New concepts in systemic autoimmunity testing

Diagnosis of systemic autoimmune diseases is highly complex, and it is beco ming increasingly difficult to make assumptions about the functional roles and diagnostic significance of autoantibodies. The latter is mainly due to the fact that results from different assay systems are not interchangeable. A laboratory "gold standard" which helps the clinician to differentiate ir relevant autoimmune phenomena from significant autoimmune diseases at an ea rly stage, is clearly missed. To meet this challenge, a rheuma entrance scr eening (RES) assay toolbox is proposed based on fully-automated enzyme immu noassay (EIA) technology on one system for the clinical and routine laborat ory. The RES concept is intended to cover the most important syndromes of s ystemic rheumatic diseases, i.e. collagenosis, early rheumatoid arthritis, early osteoarthritis, anti-phospholipid syndrome and inflammation. The sero logical part of diagnosis of these diseases comprises testing for anti-nucl ear antibodies (ANA), rheumatoid factor (RF), low levels or C-reactive prot ein (CRP), and disease-specific anti-phospholipid antibodies, e.g. anti-bet a-2 glycoprotein I (anti-beta2 GPI). To eliminate the known problems of var ying assay systems in this field, a novel, objective, rapid and reproducibl e approach to screen for such analytes in patient serum or plasma more effi ciently is the application of EIAs on the fully-automated immunoassay analy ser COBAS((R)) CORE (Roche Diagnostics GmbH, Mannheim, Germany). The combined use of the RES (COBAS((R)) CORE HEp2 ANA EIA, COBAS((R)) CORE RIF EIA Quant, COBAS((R)) CORE CRP EIA Quant and COBAS((R)) CORE Anti-beta2 GPI EIA) is intended for patients sent to the laboratory with the primary suspicion of harbouring a systemic rheumatic disease.