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CC BY-NC-ND 4.0 · Semin Thromb Hemost 2019; 45(03): 308-314
DOI: 10.1055/s-0038-1676578
Review Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

Giuseppe Lippi
1   Section of Clinical Biochemistry, Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy
,
Gian Luca Salvagno
1   Section of Clinical Biochemistry, Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy
,
Matteo Gelati
1   Section of Clinical Biochemistry, Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy
,
Giovanni Poli
1   Section of Clinical Biochemistry, Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy
,
Davide Giavarina
2   Department of Laboratory Medicine, San Bortolo Hospital, Vicenza, Italy
,
Emmanuel J. Favaloro
3   Department of Haematology, Sydney Centres for Thrombosis and Haemostasis, Institute of Clinical Pathology and Medical Research, NSW Health Pathology, Westmead Hospital, Westmead, NSW, Australia
› Author Affiliations
Further Information

Publication History

Publication Date:
30 January 2019 (online)

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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.

Keywords

blood coagulation - hemostasis - diagnosis - laboratory - instrumentation - analyzer
 

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