ENA Combi ELISA

Enzyme immunoassay for the quantitative determination of IgG antibodies against extractable nuclear antigens (ENA) in human serum or plasma.

INTENDED USE:ENA Combi ELISA is a test system for the quantitative determination of IgG antibodies against extractable nuclear antigens (ENA): SS-A (52 and 60 kDa), SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma. This product is intended for professional in vitro diagnostic use only.

GENERAL INFORMATION:The test is used as an aid in the differential diagnosis of inflammatory autoimmune diseases, e.g. systemic lupus erythematosus, mixed connective tissue disease, Sjoegren’s syndrome, scleroderma, and polymyositis/dermatomyositis. 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: 12.5 - 100 U/ml
- Sensitivity analytical: 1 U/ml
- Final Sample Volume: 100 µl
- Sample Type: serum, plasma
- Sample Pretreatment: 1:100 diluted
- Isotope / Substrate: TMB 450 nm
- Regulatory Status: CE