A pilot study assessing the implementation of 96-well plate-based aggregometry (Optimul) in Australia

Area of Science:

• Hematology
• Clinical Diagnostics
• Platelet Physiology

Background:

• Accurate diagnosis of platelet function disorders is crucial for managing bleeding risks and long-term patient care.
• Current gold standard, light transmission aggregometry (LTA), is time-consuming and inaccessible in many regional centers.
• There is a significant unmet need for accessible platelet function diagnostic services in Australia.

Purpose of the Study:

• To evaluate the feasibility of the 96-well plate-based Optimul assay as a screening tool for platelet function.
• To assess the Optimul assay's applicability in both regional and metropolitan Australian laboratories.
• To determine the agreement between the Optimul assay and LTA in patients with suspected bleeding disorders.

Main Methods:

• The Optimul assay was evaluated at a regional and a tertiary metropolitan hospital in Australia.
• Concentration-response curves were established using healthy volunteers (n=76).
• The Optimul assay was compared with LTA in patients referred for bleeding disorder evaluation.

Main Results:

• Optimul successfully detected anti-platelet effects of various medications, including aspirin, NSAIDs, and clopidogrel.
• A high level of agreement (Cohen's kappa = 0.84) was observed between Optimul and LTA.
• The Optimul assay demonstrated quick performance and simple methodology, requiring no specialized training.

Conclusions:

• The Optimul assay is a feasible and reliable screening tool for assessing platelet function.
• Its simplicity and accessibility can significantly improve diagnostic equity, particularly in underserved regional areas.
• Widespread implementation of Optimul could enhance peri-operative bleeding management and long-term treatment strategies for platelet bleeding disorders.