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ANA Screen ELISA Kit

INTENDED USE

Human ANA screen ELISA kit is designed for screening in vitro quantitative concentrations of IgG autoantibodies to nuclear antigens (antinuclear antibodies, ANA screen) in human serum or plasma. This assay has a minimum analytical sensitivity limit of diagn. 96.4%.

A mixture of purified antigens SS-A 60, SS-A 52, SS-B, RNP-70, Sm, RNP/Sm, Scl-70, Centromere B and Jo-1 is coated on to microwells.

BACKGROUND

Antinuclear antibodies (ANA) are present in the blood of individuals that have group of autoimmune disorders usually referred to as connective tissue diseases (CTD). They are a specific class of autoantibodies which can bind and destroy certain structures within the nucleus of the cells. ANAs have a number of different subtypes which include anti-histone, anti-sp100, anti-centromere, anti-Scl-70, anti-Ro, anti-La, anti-nRNP, anti-Sm and anti-dsDNA antibodies. They can also be found in many disorders such as rheumatoid arthritis, idiopathic thrombocytopaenic purpura, multiple sclerosis, systemic lupus erythematosus, Sjögren’s syndrome, autoimmune hepatitis, thyroid disease, scleroderma, psoriatic arthritis, discoid lupus, dermatomyositis, cancer and infections.

Initially, screening is carried out using a generic assay which detects human ANA of a broad specificity or indirect immunofluorescence tests. If positive, then more specific tests are carried out based on these findings. These more specific antigen have the ability to react with single auto-antigens for example: Sm/RNP, SS-B/La, dsDNA, Scl-70, Sm, SS-A/Ro etc.

ANA 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.
  • Calibrator And Control Negative.
  • Sample Buffer (5x).
  • Enzyme Conjugate.
  • Substrate: Tetramethylbenzidin (TMB).
  • Stop Solution.
  • Wash Buffer (50x Concentrate).
  • Instruction For Use.
  • Certificate Of Analysis.

SENSITIVITY

The minimum detection sensitivity level of IgG autoantibodies to human anti-nuclear antibodies (ANA, antinuclear antibodies) using current ANA screen ELISA kit was diagn. 96.4%.The dynamic range for this assay is cut-off index 1.0.

ASSAY CHARACTERISTICS

– Anti-Nuclear Antibodies (ANA Screen): ELISA
– Expected Values: In a normal range = Cut-off Index 1.0, Positive = > 1.2, Border Line = 1.0 – 1.2, Negative = < 1.0.
– Linearity: 90 – 110%
– Intra Assay Precision: 2.2 – 3.5%
– Inter Assay Precision: 3.8 – 6.5%
– Clinical Diagnosis: Sensitivity (96.4%), Specificity (98.0%), Overall agreement (97.3%).

REFERENCES

  1. Performance of antinuclear antibody connective tissue disease screen. Ann N Y Acad Sci. (2007) 1109: 322-9. López-Hoyos M., et al.
  2. Evaluation of the LIAISON ANA screen assay for antinuclear antibody testing in autoimmune diseases. Ann N Y Acad Sci. (2007) 1109: 407-13. Ghillani P., et al.
  3. ANA screening: an old test with new recommendations. Ann Rheum Dis. (2010) 69 (8): 1420-2. Meroni P.L. and Schur P.H.
  4. ANA testing in the presence of acute and chronic infections. J Immunoassay Immunochem. (2016) 37 (5): 439-52. Review. Litwin C.M. and Binder S.R.
  5. Antinuclear antibody screening by ELISA and IF techniques: discrepant results in juvenile idiopathic arthritis but consistency in childhood systemic lupus erythematous. Clin Rheumatol. (2014) 33 (5): 643-7. Spârchez M., et al.

ADDITIONAL INFORMATION

  • Full Name: ANA Screen ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 96.4%

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