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A comparative evaluation of a new fully automated assay for von Willebrand factor collagen binding activity to an established method
Author(s) -
Stufano F.,
Baronciani L.,
ManePadros D.,
Cozzi G.,
Faraudo S.,
Peyvandi F.
Publication year - 2018
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1111/hae.13371
Subject(s) - von willebrand factor , von willebrand disease , medicine , immunoassay , ristocetin , chemiluminescence , microbiology and biotechnology , immunology , chromatography , antibody , chemistry , platelet , biology
Laboratory diagnosis of von Willebrand disease ( VWD ) is made by the measurement of von Willebrand factor ( VWF ) protein level and its activities. Current VWF activity tests include ristocetin cofactor and collagen binding ( VWF : CB ) assays. Aim We have undertaken an evaluation of a new fully automated VWF : CB assay relative to an established enzyme‐linked immunosorbent assay ( ELISA ) method. Methods The two analytical systems operate with different detection principles: a chemiluminescent method performed on ACL AcuStar Analyzer (the former) and a colorimetric ELISA by Asserachrom Stago (the latter) (type III collagen from human placenta). The Hemos IL AcuStar VWF : CB assay is a chemiluminescent 2‐step immunoassay that uses magnetic particles coated with a type III collagen triple‐helical peptide. VWF : CB levels were determined in 50 healthy subjects and 100 VWD patients (22 type 1, 73 type 2 and 5 type 3). Results Eleven VWD samples reported VWF : CB values below the lower detection limit of one or both methods. The new method showed a good correlation with the ELISA method ( r > .9, mean bias 3.85 IU / dL ) in both healthy and VWD samples. One of 150 samples gave inconsistent results using the two assays, leading to an uncertain diagnosis of VWD type 1 ( ELISA method) or type 2 MCB (fully automated method). Conclusion The new assay is rapid and simple to use, with its ready‐to‐use reagent cartridges. This VWF : CB assay, in addition to the measurement of VWF :Ag and VWF : RC o made on the same platform, gives additional information for the diagnosis of VWD in both nonspecialized and reference laboratories.