Method Comparison acceptability criteria and Alternative PT test for CoaguChek
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Hello all,
Just want to ask you all what your acceptability criteria for your Method Comparison between your Main Lab and the EPOC. Do you specifically use what you got when you did your initial validation or something else. I specifically want to know about Sodium. Ours is +/- 4 mmol/L. I know that CAP uses that same criteria for our PT. Is that what everybody is using too? Every time I do my method comparison I have a couple of patients that are outside of acceptability. It's usually between +/- 4.5 - 6. We just started the EPOC last year so I only have a couple of comparisons performed since then.
My other question is. What do you use as an alternative sample for PT for the CoaguChek? Something happened to our survey samples and when I called CAP, they didn't have anymore sample to send me. They told me to ran split sample or ran a sample that has a known range. I asked them if I can use QC material and they said yes. Is that what you all do?
Thanks for your help or feed back.
Alana
Just want to ask you all what your acceptability criteria for your Method Comparison between your Main Lab and the EPOC. Do you specifically use what you got when you did your initial validation or something else. I specifically want to know about Sodium. Ours is +/- 4 mmol/L. I know that CAP uses that same criteria for our PT. Is that what everybody is using too? Every time I do my method comparison I have a couple of patients that are outside of acceptability. It's usually between +/- 4.5 - 6. We just started the EPOC last year so I only have a couple of comparisons performed since then.
My other question is. What do you use as an alternative sample for PT for the CoaguChek? Something happened to our survey samples and when I called CAP, they didn't have anymore sample to send me. They told me to ran split sample or ran a sample that has a known range. I asked them if I can use QC material and they said yes. Is that what you all do?
Thanks for your help or feed back.
Alana
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Because of shipping vulnerabilities and the firmware stuff, we incorporated spot checks of 5 samples one every shipment as part of our iqcp. This is above and beyond our 6 month checks and has proven to find 2 bad shipments of cards in the last 3 years.
Later
Tom
can I ask what your source is for Lactate and Ionized Calcium? I have been looking for guidelines for those 2 particular analytes and was unable to find anything. Thank you in advance!
Steven, let me know how your validation goes.
Thomas, yes we're taking the sample type into consideration too and sample integrity. I have not found any comparability criteria between whole blood versus plasma. I'll let you know if I find any. I called EPOC tech support and they sent me their initial study. I'm reviewing it currently.
I wonder how other POCC's method comparison are. Please share what you're comparability criteria's are and what you follow.
Thanks,
Alana