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College of American Pathologists - webapps.cap.org

1 College of American PathologistsLaboratory Accreditation ProgramLaboratory General Checklist: How to Validate a New TestD. Robert Dufour, MD, FCAP, FACBC onsultant, Veterans Affairs Medical Center, Washington DCEmeritus Professor of Pathology, George Washington UniversitySeptember 17, 2008 Copyright 2008 College of American Pathologists (CAP). All rights are reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes or altered in any Objectives As a result of participating in this activity, you will be able to: Describe the necessary steps to validating new test performance Assure that all steps are performed for all new methods introduced into your laboratory3 What is required?

27 Verify Precision • Ideally take samples with clinically important results (e.g., for TSH, should select low and high values, not both in reference range)

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