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Anti-Alpha Fodrin ELISA Kit

INTENDED USE

Human anti-alpha fodrin ELISA kit can be used for measuring in vitro quantitative levels of IgA or IgG class anti-alpha fodrin (anti alpha fodrin) autoantibodies in human plasma and serum samples. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.

BACKGROUND

Alpha-fodrin is a dimer which is made up of an alpha- and a beta-subunit, it is an intracellular actin binding and a cytoskeleton organ specific protein. During the process of apoptosis the dimers are cleaved into a 120 kDa breakdown product, this product can be abundantly found in the salivary gland and is a vital autoantigen in pathogenesis. Clinical studies on patients with Sjögren Syndrome have shown that alpha-fodrin is also involved in the stimulation of peripheral blood T-cells. These findings indicated that increased levels of protease activity along with the stimulation of T-cells have important functions in the process of alpha fodrin proteolysis during the development of primary Sjögren’s Syndrome. Alpha-fodrin autoantibodies can be detected in sera of adults that are known to be affected with primary or secondary Sjögren´s syndrome, however, they were not identified in other autoimmune disorders without sicca symptoms. In contrast to adults, this antibody is usually found in juvenile RA and SLE without any signs which suggest secondary Sjögren´s syndrome. According to the latest findings, it have been recommended that routine screening for antibodies directed against alpha fodrin can be vital tool in order to diagnose Sjögren’s syndrome in an early stage.

ALPHA FODRIN 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: Coated with human alpha-fodrin.
  • Calibrators (A-F): Concentrations 0, 6.3, 12.5, 25, 50, 100 U/ml.
  • Control Positive And Control Negative: Positive for IgG (1), positive for IgA (2) and negative for IgG and IgA (3).
  • Sample buffer (5x).
  • Enzyme Conjugate Solution: Polyclonal rabbit anti-human IgA and anti-human IgG; labelled with horseradish peroxidase.
  • TMB Substrate Solution.
  • Stop Solution.
  • Wash solution (50x).
  • Instruction for Use.
  • Certificate of Analysis.

SENSITIVITY

The minimum detection sensitivity level of human IgG or IgA class anti alpha fodrin autoantibodies using current anti-alpha fodrin ELISA kit was 1.0 U/ml. The dynamic range for this assay is 6.3 – 100.0 U/ml.

ASSAY CHARACTERISTICS

– Anti Alpha Fodrin: ELISA
– Results Interpretation: Negative: < 10 U/ml, Positive ≥ 10 U/ml
– Intra Assay Precision: 2.2 – 4.0%
– Inter Assay Precision: 1.1 – 3.4%
– Sensitivity: 1.0 U/ml.
– Specificity: Recognizes only autoantibodies specific to the alpha-fodrin.
– Interfering Substances: No interference has been observed with haemolytic (up to 1000 mg/dL), lipemic (up to 3 g/dL triglycerides) or bilirubin (up to 40 mg/dL) containing sera.

REFERENCES

  1. Sensitivity and specificity for primary Sjögren’s syndrome of IgA and IgG anti-alpha-fodrin antibodies detected by ELISA. J Rheumatol. (2004) 31 (3): 504-7. Ruffatti A., et al.
  2. Antifodrin antibodies in Sjogren’s syndrome: a review. Ann N Y Acad Sci. (2005) 1051: 235-9. Review. Witte T.
  3. The accuracy of the anti-α-fodrin antibody test for diagnosis of Sjögren’s syndrome: a meta-analysis. Clin Biochem. (2013) 46 (15): 1372-6. Review. Hu Q., et al.
  4. Diagnostic accuracy of anti-alpha-fodrin antibodies for primary Sjögren’s syndrome. Mod Rheumatol. (2014) 24 (5): 793-7. Qin Q., et al.
  5. Molecular analysis of the human autoantibody response to alpha-fodrin in Sjögren’s syndrome reveals novel apoptosis-induced specificity. Am J Pathol. (2004) 165 (1): 53-61. Maruyama T., et al.

ADDITIONAL INFORMATION

  • Full Name: Anti-Alpha Fodrin ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 1.0 U/ml

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