Multiple centre evaluation study of ADAMTS13 activity and inhibitor assays

Area of Science:

• Clinical Chemistry
• Hematology
• Diagnostic Assays

Background:

• Accurate ADAMTS13 activity evaluation is crucial for diagnosing and managing thrombotic microangiopathies.
• Commercial kits are available for routine laboratory assessment of ADAMTS13 activity.

Purpose of the Study:

• To compare Technoclone activity and Inhibitor kits with specialist reference methods.
• To assess the impact of transporting frozen samples on assay results.
• To evaluate the reliability of commercial kits for diagnosing thrombotic microangiopathies.

Main Methods:

• Multicenter study comparing Technoclone kits with FRETS and ELISA IgG reference methods.
• Investigation of frozen sample transport effects on assay performance.
• Analysis of commercial kit performance and potential diagnostic implications.

Main Results:

• Observed differences in Technoclone activity results compared to specialist testing, potentially affecting diagnosis.
• A change in the commercial kit during the study period improved detection levels.
• Frozen sample transportation yielded comparable results across different sites.

Conclusions:

• Commercial kits are suitable for clinical diagnosis of thrombotic microangiopathies when normal ranges are carefully considered.
• Frozen sample transportation between sites is a viable method.
• A strong external quality control system is vital for independent evaluation of kit production changes.