Main Article Content
Objective: The Sysmex® CA-104 (CA-104) is a new, semi-automated coagulation analyzer which has not yet been evaluated in Thailand. The objective of this study was to evaluate the CA-104 performance for prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) under local laboratory conditions.
Methods: Real patient samples and control materials were used to evaluate CA-104 in terms of precision, reference range, and comparability to the validated Sysmex® CS-2100i analyzer (CS-2100i).
Results: The highest percentages of coefficient of variation of PT and APTT were 1.34 and 1.47 for within-run, and 3.2 and 1.65 for between-run precision studies. Correlation coefficients of PT, APTT, and INR between CA-104 and CS-2100i were 0.97, 0.95, and 0.99, respectively. Mean biases of PT, APTT, and INR of CA-104 compared with those from CS-2100i were low. Most results were within 95% agreement, although a few values at the high levels were not. For INR testing, no specimen required warfarin dose adjustment when using CA-104 instead of CS-2100i.
Conclusion: Performance of CA-104 for screening coagulogram in terms of precision and comparability to CS-2100i was acceptable. However, a few discrepancies in clotting time at high values were observed. Further investigation to identify the cause of this discrepancy is warranted.
Keywords: Sysmex® CA-104, automated analyzer, performance assessment, screening coagulogram
All articles published in the Siriraj Medical Journal (SMJ) are protected by copyright. No material in this journal may be reproduced on any platform including electronic or in print or transmitted by any means, in whole or in part, without the prior written permission of the Editor of the SMJ. Written permission must also be obtained before any part of the SMJ is stored in any retrieval system of any nature.