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Calibration Verification versus AMR Verification

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Calibration Verification versus AMR Verification Posted: Thu Sep 17, 2015 12:23 pm
Is AMR verification the same as Calibration Verification? CAP requires AMR to be re-validated at least every 6 months while CLIA requires Calibration Verification every 6 months. The process seems to be similar in the sense that known concentrations are assayed throughout the reportable range for patient test results.
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sfoong
 
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Re: Calibration Verification versus AMR Verification Posted: Mon Sep 21, 2015 7:28 am
CLIA calibration verification is the assaying of materials of known concentration in the same manner as patient samples to substantiate the instrument or test system’s calibration throughout the reportable range for patient test results. This is required every six months. At least three levels will need to be tested – one at the high end of the reportable range, one at the low end of the reportable range and one near the midpoint of the reportable range. There are a few exceptions including instrument/test systems that use three or more levels of calibration material and include a low, mid-point and high value and is performed at least every six months.

CAP requires that you verify that a linear relationship holds throughout the instruments Analytical Measurement Range (AMR) every 6 months. They require the ARM validation prove both “trueness” and “linearity”. While “trueness’ can be proven with three levels most people believe that a true “linearity” study requires more than this (usually 5). A linearity study with known target values that covers the full analytical range of the assay will meet CAP’s requirements.

I have attached a CAP presentation from 2011 that I believe is still accurate that explains in detail the difference between calibration verification and ARM. I hope you find it informative.
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Todd
 
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Re: Calibration Verification versus AMR Verification Posted: Mon Oct 05, 2015 9:26 am
Thank you much Todd, this helps.
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sfoong
 
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