Post by
Smokey1958 on Mar 05, 2021 2:05pm
Approval for Testing vs Authorization for Use
Finding the right test site is imperative because they need individuals that are, unfortunately, covid positive to substantiate AcuVid. As such they would need approval to use the device at a clinic or testing site in Toronto that is in an area with the highest incidence of infection and positivity rates.
They ALREADY know AcuVid works in a lab setting, thus the numbers 86% specificity and 100% sensitivity. With the sensitivity set at the standard of high viral load ....regardless of the degree of symptoms. Presumably they would want a test site where all the individuals appear symptomatic regardless of outcome (allergy, cold, flu, covid positive).
Sensitivity: the ability of a test to correctly identify patients with a disease. Specificity: the ability of a test to correctly identify people without the disease. True positive: the person has the disease and the test is positive.
What could go wrong? Actually at this stage it's hard to imagine what would lead to a different outcome in the on-site testing.
AcuVid appears to have a higher sensitivity rating then any rapid point of care test that has currently been authorized by HC or the FDA .....and its a saliva sample. It's equally hard to imagine it not being approved provided there are no surprises in the testing.
The attack on the stock and thus the sp should not, in any way, reduce the anticipation or excitement at the prospect of a significant reward for being patient.
GLTA!!!
Comment by
TheeRook on Mar 05, 2021 2:59pm
The problem is the FDA and HC do not want to aprove test that only detect High Viral Loads. They want to find the Virus at low viral loads before it becomes a high viral load infecting others. There are many tests in the US that detect only high viral loads. FDA will not pass them. Ask Micheal Mina who is having fits trying to convince the FDA to approve them.