Performance of two new, automated chemiluminescence assay panels for anticardiolipin and anti‐beta2‐glycoprotein I antibodies in the laboratory diagnosis of the antiphospholipid syndrome

Abstract

Diagnostic performances of both Zenit RA and HemosIL Acustar were comparable with odds ratios lower limits of CI of 5 for aβ2 GPI IgG for Zenit and Acustar and 6 and 5 for aCl IgG on Zenit and Acustar, respectively. However, even with these new automated systems, titres differed largely between systems, especially for aβ2 GPI IgG.

The clinical performance of a chemiluminescent immunoassay in detecting anti-cardiolipin and anti-β2 glycoprotein I antibodies. A comparison with a homemade ELISA method

“…That study did not, however, include a statistical comparison. In accordance with other authors [23,25,28,29], our investigation demonstrated a significant agreement and correlation of antibody titers between the two methods. In particular, κ-values and Spearman's ρ coefficients for IgG aCL and IgG anti-β2GPI antibodies were found to be higher than those for the corresponding "M" isotype antibodies ( Table 2).…”

“…While in keeping with the results outlined by other studies using the same CLIA instrument [25,29], they disagree with those described by De Moerloose et al [23], who found that the HemosIL AcuStar CLIA produced a higher comparative sensitivity than some ELISA kits. That study did not, however, include a statistical comparison.…”

“…Automation can also reduce intra-and inter-laboratory variability and improve the reproducibility of the results [22]. Some studies have been performed since CLIA first became available to compare this new technology with ELISA testing, which is more commonly used to detect aCL and anti-β2GPI antibodies [23][24][25][26][27][28][29]. These comparison studies were, however, carried out using different CLIA instruments and various ELISA techniques (homemade methods and various commercial kits).…”

“…In particular, chemiluminescence immunoassay (CLIA) has been available for aCL and anti-β2GPI antibody detection since 2010 [23]. Studies comparing the performance of CLIA with that of ELISA have been performed in heterogeneous groups of patients and have produced divergent results [23][24][25][26][27][28][29].…”

Detection of IgG anti-Domain I beta2 Glycoprotein I antibodies by chemiluminescence immunoassay in primary antiphospholipid syndrome

“…It has, moreover, been found that exposure of DI epitope is different across various commercial anti-β2GPI enzyme-linked immunosorbent assay (ELISA) kits [19,20]. Chemiluminescence immunoassay (CLIA), a new fully-automated technology which exploits a light-emitting chemical reaction for antibody detection [21][22][23], has become available for testing aCL and anti-β2GPI antibodies [24][25][26][27] and, recently, also anti-DI antibodies. The aim of this study was to assess the performance of CLIA for detection of IgG anti-DI, IgG aCL, and IgG anti-β2GPI antibodies.…”