Transcription of CLIA-Compliant Analytical Method Validation Plan and ...
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CLIA-Compliant Analytical Method Validation Plan and ...
LRN-C Analytical Method Validation PLAN & TEMPLATE 20131 TABLE OF CONTENTS List of LRN Clients and Requirements for Analytical Method Performance Method Performance Specifications and Validation Analytical Method Validation Plan and TemplateFOR LRN-C LABORATORIESISSUES IN BRIEF: LRN-C Analytical Method Validation PLAN & TEMPLATE DECEMBER 2013 LIST OF ACRONYMSEQA External Quality AssessmentHPLC-MS/MS High-Performance Liquid Chromatography Tandem Mass SpectrometryIS Internal StandardLDT Laboratory Developed Test(s)LOD Limit of DetectionLOQ Limit of QuantitationPK/PD Pharmacokinetic/Pharmacodynamic modelingTEa Total Allowable ErrorULOL Upper Limit of Linearity APHL PUBLIC HEALTH LABORA
CLIA rules and guidance3 are silent on minimum requirements for validation protocols; however, validation plans, experiments, results and conclusions are rigorously reviewed for scientific merit and integrity. The laboratory director is responsible for establishing individual laboratory criteria.
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