Total Laboratory Automation of Routine Hemostasis Testing

Area of Science:

• Clinical diagnostics
• Laboratory automation
• Hemostasis testing

Background:

• Preanalytical sample management is crucial for reliable laboratory results.
• Total laboratory automation systems offer potential efficiency gains in clinical laboratories.
• Assessing the impact of automation on hemostasis test accuracy is essential.

Purpose of the Study:

• To evaluate if preanalytical sample handling via an open total laboratory automation system affects routine hemostasis test reliability.
• To compare results from samples processed through a track-line system versus direct loading into a coagulation analyzer.

Main Methods:

• Forty inpatient samples were split into two groups.
• One group was directly loaded into a hemostasis analyzer after centrifugation.
• The other group was processed through a 16.5m track-line system (FlexLab) for automated centrifugation and analysis.

Main Results:

• Statistically significant differences were observed for prothrombin time (PT) and activated partial thromboplastin time (aPTT) between the two methods.
• No significant difference was found for fibrinogen levels.
• The mean percentage bias for PT, aPTT, and fibrinogen was modest and below the total allowable error, indicating no clinical significance.

Conclusions:

• Connecting coagulation analyzers to track-line systems is a feasible approach for contemporary clinical laboratories.
• Total laboratory automation does not compromise the clinical validity of routine hemostasis testing.
• The study supports the integration of automation for enhanced laboratory efficiency without sacrificing diagnostic accuracy.