(Total Views: 392)
Posted On: 05/17/2020 11:23:19 AM
Post# of 11803
Re: Bialystock #10467
Fear of a mistake (ie. "you can't go wrong buying 'big blue,' like Abbott), or influence?
Other than the DNA based methods that the FDA appears to approve by rote, the changes in the testing protocols appear to be based on two factors, first political pressure from big pharma. If you have a cleared method, like Roche and Abbott, you protect that method. And then there is the creep of accuracy statistics. I remember no so long ago, less than 60 days ago, that a successful method was 90% and 80% sensitivity and specificity. Many of the cleared methods were in the 70s. Now the methods are expected to be 95%+ and 95%. And the false negatives have to be in the 5% range.
And Abbott, there have been no recalls, they continue to have a 30% false negative rate.
Other than the DNA based methods that the FDA appears to approve by rote, the changes in the testing protocols appear to be based on two factors, first political pressure from big pharma. If you have a cleared method, like Roche and Abbott, you protect that method. And then there is the creep of accuracy statistics. I remember no so long ago, less than 60 days ago, that a successful method was 90% and 80% sensitivity and specificity. Many of the cleared methods were in the 70s. Now the methods are expected to be 95%+ and 95%. And the false negatives have to be in the 5% range.
And Abbott, there have been no recalls, they continue to have a 30% false negative rate.
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