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ENA-4 Profile ELISA Kit

INTENDED USE

Human ENA-4 profile ELISA kit is designed for detecting in-vitro quantitative profiling of IgG auto-antibodies to extractable nuclear antigens (ENA-4 profile: RNP/Sm, SS-A, SS-B, Sm) in human plasma or serum. This assay has a minimum analytical sensitivity limit of diagn. 84.9%.

Extractable nuclear antigens (ENA-4 profile): RNP/Sm, SS-A (52 and 60 kDa) and SS-B, Sm are bound to the microwells.

BACKGROUND

Extractable nuclear antigens (ENAs) are designed to be used to detect one or more autoantibodies that can react with cell nucleus proteins. The ENA IgG profile is typically made up of either of extractable nuclear antigens-4 (ENA-4) or extractable nuclear antigens-6 (ENA-6) autoantibody tests. The following ENA-4 profile ELISA kit will usually include anti-SS-A (Ro), anti-SS-B (La), anti-RNP and anti-Sm. 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.

ENA-4 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 SS-A, SS-B, Sm and RNP/Sm.
  • Positive Control (100 U/ml).
  • Negative (0 U/ml).
  • Cut-Off Calibrators (25 U/ml): Specific for each individual ENA-4 antigen.
  • Sample Buffer (5x).
  • Enzyme Conjugate: Consisting of polyclonal rabbit anti-human IgG, labelled with horseradish peroxidase.
  • TMB Substrate.
  • Stop Solution: 1 M hydrochloric acid.
  • Wash Solution (50x).

SENSITIVITY

The minimum detection sensitivity level of IgG antibodies to extractable nuclear antigen-4 (ENA-4, 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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