Therapeutic Drug Monitoring ELISA Assay

Omalizumab mAb-Based ELISA Assay

$1,485.00

The Omalizumab ELISA Assay Kit is an enzyme immunoassay for the specific and precise measurement of free Omalizumab in serum and plasma samples. This assay utilizes the specific monoclonal antibodies as the coating material on the microtiter plate so this assay specifically measures only Omalizumab and no other TNF-a therapeutic.  The Eagle Biosciences Omalizumab ELISA Assay Kit is for research use only and not to be used in diagnostic procedures.

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Omalizumab mAb-Based ELISA Assay

The Omalizumab mAb-Based ELISA Assay is For Research Use Only

Size: 1 x 96 wells
Sensitivity: 1 ng/mL
Dynamic Range: 3 – 100 ng/mL
Incubation Time: 2 hours
Sample Type:  Serum, Plasma
Sample Size: 10 µL
Alternative Name: Xolair

Assay Background

Omalizumab (trade name Xolair®) is a recombinant DNA-derived humanized IgG1κ monoclonal antibody and it binds to human immunoglobulin E (IgE). The molecular weight of omalizumab is 149 kilodlatons and is produced by Chinese hamster ovary cell suspension culture. Omalizumab inhibits the binding of IgE to IgE receptor (FcεRI) on the surface of mast cells and basophils. Therefore, the Omalizumab is expected to limit the degree of release of mediators of the allergic response from the FcεRI bearing cells.

This ImmunoGuide Omalizumab ELISA (mAb-based) is developed for the specific measurement of Omalizumab in serum, plasma and other biological fluids by the advantage of using a site-directed IG-Ulkr4H1 mouse monoclonal antibody (mAb) specific for Omalizumab only. Binding of Omalizumab to the solid phase, pre-coated with IG-Ulkr4H1, is inhibited by human IgE in a concentration dependent manner. Therefore, the ImmunoGuide Omalizumab ELISA (mAb-based) measures the free form of Omalizumab only. The choice of specifically measuring the free form allows investigators to analyze the concentration-effect relationship. The ImmunoGuide Omalizumab ELISA  (mAb-based) kit can be efficiently used for measuring free Omalizumab levels in serum and plasma.

STORAGE AND STABILITY OF THE KIT
The kit is shipped at ambient temperature and should be stored at 2-8°C. Keep away from heat or direct sun light. The microtiter strips are stable up to the expiry date of the kit in the broken, but tightly closed bag when stored at 2–8°C.

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Additional Information

Assay Principle

This Eagle Biosciences ELISA Assay Kit is based on Omalizumab-specific monoclonal antibody (catcher Ab, ImmunoGuide clone Ulkr4H1). Standards and diluted samples are incubated in the microtiter plate coated with IG-Ulkr4H1 mAb. After incubation, the wells are washed. A horseradish peroxidase (HRP)-conjugated anti-human IgG monoclonal antibody is added and binds to the Fc part of Omalizumab. Following incubation, wells are washed and the bound enzymatic activity is detected by addition of a chromogen-substrate. The color developed is proportional to the amount of Omalizumab in the sample or standard. Results of samples can be determined by using the standard curve. Binding of Omalizumab to the solid phase, precoated with IG-Ulkr4H1, is inhibited by human IgE in a concentration dependent manner. Therefore, the ImmunoGuide Omalizumab ELISA (mAb-based) measures the free form of Omalizumab only.

Typical Standard Curve

Omalizumab mAb-Based ELISA Assay

Documents

Product Manual

 

Please note: All documents above are for reference use only and should not be used in place of the documents included with this physical product. If digital copies are needed, please contact us.

Publications

Citations

  • Rasmus K. Jensen, Melanie Plum, Luna Tjerrild, et al., Structure of the omalizumab Fab. Acta Cryst. (2015). F71, 419–426.
  • Lowe PJ, Georgiou P, Canvin J. Revision of omalizumab dosing table for dosing every 4 instead of 2 weeks for specific ranges of bodyweight and baseline IgE. Regul Toxicol Pharmacol. 2015 Feb;71(1):68-77.
  • Kaplan A, Ferrer M, Bernstein JA, Antonova E, Trzaskoma B, Raimundo K, Rosén K, Omachi TA, Khalil S, Zazzali JL. Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria. J Allergy Clin Immunol. 2015 Oct 16. pii: S0091-6749(15)01247-6. doi: 10.1016/j.jaci.2015.08.023
  • Roth M, Zhao F, Zhong J, Lardinois D, Tamm M. Serum IgE Induced Airway Smooth Muscle Cell Remodeling Is Independent of Allergens and Is Prevented by Omalizumab.  PLoS One. 2015 Sep 2;10(9):e0136549. doi: 10.1371/journal.pone.0136549. eCollection 2015.
  • Stelmach I, Majak P, Jerzyńska J, Bojo M, Cichalewski Ł, Smejda K. Children with severe asthma can start allergen immunotherapy after controlling asthma with omalizumab: a case series from Poland. Arch Med Sci. 2015;11(4):901-4.
  • Lai T, Wang S, Xu Z, Zhang C, Zhao Y, Hu Y, Cao C, Ying S, Chen Z, Li W, Wu B, Shen H. Corrigendum: Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep. 2015 Aug 14;5:9548. doi: 10.1038/srep09548.
  • Beam KT, Coop CA. Steroid sparing effect of omalizumab in seropositive allergic bronchopulmonary aspergillosis. Allergy Rhinol (Providence). 2015 ;6(2):143-5.  Wright JD, Chu HM, Huang CH, Ma C, Chang TW, Lim C.
  • Structural and Physical Basis for Anti-IgE Therapy. Sci Rep. 2015 Jun 26;5:11581. doi: 10.1038/srep11581.
  • Yalcin AD. Advances in anti-IgE therapy. Biomed Res Int. 2015;2015:317465. doi: 10.1155/2015/317465.
  • Cooke A, Bulkhi A, Casale TB. Role of biologics in intractable urticaria. Biologics. 2015;9:25-33.
  • D’Amato G, Stanziola A, Sanduzzi A, Liccardi G, Salzillo A, Vitale C, Molino A, Vatrella A, D’Amato M. Treating severe allergic asthma with anti-IgE monoclonal antibody (omalizumab): a review. Multidiscip Respir Med. 2014;9(1):23. doi: 10.1186/2049-6958-9-23. eCollection 2014. Review
  • Kornmann O, Watz H, Fuhr R, Krug N, Erpenbeck VJ, Kaiser G. Omalizumab in patients with allergic (IgE-mediated) asthma and IgE/bodyweight combinations above those in the initially approved dosing table. Pulm Pharmacol Ther. 2014;28(2):149-53.
  • Sorkness CA, Wildfire JJ, Calatroni A, Mitchell HE, Busse WW, O’Connor GT, Pongracic JA, Ross K, Gill MA, Kattan M, Morgan WJ, Teach SJ, Gergen PJ, Liu AH, Szefler SJ. Reassessment of omalizumab-dosing strategies and pharmacodynamics in inner-city children and adolescents. J Allergy Clin Immunol Pract. 2013;1(2):163-71.
  • Incorvaia C, Mauro M, Russello M, Formigoni C, Riario-Sforza GG, Ridolo E. Omalizumab, an anti-immunoglobulin E antibody: state of the art. Drug Des Devel Ther. 2014;8:197-207.
  • Baker DL, Peng K, et al., Evaluation of two commercial omalizumab/free IgE immunoassays: implications of use during therapy. Curr Med Res Opin. 2014;30(5):913-22.
  • Somerville L, Bardelas J, Viegas A, D’Andrea P, Blogg M, Peachey G. Immunogenicity and safety of omalizumab in pre-filled syringes in patients with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2014;30(1):59-66.
  • Mortensen DL, Prabhu S, Stefanich EG, Kadkhodayan-Fischer S, Gelzleichter TR, Baker D, Jiang J, Wallace K, Iyer S, Fielder PJ, Putnam WS. Effect of antigen binding affinity and effector function on the pharmacokinetics and pharmacodynamics of anti-IgE monoclonal antibodies. MAbs. 2012;4(6):724-31.
  • Song CH, Stern S, Giruparajah M, Berlin N, Sussman GL. Long-term efficacy of fixed-dose omalizumab for patients with severe chronic spontaneous urticaria. Ann Allergy Asthma Immunol. 2013;110(2):113-7.
  • Korn S, Haasler I, Fliedner F, Becher G, Strohner P, Staatz A, Taube C, Buhl R. Monitoring free serum IgE in severe asthma patients treated with omalizumab. Respir Med. 2012;106(11):1494-500.
  • Matsuno O, Komori C, Hang Y, Matsumoto T, Minamoto S. Effectiveness of omalizumab in a patient with severe asthma, low serum IgE level, and lack of sensitized allergens induced by oral steroid therapy: the usefulness of impulse oscillation for assessment of omalizumab therapy. J Asthma. 2012;49(8):839-42.

Product Citations