Analytical Assessment of the New Roche Cobas t 711 Fully Automated Coagulation Analyzer

摘要

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.