Posted by Sten Westgard, MS
Here's a question that came in about setting the control limits (or range) for a test:
"for some assays we're using this formula: actual SD * 3 and then divided by 2 plus or minus the mean is this acceptable or not because when we use that give us abit wider range than using the mean plus minus 2SD."
When we asked for an example, we got this data:
Manufacturer Data: SD = 22.5, Mean = 224
Actual Data: SD = 8.79, Mean = 223
"We're multiplying ourSD (8.79) by 3 and then we divide it by 2 to give us the new SD which is 13 (8.79*3/2 = 13).
Then we multiply this new SD 13 by 2 to give us the real 2 SD range which is 26.
So our range is now 197 - 249.
Are we following the right way or not?"
The answer, after the jump...
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Posted by Sten Westgard, MS
In the recent issue of Clinical Chemistry, an editorial reviews the current state of Vitamin D testing: "There is common agreement that 25-OHD is a 'difficult' analyte."
25-Hydroxyvitamin D: A Difficult Analyte, Graham D. Carter, Clin Chem 58:3; 486-488 (2012).
At the same time, the editorial notes that marked process is being made:
"Nevertheless, results submitted to the international Vitamin D External Quality Assessment (DEQAS) have shown a gradual reduction in interlaboratory imprecision (CV) in recent years - from >30% in 1995 to 15% in 2011."
The question is, is that reduction in imprecision good enough? Or is the quality required by Vitamin D still too "difficult"?
More after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
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:
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
A paper from Surabaya, Indonesia assessed the performance of an anonymous hematology analyzer. The study used the old CLIA 1992 goals. We updated it with an assessment using CLIA 2025 goals. And then it became clear why this instrument was not named. None of this performance would meet CLIA's standards. Is performance so bad in this analyzer, ...