Posted by Sten Westgard, MS
Often we get questions about the problems that laboratories encounter when they wrestle with their local regulations.
Here we have a case where there are Turkish laboratory regulations that are irrational. In the words of the submitter:
"I have a question about the estimation of total CV. We have a requlation about total allowable error in Turkey....It is Turkish, but I strongly believe that you can follow it.
"The marked page can be seen below: There is an example for glucose. Two levels of controls are measured and the CV%’s calculated. The total CV are calculated from the CV’s of two different levels as seen in the equation. I can not accept it, because the levels are different even if the CV’s are close."
What's gone Rong here? More after the jump...
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A recent New York Times Sunday editorial focused on the deplorable state of medical device regulation. We simply can no longer trust FDA clearances, particularly 510ks: