An Empirical Validation Study for Calibration Verification in TDM Test

검량보정 검증의 실험적 적합성에 대한 연구 -치료적 약물검사를 중심으로-

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 $304.6_{\mu}g/mL$, salicylate 0 to $1005_{\mu}g/mL$, valproic acid 3.2 to $154.19_{\mu}g/mL$, digoxin 0.17 to 5.65 ng/mL, vancomycine 1.3 to $80.51_{\mu}g/mL$, carbarmazepine 0.1 to $22.3_{\mu}g/mL$, phenytonin 0.6 to $40.21_{\mu}g/mL$, theophyline 0.2 to $40.21_{\mu}g/mL$, primidone 0 to $24.07_{\mu}g/mL$, phenobarbital 0.6 to $60.0_{\mu}g/mL$. 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.