Analytical performance evaluation of Sysmex CS-2500 and Stago STA Compact

Area of Science:

• Clinical diagnostics
• Biomedical engineering
• Laboratory medicine

Background:

• Coagulation testing is crucial for diagnosing and managing bleeding disorders.
• Automated analyzers improve efficiency and accuracy in clinical laboratories.
• The Sysmex Coagulation System-2500 (CS-2500) is a new fully automated analyzer utilizing optical detection.

Purpose of the Study:

• To evaluate the performance characteristics of the CS-2500 analyzer.
• To assess the accuracy and precision of PT and aPTT measurements.
• To compare the CS-2500 with an existing coagulometer (STA-Compact).

Main Methods:

• Performance evaluation of the CS-2500 for prothrombin time (PT) and activated partial thromboplastin time (aPTT).
• Precision, accuracy, and reference range verification studies were conducted.
• Method comparison using Passing-Bablok regression analysis against the STA-Compact analyzer.

Main Results:

• Excellent precision was observed, with coefficient of variation < 3.5% for PT-INR and aPTT.
• Good agreement between CS-2500 and STA-Compact for PT-INR (r=0.962) and aPTT (r=0.944).
• Bias was < 9.9% in accuracy studies, and manufacturer reference ranges were acceptable.

Conclusions:

• The CS-2500 demonstrates acceptable performance for PT and aPTT testing.
• Minor discrepancies between analyzers were noted, highlighting the need for standardization.
• Further studies are recommended to harmonize results across different coagulation systems.