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another chance to use the above graph. what a pearler it is !!!
2 things to consider, these results are better than Ellume achieved.. and we used samples with VTM interference, so results will be better with direct person testing. (any comment from surges!!!)
and Ellume used 198 subjects, we used 444 subjects. the difference being ellumes 96% sensitivity and 100% were from subjects with symptoms, so lower CT values, seeing all our subjects were from a test tube we would have a high mix of symptomatic and asymptomatic subjects.
"In data submitted to the FDA from a simulated home-use clinical study of 198 subjects ranging in age from 2 years to 82 years, Ellume’s COVID-19 home test demonstrated an overall sensitivity of 95% (positive percent agreement) and specificity of 97% (negative percent agreement) when compared to an emergency use-authorized RT-PCR laboratory test. In individuals presenting with COVID-19 symptoms, the Ellume COVID-19 home test demonstrated a sensitivity of 96% and specificity of 100%, and in asymptomatic individuals, the test demonstrated a sensitivity of 91% and specificity of 96%.
so our results are really fantastic !!! 96.7% sensitivity and 99.6% specificity and this is just the start of the news flow.
ellume got FDA approval 5 days after these results were announced, operon manufacturing deal, market launch, CE approval, UK trial, etc.... GLTAH......
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- Ann: AnteoTech COVID-19 Antigen Rapid Test Clinical Study Result
Ann: AnteoTech COVID-19 Antigen Rapid Test Clinical Study Result, page-49
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