
Companion
First Edition
Method Evaluation
CLSI EP06EG
Developer Validation of Linearity Establishment Guide
CLSI EP06 provides essential guidance for validating and verifying the linearity of a measurement procedure’s analytical measuring interval (AMI). This guideline outlines minimum procedures for both manufacturers and laboratory-developed test (LDT) developers to confirm linearity claims and ensure measurement accuracy. EP06 helps laboratories meet medical and regulatory requirements while maintaining precision in quantitative testing.
Guide should be used in conjunction with CLSI EP06 standard document.
August 29, 2024
Paula Ladwig, MS, MT(ASCP); Michelle Campbell
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EP06Ed2EGE
978-1-68440-251-9
15
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