CLSI EP10A3AMD

Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures, 3rd Edition

This guideline provides experimental design and data analysis for preliminary evaluation of the performance of a measurement procedure or device.

This document is available in electronic format only.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2019. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: Jan S. Krouwer, PhD

Date of Publication: May 14, 2014

Order Code PDF: CLSI EP10A3AMDE
ISBN Number: 1-56238-622-0

Order Code Print: print not available

Edition: Third

Pages: 70

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CLSI EP10A3AMD Abstract

Clinical and Laboratory Standards Institute document EP10-A3-AMD—Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition is intended to facilitate a limited, preliminary evaluation of the performance of a measurement procedure or device. Using the experimental design and data analysis procedure described, determination of whether a device has problems that require further evaluation or referral to the manufacturer can be done with a minimum expenditure of time and material. Included in Appendixes A and B are sample data sheets that should facilitate the analysis of the data. Appendix C contains a more sophisticated, powerful, statistical method for determining the possible causes of imprecision.