CLSI EP10

Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures, 4th Edition

CLSI EP10 provides experimental design and data analysis for preliminary evaluation. Using this experimental design and data analysis procedure, allows for determination of whether a device has problems that require further evaluation or referral to the manufacturer with a minimum expenditure of time and material.

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Chairholder: Michelle Campbell, MS, MLS(ASCP)CM, MBCM

Date of Publication: July 10, 2024

Order Code PDF: CLSI EP10Ed4E
ISBN Number: 978-1-68440-232-8

Order Code Print: CLSI EP10Ed4
ISBN Number: 978-1-68440-231-1

Edition: Fourth

Pages: 88

CLSI EP10 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

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CLSI EP10 Abstract

Clinical and Laboratory Standards Institute EP10—Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures 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