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GOLIMUMAB ELISA (MAB-BASED)

GOLIMUMAB ELISA (MAB-BASED)

SKU: AB107
Enzyme immunoassay for the specific and quantitative determination of free Golimumab (Simponi®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Golimumab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)100
SampleSerum or Plasma
Package Size96 Tests
Standard Range (ng/mL, 10x)0-1500
Sensitivity (ng/mL)4
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.
 
Simponi® is a trademark of Janssen Biotech, Inc./Merck & Co.

  • 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 less than the mean OD of standard D. In addition, binding of Golimumab is inhibited by recombinant human TNF-alpha in a concentration dependent manner. Therefore, the ImmunoGuide Golimumab ELISA (mAb-Based) measures the biologically active free form of Golimumab, i.e. not pre-occupied by TNF-alpha. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Rituximab, Trastuzumab, Tocilizumab, Omalizumab and Bevacizumab at concentrations up to 2 mg/mL.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 4 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 4 ng/mL, and corresponding to the detection limit of 0.2 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:50 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 Golimumab.

     

    AUTOMATION

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

  • REFERENCES

    1. Gelfer G, Perry L, Deodhar A. Golimumab for the treatment of axial spondyloarthritis. Expert Rev Clin Immunol. 2015; 2:1-10.

    2. Lichtenstein GR, Hanauer SB, Sandborn WJ. Emerging Treatment Options in Mild to Moderate Ulcerative Colitis. Gastroenterol Hepatol (N Y). 2015;11(3 Suppl 1):1-16.

    3. Emery P, Fleischmann RM, Strusberg I, Durez P, Nash P, Amante E, Churchill M, Park W, Pons-Estel B, Han C, Gathany TA, Xu S, Zhou Y, Leu JH, Hsia EC. Efficacy and safety of subcutaneous golimumab in methotrexate-naïve patients with rheumatoid arthritis: 5-year results of the GO-BEFORE trial. Arthritis Care Res (Hoboken). 2015 Oct 16. doi: 10.1002/acr.22759

    4. Lee WK, Kim GW, Cho HH, Kim WJ, Mun JH, Song M, Kim HS, Ko HC, Kim MB, Kim BS. Erythrodermic Psoriasis Treated with Golimumab: A Case Report. Ann Dermatol. 2015 Aug;27(4):446-9.

    5. Brady BL, Tkacz JP, Lofland J, Meyer R, Bolge SC. Prescribing Patterns of Intravenous Golimumab for Rheumatoid Arthritis. Clin Ther. 2015;37(9):2028-36.

    6. Yonemoto Y, Okamura K, Takeuchi K, Ayabe K, Kaneko T, Matsushita M, Tamura Y, Iso T, Okura C, Otsuka K, Inoue H, Takagishi K. Comparison of golimumab 100-mg monotherapy to golimumab 50 mg plus methotrexate in patients with rheumatoid arthritis: Results from a multicenter, cohort study. Mod Rheumatol. 2015; 3:1-5.

    7. Abreu MT Commentary: Golimumab in Moderate-to-Severe Ulcerative Colitis. Gastroenterol Hepatol (N Y). 2014;10(7):455-6.

    8. Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Järnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):85-95.

    9. Thorlund K, Druyts E, Toor K, Mills EJ. Comparative efficacy of golimumab, infliximab, and adalimumab for moderately to severely active ulcerative colitis: a network meta-analysis accounting for differences in trial designs. Expert Rev Gastroenterol Hepatol. 2015;9(5):693-700.

    10. Kanbe K, Chiba J, Inoue Y, Taguchi M, Yabuki A. Predictive factors related to the efficacy of golimumab in patients with rheumatoid arthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2015;8:25-32.

    11. McCarty DJ. Golimumab intravenous infusion for the treatment of rheumatoid arthritis. Nurse Pract. 2015;40(3):15-8.

    12. Smolen JS, Kay J, Doyle M, Landewé R, Matteson EL, Gaylis N, Wollenhaupt J, Murphy FT, Xu S, Zhou Y, Hsia EC. Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study. Arthritis Res Ther. 2015 Jan 22;17:14. doi: 10.1186/s13075-015-0516-6.

    13. Sato E, Tanaka E, Nakajima A, Inoue E, Shimizu Y, Yamaguchi R, Ochiai M, Shidara K, Hoshi D, Sugimoto N, Seto Y, Taniguchi A, Momohara S, Yamanaka H. Assessment of the effectiveness of golimumab 50-mg and 100-mg regimens in patients with rheumatoid arthritis in daily practice. Mod Rheumatol. 2015;25(4):528-33.

    14. Selmi C, Ceribelli A, Naguwa SM, Cantarini L, Shoenfeld Y. Safety issues and concerns of new immunomodulators in rheumatology. Expert Opin Drug Saf. 2015;14(3):389-99.

    15. Doyle MK, Rahman MU, Frederick B, Birbara CA, de Vries D, Toedter G, Wu X, Chen D, Ranganath VK, Westerman ME, Furst DE. Effects of subcutaneous and intravenous golimumab on inflammatory biomarkers in patients with rheumatoid arthritis: results of a phase 1, randomized, open-label trial. Rheumatology (Oxford). 2013;52(7):1214-9.

    16. Chen DY, Chen YM, Hung WT, Chen HH, Hsieh CW, Chen YH, Huang WN, Hsieh TY. Immunogenicity, drug trough levels and therapeutic response in patients with rheumatoid arthritis or ankylosing spondylitis after 24-week golimumab treatment. Ann Rheum Dis. 2015 Oct 6. pii: annrheumdis-2015-207978. doi: 10.1136/annrheumdis-2015-207978.

    17. Huynh C, Reguiai Z, Lambrecht I, Brochot P, Eschard JP, Salmon JH. First two cases of alopecia areata during golimumab therapy. Joint Bone Spine. 2015 Oct 7. pii: S1297-319X(15)00178-5. doi: 10.1016/j.jbspin.2015.08.007. [Epub ahead of print]

    18. Brunasso AM, Aberer W, Massone C. Subacute lupus erythematosus during treatment with golimumab for seronegative rheumatoid arthritis. Lupus. 2014;23(2):201-3.

    19. Zhuang Y, Lyn S, Lv Y, Xu Z, Bouman-Thio E, Masterson T, Ford JA, Keen M, Petty KJ, Davis HM, Zhou H. Pharmacokinetics and safety of golimumab in healthy Chinese subjects following a single subcutaneous administration in a randomized phase I trial. Clin Drug Investig. 2013;33(11):795-800.

    20. Murdaca G, Spanò F, Puppo F. Selective TNF-α inhibitor-induced injection site reactions. Expert Opin Drug Saf. 2013;12(2):187-93.

  • INSTRUCTIONS FOR USE

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  • SAFETY DATA SHEET

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  • BATCH/LOT INFORMATION

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