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Evaluation of a von Willebrand factor three test panel and chemiluminescent-based assay system for identification of, and therapy monitoring in, von Willebrand disease.
Thromb Res 2016; 141:202-11TR

Abstract

von Willebrand disease (VWD) is reportedly the most common bleeding disorder and arises from deficiency and/or defects of von Willebrand factor (VWF). Laboratory diagnosis and typing of VWD has important management implications and requires a wide range of tests, including VWF antigen (VWF:Ag) and various activities, involving differential identification of qualitative vs quantitative VWF defects. We have assessed a new hemostasis instrument, the chemiluminescent assay based ACL AcuStar™, and an associated HemosIL AcuStar three test panel comprising VWF:Ag, VWF ristocetin cofactor (VWF:RCo) and VWF collagen binding (VWF:CB) (Instrumentation Laboratory, Bedford, Ma. USA) for ability to identify VWD, to help provisionally type VWD, and for potential use in therapy monitoring. This test system was compared to previously evaluated and validated test systems including VWF:RCo on CS-5100 and BCS analyzers, the new Siemens INNOVANCE assay (VWF Ac) on CS-5100, and VWF:Ag and VWF:CB assays performed by automated ELISA. We employed a large total sample test set (n=535) comprising plasma and platelet-lysate samples from individuals with and without VWD, some on treatment, normal plasmas, and normal and pathological controls. We also evaluated desmopressin (DDAVP) responsiveness, plus differential sensitivity to reduction in high molecular weight (HMW) VWF. The chemiluminescent test panel (VWF:Ag, VWF:RCo, VWF:CB) showed good comparability to similar assays performed by alternate methods, and broadly similar data for identification of VWD, provisional VWD type identification, DDAVP and VWD therapy, and HMW VWF sensitivity, although some notable differences were evident. The chemiluminescent system showed best low level VWF sensitivity, and lowest inter-assay variability, compared to all other systems. In conclusion, we have validated theACL AcuStar and the chemiluminescent HemosIL AcuStar VWF test panel for use in VWD diagnostics, and have identified some favorable characteristics that may improve the future diagnosis of VWD.

Authors+Show Affiliations

Department of Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), Sydney Centres for Thrombosis and Haemostasis, Pathology West, NSW Health Pathology, Westmead Hospital, Westmead, NSW, Australia. Electronic address: emmanuel.favaloro@health.nsw.gov.au.Department of Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), Sydney Centres for Thrombosis and Haemostasis, Pathology West, NSW Health Pathology, Westmead Hospital, Westmead, NSW, Australia.

Pub Type(s)

Evaluation Studies
Journal Article

Language

eng

PubMed ID

26743192

Citation

Favaloro, Emmanuel J., and Soma Mohammed. "Evaluation of a Von Willebrand Factor Three Test Panel and Chemiluminescent-based Assay System for Identification Of, and Therapy Monitoring In, Von Willebrand Disease." Thrombosis Research, vol. 141, 2016, pp. 202-11.
Favaloro EJ, Mohammed S. Evaluation of a von Willebrand factor three test panel and chemiluminescent-based assay system for identification of, and therapy monitoring in, von Willebrand disease. Thromb Res. 2016;141:202-11.
Favaloro, E. J., & Mohammed, S. (2016). Evaluation of a von Willebrand factor three test panel and chemiluminescent-based assay system for identification of, and therapy monitoring in, von Willebrand disease. Thrombosis Research, 141, pp. 202-11. doi:10.1016/j.thromres.2015.12.010.
Favaloro EJ, Mohammed S. Evaluation of a Von Willebrand Factor Three Test Panel and Chemiluminescent-based Assay System for Identification Of, and Therapy Monitoring In, Von Willebrand Disease. Thromb Res. 2016;141:202-11. PubMed PMID: 26743192.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of a von Willebrand factor three test panel and chemiluminescent-based assay system for identification of, and therapy monitoring in, von Willebrand disease. AU - Favaloro,Emmanuel J, AU - Mohammed,Soma, Y1 - 2015/12/17/ PY - 2015/09/10/received PY - 2015/11/06/revised PY - 2015/12/12/accepted PY - 2016/1/9/entrez PY - 2016/1/9/pubmed PY - 2017/4/5/medline KW - AcuStar KW - Chemiluminescence KW - Collagen binding KW - Diagnosis KW - Laboratory testing KW - Ristocetin cofactor KW - VWD KW - VWF KW - von Willebrand disease KW - von Willebrand factor SP - 202 EP - 11 JF - Thrombosis research JO - Thromb. Res. VL - 141 N2 - von Willebrand disease (VWD) is reportedly the most common bleeding disorder and arises from deficiency and/or defects of von Willebrand factor (VWF). Laboratory diagnosis and typing of VWD has important management implications and requires a wide range of tests, including VWF antigen (VWF:Ag) and various activities, involving differential identification of qualitative vs quantitative VWF defects. We have assessed a new hemostasis instrument, the chemiluminescent assay based ACL AcuStar™, and an associated HemosIL AcuStar three test panel comprising VWF:Ag, VWF ristocetin cofactor (VWF:RCo) and VWF collagen binding (VWF:CB) (Instrumentation Laboratory, Bedford, Ma. USA) for ability to identify VWD, to help provisionally type VWD, and for potential use in therapy monitoring. This test system was compared to previously evaluated and validated test systems including VWF:RCo on CS-5100 and BCS analyzers, the new Siemens INNOVANCE assay (VWF Ac) on CS-5100, and VWF:Ag and VWF:CB assays performed by automated ELISA. We employed a large total sample test set (n=535) comprising plasma and platelet-lysate samples from individuals with and without VWD, some on treatment, normal plasmas, and normal and pathological controls. We also evaluated desmopressin (DDAVP) responsiveness, plus differential sensitivity to reduction in high molecular weight (HMW) VWF. The chemiluminescent test panel (VWF:Ag, VWF:RCo, VWF:CB) showed good comparability to similar assays performed by alternate methods, and broadly similar data for identification of VWD, provisional VWD type identification, DDAVP and VWD therapy, and HMW VWF sensitivity, although some notable differences were evident. The chemiluminescent system showed best low level VWF sensitivity, and lowest inter-assay variability, compared to all other systems. In conclusion, we have validated theACL AcuStar and the chemiluminescent HemosIL AcuStar VWF test panel for use in VWD diagnostics, and have identified some favorable characteristics that may improve the future diagnosis of VWD. SN - 1879-2472 UR - https://www.unboundmedicine.com/medline/citation/26743192/Evaluation_of_a_von_Willebrand_factor_three_test_panel_and_chemiluminescent_based_assay_system_for_identification_of_and_therapy_monitoring_in_von_Willebrand_disease_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0049-3848(15)30225-5 DB - PRIME DP - Unbound Medicine ER -