AI Article Synopsis

  • The study aimed to evaluate how well new reference calibrators improve the consistency of anti-β2 glycoprotein I immunoassays used for diagnosing antiphospholipid syndrome (APS) and systemic lupus erythematosus (SLE).
  • Researchers tested different IgG and IgM immunoassays from four manufacturers using serum samples from 269 patients and 162 women with successful pregnancies.
  • Results showed varying sensitivities and specificities for the tests, with good interassay reliability, but the correlation of results with clinical manifestations was influenced by the specific test kit used, indicating that using IgG reference materials enhances these correlations.

Article Abstract

Objectives: To investigate the performance characteristics and impact of newly developed reference calibrators on the commutability between anti-β2 glycoprotein I (anti-β2 GPI) immunoassays in antiphospholipid syndrome (APS) and/or systemic lupus erythematosus (SLE).

Methods: Immunoglobulin G (IgG) and immunoglobulin M (IgM) anti-β2 GPI immunoassays from four manufacturers were evaluated. Serum samples from 269 patients (APS only, n = 31; SLE and APS, n = 83; SLE only, n = 129; pregnancy-related clinical manifestations without APS, n = 26) and 162 women with histories of successful pregnancies were tested. Results were expressed in kit-specific arbitrary units and in the calibrator reference units (RUs) based on 99th percentile cutoff values. Diagnostic accuracies, correlation between kits, and specific clinical manifestations in APS were investigated.

Results: The sensitivities of the assays ranged from 15.8% to 27.2% (IgG) and 12.3% to 15.8% (IgM) while specificities ranged from 79.4% to 86.5% (IgG) and 80.6% to 84.5% (IgM). There was moderate to almost perfect interassay reliability (Cohen κ, 0.69-0.98), and Spearman correlation coefficients were generally improved when results of the IgG determinations were expressed in RUs.

Conclusions: Although qualitative agreements between immunoassays for both antibody isotypes are acceptable, correlations with APS clinical manifestations were kit dependent. Only the use of IgG reference material improved quantitative correlations between assays.

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Source
http://dx.doi.org/10.1093/ajcp/aqw065DOI Listing

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