Anticentromere autoantibodies. Evaluation of an ELISA using recombinant fusion protein CENP-B as antigen.

To evaluate an enzyme-linked immunosorbent assay (ELISA) for anticentromere autoantibodies (ACA).,Sera from 611 patients with scleroderma, CREST (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias), Raynaud's disease, and connective tissue disease control patients were studied by ELISA using the fusion protein CENP-B, by immunofluorescence on dividing HEp-2 cells, and by immunoblotting on chromosomes and CENP-B.,Compared with immunofluorescence, the CENP-B ELISA sensitivity was 94% and the specificity was 93%. In 19.7% of the cases, there was a probability of a false-positive result and in 1.9%, a probability of a false-negative result, yielding positive and negative predictive values of 0.80 and 0.98, respectively.,The CENP-B ELISA is a sensitive and specific assay for ACA.