>Look at page 39,40 "Detection of viral RNA may not indicate the presence of infectious virus or that 2019nCov is the causative agent for clinical symptoms. The test cannot rule out diseases caused by other bacterial or viral pathogens."
All this is saying is detection of viral RNA does not necessarily mean the subject is currently infectious (they may be pass the infectious stage) or that Covid is the sole cause of observed clinical symptoms (they may also have a cold or some other infection as well). Basically they are saying if the Covid test comes back positive don't assume that is the only possible problem, they may have other underlying issues as well (someone could come into the hospital with the flu, catch Covid while at the hospital which shows up in a test, but this doesn't negate the fact they also have the flu).
>Page 40 “Since no quantified virus isolates of the 2019-nCoV were available for CDC use at the time, the test was developed and this study conducted, with assays designed for detection of the 2019-nCoV with characterized stocks ......."
This was part of the Limit of Detection testing. They wanted to find out how sensitive the PCR test was. So they used a bunch of samples with known amounts (quantified isolates) of a target virus in them and tested how low a virus concentration the PCR test could detect. These quantified isolates (known concentrations) where not available for Covid (this doesn't mean isolates weren't available, just isolates of known quantity were not) so they used Influenza isolates that were available. Basically they were saying, if I can detect an Influenza virus at this level of concentration I should be able to detect Covid at similar levels. Its like calibrating a sound meter using rock music then taking it to a classical music concert and measuring the sound level there. You aren't trying to identify if the music is rock or classical but determine how loud it is.
The twitter post also states "Another revelation in the document is the admission by the FDA that test results are “pooled” together to produce numbers that are inaccurate."
This is a misrepresentation of what pooling was. The pooling that the FDA allowed was intended to speed up testing or manage limited resources. They stated that a lab could test up to four samples at the same time (basically mix 4 samples together and test). Then if the test came back negative you could say all four samples were negative. If the test came back positive you then have to retest all four sample individually in order to figure out which one (or more) sample(s) was responsible for the positive test. Pooled results were never used to report positives, only negatives. So if anything, pooling tests would reduce the number of reported cases.
(post is archived)