Multicentre Evaluation of IL Test™ Free PS: A Fully Automated Assay to Quantify Free Protein S

Josep Serra; Miquel Sales; Andrew Chitolie; Pere Domènech; Edoardo Rossi; Montserrat Borrell; Björn Dahlbäck

doi:10.1055/s-0037-1613343

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2002; 88(06): 975-983
DOI: 10.1055/s-0037-1613343

Involvement of Thrombin Receptors in the Subject-dependent Variability in Ca2+ Signal Generation

Schattauer GmbH

Multicentre Evaluation of IL Test™ Free PS: A Fully Automated Assay to Quantify Free Protein S

Josep Serra

¹Biokit S. A. Lliçàd’Amunt, Barcelona, Spain

,

Miquel Sales

¹Biokit S. A. Lliçàd’Amunt, Barcelona, Spain

,

Andrew Chitolie

²Department of Haematology, St George’s Hospital, London U. K

³University College Hospitals, London U. K

,

Pere Domènech

⁴Hospital de Bellvitge, CSUB, Barcelona, Spain

,

Edoardo Rossi

⁵CT Ospedale “L Sacco”, Milano, Italy

,

Montserrat Borrell

⁶Hospital de la Santa Creu i San Pau, Barcelona, Spain

,

Björn Dahlbäck

⁷Lund University, University Hospital, Malmö, Sweden

› Institutsangaben

Abstract

Summary

Deficiency of the anticoagulant vitamin K-dependent protein S (PS) is associated with increased risk of venous thrombosis. In human plasma, PS circulates in two forms: as free protein (free PS) and PS bound to C4b-binding protein (C4BP), a regulator of the complement system. Assays for free PS have higher sensitivity and specificity for protein S deficiency than assays for total protein S. We have extensively evaluated the analytical performance of a novel assay for free PS, the IL Test™ Free Protein S, which takes advantage of the affinity of C4BP for free PS, and compared its performance to existing methods. IL Test™ Free Protein S is a rapid, fully automated turbidimetric assay consisting of two reagents: a C4BP coated latex and an anti-PS monoclonal antibody coated latex. The test range, precision and linearity were adequate and the assay tolerated high concentrations of interfering substances of clinical significance. The reference range agreed with previously published studies. The analysis of 903 patient samples belonging to 20 different clinical categories with the new assay yielded free PS results that agreed well with those obtained using the assays established in the participating laboratories. The study demonstrated the IL Test™ Free Protein S to be rapid, reliable and easy to perform.

Keywords

Protein S - coagulation inhibitors - thrombosis - thrombophilia

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Referenzen

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