RE:RE:RE:Pumpers and their HC approvalThey should have at least include the data for low viral load . Which they conviently left out along with the LoD. Makes it looks like they are hiding something. Bad results.
Which makes this NR more of a P&D feeding on those who really do not know anything.
Many company put out NR releases and only put information that makes them look good.
No company puts in bad information unless relquired to explain something by the Securecties commission.
Of course they believe thats their job. Seen it with many other companies who believed and did not pass the muster at HC or FDA.
Teh test is Very suspect until low viral load data is presented along with the LoD.
Smokey1958 wrote: I'm going to take a wild stab at your info and just say that
1. They aren't necessarily going to include every piece of data they have accumulated so far and
2. Do you think for a minute they would be putting the resources into this believing CoviSafe didn't have a chance of being reviewed and accepted?
As for you including the quote from Optex. Now I know for a fact he doesn't know anything. Almost all of those tests Ccurrently under review are PCR, lab based tests. Of the POC tests only 3 are rapid and those require a blood test or a nasopharyngeal swab,
UNBELIEVABLE!!!
TheeRook wrote: The news release is missing the LioD - Limiti of Detection.
Any bad test can have a sensitivity of 100% when the sample tested is CT <25 which is a high viral load. CT<25 means your already sick and in the hospital.
For submission need the Limit of Detection. Also tests performed at the LOD.
Patients admitted to the hospital with a positive SARS-CoV-2 test and viral pneumonia. Investigators used RT-PCR testing to group patients into three genomic load cohorts: low (Ct ≥35), intermediate (25<Ct<35), and high (Ct≤ 25). Following the patients for an average of 25 days, they determined that high genomic load at presentation predicted adverse outcomes independent of age, comorbidities, and severity of illness at presentation.
optex1972 wrote: Fact- HC submission requires final device, process and verification of lab results. All this THRM does not have.
and to add to the BS pumpers slinging it's not days it's weeks and months. Go look at HC website for yourself see how many currently FDA/EU approved devices with factual validated results are sitting in que now today and look how long. It's a long careful process and THRM is long ways away also fact.
domt be blind to selling or buying but know facts lots of pumpers here that have no clue