Performance Assessment of Sysmex® CA-104 for Screening Coagulogram Testing

Abstract

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