ANA Profile ELISA Kit (Anti-Nuclear Antibody)

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 many subtypes of ANAs and each subtype can attach to different protein complexes present in the nucleus. Example of some of these subtypes include anti-dsDNA, anti-Scl-70 antibodies, anti-nRNP, anti-Ro, anti-histone, anti-Sm, anti-La, anti-sp100 and anti-centromere.

Indirect immunofluorescence (IF) and ELISA methods are commonly used for ANA screening and profiling tests. A positive test is caused by immune system attacking its own tissue (autoimmune reaction). However, a positive test has been discovered in normal healthy patients. A positive result will in many cases requires a secondary confirmatory test using other disease specific tests for example: anti-Smith antibody, anti-scleroderma antibody and anti-dsDNA. This is all dependent on the disease that is suspected.

ANAs are generally regarded as non-specific biomarkers for the identification of autoimmune diseases especially the one that are associated with connective tissue diseases, which are widely known to be induced by various chronic infections. They can bind many nuclear antigens, which results in displaying many different nuclei staining patterns (for example: speckled, homogeneous, centromere or nucleolar). Each of these nuclei stains have been discovered to be associated to a specific liver or connective tissue diseases. Anti-centromere antibodies are linked to CREST syndrome (scleroderma), where anti-nucleolar antibodies are less specifically linked to sclerderma.

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.
• 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 ELISA kit was diagn. 95.5%.The dynamic range for this assay is cut-off index 1.0.

ASSAY CHARACTERISTICS

– 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 (Anti-Nuclear Antibody)
• Reactivity: Human
• Sample Type: Plasma, Serum
• Sensitivity: 95.5%

OTHER RELATED ELISA KITS

• ANA Screen ELISA Kit
• ACPA ELISA Kit
• AMA-M2 ELISA Kit