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ANTIBODY TO OMALIZUMAB ELISA
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Omalizumab (Xolair®) in serum and plasma.
The solid phase (MTP) is coated by the drug Omalizumab. Due to the assay design this test measures the free antibodies which are not bound to Omalizumab. Results could be expressed in both qualitative and quantitative manner (nanogram per mililiter-ng/mL).
| Required Volume (µL) | 50 |
| Incubation Time (min) | 135 |
| Sample | Serum/Plasma |
| Plate Size | 96 Tests |
| Results in | Qualitative & Quantitative (ng/mL) |
| Shelf Life (years) | 2 |
Intended Use: This kit has been developed for the detection of anti-drug antibodies in research and diagnostic uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
Xolair® is a trademark of Genentech Inc.
ESSAY CHARACTERISTICS
ANALYTICAL SENSITIVITY-THRESHOLD VALUE
The Detection Threshold for the assay is 10 ng/mL.
The assay sensitivity for undiluted clinical samples corresponds to 20 ng/mL
Because the serum or plasma samples are instructed to be diluted at two-fold (1:2) before starting the assay.
ASSAY RANGE
For anti-Omalizumab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 200 ng/mL.
ASSAY PRECISION
Intra-assay CV:
Mean
CV (%)
200 <10 100 <10 50 <10
Inter-assay CV: <10%.
ASSAY RECOVERY
Recovery rate was found to be 85-115% using native serum and plasma samples spiked with exogenous Anti Drug Antibody (ADA) positive samples.
AUTOMATION
The ImmunoGuide ADA ELISA is suitable also for being used by an automated ELISA processor.
REFERENCES
1. Rasmus K. Jensen, Melanie Plum, Luna Tjerrild, Thilo Jakob, Edzard Spillner and Gregers Rom Andersen. 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. 2015 Oct 16. pii: S0091-6749(15)01247-6. doi: 10.1016/j.jaci.2015.08.023
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/journal.pone.0136549. eCollection 2015.
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 Jan;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-IgE monoclonal antibody (omalizumab): a review. Multidiscip Respir Med. 2014;9(1):23. doi: 10.1186/2049-6958-9-23. eCollection 2014. Review
12. 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.
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, 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.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION
Make-to-Order