StatSensor Creatinine Lot to Lot test strip validation
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Could anyone who uses the Statsensor Creatinine Meter give me information on what you all use to perform the lot to lot validation on new test strips? Do you run QC or linearity for this or do you test patient samples? What criteria do you use for acceptable results for these lot to lots? I'm thinking the process we currently use is not the best approach and would like to know what other facilities are doing. We are CAP accredited.
Thank you!
Thank you!
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Hi Ashley I believe according to what i understand it is linearity and correlation with new lot of test strips. I didn't think we had to do lot to lot
Tamara - Thank you! What type of correlation do you all perform? Do you use patient samples or proficiency samples? The prior POCT Manager here had QC being run 10x on each test strip lot for comparisons. I'm seeing that QC materials shouldn't necessarily be used to validate reagents due to potential variation in reagent lots which is why I wanted to re-evaluate our process.
I do a 5 pt correlation versus the 5600 chem analyzer. Use different values across the AMR.
Thank you for the information! This is very helpful!
Is this a waived test system?
No it is non waived
We run 5-6 patient samples on the current lot and the new lot. Should agree 0.3 mg/dL or 15%
Thanks to everyone for all the input! I believe we will change to performing patient samples for the lot to lot.
I had emailed Nova to see if they had recommendations for new lots of test strips. I was not expecting the extensive validation response I received and just wanted to share. They recommend a minimum of 20 patient tests on new lot, old lot and reference analyzer. They also stated that at least half of the samples should have a creatinine of <2.0mg/dL.
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