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KMID : 1101320050370010001
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Korean Journal of Clinical Laboratory Science
2005 Volume.37 No. 1 p.1 ~ p.7
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An Empirical Validation Study for Calibration Verification in TDM Test
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Chang Sang-Wu
Kim Nam-Yong
Choi Ho-Sung
Park Yong-Won
Chu Gyung-Bok
Yun Keun-Young
Park Byung-Ok
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Abstract
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The purpose of this study was to verify (i) a consistent calibration verification for the assessment of method linearity and (ii) calibration agreement with calibration settings. We validated calibration verification through method linearity with different lot number of individual calibrators that span the working range for 9 tests except salicylate with control sample in test. We evaluated that it covered broad analyte range to assay from near zero to the top of the measuring range with 5 or 6 points every three times for 10 analytes in TDM test. Target values were plotted on X-axis with assigned or observed values on the Y-axis. Working range were as follows. Calibration verification of the measuring range (maximum to minimum values) has been validated asetaminophen 0.1 to 304.6 μg/mL, salicylate 0 to 1005 μg/mL, valproic acid 3.2 to 154.19 μ g/mL, digoxin 0.17 to 5.65 ng/mL, vancomycine 1.3 to 80.51 μg/mL, carbarmazepine 0.1 to 22.3 μg/mL, phenytonin 0.6 to 40.21 μg/mL, theophyline 0.2 to 40.21 μg/mL, primidone 0 to 24.07 μg/mL, phenobarbital 0.6 to 60.0 μg/mL. Drawing a straight line through five or six points of these data showed good linearity. We are sure that it is important to assess the calibration verification of a test method to ascertain the lowest and highest test results that are reliable.
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KEYWORD
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Calibration verification, Linearity experiment, Working range
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