To assess the performance of the new classification rule, we obtained detailed data regarding a new set of 690 additional patients. Sites were again asked to submit information on patients diagnosed with SLE, and on an approximately equal number of controls with the following diagnoses: rheumatoid arthritis, undifferentiated connective tissue disease, primary antiphospholipid antibody syndrome, vasculitis, chronic cutaneous lupus, scleroderma, Sjögren syndrome, myositis, psoriasis, fibromyalgia, alopecia areata and sarcoidosis. These data were collected on standardized case report forms and sent to the coordinating site. Information included a demographics summary, a clinical scenario, specification of ACR criteria that were met and not met, specification of SLICC criteria met and not met, auto-antibody titers and complement titers.
In addition, serum from each patient was sent to the coordinating site and analyzed at the Rheumatology Diagnostic Laboratory (Los Angeles, CA) for anti-dsDNA by ELISA, Crithidia and Farr assays, anti-Smith antibody and complement C3 and C4 levels. A second set of blood samples were tested for antiphospholipid antibodies (lupus anticoagulant, ELISA assay for IgG, IgM and IgA isotypes of anticardiolipin antibodies and anti-beta2 glycoprotein1 antibodies) at the laboratory of Joan Merrill, M.D. (Oklahoma Medical Research Foundation). Direct Coombs was done at each center's own laboratory or at Quest Diagnostics. A short description of each patient (“patient scenario”) was generated containing the submitted information and the updated auto-antibody and complement profiles.
In addition, serum from each patient was sent to the coordinating site and analyzed at the Rheumatology Diagnostic Laboratory (Los Angeles, CA) for anti-dsDNA by ELISA, Crithidia and Farr assays, anti-Smith antibody and complement C3 and C4 levels. A second set of blood samples were tested for antiphospholipid antibodies (lupus anticoagulant, ELISA assay for IgG, IgM and IgA isotypes of anticardiolipin antibodies and anti-beta2 glycoprotein1 antibodies) at the laboratory of Joan Merrill, M.D. (Oklahoma Medical Research Foundation). Direct Coombs was done at each center's own laboratory or at Quest Diagnostics. A short description of each patient (“patient scenario”) was generated containing the submitted information and the updated auto-antibody and complement profiles.