RE:RE:RE:RE:RE:Others are getting FDA Approval Abbott Labs is not a Runt company like Quidel.
When they do tests they go Big time. Not a hundred tests. Thousands.!
In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. "The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," said Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County. "With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus." Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale. The portable test is about the size of a credit card, requires no additional equipment to operate, and can be conducted using a less invasive nasal swab than traditional lab tests, Abbott executives said on a call with reporters.
The test, BinaxNOW COVID-19 Ag Card, could be used to check that people participating in larger gatherings, such as those returning to schools or workplaces, do not have Covid-19 and could help aid the reopening of the U.S., the executives said.
Analyst knew this was coming many of the other Test Kit companies were selling off weeks before on record earnings all at the same time. All the While Abbott share price never Dipped.
datawork wrote: I think they may have copied what another antigen test company did. Conducted tests on subjects with high viral loads to bring the numbers up.
There really needs to be more standardization in the tesing criteria for EUA certification. IMO