demonstrators hit the streets again today, but were met with yet more vulgar examples of police brutality, including one incident caught on camera where a protester who was already pinned to the ground was stuck by a knee to the back from a riot cop who took a run up.

Police again fired rubber bullets at protesters.

Authorities have deployed police usually reserved for counter-terror operations to deal with the demonstrators.

Anyone who looks like a ‘tradie’ (a construction worker) is being harassed on the street.

Cops are violently attacking them.

Craig Kelly MP of the United Australia Party is calling for a federal investigation into police brutality, calling their behavior “unacceptable, unAustralian & illegal.”

Continue Reading


Miami International Airport (MIA) ranked best mega airport in North America by J.D. Power



MIAMI, Fla. – Miami International Airport (MIA) has been ranked the best mega airport in North America for passenger satisfaction by the J.D. Power 2021 North America Airport Satisfaction Study.

The annual study measures overall traveler satisfaction with mega, large, and medium North American airports by examining six factors: Terminal facilities; airport arrival/departure; baggage claim; security check; check-in/baggage check; and food, beverage, and retail.

“We can all be proud that Miami-Dade County is home to the best mega airport for customer satisfaction in North America!,” said Miami-Dade County Mayor Daniella Levine Cava.

Read more from CBS Miami.

Continue Reading


Florida Department of Health issues no-swim advisory for several beaches in Miami Beach



MIAMI BEACH, Fla. — The Florida Department of Health has issued a no-swim advisory for several beaches in Miami Beach.

Officials said the levels of bacteria in the ocean at 73rd Street exceeds acceptable levels and could make people sick.

They are also asking people to stay out of the water at the 53rd Street Beach and both the north and south sections of Haulover Beach.

Read more from Fox Miami (WSVN 7).

Continue Reading