Comparison of a new automated von Willebrand factor activity assay with an aggregation von Willebrand ristocetin cofactor activity assay for the diagnosis of von Willebrand disease

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  • KDKatrien Devreese
    Katrien Devreese
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Abstract
Von Willebrand disease (VWD) is caused by quantitative and/or qualitative defects of von Willebrand factor (VWF). The HemosIL von Willebrand Factor Activity assay, a new automated immunological test to measure VWF activity, was implemented on STAC and compared with the von Willebrand ristocetin cofactor activity (VWF:RCo) aggregation method. Imprecision and dilution studies were also performed. Within-run imprecision was 17.2% and between-run imprecision was 8.3% (coefficients of variation). Dilution studies showed a linearity between 12.5 and 100%. Passing and Bablok regression comparing the HemosIL von Willebrand Factor Activity assay and the aggregation method yielded a slope of 1.25 (95% confidence interval: 1.11-1.38) and intercept of -1.40 (95% confidence interval: -8.07 to 0.00). The correlation coefficient was 0.84 (95% confidence interval: 0.78-0.89). With a cut-off value of 50% for VWF activity, the assay has a sensitivity of 94.1% and a specificity of 92.8%, compared with the VWF:RCo aggregation assay with a cut-off value of 60% producing a sensitivity of 100.0% (specificity 87.6%). With a cut-off value of 60%, the HemosIL von Willebrand Factor Activity assay on STAC is a reliable assay for VWD. VWF:RCo or other functional testing is still required to confirm the diagnosis and for further classification of VWD.

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