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

Abstract

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.

Performance of 6 routine coagulation assays on the new Roche Cobas t711 analyzer

“…For fibrinogen, our results of 1.6% and 3.2% at 1.19 g/L and 2.82 g/L compared well to the results from Lippi et al. [7] of 1.7% and 2.0% at 1.21 g/L and 2.56 g/L, respectively.…”

“…Additionally, our results were comparable to the study performed by Lippi et al. [7], who described between-run CV’s of 0.6% and 0.5% for PT-rec at 7.97 s and 27.8 s, and 1.7% and 1.5% for aPTT at 25.8 s and 40.8 s, respectively.…”

“…Patient results for both the aPTT and PT were significantly lower on the t711 compared with the STA-R Evolution. This was also found in a previous study and can be explained by the differences in coagulation activators and detection methods (Table 1) [7]. Bland-Altman plots showed a consistent difference between the t711 and the STA-R Evolution for the PT and aPTT assays (Supplemental Fig.…”

“…The aims of this study were first to reproduce previous results on imprecision and method comparison [[4], [5], [6], [7]], second to evaluate the performance of the anti-Xa assay (not previously published), third to determine whether the aPTT can be used to monitor UFH therapy, fourth to investigate a fast centrifugation protocol in order to shorten turn-around time, and finally to study sample stability over time, since this is known to be method and reagent dependent [8].…”

Innovations in Thrombosis and Hemostasis: A Glimpse Towards the Future of Diagnostic Analyzers

“…In the first, the analytical performance of a new coagulation analyzer that utilizes a novel approach of employing liquid and lyophilized reagent cassettes, the Cobas t 711 (Roche), is presented. 12 Resuspension of lyophilized reagent cassettes is automated and more accurate than manual resuspension. Finally, in a Letter to the Editor, this issue ends with a validation of the HIL capabilities of the new Atellica COAG 360 coagulation analyzer.…”