Department of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Biochem Med (Zagreb). 2020 Feb 15;30(1):010706. doi: 10.11613/BM.2020.010706.
The aim of the study was to perform analytical verification and comparison of chromogenic assays for determination of dabigatran, rivaroxaban and apixaban concentration on BCSXP and STA Compact Max analysers.
Precision, linearity, measurement uncertainty estimation and determination of limit of blank, limit of determination and limit of quantification were calculated. Analytical performance specifications were set according to manufacturer specifications and literature data on between laboratory variability. Comparison of the methods was done using Bland-Altman and Passing-Bablok regression analysis.
Obtained results have shown acceptable precision on STA Compact Max only for dabigatran (CV = 3.5%) at lower concentration level comparing to manufacturer declaration (CV = 3.6%). On BCSXP, the highest coefficient of variation has been shown for apixaban (6.1%) at lower concentration level. Within laboratory precision was not met on STA Compact Max for all assays. Bland-Altman analysis has shown statistically significant bias for dabigatran (23.2%, 95%CI 11.2 - 35.3; P < 0.001) and apixaban (8.4%, 95%CI 1.2 - 15.6; P = 0.023). Passing-Bablok regression analysis has shown systematic and proportional deviation between methods for rivaroxaban (y = 6.52 (2.94 to 11.83) + 0.84 (0.80 to 0.89) x.
Chromogenic assays for dabigatran, rivaroxaban and apixaban on BCSXP and STA Compact Max analysers are shown as methods with satisfactory long-term analytical performance specifications for determination of direct oral anticoagulants in clinical laboratories. However, we cannot recommend interchangeable use because of the significant bias between assays.
本研究的目的是对 BCSXP 和 STA Compact Max 分析仪上用于测定达比加群、利伐沙班和阿哌沙班浓度的显色测定法进行分析验证和比较。
计算了精密度、线性、测量不确定度估计以及空白限、检出限和定量限的确定。根据制造商的规格和文献中关于实验室间变异性的数据，设定了分析性能规格。通过 Bland-Altman 和 Passing-Bablok 回归分析比较了这些方法。
仅在较低浓度水平下，STA Compact Max 上的达比加群（CV = 3.5%）的结果显示出可接受的精密度，与制造商声明（CV = 3.6%）相比。在 BCSXP 上，较低浓度水平下阿哌沙班的变异系数最高（6.1%）。所有检测项目在 STA Compact Max 上的实验室内精密度均未达到要求。Bland-Altman 分析显示达比加群（23.2%，95%CI 11.2-35.3；P < 0.001）和阿哌沙班（8.4%，95%CI 1.2-15.6；P = 0.023）存在统计学显著偏差。Passing-Bablok 回归分析显示两种方法之间存在系统和比例偏差，利伐沙班的回归方程为 y = 6.52（2.94 至 11.83）+ 0.84（0.80 至 0.89）x。
BCSXP 和 STA Compact Max 分析仪上用于达比加群、利伐沙班和阿哌沙班的显色测定法被认为是一种具有满意的长期分析性能规格的方法，可用于临床实验室中直接口服抗凝剂的测定。然而，由于检测方法之间存在显著偏差，我们不能推荐它们可以互换使用。
