Just a few observations/comments on the Pedima package insert:
Page 2 Intended Use:
This sounds to me like DECN may still be limited by our corrupt FDA. Maybe not great news.
Page 3 Principles of the Procedure
Earlier it said it was a qualitative test. Quantitative is better IMO. Might be a measure of confidence that the Covid19 bug is present?
Page 10 Positives and Negatives
Great numbers for a 10 second saliva test. It is difficult to find comparable numbers for the other lab or rapid tests, especially since they are testing for everything but the kitchen sink.
Page 10 Cross Sensitivities (Specificity)
That is a VERY specific test. From what I can tell, those are much higher viral concentrations (4 to 6 times higher than the CV19) and they still don't affect the test. Again, since the powers that be want to keep this scamdemic going (IMO) a specific test will be impeded from entering the market (IMO). Notice how flu has disappeared this year? Yeah, hospitals are putting everything into the Covid bucket because they get paid so well to do that. Who can blame them? The WHO? Not likely.
All in all very positive information, IMO. I don't know how long the PTB will be able to keep a lid on this. Perhaps it will break out in other countries that are not as invested in Big Pharma making money preferring to help people instead?
I have a pie-in-the-sky dream that Berman is developing a NON-specific test that can identify a broad range of infections from the same sample in less than a minute. That would really be something, no? Probably a little busy at this point to dilute his resources and effort but a fella can dream...
Time will tell.
GLTA DECN shareholders.
Page 2 Intended Use:
Quote:he GenViro!® COVID-19 Antigen test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
This sounds to me like DECN may still be limited by our corrupt FDA. Maybe not great news.
Page 3 Principles of the Procedure
Quote:A low-amplitude alternating voltage is then passed across the two electrodes and the resulting current is measured. As the virus concentration of the sample increases, the measured impedance increases, and quantitative detection according to the virus concentration is possible.
Earlier it said it was a qualitative test. Quantitative is better IMO. Might be a measure of confidence that the Covid19 bug is present?
Page 10 Positives and Negatives
Quote:Number Tested Virus Result Result % [95% CI]
240 positive samples Sensitivity 87% [86.5% - 87.2%]
200 negative samples Specificity 98% [97.8% - 98.05%]
440 Total Positive Predictive Value 97% [96.9% - 97.2%]
Negative Predictive Value 90% [90.1% - 90.6%]
Total Accuracy 93%
Great numbers for a 10 second saliva test. It is difficult to find comparable numbers for the other lab or rapid tests, especially since they are testing for everything but the kitchen sink.
Page 10 Cross Sensitivities (Specificity)
Quote:Cross Reactivity
GenViro!® COVID-19 Analytical Specificity Microorganisms
The following pathogens had no effect on the test result of the positives or the negatives, which were tested with GenViro! Covid-19 test. No cross reaction was observed. GenViro! Covid-19 test can differentiate between SARS-CoV und SARS-CoV-2.
Human coronavirus 229E concentration 1.5×104 TCID50/mL
Human coronavirus OC43 concentration 1.5×104 TCID50/mL
Human coronavirus NL63 concentration 1.5×104 TCID50/mL
Human coronavirus HKU1 concentration 1.5×104 TCID50/mL
MERS coronavirus concentration 1.5×104 TCID50/mL
SARS-CoV
11 - GENVIRO! SWIFT COVID-19 Product Insert Interference Substances reaction A dilution of SARS-Covid 2 (1.5×104 TCID50/mL) was added to the following substances at the stated concentrations. When tested with GenViro! Covid-19 test the substances showed no interference.
Influenza A H1N1 virus concentration 6×105 TCID50/mL
Influenza A H3N2 virus concentration 9×105 TCID50/mL
Influenza A H5N1 virus concentration 8×104 TCID50/mL
Influenza A H7N9 virus concentration 9×104 TCID50/mL
Influenza B concentration 3×105 TCID50/mL
Respiratory syncytial virus (RSV) type A/B concentration 3×105 TCID50/m
That is a VERY specific test. From what I can tell, those are much higher viral concentrations (4 to 6 times higher than the CV19) and they still don't affect the test. Again, since the powers that be want to keep this scamdemic going (IMO) a specific test will be impeded from entering the market (IMO). Notice how flu has disappeared this year? Yeah, hospitals are putting everything into the Covid bucket because they get paid so well to do that. Who can blame them? The WHO? Not likely.
All in all very positive information, IMO. I don't know how long the PTB will be able to keep a lid on this. Perhaps it will break out in other countries that are not as invested in Big Pharma making money preferring to help people instead?
I have a pie-in-the-sky dream that Berman is developing a NON-specific test that can identify a broad range of infections from the same sample in less than a minute. That would really be something, no? Probably a little busy at this point to dilute his resources and effort but a fella can dream...
Time will tell.
GLTA DECN shareholders.
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