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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter

IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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Volume 49, Issue 7


Direct chromogenic substrate immuno-capture activity assay for testing of factor VII-activating protease

Sina Stephan / Herbert Schwarz / Anja Haude-Barten / Johannes J. Sidelmann
  • Department for Thrombosis Research, Institute of Public Health, University of Southern Denmark, Esbjerg, Denmark
  • Other articles by this author:
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/ Bodo Fischer / Harald Althaus / Martin Hahn / Andreas Kappel / Matthias Ehm / Frank Vitzthum
Published Online: 2011-06-13 | DOI: https://doi.org/10.1515/CCLM.2011.199


Background: The Marburg I (MRI) single nucleotide polymorphism (SNP) of the factor VII-activating protease (FSAP) gene has been associated with thrombophilia and atherosclerotic disease. PCR is used to detect the SNP. Also, the specific FSAP activity to cleave single-chain urokinase-type plasminogen activator (scu-PA) serves as a surrogate for PCR testing. Development of further assays is indicated in order to increase testing opportunities for future studies.

Methods: A direct chromogenic substrate immuno-capture activity assay for FSAP (FSAP dcs activity assay) was established. Performance characteristics of the FSAP dcs activity assay were compared to the FSAP scu-PA activity assay.

Results: The FSAP dcs activity assay detects FSAP activity from 25% to 150% of the norm. Total CVs ranged from 6% to 10% for FSAP wild type samples and 9%–18% for MRI samples. Correlation between the FSAP dcs and scu-PA activity assays was low (R=0.7). The FSAP dcs activity determined the presence of the MRI FSAP alloenzyme with a diagnostic sensitivity and specificity of 100% [95% confidence interval (CI): 89.6%–100%] and 96.2% (95% CI: 93.2%–97.4%), respectively, whereas the specific FSAP dcs activity increased specificity to 99.0% (95% CI: 97.2%–99.6%).

Conclusions: The specific FSAP dcs activity represents a reliable method for the detection of the FSAP MRI alloenzyme. Due to the limited correlation between the FSAP dcs and scu-PA activity assays, these different measurands may exhibit different utility in research and clinical applications. Thus, the FSAP dcs activity assay can represent a valuable complement or alternative for FSAP testing in future studies.

Keywords: chromogenic activity test; factor VII-activating protease; immunoassay; Marburg I polymorphism

About the article

Corresponding author: Frank Vitzthum, Siemens Healthcare Diagnostics Products GmbH, Pre-Development, P.O. Box 1149, D-35001 Marburg, Germany Fax: +49 6421 39 3144

Received: 2010-11-01

Accepted: 2011-03-09

Published Online: 2011-06-13

Published in Print: 2011-07-01

Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 49, Issue 7, Pages 1199–1204, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2011.199.

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