Performance Evaluation and Local International Sensitivity Index Verification Using Automated Coagulation Analyzer Coapresta 2000

ABSTRACT

BACKGROUND: The Coapresta 2000 (CP2000; Seikisui, Japan) system is a fully-automated random-access multiparameter coagulation analyzer equipped with a photo-optical clot detection unit. It can perform clotting time assays as well as colorimetric assays. METHODS: We evaluated the analytical performance of CP2000 for several coagulation test parameters and compared its performance with that of the CA-7000 (Sysmex, Japan) system. Fresh and frozen plasma samples were used to evaluate the performance of CP2000 with respect to four routine coagulation test parameters: prothrombin time (PT), activated partial thromboplastin time, fibrinogen, and D-dimer. On-board stability of the liquid reagents was confirmed. Additionally, local international sensitivity index (ISI) verification was performed with four levels of calibrants and direct PT/international normalized ratio (INR) line. RESULTS: The intra- and inter-assay coefficients of variation were below 5% for every parameter in both normal and pathological ranges. Carryover was not detected. The results obtained using CP2000 showed good correlation (r 2 over 0.95) with those obtained by the CA-7000 analyzer. On-board stability in open-vial state, which was expected to be much longer than that of other reagents, was confirmed. Local verification of ISI showed an acceptable bias range of INR, compared with the values using calibrants. CONCLUSIONS: The high-throughput, CP2000 analyzer is a fast, user-friendly system with long on-board reagent stability. Its results were concordant with the CA-7000 analyzer, for analysis of the routine coagulation test parameters. Furthermore, this system would add greater confidence to the reporting of INR data.