Validation of a new screening strategy for anti-extractable nuclear antigen antibodies.

ABSTRACT

OBJECTIVE: Although indirect immunofluorescence (IIF) is the most widely applied screening test for antinuclear antibodies (ANA), it lacks specificity for the identification of specific diseases or antigen reactivities. The aim of the present study was to validate an anti-extractable nuclear antigen (ENA) screening strategy encompassing a three-step cascade whereby an ELISA with pooled specific ENA is positioned between the IIF and the final anti-ENA identification. METHODS: Sera from 4 populations were tested for anti-ENA using an automated ELISA (EliA Symphony) and a line immunoassay (INNO-LIA ANA update). RESULTS: At the manufacturer's cut-off, a 96% sensitivity (95% CI 94%-98%) and 96% specificity (95% CI 94%-98%) of EliA Symphony for anti-ENA was obtained in a consecutive selection of 328 IIF positive serum samples referred for ANA testing. In addition, a high sensitivity was demonstrated for anti-ENA reactivities in patients with SLE (99%, 95% CI 97%-101%) and SSc (100%), and for anti-ENA monoreactivities. CONCLUSION: The EliA Symphony test was shown to be a sensitive second-line screening test for anti-ENA antibodies. In the context of a high clinical suspicion of connective tissue disease or autoreactivities not included in the EliA Symphony assay, third-line testing may be useful, even if the anti-ENA screening is negative.