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Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition

This guideline includes descriptions of the types of qualitative, binary output examinations and procedures for evaluating their performance.

This edition of the document was corrected in February 2024. Read the correction notices by accessing the link above, and learn more about our correction process here.

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Chairholder: Jeffrey R. Budd, PhD

Date of Publication: March 7, 2023

Order Code PDF: CLSI EP12Ed3E
ISBN Number: 978-1-68440-177-2

Order Code Print: CLSI EP12Ed3
ISBN Number: 978-1-68440-176-5

Edition: Third

Pages: 140

CLSI EP12 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI EP12 Abstract

Clinical and Laboratory Standards Institute guideline EP12—Evaluation of Qualitative, Binary Output Examination Performance describes the categories of qualitative, binary output examinations and covers their performance evaluations for imprecision, including estimating C5 and C95, clinical performance (sensitivity and specificity), and stability and interferences.