Evaluation of the automated coagulation analyzer Sysmex CA-7000.
BACKGROUND
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.


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 micromol/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.
Dorn-Beineke
Alexandra
A
Institute for Clinical Chemistry, Faculty for Clinical Medicine Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, Mannheim 68167, Germany. alexandra.dorn-beineke@ikc.ma.uni-heidelberg.de
Dempfle
Carl-Erik
CE
Bertsch
Thomas
T
Wisser
Herrmann
H
D000990:Antithrombin III / Q000032:analysis; D001331:Automation; D001780:Blood Coagulation Tests / Q000295:instrumentation* / Q000379:methods / Q000592:standards; D005340:Fibrinogen; D006801:Humans; D019934:International Normalized Ratio; D010314:Partial Thromboplastin Time; D011517:Prothrombin Time; D015203:Reproducibility of Results
D000990:Antithrombin III; D005340:Fibrinogen