CLSI EP27
Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
This guideline offers recommendations for constructing and using error grids to assess the clinical acceptability of quantitative measurement procedures. It focuses on evaluating the potential harm that could result from erroneous measurements that have clinical consequences. By following these recommendations, laboratories can ensure that their measurement procedures are safe and reliable, ultimately improving patient outcomes.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline EP27—Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures explains the function of an error grid, illustrates the concept with examples, and provides recommendations on constructing and using one. For a given measurand, error grids characterize the relationship between measurement errors and clinical management errors that may harm patients. This guideline covers the process of creating error grids with multiple error zones and describes the two primary options for doing so. After error grids have been constructed, they can be populated with data from a measurement procedure comparison experiment, as described in this guideline. A candidate measurement procedure’s clinical performance is evaluated by visually comparing the experimental data points with the error grid and tabulating the number of points that fall within each error zone. This guideline includes an example experiment that demonstrates proper interpretation of an error grid plot and its tabulated results.
This guideline replaces the previous edition of the approved guideline, EP27-A, published in 2012. Several changes were made in this edition, including:
• Adding an initial flow chart that depicts the processes of creating and using an error grid
• Aligning the guidance with CLSI document EP21 on allowable total error
• Updating and adding plots to more clearly demonstrate the process of error grid creation
• Adding an example plot from an error grid experiment, including the grid and its data points
• Moving error grid construction examples to appendixes to more closely follow the initial flow chart
This guideline provides recommendations on constructing and using error grids to evaluate the clinical acceptability of quantitative measurement procedures, based on the potential harm that may be caused by erroneous measurements with clinical consequences. This guideline is intended for use by laboratories and manufacturers (collectively referred to as “developers”) and users of quantitative measurement procedures.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.
Clinical and Laboratory Standards Institute guideline EP27—Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures explains the function of an error grid, illustrates the concept with examples, and provides recommendations on constructing and using one. For a given measurand, error grids characterize the relationship between measurement errors and clinical management errors that may harm patients. This guideline covers the process of creating error grids with multiple error zones and describes the two primary options for doing so. After error grids have been constructed, they can be populated with data from a measurement procedure comparison experiment, as described in this guideline. A candidate measurement procedure’s clinical performance is evaluated by visually comparing the experimental data points with the error grid and tabulating the number of points that fall within each error zone. This guideline includes an example experiment that demonstrates proper interpretation of an error grid plot and its tabulated results.
This guideline replaces the previous edition of the approved guideline, EP27-A, published in 2012. Several changes were made in this edition, including:
• Adding an initial flow chart that depicts the processes of creating and using an error grid
• Aligning the guidance with CLSI document EP21 on allowable total error
• Updating and adding plots to more clearly demonstrate the process of error grid creation
• Adding an example plot from an error grid experiment, including the grid and its data points
• Moving error grid construction examples to appendixes to more closely follow the initial flow chart
This guideline provides recommendations on constructing and using error grids to evaluate the clinical acceptability of quantitative measurement procedures, based on the potential harm that may be caused by erroneous measurements with clinical consequences. This guideline is intended for use by laboratories and manufacturers (collectively referred to as “developers”) and users of quantitative measurement procedures.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.