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ANA Hep Screen ELISA Kit

  • Created on the 26 May, 2017.

BACKGROUND

Antinuclear antibodies (ANA) which are also referred to as antinuclear factor (ANF) are essentially autoantibodies that have the ability to bind to specific contents of the cell nucleus. There are many subtypes of ANAs and each of these can bind a different proteins or protein complexes within the nucleus. Some of the common examples of the different subgroups include anti-Ro, anti-La, anti-Sm, anti-nRNP, anti-Scl-70, anti-dsDNA, anti-histone, anti-centromere and anti-sp100 antibodies.  ANAs are found in many disorders such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, scleroderma, primary biliary cirrhosis, multiple sclerosis, autoimmune hepatitis, dermatomyositis, Sjögren’s syndrome, thyroid disease, drug induced lupus, systemic lupus erythematosus, discoid lupus, idiopathic thrombocytopaenic purpura, cancer and infection. They can also be present in some healthy individuals.

The detection of ANA in blood is usually determined using a screening test. Even though there are a number of different tests possible, the most common ones used for screening are either ELISA or indirect immunofluorescence (IF) methods. If positive result is obtained then more specific tests are performed based the IF-ANA staining patterns and the clinical findings. Antigen specific ELISA assays are available which have the ability to react with single autoantigens for example dsDNA, Scl-70, Sm/RNP, SS-A/Ro etc.

INTENDED USE

Human ANA Hep screen ELISA kit intended for determining in vitro quantitative amounts of IgG autoantibodies to nuclear antigens in human plasma and serum. This assay has a minimum analytical sensitivity limit of diagn. 98.9%.

A mixture of purified antigens SS-A-52 (Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl -70, Jo-1, dsDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B is coated on to microwells.

SENSITIVITY

The minimum detection sensitivity level of human IgG autoantibodies to anti-nuclear antibodies using this human ANA Hep screen ELISA kit was diagn. 98.9%.The dynamic assay range for this kit is cut-off index 1.0.

REFERENCES

  1. Comparison of three commercially available enzyme immunoassays for the screening of autoantibodies to extractable nuclear antigens. J Clin Lab Anal. (1995) 9 (3): 166-72. Jaskowski T.D., et al.
  2. Precise quantitation of antinuclear antibodies on HEp-2 cells without the need for serial dilution. Clin Diagn Lab Immunol. (1996) 3 (4): 374-7. Hollingsworth P.N., et al.
  3. Can an ELISA replace immunofluorescence for the detection of anti-nuclear antibodies?–The routine use of anti-nuclear antibody screening ELISAs. Clin Lab. (2007) 53 (3-4): 183-91. Sinclair D., et al.
  4. The clinical significance of the dense fine speckled immunofluorescence pattern on HEp-2 cells for the diagnosis of systemic autoimmune diseases. Clin Dev Immunol. (2012) 2012: 494356. Review. Mahler M. and Fritzler M.J.
  5. Antinuclear antibodies (ANA) screening by enzyme immunoassay with nuclear HEp-2 cell extract and recombinant antigens: analytical and clinical evaluation. Clin Biochem. (2002) 35 (6): 463-9. González C., et al.

ADDITIONAL INFORMATION

  • Full Name: ANA Hep Screen ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 98.9%

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