ENA Screen ELISA

Enzyme immunoassay for the qualitative screening of IgG class autoantibodies against extractable nuclear antigens in human serum or plasma.

INTENDED USE: ENA Screen is an ELISA-based test system for the qualitative screening of IgG class autoantibodies against extractable nuclear antigens (ENA): SS-A 60, SS-A 52, SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only.

GENERAL INFORMATION: The test is used as an aid for screening and differentiation of inflammatory autoimmune diseases, e.g. systemic lupus erythematosus, mixed connective tissue disease, Sjoegren’s syndrome, scleroderma. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings.

KIT CHARACTERISTICS:
- Method: ELISA
- Tests: 96
- Incubation Time / Conditions: 30, 15, 15, 5 min (RT)
- Standard Range: Cut-off
- Sensitivity analytical: diagn. 92.7 %
- Final Sample Volume: 100 µl
- Sample Type: serum, plasma
- Sample Pretreatment: 1:100 diluted
- Isotope / Substrate: TMB 450 nm
- Regulatory Status: CE