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ANA Profile ELISA Kit

INTENDED USE

Human ANA profile ELISA kit is a procedure for screening in vitro quantitative levels of IgG autoantibodies to anti-nuclear antibodies (antinuclear antibodies, ANA profile) in human serum and plasma samples. This assay has a minimum analytical sensitivity limit of diagn. 95.5%.

Purified antigens SS-A (52 and 60 kDa), SS-B, RNP-70, Sm, RNP/Sm, Scl-70, Centromere B and Jo- 1 are bound to individual rows A to H of the microwell plate.

BACKGROUND

Anti-nuclear antibodies (ANA) are autoantibodies that bind to specific contents of the cell nucleus. There are a number of different subtypes of ANAs and each subtype has the ability to attach to different protein complexes or proteins in the nucleus. Example of some of these subtypes include anti-dsDNA, anti-Ro, anti-histone, anti-nRNP, anti-Sm, anti-centromere, anti-La, anti-sp100 and anti-Scl-70 antibodies.

Anti-nuclear antibodies have been discovered to be present in a variety of disorders for example scleroderma, Sjögren’s syndrome, rheumatoid arthritis, dermatomyositis, systemic lupus erythematosus, multiple sclerosis, psoriatic arthritis, idiopathic thrombocytopaenic purpura, autoimmune hepatitis, discoid lupus, thyroid disease, infection and cancer. There is also evidence that it can be found in normal healthy individuals too. Indirect immunofluorescence (IF) and ELISA methods are commonly used for human ANA screening and profiling tests. A positive ANA test is caused by immune system attacking its own tissue (autoimmune reaction). However, in some people a positive ANA test is obtained for healthy individuals.

ANA 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: Anti-nuclear antibodies (ANA profile) are bound to microwells.
  • Calibrator And Control Negative: ANA antibodies in a serum/buffer matrix.
  • Sample Buffer (5x).
  • Enzyme Conjugate.
  • TMB Substrate.
  • Stop Solution.
  • Wash Buffer (50x).
  • Instruction For Use.
  • Certificate Of Analysis.

SENSITIVITY

The minimum detection sensitivity level of human IgG autoantibodies to anti-nuclear antibodies (antinuclear antibodies) using current ANA profile ELISA kit was diagn. 95.5%.The dynamic range for this assay is cut-off index 1.0.

ASSAY CHARACTERISTICS

– Anti-Nuclear Antibodies (ANA Profile): ELISA
– Expected Values: In a normal range = Cut-off Index 1.0, Border Line = 1.0 – 1.2, Negative = < 1.0, Positive = > 1.2.
– Linearity: 85 – 106%
– Intra Assay Precision: 1.7 – 5.5%
– Inter Assay Precision: 1.8 – 6.7%
– Clinical Diagnosis: Sensitivity (95.5%), Specificity (97.6%), Overall agreement (96.9%).

REFERENCES

  1. Choosing wisely: Review and commentary on anti-nuclear antibody (ANA) testing. Autoimmun Rev. (2016) 15 (3): 272-80. Review. Fritzler M.J.
  2. Are anti-nuclear antibodies common in affective disorders? A review of the past 35 years. Psychosomatics. (2007) 48 (4): 286-9. Review. Appleby B.
  3. Antinuclear antibody determination methods. Clin Rheumatol. (1990) 9 (1 Suppl 1): 51-60. Review. Williams D.G., et al.
  4. 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.
  5. Current concepts and future directions for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. J Immunol Res. (2014) 2014: 315179. Review. Mahler M., et al.
  6. New methods for detection of anti-nuclear antibodies. Clin Immunol Immunopathol. (1998) 88 (3): 211-20. Review. Cook L.

ADDITIONAL INFORMATION

  • Full Name: ANA Profile ELISA Kit
  • Reactivity: Human
  • Sample Type: Plasma, Serum
  • Sensitivity: 95.5%

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