Wrong, Moderna and Pfizer mRNA vaccines for SARS-CoV-2 received FDA approval for BLAs.
RT-qPCR used for SARS-CoV-2 diagnostics tests is nearly a gold standard. Cycle thresholds at 35 to 45 are validated because cut-off values are based on the limit of detection (LOD), so background fluorescence is distinguished from positive amplification.
Emergency use authorization you mean. With no refunds.
And PCR should be ran at 27 CT to detect active infection. 45 gives massive amounts of false positives (which is probably a feature rather than a bug).
Shouldn't the stage 3 trials have ended by now? In which case the manufacturers won't have their legal immunity. I guess that will happen when Biden declares the "emergency" over next month and everything will be memory holed.
False positive rates are near zero because of optimized primer-probe sets specific for SARS-CoV-2. Analytical validation determines cut-off cycle thresholds for specific genes: N1, S.
And yet no product was ever licensed for human use. Why was that if they were so well tested?
As for PCR, labeling something gold standard doesn't make it so. I know the sequencing center here was running them at a 35 cycle threshold.
Wrong, Moderna and Pfizer mRNA vaccines for SARS-CoV-2 received FDA approval for BLAs.
RT-qPCR used for SARS-CoV-2 diagnostics tests is nearly a gold standard. Cycle thresholds at 35 to 45 are validated because cut-off values are based on the limit of detection (LOD), so background fluorescence is distinguished from positive amplification.
Emergency use authorization you mean. With no refunds.
And PCR should be ran at 27 CT to detect active infection. 45 gives massive amounts of false positives (which is probably a feature rather than a bug).
Shouldn't the stage 3 trials have ended by now? In which case the manufacturers won't have their legal immunity. I guess that will happen when Biden declares the "emergency" over next month and everything will be memory holed.
False positive rates are near zero because of optimized primer-probe sets specific for SARS-CoV-2. Analytical validation determines cut-off cycle thresholds for specific genes: N1, S.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7850182/#:~:text=Public%20Health%20England%20reports%20that,of%20cases%20are%20false%20positives.&text=The%20impact%20of%20false%20positive%20results%20includes%20risk%20of%20overestimating,the%20extent%20of%20asymptomatic%20infection.
Just ramp up the cycle threshold and you can get a positive out of anything. Absolute bullshit.
How much do they pay you for these posts?
Actually FDa said it's not a gold standard
Academic journals cite RT-qPCR as the gold standard for detecting SARS-CoV-2 in diagnostic tests.