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CETUXIMAB ELISA (MAB-BASED)

CETUXIMAB ELISA (MAB-BASED)

SKU: AB112
Enzyme immunoassay for the specific and quantitative determination of free Cetuximab (Erbitux®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Cetuximab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL) 10
Incubation Time (min) 100
Sample Serum or Plasma
Plate Size96 Tests
Standard Range (ng/mL, 10x) 0-2000
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.
 
Erbitux® is a trademark of ImClone LLC.

  • 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 0.011 to 0.058) less than the mean OD (0.125) of standard D (6 ng/mL). In addition, binding of Cetuximab is inhibited by recombinant human epidermal growth factor receptor (hEGFR) protein in a concentration dependent manner. Therefore, the ImmunoGuide Cetuximab ELISA (mAb-Based) measures the biologically active free form of Cetuximab, i.e. not pre-occupied by human EGF Receptor. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Rituximab, Tocilizumab, Trastuzumab, Aflibercept and Bevacizumab at concentrations up to 2 mg/mL. All produced mean OD450/620 nm values ranged from 0.009 to 0. 027.

     

    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 Cetuximab.

     

    AUTOMATION

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

  • REFERENCES

    1. Greening DW, Lee ST, Ji H, Simpson RJ, Rigopoulos A, Murone C, Fang C, Gong S, O'Keefe G, Scott AM. Molecular profiling of cetuximab and bevacizumab treatment of colorectal tumours reveals perturbations in metabolic and hypoxic response pathways. Oncotarget. 2015;6(35):38166-80.

    2. Lupini L, Bassi C, Mlcochova J, Musa G, Russo M, Vychytilova-Faltejskova P, Svoboda M, Sabbioni S, Nemecek R, Slaby O, Negrini M. Prediction of response to anti-EGFR antibody-based therapies by multigene sequencing in colorectal cancer patients. BMC Cancer. 2015 Oct 27;15:808. doi: 10.1186/s12885-015-1752-5.

    3. Tabernero J, Ciardiello F, Rivera F, Rodriguez-Braun E, Ramos FJ, Martinelli E, Vega-Villegas ME, Roselló S, Liebscher S, Kisker O, Macarulla T, Baselga J, Cervantes A. Cetuximab administered once every second week to patients with metastatic colorectal cancer: a two-part pharmacokinetic/pharmacodynamic phase I dose-escalation study. Ann Oncol. 2010;21(7):1537-45.

    4. Zhu AX, Stuart K, Blaszkowsky LS, Muzikansky A, Reitberg DP, Clark JW, Enzinger PC, Bhargava P, Meyerhardt JA, Horgan K, Fuchs CS, Ryan DP. Phase 2 study of cetuximab in patients with advanced hepatocellular carcinoma. Cancer. 2007;110(3):581-9.

    5. Tan AR, Moore DF, Hidalgo M, Doroshow JH, Poplin EA, Goodin S, Mauro D, Rubin EH. Pharmacokinetics of cetuximab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors. Clin Cancer Res. 2006;12(21):6517-22.

    6. Lu X, Chen X, Sun J, Gao P, Song Y, Huang X, Luo Y, Chen P, Wang Z. Polymorphism in epidermal growth factor is related to clinical outcomes of metastatic colorectal cancer patients treated with cetuximab: a systematic review and meta-analysis. Int J Clin Exp Med. 2015;8(7):10929-37.

    7. Boeckx C, Blockx L, de Beeck KO, Limame R, Camp GV, Peeters M, Vermorken JB, Specenier P, Wouters A, Baay M, Lardon F. Establishment and characterization of cetuximab resistant head and neck squamous cell carcinoma cell lines: focus on thecontribution of the AP-1 transcription factor. Am J Cancer Res. 2015;5(6):1921-38.

    8. Kurokawa M, Watanabe Nemoto M, Harada R, Kobayashi H, Horikoshi T, Kanazawa A,Togasaki G, Abe Y, Chazono H, Hanazawa T, Okamoto Y, Uno T. Initial experience ofradiotherapy plus cetuximab for Japanese head and neck cancer patients. J Radiat Res.2015;56(5):849-55.

    9. de Boer E, Warram JM, Tucker MD, Hartman YE, Moore LS, de Jong JS, Chung TK,Korb ML, Zinn KR, van Dam GM, Rosenthal EL, Brandwein-Gensler MS. In VivoFluorescence Immunohistochemistry: Localization of Fluorescently Labeled Cetuximab inSquamous Cell Carcinomas. Sci Rep. 2015 Jun 29;5:10169. doi: 10.1038/srep10169

    10. Fiorentini G, Aliberti C, Sarti D, Coschiera P, Tilli M, Mulazzani L, Giordani P, GrazianoF, Gonzalez AM, Marcos RG, Mugnoz FG, Cantore M, Ricci S, Catalano V, Mambrini A.Locoregional therapy and systemic cetuximab to treat colorectal liver metastases. World JGastrointest Oncol. 2015;7(6):47-54.

    11. Hecht JR, Douillard JY, Schwartzberg L, Grothey A, Kopetz S, Rong A, Oliner KS, SidhuR. Extended RAS analysis for anti-epidermal growth factor therapy in patients withmetastatic colorectal cancer. Cancer Treat Rev. 2015;41(8):653-9.

    12. Li XX, Liang L, Huang LY, Cai SJ. Standard chemotherapy with cetuximab for treatmentof colorectal cancer. World J Gastroenterol. 2015;21(22):7022-35.

    13. Shih YH, Peng CL, Lee SY, Chiang PF, Yao CJ, Lin WJ, Luo TY, Shieh MJ. 111In-cetuximab as a diagnostic agent by accessible epidermal growth factor (EGF) receptortargeting in human metastatic colorectal carcinoma. Oncotarget. 2015;6(18):16601-10.

    14. Song QB, Wang Q, Hu WG. Anti-epidermal growth factor receptor monoclonalantibodies in metastatic colorectal cancer: a meta-analysis. World J Gastroenterol.2015;21(14):4365-72.

    15. Tsukihara H, Nakagawa F, Sakamoto K, Ishida K, Tanaka N, Okabe H, Uchida J,Matsuo K, Takechi T. Efficacy of combination chemotherapy using a novel oralchemotherapeutic agent, TAS-102, together with bevacizumab, cetuximab, or panitumumabon human colorectal cancer xenografts. Oncol Rep. 2015;33(5):2135-42.

    16. Takahashi N, Yamada Y, Furuta K, Nagashima K, Kubo A, Sasaki Y, Shoji H, Honma Y,Iwasa S, Okita N, Takashima A, Kato K, Hamaguchi T, Shimada Y. Association betweenserum ligands and the skin toxicity of anti-epidermal growth factor receptor antibody inmetastatic colorectal cancer. Cancer Sci. 2015;106(5):604-10.

    17. Stintzing S. Management of colorectal cancer. F1000Prime Rep. 2014 Nov 4;6:108. doi:10.12703/P6-108. eCollection 2014. Review.

    18. Shirao K, Yoshino T, Boku N, Kato K, Hamaguchi T, Yasui H, Yamamoto N, TanigawaraY, Nolting A, Yoshino S. A phase I escalating single-dose and weekly fixed-dose study ofcetuximab pharmacokinetics in Japanese patients with solid tumors. Cancer ChemotherPharmacol. 2009;64(3):557-64.

    19. Gao B, Yeap S, Clements A, Balakrishnar B, Wong M, Gurney H. Evidence fortherapeutic drug monitoring of targeted anticancer therapies. J Clin Oncol.2012;30(32):4017-25.

    20. Cézé N, Ternant D, Piller F, Degenne D, Azzopardi N, Dorval E, Watier H, Lecomte T,Paintaud G. An enzyme-linked immunosorbent assay for therapeutic drug monitoring ofcetuximab. Ther Drug Monit. 2009;31(5):597-601.

  • INSTRUCTIONS FOR USE

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  • SAFETY DATA SHEET

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  • BATCH/LOT INFORMATION

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