Development and validation of a new assay for assessing clot integrity

Area of Science:

• Biochemistry
• Hematology
• Medical Diagnostics

Background:

• Traditional clot integrity assessments are time-consuming and expensive.
• Real-time analysis limits batch processing and scalability.
• Hypercoagulability is a key risk factor for cardiovascular events.

Purpose of the Study:

• To develop and validate a micro-titre based assay for quantifying thrombogenesis and fibrinolysis.
• To assess patient risk for cardiovascular events linked to hypercoagulability.
• To compare the novel assay's performance against the thrombelastograph (TEG).

Main Methods:

• The assay quantifies three thrombogenesis indices (lag time, rate of clot formation, maximum clot density) and two fibrinolysis indices (rate of clot dissolution, time for 50% clot lysis).
• Plasma samples were tested fresh, frozen, and after storage at room temperature for up to 24 hours.
• Assay performance was evaluated for intra- and inter-assay variability and compared with TEG.

Main Results:

• The micro-titre assay demonstrated good intra- and inter-assay coefficients of variation (CVs) for all measured indices, with lower variability than TEG.
• The assay showed stability for plasma samples stored at room temperature for up to 6 hours.
• Cost analysis revealed the plate assay is significantly more economical (£2/sample) than TEG (£15/sample).

Conclusions:

• The developed micro-titre assay provides reliable quantification of thrombogenesis and fibrinolysis.
• It offers improved efficiency and cost-effectiveness compared to the traditional TEG method.
• This assay is suitable for assessing hypercoagulability and cardiovascular event risk.