RE:RE:RE:RE:RE:RE:NewsSmokey1958 wrote: Actually they weren't excluded as news just not repeated in today's NR. This can be found in an earlier NR. Overall sensitivity has been as high as 86% ...above expectations for HC approval. For high viral loads the sensitivity is 100% per the previous NR. Have there been even more improvements ...hope so ....but not important. The 100% specificity of AcuVid is critical as there will be no false negatives. Therefore there will be no individuals tested that will take the infection public.
With an 86% sensitivity there could be false positives ....all individuals testing positive will then require a PCR Test to confirm.
THRMs AcuVid ticks off ALL the boxes ....rapid, accurate, inexpensive and requiring a much more preferable sample type!!!
hemi3tc wrote: The test only works on high viral loads. So test results that were low to mid viral loads that tested negative were excluded.
Whydunnit wrote: forrest6748 wrote: Interesting number changes. Major upgrade
Mr. Fia went on to say, "Recent lab results of our locked test showed 100% sensitivity and 100% specificity in most patients when tested within 7 days of onset of symptoms. This is the test that will be entering the performance study."
Those are great numbers but the thing that bothers me is what does "most patients" mean? If something is going to be 100% shouldn't it include all patients? Did they exclude 10% of patients for whom it wasn't 100%? That would make it sort of 100% but not really. Also, it says they are lab results. Shouldn't it say field results if patients were involved? I wish they'd learn how to write their NRs clearly and unambiguously.
Anyway, it's great that they're field testing in Brazil. This would be separate from a HC application and could very well get official approval in Brazil and then the rest of South America, with the data to be used also as corroboration for HC, FDA and European applications with their own separate date sets.
Okay, thanks for that, that explains it better. I thought I'd read something about higher viral loads returning 100% specificity but wasn't sure if it was something THRM put out. The part you bolded is most important.