RE:RE:RE:RE:RE:Newshemi3tc 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.
I've heard that accuracy increases with viral load, and that only makes sense. In the case of this test, is it that the test doesn't work or doesn't work as well with lower loads? They're hoping to eventually use it for asymptomatic cases so presumably it must still work with lower viral loads, just not at a 100% level. Maybe that's where the previously mentioned 86% comes in, which would still be a good number.