Aeskulisa ANA HEp-2- Features and Benefits




  • US FDA approved ANA HEp-2 ELISA kit is the “ideal” screening test and has the microwells coated with HEp-2 cell extracts and additionally spiked with necessary recombinant antigens. The inclusion of these spiked antigens together with the nucleolar and HEp-2 cell extracts significantly increases the sensitivity to detect ANA positive sera (including those with unknown specificity).
  • The additionally spiked recombinant nuclear antigens are SS-A, SS-B, U1 snRNP, Scl-70, Centromere-B, Sm, dsDNA enabling complete detection.
  • ANA HEp-2 ELISA results are at par with ANA IFA (Gold Standard) since it uses same cell line as used in IFA. Concordance between ELISA and immunofluorescence results is guaranteed as the identical antigenic targets are presented. The Aesku ANA-HEp2 ELISA shows 95% sensitivity as compared to HEp-2 immunofluorescence tests. Thus, this test is an ideal screening test for laboratories with a high sample turnover.
  • Breakable microwells & ready to use reagents.
  • Uses One Aesku ie. Same incubation time, same common reagents like sample buffer, substrate, stop solution and wash buffer, thus user friendly kit and ideal for automation.
  • CE –marked product.
  • Calibrated according to CDC reference sera, Atlanta.
Detection of autoantibodies directed against nuclear antigens (ANA) has been considered to be important biomarker for the detection of CTD (connective tissue diseases). The diseases include systemic lupus erythematosus (SLE), scleroderma (progressive systemic sclerosis), mixed connective tissue disease (MCTD), Sjögren´s Syndrome, polymyositis/dermatomyositis and rheumatoid arthritis (RA).

What are ConnectiveTissue Diseases?

Connective tissue disease (CTD) describes a group of systemic inflammatory autoimmune diseases characterized by multiple organ involvement and connective tissue damage resulting out of the deposition of circulating immune complexes. It includes systemic lupus erythematosus (SLE), scleroderma (progressive systemic sclerosis), mixed connective tissue disease (MCTD), Sjögren´s Syndrome and polymyositis /dermatomyositis. Rheumatoid arthritis (RA) is also included in a broader sense. CTD tend to exhibit overlapping symptoms thus accurate diagnosis and therapy is rather difficult. Despite their diversity in clinical appearance, the majority of CTD share a common serological marker, autoantibodies directed against nuclear antigens (ANA). Determination of ANA is essential for differential diagnosis and discrimination from other types of rheumatic inflammatory diseases. Hence ANA subtyping is an important tool for accurate diagnosis. Furthermore ANA are important for monitoring the progression of the disease as well as the success of the chosen therapy.

This FDA approved ANA HEp-2 ELISA kit is the “ideal” screening test and has the microwells coated with HEp-2 cell extracts .