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Performance Evaluation and Local International Sensitivity Index Verification Using Automated Coagulation Analyzer Coapresta 2000
J Lab Med Qual Assur 2018;40:38-45
Published online March 31, 2018
© 2018 Korean Association of External Quality Assessment Service.

Ji Yeon Ham and Jang Soo Suh

Department of Clinical Pathology, School of Medicine, Kyungpook National University, Daegu, Korea
Correspondence to: Jang Soo Suh
Department of Clinical Pathology, School of Medicine, Kyungpook National University, 680 Gukchaebosang-ro, Jung-gu, Daegu 41944, Korea
Tel: +82-53-200-5293
Fax: +82-53-200-3367
E-mail: suhjs@knu.ac.kr
Received October 12, 2017; Revised January 15, 2018; Accepted January 18, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
 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.
Keywords : Coapresta 2000, Coagulation test, Local international sensitivity index verification, Direct prothrombin time/international normalized ratio line
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