Comparison Studies: Acceptable differences between Coaguchek XS Pro and Stago
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I am having trouble finding an acceptable limit between our Coaguchek XS Pro and the lab's Stago. For those who are performing biannual comparison studies between the two, what acceptable limit parameter are you using?
Thanks for your input!
Thanks for your input!
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+/- 0.3 for INR less than 2.5
+/- 1.0 for INR equal or greater than 2.5
+/- 2.0 for INR equal or greater than 4.5
I called CAP about this issue. She told me not to stress about this...it's comparing apples to oranges. She said it's fine to review historical data to determine acceptable limits. As an example, the Stago results are x% lower than Coaguchek, and to adjust our acceptable parameters to reflect the x% difference.
We have new Coaguchek analyzers, and the comparison was redone, so I'm hoping they may show more consistency.
I was curious what others found with their comparisons, and if we had similar parameters
Thank you for your response!
We are about to start our comparison as well for the Coagucheck against Stago. I am curious how to support the variations as we tried to validate about 7 years ago.
On our comparison report, we will put the acceptable limit ranges determined by historical data.
I don't have a backup statement in our QAP. I've been all over the internet trying to find information regarding the differences but with little luck. That's why I consulted CAP for guidance. I also should have qualified that we measure PT seconds by % difference and INR by the ranges listed in the previous comment. The INR ranges came from our medical director at our Anti coagulation Management Services. The literature he used came from Roche's Coaguchek website indicating the higher the INR, the greater the deviation. He also noted this trend in our own patient studies.
As far as supporting the variations, if you find something in literature, please add it to this thread. Honestly, I'm stumped.