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Choi, Song, Park, Choi, and Song: Evaluation of an Automated Coagulation Analyzer Coapresta 2000

Abstract

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.

Figures and Tables

Fig. 1
Correlation of the test results between ACL-TOP and CP 2000 analyzers for 8 coagulation test items.
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Fig. 2
Bias of the test results between ACL-TOP and CP 2000 analyzers for 8 coagulation test items.
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Table 1
Reagents and calibrators used in this study for comparison of two coagulation analyzers
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Table 2
Intra-assay & inter-assay precisions of the CP 2000 analyzer
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Table 3
Comparison of the results of coagulation tests performed on the ACL-TOP and the CP 2000 analyzers
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Results are expressed as the median values with ranges in parentheses.

Notes

This article is available from http://www.labmedonline.org

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