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BEVACIZUMAB ELISA (MAB-BASED)

BEVACIZUMAB ELISA (MAB-BASED)

SKU: AB104
Enzyme immunoassay for the specific and quantitative determination of free Bevacizumab (Avastin) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Bevacizumab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies, even with its 5 pointmutation Fab counterpart (Ranibizumab) is excluded.
 
Required Volume (µL) 10
Incubation Time (min) 100
Sample Serum or Plasma
Plate Size96 Tests
Standard Range (µg/mL, 1000x) 0-200
Detection Limit (ng/mL)5
Spike Recovery (%) >95%
Shelf Life (years)2
 
Intended Use: This kit has been developed for the measurement of drug levels in research and diagnostic uses.  It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
 
Avastin® is a trademark of Genentech Inc./Roche.

  • ESSAY CHARACTERISTICS

    SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 48 different native human sera. All produced OD450/620 nm values (ranged from 0.022 to 0.042) less than the mean OD (0.132) of standard D (6 ng/mL). In addition, binding of Bevacizumab is inhibited by recombinant human VEGF-A in a concentration dependent manner. Therefore, the ImmunoGuide Bevacizumab ELISA (mAb-Based) measures the biologically active free form of Bevacizumab, i.e. not pre-occupied by VEGF. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Rituximab, Tocilizumab, Trastuzumab, Aflibercept and Golimumab at concentrations up to 2 mg/mL. All produced mean OD450/620 nm values ranged from 0.009 to 0.022. In addition, there is no cross reaction with Ranibizumab as well. Because when anti-human kappa monoclonal antibody was used as the conjugate instead, Ranibizumab did not bind to MAY-2B5 mAb-coated plate.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 2 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 2 ng/mL, and corresponding to the detection limit (limit of quantification) of 2 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

    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 Bevacizumab at 200 µg/mL, 60 µg/mL, 20 µg/mL or 6 µg/mL.

     

    AUTOMATION

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

  • REFERENCES

    1. Li J, Gupta M; Jin D, Xin Y, Visich J, Allison DE, Characterization of the long-term pharmacokinetics of bevacizumab following last dose in patients with resected stag II and III carcinoma of the colon, Cancer Chemother Pharmacol, 2013; 71: 575–580.

    2. Panoilia E, Schindler E, Samantas E, Aravantinos G, Kalofonos HP, Christodoulou C, Patrinos GP, Friberg LE, Sivolapenko G, A pharmacokinetic binding model for bevacizumab and VEGF165 in colorectal cancer patients, Cancer Chemother Pharmacol. 2015; 75:791–803.

    3. Knight B, Rassam D, Liao S, Ewesuedo R. A phase I pharmacokinetics study comparing PF‑06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers, Cancer Chemother Pharmacol. 2016;77:839–846.

    4. Azzopardi N, Dupuis-Girod S, Ternant D, Fargeton AE, Ginon I,et al., Dose – response relationship of bevacizumab in hereditary hemorrhagic telangiectasia, mAbs. 2015; 7 (3): 630—637.

    5. Han K, Peyret T, Quartino A, Gosselin NH, Gururangan S, Daw NC, Navid F, Jin J, Allison DE. Bevacizumab dosing strategy in pediatric cancer patients based on population pharmacokinetic analysis with external validation. Br J Clin Pharmacol. 2015 Sep 7. doi: 10.1111/bcp.12778.

    6. Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41.

    7. Bunni J, Shelley-Fraser G, Stevenson K, Oltean S, Salmon A, Harper SJ, Carter JG, Bates DO. Circulating levels of anti-angiogenic VEGF-A isoform (VEGF-Axxxb) in colorectal cancer patients predicts tumour VEGF-A ratios. Am J Cancer Res. 2015;5(6):2083-9.

    8. Imbs DC, Négrier S, Cassier P, Hollebecque A, Varga A, Blanc E, Lafont T, Escudier B, Soria JC, Pérol D, Chatelut E. Pharmacokinetics of pazopanib administered in combination with bevacizumab. Cancer Chemother Pharmacol. 2014 Jun;73(6):1189-96.

    9. Stewart MW, Rosenfeld PJ, Penha FM, Wang F, Yehoshua Z, Bueno-Lopez E, Lopez PF. Pharmacokinetic rationale for dosing every 2 weeks versus 4 weeks with intravitreal ranibizumab, bevacizumab, and aflibercept (vascular endothelial growth factor Trap-eye). Retina. 2012 Mar;32(3):434-57.

    10. Li Q, Yan H, Zhao P, Yang Y, Cao B. Efficacy and Safety of Bevacizumab Combined with Chemotherapy for Managing Metastatic Breast Cancer: A Meta-Analysis of Randomized Controlled Trials. Sci Rep. 2015 Oct 27;5:15746. doi: 10.1038/srep15746.

    11. Tang N, Guo J, Zhang Q, Wang Y, Wang Z. Greater efficacy of chemotherapy plus bevacizumab compared to chemo- and targeted therapy alone on non-small cell lung cancer patients with brain metastasis. Oncotarget. 2015 Oct 20. doi: 10.18632/oncotarget.6184.

    12. Ogata H, Kikuchi Y, Natori K, et al. Liver Metastasis of a Triple-Negative Breast Cancer and Complete Remission for 5 Years After Treatment With Combined Bevacizumab/Paclitaxel/Carboplatin: Case Report and Review of the Literature. Medicine (Baltimore). 2015 Oct;94(42):e1756. doi: 10.1097/MD.0000000000001756.

    13. Guo J, Glass JO, McCarville MB, Shulkin BL, Daryani VM, Stewart CF, Wu J, Mao S, Dwek JR, et al. Assessing vascular effects of adding bevacizumab to neoadjuvant chemotherapy in osteosarcoma using DCE-MRI. Br J Cancer. 2015;113(9):1282-8. Mol Clin Oncol. 2014;2(1):166-170.

    14. Ba J, Peng RS, Xu D, Li YH, Shi H, Wang Q, Yu J. Intravitreal anti-VEGF injections for treating wet age-related macular degeneration: a systematic review and meta-analysis. Drug Des Devel Ther. 2015;9:5397-405.

    15. Li X, Huang R, Xu Z. Risk of Adverse Vascular Events in Newly Diagnosed Glioblastoma Multiforme Patients Treated with Bevacizumab: a Systematic Review and Meta-Analysis. Sci Rep. 2015 Oct 1;5:14698. doi: 10.1038/srep14698

    16. Gruenberg J, Manivel JC, Gupta P, Dykoski R, Mesa H. Fatal acute cardiac vasculopathy during cisplatin-gemcitabine-bevacizumab (CGB) chemotherapy for advanced urothelial carcinoma. J Infect Chemother. 2015 Sep 27. pii: S1341-321X(15)00198-1. doi: 10.1016/j.jiac.2015.08.015.

    17. Kaneko E, Niwa R. Optimizing therapeutic antibody function: progress with Fc domain engineering. BioDrugs. 2011;25(1):1-11.

    18. Wong ET, Lok E, Swanson KD. Clinical benefit in recurrent glioblastoma from adjuvant NovoTTF-100A and TCCC after temozolomide and bevacizumab failure: a preliminary observation. Cancer Med. 2015;4(3):383-91.

    19. Salgia R, Patel P, Bothos J, Yu W, Eppler S, Hegde P, Bai S, Kaur S, Nijem I, Catenacci DV, Peterson A, Ratain MJ, Polite B, Mehnert JM, Moss RA Phase I dose-escalation study of onartuzumab as a single agent and in combination with bevacizumab in patients with advanced solid malignancies. Clin Cancer Res. 2014;20(6):1666-75.

    20. Wang H, Shi J, Wang Q, Li H, Cai K, Hou X, Li T, Zhong Q, Yu D. Assessment of the pre-clinical immunogenicity of a new VEGF receptor Fc-fusion protein FP3 with ELISA and BIACORE. Cancer Immunol Immunother. 2010;59(2):239-46.

     

  • INSTRUCTIONS FOR USE

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  • SAFETY DATA SHEET

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  • BATCH/LOT INFORMATION

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