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

  • Sina Stephan , Herbert Schwarz , Anja Haude-Barten , Johannes J. Sidelmann , Bodo Fischer , Harald Althaus , Martin Hahn , Andreas Kappel , Matthias Ehm and Frank Vitzthum EMAIL logo
Published/Copyright: June 13, 2011
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Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 49 Issue 7

Abstract

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
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: 2010-11-1
Accepted: 2011-3-9
Published Online: 2011-06-13
Published in Print: 2011-07-01

©2011 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/CCLM.2011.199
Keywords for this article
chromogenic activity test; factor VII-activating protease; immunoassay; Marburg I polymorphism

Articles in the same Issue

  1. Editorial
  2. Method comparison: where do we draw the line?
  3. Review
  4. Current role of liquid chromatography coupled to mass spectrometry in clinical toxicology screening methods
  5. Minireview
  6. Molecular diagnostics for pharmacogenomic testing of fluoropyrimidine based-therapy: costs, methods and applications
  7. Opinion Paper
  8. Preanalytical quality improvement: from dream to reality
  9. Point
  10. Towards more complete specifications for acceptable analytical performance – a plea for error grid analysis
  11. Counterpoint
  12. Closing the brain-to-brain loop in laboratory testing
  13. General Clinical Chemistry and Laboratory Medicine
  14. Harmonization of growth hormone measurements with different immunoassays by data adjustment
  15. Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications
  16. High-throughput LC-MS/MS method for monitoring sirolimus and everolimus in the routine clinical laboratory
  17. Performance of the Roche Total Mycophenolic Acid® assay on the Cobas Integra 400®, Cobas 6000® and comparison to LC-MS/MS in liver transplant patients
  18. Diagnostic efficiency of truncated area under the curve from 0 to 2 h (AUC0–2) of mycophenolic acid in kidney transplant recipients receiving mycophenolate mofetil and concomitant tacrolimus
  19. Good performance of an immunoassay based method for nevirapine measurements in human breast milk
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  22. Granularity Index of the SYSMEX XE-5000 hematology analyzer as a replacement for manual microscopy of toxic granulation neutrophils in patients with inflammatory diseases
  23. Direct chromogenic substrate immuno-capture activity assay for testing of factor VII-activating protease
  24. The antinuclear antibody assay: developing criteria for reflexive anti-dsDNA antibody testing in a laboratory setting
  25. A simple liquid chromatography-tandem mass spectrometry method for measuring metanephrine and normetanephrine in urine
  26. Monoclonal gammopathy missed by capillary zone electrophoresis
  27. Adaptation of the Diazyme Direct Enzymatic HbA1c Assay for a microplate reader at room temperature
  28. Validation and Outcome Studies
  29. Laboratory assessment of iron status in pregnancy
  30. Cardiovascular Diseases
  31. Blood cells characteristics as determinants of acute myocardial infarction
  32. No evidence for an association between the rs2824292 variant at chromosome 21q21 and ventricular fibrillation during acute myocardial infarction in a German population
  33. Letters to the Editor
  34. Letter to the Editor Reply: Statistical methods for assessment of added usefulness of new biomarkers
  35. Reply to Vavrova et al. Clin Chem Lab Med 2011;49:89–92
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