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Analytical Measurement Range: Examples and Approaches ...

2013 Laboratory Accreditation Program Audioconferences and Webinars Analytical Measurement Range: Examples and Approaches William Castellani, MD, FCAP. March 20, 2013. Objectives Define and describe the Analytical y Measurement range g Compare this range to CLIA'88 requirements for calibration and calibration verification Discuss strategies for satisfying accreditation requirements q 2013 College of American Pathologists. All rights reserved. 2. Conflicts Nothing g to disclose 2013 College of American Pathologists. All rights reserved. 3. It All Begins Here Calibration means a pprocess of testing g and adjusting j g an instrument or test system to establish a correlation between the Measurement response and the concentration or amount of the substance that is being g measured by the test procedure. Calibration verification means the assaying of materials off known k concentration t ti ini the th same manner as patient ti t specimens to substantiate the instrument or test system's calibration throughout the reportable range for patient ti t test t t results.

o Reportable range: as part of method validation/verification −Initial documentation of the analytical measurement range −Documentation of any dilution or concentrationDocumentation of any dilution or concentration protocol that can be done to expand the range of values that can be reported by the method

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