• Julia U Holle, Kristine Herrmann, Wolfgang L Gross, and Elena Csernok.
• University Hospital Schleswig-Holstein, Campus Lübeck and Klinikum Bad Bramstedt, Dept. of Rheumatology and Immunology, Germany. hollejulia@hotmail.com
• Clin Exp Rheumatol. 2012 Jan 1; 30 (1 Suppl 70): S66-9.

ObjectivesTo assess the diagnostic performance of 11 commercial PR3- and MPO-ANCA ELISA systems (direct, capture and high sensitive [hs] ELISA).MethodsSera from 90 patients with AAV (GPA, MPA and CSS) and 20 disease controls (SLE; RA) and healthy individuals were tested for the presence of ANCA by IFT and by different ELISAs for the presence of PR3-and MPO-ANCA, respectively. Furthermore, the binding capacity of the IUIS-CDC reference sera for PR3-/MPO-ANCA in different commercial assays was analysed.ResultsCommercial ELISA kits for PR3-ANCA differed moderately in their sensitivity (from 45% to 62.5%). The highest sensitivity for PR3-ANCA was obtained with hs ELISA (kit A) and capture ELISA (kit N). Testing for MPO-ANCA the highest sensitivity (85%) was obtained with direct ELISA (kit D and I). Specificity was high in all kits. Only three PR3-ANCA commercial kits and three MPO-ANCA kits produced binding at the expected value for the IUIS-CDC reference sera (100 U/ml). In all of the kits, serial dilutions of the reference sera did not yield linearity.ConclusionsSecond (capture) and third (high sensitivity) generation PR3-ANCA ELISA kits are superior to conventional ELISAs. Direct and capture MPO-ANCA ELISAs showed a good overall performance in all kits. Most of the kits have not been standardised to allow their results to be compared.

20 keywords...

hide…