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ANA Hep Screen ELISA Kit

INTENDED USE

Human ANA Hep screen ELISA kit intended for determining in vitro quantitative amounts of IgG autoantibodies to anti-nuclear antigens (antinuclear antibodies, ANA Hep) in human plasma and serum. This screening 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.

BACKGROUND

Antinuclear antibodies (ANA) which are also referred to as antinuclear factor (ANF) are essentially autoantibodies that can bind to specific contents of the cell nucleus. ANAs are made of many different subtypes, each subtype can bind a specific protein complex that is present 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 discovered in various types of disorders, some of these diseases include: primary biliary cirrhosis, drug induced lupus, autoimmune hepatitis, lupus, juvenile idiopathic arthritis, dermatomyositis, lupus, thyroid disease, rheumatoid arthritis, Sjögren’s syndrome, multiple sclerosis, psoriatic arthritis and systemic lupus erythematosus. There is also evidence t indicate that ANAs can be present in normal healthy individuals.

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

The identification of large amount of ANAs present within the human body provides a clear indication of the presence of an autoimmune disease. There is also a theory that the presence of ANAs could signal the start of the process whereby the body begins to attack itself, this will ultimately lead to an autoimmune disease many examples of this include: drug-induced lupus, polymyositis/dermatomyositis, hashimoto thyroiditis , autoimmune hepatitis, Sjögren’s syndrome , scleroderma, inflammatory bowel disease, lupus and mixed connective tissue disease.

ANA HEP SCREEN 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: Anti-nuclear antibodies (ANA screen) are bound to microwells.
  • Control A (Negative), Control B (Cut-Off), Control C (Positive): Consisting of ANA antibodies in a serum/buffer matrix.
  • Sample Buffer (5x).
  • Enzyme Conjugate.
  • TMB Substrate.
  • Stop Solution.
  • Wash Buffer (50x Concentrated).
  • Instruction For Use.
  • Certificate Of Analysis.

SENSITIVITY

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

ASSAY CHARACTERISTICS

– Anti-Nuclear Antibodies Hep (ANA Hep): ELISA
– Expected Values: In a normal range = Cut-off Index 1.0, Negative = < 1.0, Positive = > 1.2, Border Line = 1.0 – 1.2.
– Linearity: 89 – 107%
– Intra Assay Precision: 6.9 – 10.4%
– Inter Assay Precision: 9.9 – 11.2%
– Clinical Diagnosis: Sensitivity (98.9%), Specificity (98.0%), Overall agreement (98.3%).

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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