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SS-A 52 Ab ELISA Kit (Sjögren Syndrome Type A Antigen 52)

Full Name: SS-A 52 Ab ELISA Kit (Sjögren Syndrome Type A Antigen 52)
Reactivity: Human
Sample Type: Serum, Plasma
Sensitivity: 1.0 U/ml

BACKGROUND

Sjögren syndrome type A antigen (SS-A) is made up of a 52 kD and 60 kD protein antigens that are joined to the cytoplasmic RNA species. Anti SS-A 52 can be found in patients having Sjögren’s syndrome, SLE and is some instances other autoimmune disorders. These are however, specifically associated to tRNA synthetases such as PL-7, PL-12, Jo-1, OJ and EJ.

Many publication have also identified that approx. 10-50% of myositis is positive with SSA52 antibody. Autoantibodies that are found directed against antigen SS-A 52 antigens are predominately present in collagenosis (especially Sjögren’s syndrome), systemic sclerosis, dermatomyositis and polymyostitis.

INTENDED USE

Human SS-A 52 Ab ELISA kit is designed for measuring in-vitro quantitative amounts of IgG autoantibodies to Sjögren syndrome type A antigen 52 (SS-A 52 antibody, anti SS-A 52, SS-A 52 Ab) in human plasma or serum samples. This assay has a minimum analytical sensitivity limit of 0.5 U/ml.

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: Consisting of 12 modules of 8 wells, highly purified SS-A 52 antibodies bound to microwells.
  • Calibrators (A-F): Concentration 0-200 U/ml, made up from anti SS-A 52 in serum/buffer matrix.
  • Controls Positive and Control Negative: Containing human SS-A 52 antibody.
  • Sample Buffer (5x).
  • Enzyme Conjugate: Contains anti-human IgG antibodies, HRP labelled.
  • TMB Substrate.
  • Stop Solution: Contains acid.
  • Wash Buffer (50x Concentrated).
  • Instruction Manual.
  • Certificate of Analysis.

SENSITIVITY

The minimum detection sensitivity level of human Sjögren syndrome type A antigen 52 (anti SS-A 52, SS-A 52 Ab) IgG auto-antibodies using current SS-A 52 Ab ELISA kit was 0.5 U/ml. The dynamic range for this assay is 12.5 – 200.0 U/ml.

ASSAY CHARACTERISTICS

– Sensitivity: 0.5 U/ml.
– Specificity: Highly specific to autoantibodies against SS-A 52, no cross reaction to ENA antigens was displayed.
– Interference: None.
– Results Interpretation: Normal < 15 U/ml, Cut-Off 15-25 U/ml, Elevated ≥ 25 U/ml.
– Intra Assay Precision: 2.6 – 3.6%
– Inter Assay Precision: 1.1 – 6.4%

REFERENCES

  1. Clinical and laboratory aspects of Ro/SSA-52 autoantibodies. Autoimmun Rev. (2011) 10 (3): 150-4. Defendenti C., et al.
  2. A 52-kD protein is a novel component of the SS-A/Ro antigenic particle. J Exp Med. (1988) 167 (5): 1560-71. Ben-Chetrit E., et al.
  3. New developments in Sjögren’s syndrome. Curr Opin Rheumatol. (1991) 3 (5): 815-22. Review. Moutsopoulos H.M. and Youinou P.
  4. The 52-kd protein as a target of intermolecular spreading of the immune response to components of the SS-A/Ro-SS-B/La complex. Arthritis Rheum. (1997) 40 (5): 936-44. Tseng C.E., et al.
  5. Differential recognition of the 52-kd Ro(SS-A) antigen by sera from patients with primary biliary cirrhosis and primary Sjögren’s syndrome. Hepatology. (1996) 24 (6): 1404-7. Dörner T., et al.

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