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Estimating the precision of a measurement procedure (CLSI EP05-A3)

Learn how to estimate the precision of a measurement procedure for product performance characteristics, for FDA 510k submissions and product marketing.

In this tutorial you will use the CLSI EP05-A3 procedure to establish the precision.

  1. Estimating precision
    Estimate the precision of the measurement procedure at a single site.
  2. Estimating precision for a multi-site study
    Estimate the precision of the measurement procedure at multiple sites and samples.
  3. Fitting a precision profile
    Fit a precision profile function to describe the imprecision across the measuring interval.
Related information
CLSI. (2014). Evaluation of Precision Performance of Quantitative Measurement Methods (EP05-A3). Clinical and Laboratory Standards Institute.

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  •  Estimating the precision of a measurement procedure (CLSI EP05-A3)
  •  Estimating precision
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  •  Fitting a precision profile
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Published 18-Apr-2023
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Statistical analysis and method validation software for Microsoft Excel.

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