Straka R J, Hoon T J, Lalonde R L, Pieper J A, Bottorff M B
Department of Clinical Pharmacy, College of Pharmacy, University of Tennessee, Memphis 38163.
Clin Chem. 1987 Oct;33(10):1898-900.
We analyzed 99 patients' serum samples for concentrations of a new antiarrhythmic agent, flecainide acetate, by fluorescence polarization immunoassay (FPIA) and "high-performance" liquid chromatography (HPLC). Within-day and between-day coefficients of variation at concentrations in the low and high ends of the therapeutic range were less than 7% for HPLC and less than 9% for FPIA. There was no statistical difference in the mean (+/- SD) concentrations of the clinical serum samples measured by the two methods (607 +/- 334 micrograms/L by HPLC, 602 +/- 344 micrograms/L by FPIA), but results by each differed by a mean of 0.13%. FPIA and HPLC measurements correlated significantly (r = 0.98, P less than 0.05), and were linearly related (slope = 0.970, intercept = 13 micrograms/L) as assessed by orthogonal regression. Both assay methods produced similar concentration measurements and were sufficiently accurate and precise to be used in therapeutic drug monitoring.
我们通过荧光偏振免疫分析法（FPIA）和“高效”液相色谱法（HPLC）分析了99例患者的血清样本，以检测一种新型抗心律失常药物醋酸氟卡尼的浓度。在治疗范围的低浓度和高浓度端，HPLC的日内和日间变异系数均小于7%，FPIA的则小于9%。两种方法测得的临床血清样本平均（±标准差）浓度无统计学差异（HPLC为607±334μg/L，FPIA为602±344μg/L），但每种方法的结果平均相差0.13%。FPIA和HPLC测量结果显著相关（r = 0.98，P＜0.05），经正交回归评估呈线性关系（斜率 = 0.970，截距 = 13μg/L）。两种检测方法得出的浓度测量结果相似，且足够准确和精密，可用于治疗药物监测。
