Urine Dipstick Method Comparison to main lab
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Hello! I need to do a method comparison study on my urine dipstick to the core lab Iris beckman. Does anyone know how to find the acceptable criteria for a successful comparison? Thank you! Also if you have a template for this already, I'd appreciate a share.
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We came up with a method for the same two systems since inception of our program 11 years ago. We decided our criteria after discussion with my chief and the hematology supervisor who owned the Iris. The whole process was something above and beyond the requirements, but we wanted a method to catch problems early if possible. We do this every 6 months and a larger study was done to validate the system. Interestingly, we used information from the validation to determine not to report the SG from the Clinitek.
What we do is pull out the ER printouts from the IRIS then search our RALS DB for corresponding Clinitek samples run within a 2hour period. A bit tedious, but we have enough volume to make it practical. We usually do 15 samples but sometimes we only get 10. (for validation I think we did 40) Then we transcribe the results to a chart with the instrument serial number vs Iris (to identify instrument to instrument variability) Our expectation is to see no more than one gradation difference. Exceptions are noted and investigated to the degree possible. Over the years we have found a few things on both sides, but nothing earth shattering. It's been helpful to point to a group of users not cleaning the test table properly and other pre analytic issues. Mosly it's serves as a baseline from which to work from over time. We also include the microscopic data even though, my heme super loves to point out every time the chemistry is based on lysed cells. I think it helps provide a clearer picture. Anyroad, it looks like this attachment. Hope its helpful.
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I got this from my Siemens rep a long time ago.