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Beta-2 Glycoprotein I Screen ELISA Kit

INTENDED USE

Human beta-2 glycoprotein 1 screen ELISA kit is designed to screen in vitro quantitative levels of IgM, IgA and IgG auto-antibodies to beta2-glycoprotein I screen (apolipoprotein H, beta-2 GP1, ApoH) in human serum and plasma samples. This assay has a minimum analytical sensitivity limit of 0.5 U/ml.

BACKGROUND

Beta-2 glycoprotein 1 (also called beta-2 GP1, apolipoprotein H, ApoH) can be synthesised by endothelial cells, trophoblast cells and hepatocytes. It is a 326 amino acid polypeptide which consists of 5 homologous domains that are each approx. 60 amino acids. In clinical research auto-antibodies to beta-2 GP1 antibodies can be identified using many different types of assays for example functional coagulation assays and immunoassays.

Beta-2 GP1 antibodies are found in patients which have antiphospholipid syndrome (APS), this condition has been linked to many clinical symptoms such as pregnancy complications, thrombocytopenia, thrombosis, systemic rheumatic diseases, hemolytic anemia, nonbacterial thrombotic endocarditis and unexplained cutaneous circulatory disturbances. Beta-2 GP1 antibodies are frequently discovered at elevated in patients that display systemic rheumatic diseases, in particular systemic lupus erythematosus. Whereas, plasma from normal individuals display relatively low levels of IgG autoantibodies to beta-2 GP1 (beta-2 GP1 antibodies).

BETA-2 GLYCOPROTEIN 1 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: Consisting of 12 modules of 8 wells, highly purified beta-2 glycoprotein 1 is bound to microwells.
  • Calibrators A-D: Concentration 3.3-90 U/ml, made up from human beta-2 GP1 antibodies in a serum/buffer matrix.
  • Sample Buffer P (5x).
  • Enzyme Conjugate: Contains anti-human IgG, IgA and IgM antibodies, HRP labelled.
  • TMB Substrate.
  • Stop Solution: Contains acid.
  • Wash Buffer (50x).
  • Instruction for Use.
  • Certificate of Analysis.

SENSITIVITY

The minimum detection sensitivity level of human beta-2 GP1 screen (IgA, IgM or IgG) using current human beta-2 glycoprotein 1 screen ELISA kit was 0.5 U/ml. The dynamic range for this assay is 3.3 – 90.0 U/ml.

ASSAY CHARACTERISTICS

– Beta-2 Glycoprotein 1 Screen (Beta-2 GP1 Screen): ELISA
– Measuring Range: 0 – 90 U/ml.
– Expected Values: Samples from healthy blood donors display a cut-off 10 U/ml.
– Results Interpretation: Negative: < 10 U/ml, Positive: ≥ 10 U/ml.
– Linearity: 97 – 103%
– Limit Of Detection (LOD): Functional sensitivity 0.5 U/ml.
– Intra Assay: 3.9 – 9.1%
– Inter Assay: 2.5 – 5.2%
– Interfering Substances: None
– Clinical Diagnosis: Sensitivity (94.5%), Specificity (97.3%), Overall agreement (96.4%).

REFERENCES

  1. β(2) -Glycoprotein I: evolution, structure and function. J Thromb Haemost. (2011) 9 (7): 1275-84. Review. de Groot P.G. and Meijers J.C.
  2. New tests to detect antiphospholipid antibodies: anti-domain I beta-2-glycoprotein-I antibodies. Curr Rheumatol Rep. (2014) 16 (2): 402. Review. Chighizola C.B., et al.
  3. Anticardiolipin and anti-beta-2-glycoprotein I antibodies. Autoimmunity. (2005) 38 (1): 33-8. Review. Marai I., et al.
  4. Anti-β2-glycoprotein I antibodies. Ann N Y Acad Sci. (2013) 1285: 44-58. Review. Willis R. and Pierangeli S.S.
  5. Laboratory methods to detect antiphospholipid antibodies. Hematology Am Soc Hematol Educ Program. (2014) 2014 (1): 321-8. Review. Krilis S.A. and Giannakopoulos B.

ADDITIONAL INFORMATION

  • Full Name: Beta-2 Glycoprotein I Screen ELISA Kit
  • Reactivity: Human
  • Sample Type: Plasma, Serum
  • Sensitivity: 0.5 U/ml

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