Sheffield Haemostasis and Thrombosis Centre, Sheffield, UK.
Institute for Clinical Chemistry and Laboratory Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Int J Lab Hematol. 2018 Dec;40(6):645-654. doi: 10.1111/ijlh.12897. Epub 2018 Jul 22.
New methods for coagulation tests require careful assessment before routine use. We evaluated the analytical performance of five new coagulation assays for measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT).
PT Rec, PT Owren, aPTT, aPTT Lupus and aPTT Screen assays (Roche Diagnostics) were evaluated on cobas t 711 and cobas t 511 analysers (Roche Diagnostics) at four European centres. Analytical performance and method comparisons with relevant commercially available assays were performed to Clinical Laboratory Standards Institute guidelines using residual anonymized samples. Lot-to-lot comparison and equivalency of the cobas t analysers were also assessed; reference ranges were determined using samples from apparently healthy volunteers.
Overall, coefficients of variation were ≤1.3% for within-run precision and ≤6.3% for total reproducibility across all sites. Deming regression analyses showed good agreement between each assay (cobas t 711) and respective comparator method (Pearson's r: 0.964-0.999, n > 120 samples/assay/site). Passing-Bablok regression analyses demonstrated equivalence of the two cobas t platforms for use with each assay (Pearson's r ≥ 0.995). Lot-to-lot consistency was high for all assays and comparisons (Pearson's r ≥ 0.998). Reference ranges (2.5th-97.5th percentiles; n = 200 samples/assay) in seconds were 8.4-10.6 (PT Rec), 18.2-27.2 (PT Owren), 23.6-30.6 (aPTT), 24.1-31.7 (aPTT Lupus) and 23.9-33.2 (aPTT Screen).
Based on the excellent analytical performance and good agreement with relevant comparator methods, the five coagulation assays on the novel cobas t 711 and cobas t 511 analysers are suitable for routine use in core laboratories.
新的凝血检测方法在常规使用前需要进行仔细评估。我们评估了五种新的凝血检测方法（Prothrombin Time [PT] Rec、PT Owren、Activated Partial Thromboplastin Time [aPTT]、aPTT Lupus 和 aPTT Screen）测量凝血酶原时间（PT）和活化部分凝血活酶时间（aPTT）的分析性能。
在四个欧洲中心，使用 Roche Diagnostics 的 cobas t 711 和 cobas t 511 分析仪评估了 PT Rec、PT Owren、aPTT、aPTT Lupus 和 aPTT Screen 检测方法。根据临床实验室标准化协会的指南，使用剩余的匿名样本进行分析性能评估和与相关商业可用检测方法的方法比较。还评估了批间比较和 cobas t 分析仪的等效性；使用来自明显健康志愿者的样本确定参考范围。
总体而言，所有站点的批内精密度的变异系数（CV）≤1.3%，总重现性的 CV≤6.3%。Deming 回归分析显示，每种检测方法（cobas t 711）与各自的比较方法之间具有良好的一致性（Pearson's r：0.964-0.999，n>120 个样本/检测/站点）。通过 Bablok 回归分析证明了两种 cobas t 平台在使用每种检测方法时的等效性（Pearson's r≥0.995）。所有检测方法和比较的批间一致性均很高（Pearson's r≥0.998）。各检测方法的秒参考范围（2.5 百分位数-97.5 百分位数；n=200 个样本/检测）为 8.4-10.6（PT Rec）、18.2-27.2（PT Owren）、23.6-30.6（aPTT）、24.1-31.7（aPTT Lupus）和 23.9-33.2（aPTT Screen）。
基于出色的分析性能和与相关比较方法的良好一致性，新型 cobas t 711 和 cobas t 511 分析仪上的五种凝血检测方法适合在核心实验室常规使用。
