Section of Clinical Biochemistry, Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy.
Department of Laboratory Medicine, San Bortolo Hospital, Vicenza, Italy.
Semin Thromb Hemost. 2019 Apr;45(3):308-314. doi: 10.1055/s-0038-1676578. Epub 2019 Jan 30.
This study aimed to provide a preliminary evaluation of the analytical performance of the new Roche COBAS T 711: fully automated coagulation analyzer, which uses both liquid and lyophilized reagent cassettes. The analytical assessment included analysis of imprecision and linearity of prothrombin time (PT), activated partial thromboplastin time (APTT), and fibrinogen on COBAS T 711: analyzer. Test results of 120 routine plasma samples were also compared with those obtained using two other coagulation analyzers (Instrumentation Laboratory ACL TOP 700 and Stago STA-R MAX). The accuracy, imprecision, and comparability of manual and automatic lyophilized material resuspension were also evaluated using 200 routine plasma samples. Overall, automatic resuspension was found to be more precise than, and equally accurate as, manual reconstitution, with coefficient of variations (CV%) three- to sixfold lower compared with manual reconstitution. The analytical imprecision was found to be excellent, as attested by total CV% of 0.7% for PT, 1.7 to 1.8% for APTT, and 1.9 to 3.2% for fibrinogen. Linearity was excellent over a clinically significant range of PT, APTT, and fibrinogen values, displaying correlation coefficients comprised between 0.994 and 0.999. Methods comparison studies revealed that results of PT, APTT, and fibrinogen on COBAS T 711: are globally aligned with those obtained using identical plasma samples on IL ACL TOP 700 and Stago STA-R MAX, displaying correlation coefficients of 0.97 for PT, 0.81 and 0.88 for APTT, 0.90 and 0.94 for fibrinogen, respectively. In conclusion, the results of this preliminary evaluation demonstrate that PT, APTT, and fibrinogen on COBAS T 711: coagulation analyzer displays excellent performance for routine use in clinical laboratories.
本研究旨在对罗氏 COBAS T 711：全自动凝血分析仪的分析性能进行初步评估，该仪器同时使用液态和冻干试剂盒。分析评估包括对 COBAS T 711：分析仪上的凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）和纤维蛋白原的不精密度和线性分析。还比较了 120 例常规血浆样本的测试结果与另外两种凝血分析仪（Instrumentation Laboratory ACL TOP 700 和 Stago STA-R MAX）的结果。还使用 200 例常规血浆样本评估了手动和自动冻干材料重悬的准确性、不精密度和可比性。总体而言，自动重悬比手动重悬更精确，且与手动重悬具有相同的准确性，与手动重悬相比，变异系数（CV%）低三至六倍。分析不精密度非常好，PT 的总 CV%为 0.7%，APTT 的 CV%为 1.7%至 1.8%，纤维蛋白原的 CV%为 1.9%至 3.2%，这证明了这一点。在临床有意义的 PT、APTT 和纤维蛋白原范围内，线性度极好，显示相关系数在 0.994 到 0.999 之间。方法比较研究表明，COBAS T 711：上的 PT、APTT 和纤维蛋白原的结果与使用 IL ACL TOP 700 和 Stago STA-R MAX 相同的血浆样本获得的结果全球一致，相关系数分别为 0.97 用于 PT，0.81 和 0.88 用于 APTT，0.90 和 0.94 用于纤维蛋白原。总之，这项初步评估的结果表明，COBAS T 711：凝血分析仪上的 PT、APTT 和纤维蛋白原的性能非常适合在临床实验室常规使用。
