Evaluation of the automated coagulation analyzer Sysmex® CA-7000

The Sysmex® CA-7000 is a fully automated multiparameter hemostasis analyzer equipped with a photo-optical clot detection unit and a cap-piercing system. It is designed to perform coagulation tests as well as chromogenic and immunologic assays. It was evaluated in a coagulation laboratory of a university hospital with respect to its technical characteristics in the determination of routine coagulation (prothrombin time, activated partial thromboplastin time, fibrinogen and single coagulation factors), chromogenic (antithrombin, and anti-FXa activity) and immunologic assays (von Willebrand factor). The intra-assay and inter-assay coefficients of variation (CV) were below 5% for most parameters both in the normal and in the pathological range (exceptions: intra-assay CV = 5.2% for the fibrinogen and 5.1% for antithrombin in the low range of concentrations; and inter-assay CV = 5.7% and 7.2% for clotting factors V and VII levels in the normal ranges, and in the range from 6.1% to 7.8% for anti-FXa activity). No significant interference could be demonstrated with hemolytic and icteric samples as demonstrated by results similar to those obtained using a mechanical clot detection-based analyzer (STAR). No carryover was detected in alternating measurements of heparinized (1.0 IU/mL unfractionated heparin) and normal plasma samples. The results of the different coagulation, chromogenic and immunologic assays obtained with the CA-7000 analyzer were well correlated with those obtained on the STAR analyzer (r in the range from 0.885 to 0.990). Our results demonstrated that using the CA-7000 analyzer, routine coagulation testing can be performed with satisfactory precision and the same applied to more specialized and specific tests such as single factor activity or antigen concentration.