Or, a breakthrough in wishful thinking.... Or in the Larry Scott hype. Any excuse to get the money-making machine rolling ....
FDA: "This test is to be performed only using respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms."
FDA: "Indication: Qualitative detection ... from individuals who are suspected of COVID-19 by their healthcare provider.
I interpret that to mean that using this test to screen healthy individuals is not in the EUA granted for this test.
Has anyone here found the sensitivity and specificity for this test? Not very easy to find. Here's an article saying the company reported (some time back) a sensitivity of 87.5% and a specificity of 100%. As I understand it that means it misses 1 out of 8 positive cases it is tested on, reporting a negative result.
From the FDA document: "Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids."
"When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19."
FDA: "This test is to be performed only using respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms."
FDA: "Indication: Qualitative detection ... from individuals who are suspected of COVID-19 by their healthcare provider.
I interpret that to mean that using this test to screen healthy individuals is not in the EUA granted for this test.
Has anyone here found the sensitivity and specificity for this test? Not very easy to find. Here's an article saying the company reported (some time back) a sensitivity of 87.5% and a specificity of 100%. As I understand it that means it misses 1 out of 8 positive cases it is tested on, reporting a negative result.
From the FDA document: "Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids."
"When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19."