Abstract Number: PB1876
Meeting: ISTH 2020 Congress
Background: ADAMTS13 activity is a unique marker for thrombotic thrombocytopenic purpura (TTP). Thus, laboratory assays must be especially accurate and precise in the pathological range (below 0.1IU/mL). Additionally, a rapid TTP diagnostic improves patient management and clinical outcomes, which is a challenge with most currently available assays. The automated method presented herein will help the clinician to easily and accurately assess ADAMTS13 activity in 25 minutes.
Aims: To demonstrate the performance characteristics of a rapid and fully quantitative automated ADAMTS13 activity assay suitable for use in routine laboratories.
Methods: The ADAMTS13 activity of 35 samples, including 2 TTP cases and 2 ADAMTS13 depleted plasmas, was assessed using a chromogenic ELISA method and the new automated method employing a lyophilized FRETS-VWF73 Fluorescence-Quenching Substrate on the new automated analyzer.
Results: Calibrators supplied with the assay span the range 0.0-1.01 IU/mL and are traceable to WHO international standard 12/252. Using samples with ADAMTS13 activity above 1.01IU/mL diluted in ADAMTS13 deficient plasma, linearity of the calibration curve within and beyond that range was calculated as >98%. The analytical sensitivity of the assay exhibited a LOB of 0 IU/mL and the LOD at 0.008 IU/mL using the standard assay sample dilution.
Correlation of the automated FRETS assays with the established ELISA assay for 35 samples was linear (r>0.95) with an intercept of < 0.01IU/mL. Samples with an activity above the 1,01IU/mL were diluted with an ADAMTS13 deficient plasma..Using samples with level spanning the measuring range 0.02-1.01IU/mL, imprecision was determined to be < 5%.
Conclusions: This performance evaluation study evidences that the FRETS assay performed on the automated analyzer enables quick and accurate assessment of ADAMTS13 activity levels suitable for use in clinical diagnostic laboratories.
To cite this abstract in AMA style:Llusa M, Griffiths M, Binder NB. Performance Evaluation of a New Fully Automated Fluorogenic ADAMTS13 Activity Assay [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/performance-evaluation-of-a-new-fully-automated-fluorogenic-adamts13-activity-assay/. Accessed October 1, 2023.
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