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But we need widespread testing to identify who has the virus. The people who are concerned about opening up the country are concerned because it is too soon.
We need the tests... why don't you write to your Congress persons and the President to tell them to get on the ball and make those tests available.
Test's have to be approved by the FDA either under EUA or EUN.
EUA = Emergency Use Authorization where performance data has actually been submitted to the FDA for review.
EUN = Emergency Use Notification which has not been officially submitted, the assay manufacturer has simply notified the FDA of intended use.
My company has been approved for EUA and our test is launching next week. Unfortunately there are a lot of other medical device manufactures who are releasing under EUN and we are finding that those tests are not very sensitive or specific and have a low PPV (Postive Predictive Value).
Because of this the FDA has now come out with new rules on how to submit for Coronavirus serology testing.
In the town hall Wednesday, Timothy Stenzel, director of FDA's Office of In Vitro Diagnostics and Radiological Health, offered further insights about validation of serology testing.
"We continue to see problematic claims and uses of serology tests, particularly those that have been listed on our [Frequently Asked Questions] page under pathway D," Stenzel said. "These devices are only for high-complexity labs; they are not to be used in moderate complexity labs or in point-of-care, near-patient settings, nor in the home."
So far, there are only four serology tests that have received EUA from the FDA .
Key takeaway: Serology tests are particularly vulnerable to specificity issues that can produce false positive results, which can lead people to believe they are immune to COVID-19 when they were in fact still susceptible. The FDA is "looking for ways to additionally highlight these concerns," Stenzel said. "In a setting of very low prevalence, even a very specific test can have a number of false positives, and the positive predictive value is relatively low," he added, noting the prevalence of SARS-CoV-2 in the US is currently unknown.
So writing to Congress and the President is not going to get anyone anywhere.
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Originally Posted by MillennialUrbanist
Nice!!! God bless America!
The social unrest is beginning sooner than I thought. People are standing up against their tyrannical, goose-stepping, hypocrite governors. I am truly proud to be an American now.
Well my figure is just 570,000 people will die in the US from a Covid 19 infection. What is your estimate?
Nice straw-man. I haven’t heard or read of single person who thinks that “staying indoors is supposed to eradicate the virus”, let alone “some people”......
lol - 1/2 the people in this thread thinks that if we "just stay inside long enough" everything will be fine.
Well my figure is just 570,000 people will die in the US from a Covid 19 infection. What is your estimate?
57,000 or not even. No more than die from your garden-variety flu. The boogeyman of the year named Flu-19 is basically the same thing, only with scary-looking crowns on the outside. The deaths in the "official" CDC reports could be from pre-existing conditions, and Flu-19 was simply the last straw, like a garden-variety flu could be.
It's like answering a question "Where are you?" The answer could be "in my living room" or "in my clothes", depending on how you want to spin it. That's exactly what the CDC and its Democrat lackeys are doing.
Last edited by MillennialUrbanist; 04-16-2020 at 07:37 PM..
Test's have to be approved by the FDA either under EUA or EUN.
EUA = Emergency Use Authorization where performance data has actually been submitted to the FDA for review.
EUN = Emergency Use Notification which has not been officially submitted, the assay manufacturer has simply notified the FDA of intended use.
My company has been approved for EUA and our test is launching next week. Unfortunately there are a lot of other medical device manufactures who are releasing under EUN and we are finding that those tests are not very sensitive or specific and have a low PPV (Postive Predictive Value).
Because of this the FDA has now come out with new rules on how to submit for Coronavirus serology testing.
In the town hall Wednesday, Timothy Stenzel, director of FDA's Office of In Vitro Diagnostics and Radiological Health, offered further insights about validation of serology testing.
"We continue to see problematic claims and uses of serology tests, particularly those that have been listed on our [Frequently Asked Questions] page under pathway D," Stenzel said. "These devices are only for high-complexity labs; they are not to be used in moderate complexity labs or in point-of-care, near-patient settings, nor in the home."
So far, there are only four serology tests that have received EUA from the FDA .
Key takeaway: Serology tests are particularly vulnerable to specificity issues that can produce false positive results, which can lead people to believe they are immune to COVID-19 when they were in fact still susceptible. The FDA is "looking for ways to additionally highlight these concerns," Stenzel said. "In a setting of very low prevalence, even a very specific test can have a number of false positives, and the positive predictive value is relatively low," he added, noting the prevalence of SARS-CoV-2 in the US is currently unknown.
So writing to Congress and the President is not going to get anyone anywhere.
Thank you for the information. It is good to know these are being worked on by some companies. And yes, I understand that the tests have to be proven to be accurate.
My point about writing to Congress and the president is to get them to find and incentivize more companies to work on developing the various tests we need. The president keeps saying at the daily pressers that we have the best tests of anyone in the world; that we have done more tests than anyone else. He does not acknowledge the problem.
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God bless America! 
