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ADALIMUMAB ELISA (MAB-BASED)

ADALIMUMAB ELISA (MAB-BASED)

SKU: AB103
Enzyme immunoassay for the specific and quantitative determination of free Adalimumab (Humira®) in serum and plasma.
The solid phase (MTP) is coated with a highly specific monoclonal antibody against Adalimumab.
Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)105
SampleSerum or Plasma
Plate Size96 Tests
Standard Range (ng/mL, 10x)0-1500
Sensitivity (ng/mL)3
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.
 
Humira® is a trademark of Abbott Laboratories.
 

  • ESSAY CHARACTERISTICS

    SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 80 different native human sera. All produced OD450/620 nm values less than the mean OD of standard D. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Golimumab, Etanercept, Vedolizumab, Tocilizumab, Aflibercept, Rituximab, Trastuzumab, Bevacizumab, Nivoluzimab, Omalizumab and Cetuximab each tested up to 2mg/mL. All produced mean OD450/620 nm values less than the mean OD of standard D. Because the conjugate, i.e. POD-1B5, used in the AB103 ELISA system is specific for the Fc part of human IgG, cross reaction with Certolizumab Pegol (CZP) could not be evaluated. Therefore, cross reaction of the IG-3D12b monoclonal antibody with CZP was tested using a different but a convenient conjugate, i.e. peroxidase labeled anti human kappa monoclonal antibody, and the result was negative as well.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 3 ng/mLL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 3 ng/mL, and corresponding to the detection limit of 0.3 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:100 before starting the assay

     

    PRECISION

    Intra-assay CV: <10%.

    Inter-assay CV: <10%.

     

    RECOVERY

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

     

    AUTOMATION

    The ImmunoGuide Adalimumab ELISA is suitable also for being used by an automated ELISA processor.

  • REFERENCES

    1. Romero G, Ochoteco O, Sanz DJ, Estrela-Lopis I, Donath E, Moya SE. Poly(lactide-co-glycolide) nanoparticles, layer by layer engineered for the sustainable delivery of antiTNF-α. Macromol Biosci. 2013 Jul;13(7):903-12.

    2. Takahashi H, Tsuji H, Ishida-Yamamoto A, Iizuka H. Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis. J Dermatol. 2013;40(1):39-42.

    3. Gutiérrez A, Scharl M, Sempere L, Holler E, Zapater P, Almenta I, González-Navajas JM, Such J, Wiest R, Rogler G, Francés R. Genetic susceptibility to increased bacterial translocation influences the response to biological therapy in patients with Crohn's disease. Gut. 2014;63(2):272-80.

    4. Oh K, Ito S, Unno M, Kobayashi D, Azuma C, Abe A, Otani H, Ishikawa H, Nakazono K, Narita I, Murasawa A. The rate of decrease in the disease activity of rheumatoid arthritis during treatment with adalimumab depends on the dose of methotrexate. Intern Med. 2015;54(9):1035-41.

    5. Chen DY, Chen YM, Hsieh TY, Hung WT, Hsieh CW, Chen HH, Tang KT, Lan JL. Drug trough levels predict therapeutic responses to dose reduction of adalimumab for rheumatoid arthritis patients during 24 weeks of follow-up. Rheumatology (Oxford). 2015 Aug 31. pii: kev298.

    6. Brandse JF, Vos LM, Jansen J, Schakel T, Ponsioen CI, van den Brink GR, D'Haens GR, Löwenberg M. Serum Concentration of Anti-TNF Antibodies, Adverse Effects and Quality of Life in Patients with Inflammatory Bowel Disease in Remission on Maintenance Treatment. J Crohns Colitis. 2015;9(11):973-81.

    7. Eng GP, Bendtzen K, Bliddal H, Stoltenberg M, Szkudlarek M, Fana V, Lindegaard HM, Omerovic E, Højgaard P, Jensen EK, Bouchelouche PN. Antibodies to infliximab and adalimumab in patients with rheumatoid arthritis in clinical remission: a cross-sectional study. Arthritis. 2015;2015:784825. doi: 10.1155/2015/784825.

    8. Bodini G, Savarino V, Peyrin-Biroulet L, de Cassan C, Dulbecco P, Baldissarro I, Fazio V, Giambruno E, Savarino E. Low serum trough levels are associated with post-surgical recurrence in Crohn's disease patients undergoing prophylaxis with adalimumab. Dig Liver Dis. 2014;46(11):1043-6.

    9. Tanida S, Mizoshita T, Nishie H, Ozeki K, Katano T, Kubota E, Kataoka H, Kamiya T, Joh T. Combination Therapy With Adalimumab Plus Intensive Granulocyte and Monocyte Adsorptive Apheresis in Patients With Refractory Ulcerative Colitis. J Clin Med Res. 2015;7(11):884-9.

    10. Sohn IW, Kim ST, Kim B, Lee HJ, Park SJ, Hong SP, Kim TI, Kim WH, Cheon JH. Efficacy of Adalimumab in Korean Patients with Crohn's Disease. Gut Liver. 2015 Oct 19. doi: 10.5009/gnl15165.

    11. Fox JD, Baquerizo-Nole KL, Keegan BR, Macquhae F, Escandon J, Espinosa A, Perez C, Romanelli P, Kirsner RS. Adalimumab treatment leads to reduction of tissue tumor necrosis factor-alpha correlated with venous leg ulcer improvement: a pilot study. Int Wound J. 2015 Sep 24. doi: 10.1111/iwj.12497.

    12. Bálint A, Farkas K, Palatka K, Lakner L, Miheller P, Rácz I, Hegede G, Vincze Á, Horváth G, Szabó A, Nagy F, Szepes Z, Gábor Z, Zsigmond F, Zsóri Á, Juhász M, Csontos Á, Szűcs M, Bor R, Milassin Á, Rutka M, Molnár T. Efficacy and Safety of Adalimumab in Ulcerative Colitis Refractory to Conventional Therapy inRoutine Clinical Practice. J Crohns Colitis. 2015 Sep 20. pii: jjv169.

    13. Migliore A, Bizzi E, Egan CG, Bernardi M, Petrella L. Efficacy of biologicalagents administered as monotherapy in rheumatoid arthritis: a Bayesian mixed-treatment comparison analysis. Ther Clin Risk Manag. 2015;11:1325-35.

    14. Sagami S, Ueno Y, Tanaka S, Nagai K, Hayashi R, Chayama K. SuccessfulUse of Adalimumab for Treating Pyoderma Gangrenosum with Ulcerative Colitisunder Corticosteroid-tapering Conditions. Intern Med. 2015;54(17):2167-72.

    15. Thomas SS, Borazan N, Barroso N, Duan L, Taroumian S, Kretzmann B,Bardales R, Elashoff D, Vangala S, Furst DE. Comparative Immunogenicity ofTNF Inhibitors: Impact on Clinical Efficacy and Tolerability in the Management ofAutoimmune Diseases. A Systematic Review and Meta-Analysis. BioDrugs. 2015Aug;29(4):241-58.

    16. Otsuka A, Morita M, Yamada H. Clinical characteristics of Japanese patientswith axial spondyloarthritis, and short-term efficacy of adalimumab. J Orthop Sci.2015 Aug 6.

    17. Real-Fernández F, Cimaz R, Rossi G, Simonini G, Giani T, Pagnini I, PapiniAM, Rovero P. Surface plasmon resonance-based methodology for anti-adalimumab antibody identification and kinetic characterization. Anal BioanalChem. 2015;407(24):7477-85.

    18. Arstikyte I, Kapleryte G, Butrimiene I, Venalis A. Influence of Immunogenicityon the Efficacy of Long-Term Treatment with TNF α Blockers in RheumatoidArthritis and Spondyloarthritis Patients. Biomed Res Int. 2015;2015:604872. doi:10.1155/2015/604872. Epub 2015 Apr 27.

    19. Garcês S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNFtherapy in immune-mediated inflammatory diseases: a systematic review of theliterature with a meta-analysis. Ann Rheum Dis. 2013;72(12):1947-55.

    20. Deehan M, Garcês S, Kramer D, Baker MP, Rat D, Roettger Y, Kromminga A.Managing unwanted immunogenicity of biologicals. Autoimmun Rev.2015;14(7):569-74.

  • INSTRUCTIONS FOR USE

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  • SAFETY DATA SHEET

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  • BATCH/LOT INFORMATION

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