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ENA-4 Profile ELISA Kit

  • Created on the 2 June, 2017.

INTENDED USE

Human ENA-4 profile ELISA kit is designed for detecting in-vitro quantitative profile screening of IgG auto-antibodies to extractable nuclear antigens (ENAs) in human plasma or serum. This assay has a minimum analytical sensitivity limit of diagn. 84.9%.

Extractable nuclear antigens RNP/Sm, SS-A (52 and 60 kDa) and SS-B, Sm are bound to the microwells.

BACKGROUND

Extractable nuclear antigen profile (ENA-4) is designed to be used to detect one or more autoantibodies that can react with cell nucleus proteins. There are certain autoimmune disorders that have been specifically linked with the presence of one or more anti-ENA antibodies and it is this association which can be used in the diagnosis of an autoimmune disorder and also in helping to distinguish between disorders. The ENA IgG profile is typically is made up of either of 4 (ENA-4) or 6 (ENA-6) auto-antibody tests. The following ENA-4 profile ELISA kit will usually include anti-SS-A (Ro), anti-SS-B (La), anti-RNP and anti-Sm.

SENSITIVITY

The minimum detection sensitivity level of IgG antibodies to human extractable nuclear antigen profile (ENA-4 profile, ENA-IgG) using current human ENA-4 profile ELISA kit was diagn. 84.9%. The dynamic range for this assay is to a cut-off index 1.0.

REFERENCES

  1. Practical evaluation of methods for detection and specificity of autoantibodies to extractablenuclear antigens. Clin Diagn Lab Immunol. (2004) 11 (2): 297-301. Orton S.M., et al.
  2. [Evolution of autoantibodies profile in systemic lupus erythematosus according to age and clinical manifestations]. Ann Biol Clin (Paris). (2014) 72 (3): 351-8. French. Diallo M.S., et al.
  3. Comparison of two extractable nuclear antigen testing algorithms: ALBIA versus ELISA/line immunoassay. Pathology. (2016) 48 (5): 491-7. Chandratilleke D., et al.
  4. Clinical performance evaluation of a novel rapid response chemiluminescent immunoassay for the detection of autoantibodies to extractable nuclear antigens. Clin Chim Acta. (2013) 424: 141-7. Bentow C., et al.
  5. Autoantibody profile in systemic sclerosis. Acta Med Iran. (2010) 48 (1): 12-20. Behmanesh F., et al.

ADDITIONAL INFORMATION

  • Full Name: ENA-4 Profile ELISA Kit
  • Reactivity: Human
  • Sample Type: Plasma, Serum
  • Sensitivity: 84.9%

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