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OMALIZUMAB ELISA (MAB-BASED)

OMALIZUMAB ELISA (MAB-BASED)

SKU: AB111
Enzyme immunoassay for the specific quantitative determination of free Omalizumab (Xolair®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Omalizumab.  Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)100
SampleSerum or Plasma
Plate Size96 Tests
Standard Range (ng/mL, 10x)0-1000
Detection Limit (ng/mL)2
Spike Recovery (%)>95
Shelf Life (years)2
 
Intended Use: This kit has been developed for the measurement of drug levels in research, diagnostic and biosimilar uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
 
Xolair® is a trademark of Genentech Inc.

  • ESSAY CHARACTERISTICS

    SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with different native human sera. All produced OD450/620 nm values less than the mean OD of standard D (3 ng/mL). In addition, human IgE antibody was also separately tested at concentrations up to 100 µg/mL and cross reaction was NOT observed. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Rituximab, Trastuzumab, Tocilizumab and Bevacizumab at concentrations up to 2 mg/mL. All produced mean OD450/620 nm values less than the mean OD of standard D.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 1 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 1 ng/mL, and corresponding to the detection limit (limit of quantification) of 1 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:1000 before starting the assay.

     

    PRECISION OF THE KIT

    Intra-assay CV: <10%.

    Inter-assay CV: <10%.

     

    RECOVERY

    Recovery rate was found to be >95% with native human serum and plasma samples when spiked with exogenous Omalizumab.

     

    AUTOMATION

    The ImmunoGuide Omalizumab ELISA (mAb-based) is suitable also for being used by an automated ELISA processor.

  • REFERENCES

    1. Rasmus K. Jensen, Melanie Plum, Luna Tjerrild, et al., Structure of the omalizumab Fab. Acta Cryst. (2015). F71, 419–426.

    2. 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.

    3. 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. 2016 Feb;137(2):474-81.

    4. 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.

    5. 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.

    6. 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.

    7. Beam KT, Coop CA. Steroid sparing effect of omalizumab in seropositive allergic bronchopulmonary aspergillosis. Allergy Rhinol (Providence). 2015; 6(2): 143-5.

    8. 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.

    9. Yalcin AD. Advances in anti-IgE therapy. Biomed Res Int. 2015;2015:317465. doi: 10.1155/2015/317465.

    10. Cooke A, Bulkhi A, Casale TB. Role of biologics in intractable urticaria. Biologics. 2015;9:25-33.

    11. 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-IgEmonoclonal antibody (omalizumab): a review. Multidiscip Respir Med.2014;9(1):23. doi: 10.1186/2049-6958-923. eCollection 2014. Review

    12. Kornmann O, Watz H, Fuhr R, Krug N, Erpenbeck VJ, Kaiser G. Omalizumabin patients with allergic (IgE-mediated) asthma and IgE/bodyweight combinationsabove those in the initially approved dosing table. Pulm Pharmacol Ther.2014;28(2):149-53.

    13. 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, LiuAH, Szefler SJ. Reassessment of omalizumab-dosing strategies andpharmacodynamics in inner-city children and adolescents. J Allergy Clin ImmunolPract. 2013;1(2):163-71.

    14. 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 DevelTher. 2014;8:197-207.

    15. Baker DL, Peng K, et al., Evaluation of two commercial omalizumab/free IgEimmunoassays: implications of use during therapy. Curr Med Res Opin.2014;30(5):913-22.

    16. Somerville L, Bardelas J, Viegas A, D'Andrea P, Blogg M, Peachey G.Immunogenicity and safety of omalizumab in pre-filled syringes in patients withallergic (IgE-mediated) asthma. Curr Med Res Opin. 2014;30(1):59-66.

    17. Mortensen DL, Prabhu S, Stefanich EG, Kadkhodayan-Fischer S, GelzleichterTR, Baker D, Jiang J, Wallace K, Iyer S, Fielder PJ, Putnam WS. Effect of antigenbinding affinity and effector function on the pharmacokinetics andpharmacodynamics of anti-IgE monoclonal antibodies. MAbs. 2012;4(6):724-31.

    18. Song CH, Stern S, Giruparajah M, Berlin N, Sussman GL. Long-term efficacyof fixeddose omalizumab for patients with severe chronic spontaneous urticaria.Ann Allergy Asthma Immunol. 2013;110(2):113-7.

    19. Korn S, Haasler I, Fliedner F, Becher G, Strohner P, Staatz A, Taube C, BuhlR. Monitoring free serum IgE in severe asthma patients treated with omalizumab.Respir Med. 2012;106(11):1494-500.

    20. Matsuno O, Komori C, Hang Y, Matsumoto T, Minamoto S. Effectiveness ofomalizumab in a patient with severe asthma, low serum IgE level, and lack ofsensitized allergens induced by oral steroid therapy: the usefulness of impulseoscillation for assessment of omalizumab therapy. J Asthma. 2012;49(8):839-42.

  • INSTRUCTIONS FOR USE

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  • SAFETY DATA SHEET

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  • BATCH/LOT INFORMATION

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