Evaluation of the automated coagulation analyzer Sysmex CA-7000

Area of Science:

• Clinical Chemistry
• Hematology
• Laboratory Medicine

Background:

• Hemostasis testing is crucial for diagnosing and managing bleeding and thrombotic disorders.
• Automated analyzers improve efficiency and accuracy in clinical laboratories.

Purpose of the Study:

• To evaluate the technical performance of the Sysmex CA-7000, a fully automated multiparameter hemostasis analyzer.
• Assess its accuracy and precision for routine coagulation, chromogenic, and immunologic assays.

Main Methods:

• The Sysmex CA-7000 was evaluated in a university hospital coagulation laboratory.
• Technical characteristics were assessed for prothrombin time, activated partial thromboplastin time, fibrinogen, coagulation factors, antithrombin, anti-FXa activity, and von Willebrand factor.
• Interference, carryover, and correlation with a mechanical clot detection analyzer (STAR) were investigated.

Main Results:

• Intra-assay and inter-assay coefficients of variation (CV) were generally below 5% for most parameters.
• No significant interference was observed with hemolytic or icteric samples.
• Excellent correlation (r=0.885-0.990) was found between the CA-7000 and the STAR analyzer.
• No carryover was detected between heparinized and normal plasma samples.

Conclusions:

• The Sysmex CA-7000 analyzer demonstrates satisfactory precision for routine coagulation testing.
• It is also suitable for specialized tests like single factor activity and antigen concentration.
• The analyzer provides reliable results comparable to established methods.