ARUP Institute for Clinical and Experimental Pathology, ARUP Laboratories Inc, Salt Lake City, UT, USA.
Ther Drug Monit. 2011 Aug;33(4):398-401. doi: 10.1097/FTD.0b013e318220bb65.
Gabapentin is an antiepileptic drug used as adjunct therapy in the treatment of seizures. Absorption is saturable, and drug clearance can be reduced if patients have impaired renal function. Therapeutic drug monitoring can be useful for optimizing the dose in patients with impaired renal function, for evaluating individual patient absorption thresholds, and for monitoring compliance. Although chromatographic techniques have historically been used to support gabapentin monitoring, an immunoassay was recently introduced by ARK Diagnostics, for use with open channel chemistry analyzers. Here, we evaluated the immunoassay on a random access instrument.
The ARK gabapentin assay was validated using a Beckman AU400e automated chemistry analyzer. Imprecision was assessed with 5 replicates of 3 concentrations (2.5, 8.0, and 25.0 mg/L), analyzed for 4 days. The analytical measurement range was evaluated with duplicate measurements of a prepared sample (40.0 mg/L) that was serially diluted. Patients' results were compared with the results generated with a previously validated ultra-high performance liquid chromatography coupled to tandem mass spectrometry method (n = 45, range, 1.5-45.6 mg/L).
The within-run and between-run coefficients of variation were ≤8.1%. The analytical measurement range was confirmed to be 1.5-40.0 mg/L, as stated by the manufacturer. The Deming regression for the results of 45 patients produced a correlation coefficient of 0.9987, a linear regression slope of 1.01, and an intercept of 0.24 when compared with the ultra-high performance liquid chromatography coupled to tandem mass spectrometry assay.
The ARK immunoassay is suitable for the clinical use of monitoring gabapentin in serum or plasma on the Beckman AU400e.
加巴喷丁是一种抗癫痫药物，用作治疗癫痫的辅助疗法。吸收是饱和的，如果患者肾功能受损，药物清除率可能会降低。治疗药物监测对于优化肾功能受损患者的剂量、评估个体患者的吸收阈值以及监测依从性非常有用。尽管色谱技术在过去曾用于支持加巴喷丁监测，但 ARK 诊断公司最近推出了一种免疫分析法，可与开放式通道化学分析仪一起使用。在这里，我们在随机访问仪器上评估了该免疫分析法。
使用贝克曼 AU400e 自动化化学分析仪对 ARK 加巴喷丁检测进行了验证。使用 3 个浓度（2.5、8.0 和 25.0mg/L）的 5 个重复样本评估精密度，分析持续 4 天。使用制备好的样品（40.0mg/L）的重复测量评估分析测量范围，该样品连续稀释。将患者的结果与之前验证过的超高效液相色谱串联质谱法（n=45，范围 1.5-45.6mg/L）生成的结果进行比较。
批内和批间变异系数均≤8.1%。分析测量范围确认为制造商所述的 1.5-40.0mg/L。45 名患者结果的 Deming 回归产生了 0.9987 的相关系数、1.01 的线性回归斜率和 0.24 的截距，与超高效液相色谱串联质谱法相比。
ARK 免疫分析法适用于贝克曼 AU400e 上对血清或血浆中加巴喷丁进行临床监测。
