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

Giuseppe Lippi; Gian Luca Salvagno; Matteo Gelati; Giovanni Poli; Davide Giavarina; Emmanuel J. Favaloro

doi:10.1055/s-0038-1676578

Seminars in Thrombosis and Hemostasis, Inhaltsverzeichnis

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

¹Section of Clinical Biochemistry, Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy

,

Gian Luca Salvagno

¹Section of Clinical Biochemistry, Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy

,

Matteo Gelati

¹Section of Clinical Biochemistry, Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy

,

Giovanni Poli

¹Section of Clinical Biochemistry, Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy

,

Davide Giavarina

²Department of Laboratory Medicine, San Bortolo Hospital, Vicenza, Italy

,

Emmanuel J. Favaloro

³Department of Haematology, Sydney Centres for Thrombosis and Haemostasis, Institute of Clinical Pathology and Medical Research, NSW Health Pathology, Westmead Hospital, Westmead, NSW, Australia

› Institutsangaben

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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Referenzen

References
1 Lippi G, Favaloro EJ. Laboratory hemostasis: from biology to the bench. Clin Chem Lab Med 2018; 56 (07) 1035-1045
2 Bonar RA, Lippi G, Favaloro EJ. Overview of hemostasis and thrombosis and contribution of laboratory testing to diagnosis and management of hemostasis and thrombosis disorders. Methods Mol Biol 2017; 1646: 3-27
3 Lippi G, Favaloro EJ. Venous and arterial thromboses: two sides of the same coin?. Semin Thromb Hemost 2018; 44 (03) 239-248
4 Bennett ST, Lehman CM, Rodgers GM. Laboratory Hemostasis: A Practical Guide for Pathologists, 2nd ed. New York, NY: Springer Nature; 2014
5 Lippi G, Franchini M, Favaloro EJ. Diagnostics of inherited bleeding disorders of secondary hemostasis: an easy guide for routine clinical laboratories. Semin Thromb Hemost 2016; 42 (05) 471-477
6 Lippi G, Pasalic L, Favaloro EJ. Detection of mild inherited disorders of blood coagulation: current options and personal recommendations. Expert Rev Hematol 2015; 8 (04) 527-542
7 Zantek ND, Hayward CP, Simcox TG, Smock KJ, Hsu P, Van Cott EM. An assessment of the state of current practice in coagulation laboratories. Am J Clin Pathol 2016; 146 (03) 378-383
8 Lippi G, Bovo C, Favaloro EJ. Reflections on the next generation of hemostasis instrumentation. A glimpse into the future?. J Lab Med 2016; 40: 1-7
9 Lippi G, Plebani M, Favaloro EJ. The changing face of hemostasis testing in modern laboratories: consolidation, automation, and beyond. Semin Thromb Hemost 2015; 41 (03) 294-299
10 Lippi G, Plebani M, Favaloro EJ. Technological advances in the hemostasis laboratory. Semin Thromb Hemost 2014; 40 (02) 178-185
11 Lippi G, Lima-Oliveira G, Brocco G, Bassi A, Salvagno GL. Estimating the intra- and inter-individual imprecision of manual pipetting. Clin Chem Lab Med 2017; 55 (07) 962-966
12 Lippi G, Plebani M, Favaloro EJ. Interference in coagulation testing: focus on spurious hemolysis, icterus, and lipemia. Semin Thromb Hemost 2013; 39 (03) 258-266
13 Milos M, Herak D, Kuric L, Horvat I, Zadro R. Evaluation and performance characteristics of the coagulation system: ACL TOP analyzer - HemosIL reagents. Int J Lab Hematol 2009; 31 (01) 26-35
14 Su HT, Whelchel KL, Sonnek MJ. , et al. Laboratory evaluation of the STA Satellite Benchtop coagulation instrument. Lab Med 2013; 44: 156-162
15 Favaloro EJ, Lippi G. On the complexity of hemostasis and the need for harmonization of test practice. Clin Chem Lab Med 2018; 56 (10) 1568-1574
16 Favaloro EJ, Gosselin R, Olson J, Jennings I, Lippi G. Recent initiatives in harmonization of hemostasis practice. Clin Chem Lab Med 2018; 56 (10) 1608-1619
17 Lippi G, Favaloro EJ. Hemostasis practice: state-of-the-art. J Lab Precis Med 2018; 3: 67