Comparative analysis of different enzyme immunoassays for assessment of phosphatidylserine-dependent antiprothrombin antibodies

Rheumatol Int. 2014 Sep;34(9):1225-30. doi: 10.1007/s00296-014-2951-0. Epub 2014 Feb 5.

Abstract

Phosphatidylserine-dependent antiprothrombin antibodies (aPS/PT) were strongly correlated with the presence of lupus anticoagulant showing a high specificity for the diagnosis of antiphospholipid syndrome. However, the main criticism for the clinical applicability of aPS/PT testing is the lack of reproducibility of the results among laboratories. In this study, we measured IgG and IgM aPS/PT using our original in-house enzyme-linked immunosorbent assays (ELISA) and commercial ELISA kits to assess the assay performance and to evaluate the accuracy of aPS/PT results. The study included 111 plasma samples collected from patients and stored at our laboratory for aPS/PT assessment. Sixty-one samples were tested for IgG aPS/PT using two assays: (1) aPS/PT in-house ELISA and (2) QUANTA Lite™ aPS/PT IgG ELISA kit (INOVA Diagnostics, Inc., USA). Fifty samples were evaluated for IgM aPS/PT using two assays: (1) aPS/PT in-house ELISA and (2) QUANTA Lite™ aPS/PT IgM ELISA kit (INOVA Diagnostics). Ninety-eight percent of samples yielded concordant results for IgG aPS/PT and 82 % for IgM aPS/PT. There was an excellent agreement between the IgG aPS/PT assays (Cohen κ = 0.962) and moderate agreement between the IgM aPS/PT assays (κ = 0.597). Statistically significant correlations in the aPS/PT results were obtained from both IgG and IgM aPS/PT assays (r = 0.749, r = 0.622, p < 0.001, respectively). In conclusion, IgG and IgM detection by ELISA is accurate. The performance of aPS/PT is reliable, and concordant results can be obtained using different ELISA methods.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Antiphospholipid / blood*
  • Antiphospholipid Syndrome / blood
  • Antiphospholipid Syndrome / diagnosis*
  • Antiphospholipid Syndrome / immunology
  • Biomarkers / blood
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Enzyme-Linked Immunosorbent Assay / standards
  • Female
  • Humans
  • Immunoglobulin G / blood*
  • Immunoglobulin M / blood*
  • Male
  • Middle Aged
  • Observer Variation
  • Phosphatidylserines / immunology*
  • Predictive Value of Tests
  • Prothrombin / immunology*
  • Quality Control
  • Reagent Kits, Diagnostic
  • Reproducibility of Results
  • Young Adult

Substances

  • Antibodies, Antiphospholipid
  • Biomarkers
  • Immunoglobulin G
  • Immunoglobulin M
  • Phosphatidylserines
  • Reagent Kits, Diagnostic
  • Prothrombin