Abstract
Introduction Centralization of laboratory diagnostics and an increasing number of urgent requests and nonstandard samples raise the need for short turn-around times and high-throughput analyzers for coagulation tests. The aim of the present study was to evaluate the analytical and technical performance of the Sysmex® CA-7000 coagulation analyzer under routine laboratory conditions. Materials and methods We evaluated the Sysmex® CA-7000 in comparison to the Sysmex® CA-6000 analyzer for PT, INR, aPTT, Clauss, and derived fibrinogen. We also compared antithrombin (AT) measured on the Sysmex® CA-7000 and Dimension® RxL. Imprecision studies were performed, and throughput, online, and STAT functions and the handling of routine samples were evaluated. Results The Sysmex® CA-7000 showed very low intra-assay and interassay variability for all parameters. The method comparison study showed good comparability to the Sysmex® CA-6000 and Dimension® RxL. The throughput of the Sysmex® CA-7000 was 2.5–3 times faster than that of Sysmex® CA-6000. No interference was seen for total bilirubin up to 710 μmol/L. Triglyceride levels >11.4 mmol/L resulted in invalid PT measurements and levels >3.42 mmol/L gave invalid results for Clauss fibrinogen on the CA-7000 analyzer. Conclusions This is the first published evaluation of the analytical and technical performance of the coagulation analyzer Sysmex® CA-7000. We conclude that the CA-7000 is well suited for coagulation laboratories with high sample throughput and a high number of nonstandard samples.
Published Version
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