ORGENTEC's more recent development in the field of autoimmune ELISA diagnostics
is the ANA Detect ELISA system.
More than twenty different antigens are coated on the microplate. These
include SS-A 60, SS-A 52, SS-B, RNP/Sm, RNP-70, RNP-A, RNP-C, SM-BB',
Sm-D, SM-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, poly- and mono-nucleosomes,
histone complex, Histone H1, Histone H2A, Histone H2B, Histone H3, Histone
H4, Centromere B and PM-Scl-100.
The system is highly sensitive and compares well with the conventional
Hep-2 immunofluorescence assay. The results correlate closely with
the clinical data, thus making the ANA-Detect ELISA an ideal screening
tool. The kit is a semi-quantitative assay that only takes 60 minutes
to run and contains color coded, ready to use reagents.
The reagents used in the ANA Detect ELISA system are interchangeable
with ORGENTEC's other assays.
The assay is easy to carry out and is suitable for both manual and fully
automated operation.
FDA 510(k) cleared for detection of ANAs in human serum against dsDNA,
nDNA, histones, SS-A/Ro, SS-A-La, Sm, SmRNP, Scl-70, Jo-1 and centromeric
antigens.