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

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.

Performance Evaluation of the Automated Coagulation Analyzer Coapresta 2000 / 임상검사와정도관리

BACKGROUND: The Coapresta 2000 (Sekisui Medical Co., Japan) is a newly developed, fully automated coagulation analyzer that can perform clotting time assays using the synthetic substrate method and the latex turbidimetric method. In this study, we evaluated the analytical performance of the Coapresta 2000 for measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT), and compared the results to those of the CA-7000 (Sysmex Co., Japan) and ACL-9000 (Instrumentation Laboratory, USA) analyzers. METHODS: The Coapresta 2000 was evaluated for its precision at measuring PT and aPTT in fresh normal plasma and fresh abnormal plasma. Three hundred venous blood specimens were collected in 3.2% sodium citrate tubes, and PT and aPTT results were compared among the Coapresta 2000, ACL-9000, and CA-7000 analyzers. RESULTS: The coefficients of variation of both intra- and inter-assays for the Coapresta 2000 were <5% for PT and aPTT in the normal and pathological ranges. The results obtained using the Coapresta 2000 analyzer correlated well with those obtained using the ACL-9000 analyzer (r in the range of 0.9799-0.9886) except for aPTT (r=0.7626) and with those obtained using the CA-7000 analyzer (r in the range of 0.8258 - 0.9735). CONCLUSIONS: The Coapresta 2000 provided satisfactory precision, and the results obtained correlated well with those obtained using the existing CA-7000 and ACL-9000 coagulation analyzers. We conclude that the Coapresta 2000 would be a useful analyzer for routine coagulation tests.

Evaluation of an Automated Coagulation Analyzer Coapresta 2000

BACKGROUND: The Coapresta 2000 (Sekisui Medical CO., LTD, Japan) is a fully automated random-access multiparameter hemostasis coagulation analyzer, which is equipped with a photo-optical clot detection unit and a cap-piercing system. It is able to perform clotting time assays as well as colorimetric assays (synthetic substrate method and latex turbidimetric method). In this study, we evaluated the analytical performance of the Coapresta 2000 for coagulation test items and compared with that of the ACL-TOP (Instrumentation Laboratory, Lexingtion, MA, USA) analyzer, which is currently used for routine coagulation test items in our hospital. METHODS: The Coapresta 2000 was evaluated with respect to its technical characteristics in the determination of 8 routine coagulation test items: prothrombin time, activated partial thromboplastin time, fibrinogen, fibrin-degradation product (FDP) antithrombin III, D-dimer, factors VIII and IX. Analyse-it (Analyse-it Software Ltd, UK) and SigmaStat (Systat Software, Inc., USA) were used for statistical analysis between items on the Coapresta 2000 and the ACL-TOP analyzer. RESULTS: The intra-assay and inter-assay coefficients of variation (CV) were below 5% for both groups of samples having values within the reference interval and outside the reference interval. Significant interference was observed with hemolytic and icteric samples. Carryover was not detected. The results obtained by Coapresta 2000 were well correlated with those obtained by the ACL-TOP analyzer (r2 in the range from 0.781 to 0.969). CONCLUSIONS: We concluded that Coapresta 2000 analyzer was well correlated with ACL-TOP analyzer for the routine coagulation test items tested.