Intended Use
The SS-A (Ro) IgG ELISA Kit is intended for the detection of IgG antibody to SSA in human serum or plasma.
Contents of Kit
1. Microwells coated with SSA antigen 12x8x1
2. Sample Diluent: 1 bottle (ready to use) 22 ml
3. Calibrator: 1 Vial (ready to use) 1.5 ml
4. Positive Control: 1 vial (ready to use) 1.5 ml
5. Negative Control: 1 vial (ready to use) 1.5 ml
6. Enzyme conjugate: 1 bottle (ready to use) 12 ml
7. TMB Substrate: 1 bottle (ready to use) 12 ml
8. Stop Solution: 1 bottle (ready to use) 12 ml
9. Wash concentrate 20×: 1 bottle 25 ml
Storage
Store the kit at 2-8°C. Keep microwells sealed in a dry bag with desiccants. The reagents are stable until expiration of the kit. Do not expose test reagents to heat, sun or strong light.
Performance Characteristics
Interpretation
The following is intended as a guide to interpretation of SSA test results; each laboratory is encouraged to establish its own criteria for test interpretation based on sample populations encountered.
Antibody Index Interpretation
<0.9 No detectable antibody to SSA by ELISA.
0.9-1.1 Borderline positive. Follow-up testing is recommended.
>1.1 Detectable antibody to SSA by ELISA.
Precision
Intra-Assay Study

Inter-Assay Study

General Description
Systemic autoimmune disease is characterized by the presence of circulating auto-antibodies directed to a wide variety of cellular antigens. Systemic lupus erythematosis (SLE), commonly referred to as Lupus is the best known of these diseases. Other possible connective tissue diseases include mixed connective tissue disease (MCTD), Sjogren syndrome, sclerodema, and polymyositis/dermatomyositis. The majority can be diagnosed by clinical presentation and their antibody profiles to the various antigens involved, which include dsDNA, SM, RNP, SSA, SSB, Scl-70, Jo1 and Histones. Therefore, immunoassays for autoantibodies are useful for diagnostic and prognostic evaluations of autoimmune disease. SSA (Ro) antigen (60kd) and 52 kd polypeptides complexed with Ro RNAs are detected in about 75% of primary and secondary Sjögren syndrome, In>90% of subacute cutaneous lupus and in the vasculitis-associated Sjögren syndrome, SS-A autoantibodies are present and are accompanied in ~50% by SS-B/La autoantibodies. The coexistence of SSA and SSB autoantibodies probably reflects the presence of these polypeptides on the same particle and the spreading among autoimmunity to these self antigens.
Citations
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