Human ENA-6 profile ELISA kit is a procedure for profile screening in-vitro quantitative levels of IgG auto-antibodies to extractable nuclear antigens (ENA-6 profile: Sm, RNP/Sm, Jo-1, SS-A, SS-B, Scl-70) in human serum and plasma samples. This assay has a minimum analytical sensitivity limit of diagn. 86.4%.
Extractable nuclear antigens (ENA-6 profile): Sm, RNP/Sm, Jo-1, SS-A (52 and 60 kDa), SS-B and Scl-70 are bound to the microwells.
Extractable nuclear antigen-6 (ENA-6) are intending for profiling one or more autoantibodies that has the ability to react with proteins within the cell nucleus. These are vital in helping to diagnose autoimmune disorder and aiding in distinguishing between different disorders, this is possible because one or more anti-ENA antibodies are found to be associated to specific autoimmune disorders. The ENA IgG profile assay can be either an ENA-4 or an ENA-6 autoantibody tests.
ENA-6 PROFILE ELISA KIT CONTENT
All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.
- Divisible Microplate: Consisting of 12 modules of 8 wells each, coated with individual highly purified Sm, RNP/Sm, Scl-70, SS-A, SS-B, Jo-1.
- Calibrators (Cut-Off): Made up from ENA-6 antigens.
- Control Positive and Control Negative: Containing human ENA-6 profile antibodies in a serum/buffer matrix.
- Sample Buffer (5x).
- Enzyme Conjugate: Consists of anti-human IgG antibodies, HRP labelled.
- Substrate: Tetramethylbenzidin (TMB).
- Stop Solution: Contains acid.
- Wash Buffer (50x).
- Instruction for Use.
- Certificate of Analysis.
The minimum detection sensitivity level of IgG antibody to extractable nuclear antigen-6 profile (ENA-6, anti-ENA-6, ENA-6 IgG) using current ENA-6 profile ELISA kit was diagn. 86.4%. The dynamic range for this assay is to a cut-off index 1.0.
– Extractable Nuclear Antigen-6 Profile (ENA-6 IgG Profile): ELISA
– Calibration: Calibrated against the internationally recognised reference sera.
– Expected Values: Samples from healthy blood donors displayed a cut-off Index 1.0
– Results Interpretation: Negative: < 1.0, Borderline: 1.0 -1.2, Positive: > 1.2.
– Linearity: 89 – 105%
– Intra Assay Precision: 3.1 – 5.0%
– Inter Assay Precision: 2.9 – 4.0%
– Interfering Substances: None.
– Clinical Diagnosis: Sensitivity (86.4%), Specificity (97.6%), Overall agreement (93.7%).
- A distinctive autoantibody profile in black female patients with lupus nephritis. Arthritis Rheum. (1993) 36 (11): 1560-5. McCarty G.A., et al.
- Relationship between snRNA species contained in nuclear antigens recognized by autoantibodies and the clinical profile in systemic rheumatic diseases. Biomed Pharmacother. (1982) 36 (3): 134-9. Assens C., et al.
- Extractable nuclear antigen autoantibodies and their association with other autoantibodies and thymoma in myasthenia gravis. J Neuroimmunol. (1985) 8 (2-3): 185-97. Warlow R., et al.
- Full Name: ENA-6 Profile ELISA Kit
- Reactivity: Human
- Sample Type: Plasma, Serum
- Sensitivity: Diagn. 86.4%