Accuchek Inform II Range Validation
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My hospital has had the Accuchek Inform II for a long time now. I came into the POCC position a couple of years ago. I'm reviewing our current standard for this POC testing. On our standard, it states "normal" ranges for age groups, but the manufacture has not established any ranges so I'm wondering where these ranges came from. I understand that it is a CLIA-waived test, but how does one go about establishing a "normal" reference range for the meter.
For hospitals who use Accucheks, what "normal" ranges do you go by? Have you validated ranges or do you use your lab's "normal" ranges?
Critical values are already established per the hospital's lab.
Another question is how does one determine the linearity. I understand that the manufacture states the meter can read from 10-600. Our current linearity states that it is 40-500. This was before my time, and I'm still new to this. Was this established due to extra testing so that we didn't go with the manufacture linearity reading range?
I'm confused with a lot of questions.
For hospitals who use Accucheks, what "normal" ranges do you go by? Have you validated ranges or do you use your lab's "normal" ranges?
Critical values are already established per the hospital's lab.
Another question is how does one determine the linearity. I understand that the manufacture states the meter can read from 10-600. Our current linearity states that it is 40-500. This was before my time, and I'm still new to this. Was this established due to extra testing so that we didn't go with the manufacture linearity reading range?
I'm confused with a lot of questions.
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When your hospital began using the AccuChek someone should have done comparisons between methods (Lab vs AccuChek) to confirm that the results were comparable. This is generally done with at least 40 samples spanning the entire reportable range. Perhaps your predecessor was only able to verify that results were linear from 40-500. You should search for the results from the initial AccuChek validation studies.
Twice a year you should run a small number of comparisons (5-10) to verify that the results are still comparable. If the laboratory method/instrument is ever replaced, then a complete validation must be done again.
I'm glad you were brave enough to ask these questions. The community on this site is amazing. Good luck, and welcome to POCT!