An evaluation of four automated coagulation instruments

Area of Science:

• Clinical Chemistry
• Hematology
• Medical Device Evaluation

Background:

• Accurate measurement of prothrombin time (PT) and activated partial thromboplastin time (APTT) is crucial for hemostasis monitoring.
• Automated analyzers offer potential for improved efficiency and standardization in coagulation testing.

Purpose of the Study:

• To evaluate and compare the performance of four automated coagulation instruments: Dade Auto-Fi, General Diagnostics Dual Channel Coag-a-Mate, MLA Electra 600D, and Sherwood Lancer Coagulyzer.
• To assess key performance metrics including accuracy, reproducibility, cost, user acceptance, and computer interfacing.

Main Methods:

• Comparative performance evaluation of four automated coagulation analyzers.
• Statistical analysis of prothrombin time and activated partial thromboplastin time results.
• Assessment of instrument costs, disposable supply expenses, technician feedback, and computer compatibility.

Main Results:

• Minor statistical differences were observed in PT and APTT values across instruments.
• Reproducibility was equivalent on all instruments except the Coag-a-Mate, which had a correctable alignment issue.
• Significant variations were noted in purchase price, disposable costs, technician preference (favoring Sherwood and MLA), and computer interfacing capabilities.
• The Dade instrument yielded longer coagulation times with specific reagents.

Conclusions:

• All evaluated automated coagulation instruments demonstrate generally comparable performance for PT and APTT testing.
• Significant differences in cost, user-friendliness, and technical integration necessitate careful consideration during instrument selection.
• The MLA and Sherwood instruments present favorable options regarding cost and technician acceptance.