Evaluation of antinuclear antibody test by chemiluminescent enzyme immunoassay (CLEIA)

Abstract

Detection of the antinuclear antibody (ANA) is widely used for the screening of collagen diseases. Although indirect immunofluorescence (IIF) assay is considered as a standard test, it has disadvantages in terms of its specificity and rapidity. We performed basic and clinical evaluation of a new ANA assay by chemiluminescent enzyme immunoassay (CLEIA). The basic performance of the assay was within acceptable level. Its clinical sensitivity was 91.5% and its specificity was 74.2%, which are higher than those of the IIF assay. The measurement time of CLEIA was 19 minutes, which was shorter than that of the conventional method. On the basis of these results, it is considered that this method is useful for the screening of connective tissue diseases.