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...
-----
From Dr. Carmen Ricos, on behalf o the SEQC-Analytical Quality Commission:
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
At the AACC/ASCLS conference in San Diego, many of the Sigma VP laboratories contributed to a poster on evaluating the applicability of various analytical performance specifications for AST:
Multisite study of AST analytical performance reveals disparities in global performance specifications
The full poster can be downloaded from our westgard.com download section here. (free membership required)
But what was most rewarding was meeting with many of the co-authors who came to the meeting.
Ms Ginny Foo, Mr. Rajkumar Rengaraju, Co-authors from Innovative Diagnostics, Singapore
more pictures after the jump
-----
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 recent question came to me via social media: "Hello Sir, Good morning, How are you? I wanted to know is still 10x rule is coumpulsary?[stet.] Even [when] we are using lab mean and lab SD. Please share the details.Thanks and Regards, [anonymous]"10:x is not compulsory by any regulation that I am aware of. Many regulations require you to...