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.
Fischer
Florence
F
Département d'Hématologie, CHU, Hôpital de Cimiez, 4 avenue de la Reine Victoria, BP 1179, F-06003 Nice Cedex, France.
Appert-Flory
Anny
A
Jambou
Didier
D
Toulon
Pierre
P
D001780:Blood Coagulation Tests / Q000295:instrumentation* / Q000379:methods*; D005069:Evaluation Studies as Topic; D006801:Humans; D015203:Reproducibility of Results