Abstract Number: PB0813
Meeting: ISTH 2022 Congress
Background: Initial evaluation of patients with suspected Von Willebrand Disease (VWD) usually includes the measurement of coagulation factor VIII, VWF antigen (Ag), and VWF activity. For the clinical laboratory it is beneficial if these assays can be performed on the same analyzer. In the U.S.A., a VWF Ag assay is not yet available on the Sysmex CS-2500 System.
Aims: The aim of this study was to establish analytical and clinical performance data of the Siemens Healthineers VWF Ag assay on the SYSMEX CS-2500 system.
Methods: Verification of the reportable range, linearity and the limit of quantification (LOQ) were performed. Reproducibility was tested at three US sites (five days with two runs per day and three replicates per run) using five samples spanning the reportable range. A method comparison to the STA-LIATEST® VWF:Ag on Stago’s STA R MAX system was performed with samples from the intended use population. Reference intervals were determined at three US sites with samples from healthy donors (n=306).
Results: The verified assay reportable range is 4 to 300% of normal. The reproducibility studies demonstrate CVs between 2.03% and 5.96%. The method comparison study shows a good correlation. The reference intervals for blood group O (n= 147 subjects), for blood groups non-O (n=159 subjects) and for both groups combined are comparable to those published for other VWF Ag assays.
Conclusion(s): The Siemens Healthineers vWF Ag assay on the Sysmex CS-2500 analyzer is very precise, has a clinically useful reportable range and shows good comparability to another commercial assay. The assay can thus be used to aid in the diagnosis of VWD.
Disclaimer: Sysmex is a trademark of SYSMEX CORPORATION. The Siemens Healthineers vWF Ag assay is not available for sale in the U.S.A. Product availability may vary from country to country and is subject to varying regulatory requirements.
To cite this abstract in AMA style:Gunnesch C, Boehm-Weigert M, Barten R, Biddle R, Eby C, Francis R, Pipe S, Siegemund A. Performance Evaluation of a VWF Antigen Assay in a Multicenter Study [abstract]. https://abstracts.isth.org/abstract/performance-evaluation-of-a-vwf-antigen-assay-in-a-multicenter-study/. Accessed February 27, 2024.
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