New Analyzer Verification of Accuracy and Spanning the AMR
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I have read various sources and asked CHATGPT and I am still unsure of the answer.
I have spoken to my lab director about this as well but there are conflicting opinion.
When doing a validation/verification for a new device it is preferable in an ideal world that you test patient samples that span the AMR of the device.
We do not live in an ideal world where we can get patients that span that range for the various analytes for example an analyzer like the GEM or the epoc.
Does running linearity material by itself and comparing it to the manufacturer range satisfy that we verified accuracy and reportable range if we combined it with the 25 patient sample's accuracy.
How do people normally span the range for analytes like pH, pO2, pCO2, k, cl, ica, na, ?
My lab director will not sign the validation document if it doesn't span the ranges with patient blood but that is unreasonable and unpractical.
What is a reasonable approach to this question?
I have spoken to my lab director about this as well but there are conflicting opinion.
When doing a validation/verification for a new device it is preferable in an ideal world that you test patient samples that span the AMR of the device.
We do not live in an ideal world where we can get patients that span that range for the various analytes for example an analyzer like the GEM or the epoc.
Does running linearity material by itself and comparing it to the manufacturer range satisfy that we verified accuracy and reportable range if we combined it with the 25 patient sample's accuracy.
How do people normally span the range for analytes like pH, pO2, pCO2, k, cl, ica, na, ?
My lab director will not sign the validation document if it doesn't span the ranges with patient blood but that is unreasonable and unpractical.
What is a reasonable approach to this question?
5 Replies
Hi Jo! We just received a proposed validation plan from Siemens and they included ways to manipulate the samples to obtain higher or lower ranges of certain analytes. I recommend reaching out to the vendors for their recommendations.
@Jenna, I have something for epoc but the document doesn't actually talk about all the analytes that you can expand, only some. It also included this quote "These are target distributions and will rarely be completely achieved, but efforts should be made to obtain as wide a clinically relevant range as possible" There is no real clear hard line.
That's unfortunate. We are preparing to make a switch to EPOC and will have the same questions soon. Hopefully someone else has some knowledge. I think ultimately it depends what your Medical Director is comfortable approving.
In trying to meet AMR, sometimes we need to get creative. I have used calibration verification materials, PT or Cross Check supplies orderable after submission dates. Those items will give you targeted acceptable values. If you have a device that you are comparing it to, I have used manipulated human samples. For gases, that might mean open to room air or diluting out. Looking forward to seeing the creativity of others!
@Erika, thank you for your input. My lab director is very particular in the sense that she says only blood samples/same matrix for patient testing can be used for an accuracy that spans the reportable range. your thoughts?
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