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FDA Cleared: EUROLINE ENA Profile 9 Ag

EUROIMMUN US is proud to announce FDA clearance of its EUROLINE ENA Profile 9 Ag (IgG) kit.

EUROIMMUN US offers the complete, FDA cleared package for ANA testing, including screening with HEp-20-10 cells or ELISA, as well as confirmatory, mono-specific ELISA and immunoblots like the EUROLINE ENA Profile 9 Ag. EUROIMMUN also offers automation solutions for IFA, ELISA, and immunoblots with instrumentation such as EUROPattern, EUROAnalyzer I and EUROAnalyzer I-2P, and the EUROBlotOne.

The ENA Profile 9 Ag is an immunoblot test intended for the qualitative detection of IgG class antibodies against nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, CENP B and ribosomal P-proteins in human serum. Detection of these antibodies is used as an aid in the diagnosis of systemic lupus erythematosus, systemic sclerosis, poly-/dermatomyositis, mixed connective tissue disease and Sjögren’s syndrome, in conjunction with other laboratory and clinical findings. The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) test kit is intended to be used in a clinical, reference or hospital laboratory. This kit is not designed for point-of-care testing.

Autoantibodies (AAb) against nuclear antigens (ANA) are directed against various cell nuclear components. Among the most important nuclear antigens, including cytoplasmic antigens, are nRNP/Sm, Sm, SS-A, SS-B, Scl-70, PM-Scl, Jo-1, centromeres, PCNA, dsDNA, nucleosomes, histones and ribosomal P-proteins. They are mainly components of functional nuclear particles, are bound to nucleic acids or fulfill functions in the cell cycle, e.g. in transcription or translation.

The investigation of ANA and subsequent differentiation within the ANA (or ENA) spectrum contributes greatly to establishing a diagnosis, particularly in the following rheumatic diseases:

– systemic lupus erythematosus (SLE)
– systemic sclerosis (SSc)
– poly-/dermatomyositis (PM/DM)
– mixed connective tissue disease (MCTD)
– Sjögren’s syndrome (SS)