top of page
ETANERCEPT ELISA (MAB-BASED)

ETANERCEPT ELISA (MAB-BASED)

SKU: AB102
Enzyme immunoassay for the specific and quantitative determination of free Etanercept (Enbrel®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Etanercept. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)100
SampleSerum 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.
 
Enbrel® is a trademark of Amgen.
 

  • ESSAY CHARACTERISTICS

    SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum and no cross reaction was observed with the other therapeutic antibodies including Infliximab, Adalimumab and Golimumab tested at concentrations up to 500 µg/mL.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 5 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 5 ng/mL, and corresponding to the detection limit (limit of quantification) of 0.25 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%.10

     

    RECOVERY

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

     

    AUTOMATION

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

  • REFERENCES

    1. Cheong CU, Chang CP, Chao CM, Cheng BC, Yang CZ, Chio CC. Etanercept attenuates traumatic brain injury in rats by reducing brain TNF- α contents and by stimulating newly formed neurogenesis. Mediators Inflamm. 2013;2013:620837. doi: 10.1155/2013/620837.

    2. Jung YS, Park W, Na K. Temperature-modulated noncovalent interaction controllable complex for the long-term delivery of etanercept to treat rheumatoid arthritis. J Control Release. 2013 Oct 28;171(2):143-51.

    3. Erdemli Ö, Özen S, Keskin D, Usanmaz A, Batu ED, Atilla B, Tezcaner A. In vitro evaluation of effects of sustained anti-TNF release from MPEG-PCL-MPEG and PCL microspheres on human rheumatoid arthritis synoviocytes. J Biomater Appl. 2014 Oct;29(4):524-42.

    4. Chen DY, Chen YM. Response to: 'Towards optimal cut-off trough levels of adalimumab and etanercept for a good therapeutic response in rheumatoid arthritis. Results of the INMUNOREMAR study' by Sanmarti et al. Ann Rheum Dis. 2015;74(8):e43. doi: 10.1136/annrheumdis-2015-207543.

    5. Jani M, Chinoy H, Warren RB, Griffiths CE, Plant D, Fu B, Morgan AW, Wilson AG, Isaacs JD, Hyrich K, Barton A; Biologics in Rheumatoid Arthritis Genetics and Genomics Study Syndicate Collaborators. Clinical utility of random anti-tumor necrosis factor drug-level testing and measurement of antidrug antibodies on the long-term treatment response in rheumatoid arthritis. Arthritis Rheumatol. 2015 May;67(8):2011-9

    6. Kneepkens EL, Krieckaert CL, van der Kleij D, Nurmohamed MT, van der Horst-Bruinsma IE, Rispens T, Wolbink GJ. Lower etanercept levels are associated with high disease activity in ankylosing spondylitis patients at 24 weeks of follow-up. Ann Rheum Dis. 2015 Oct;74(10):1825-9.

    7. Chen DY, Chen YM, Tsai WC, Tseng JC, Chen YH, Hsieh CW, Hung WT, Lan JL. Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis. Ann Rheum Dis. 2015 Mar;74(3):e16. doi: 10.1136/annrheumdis-2013-203893.

    8. Garcês S, Antunes M, Benito-Garcia E, da Silva JC, Aarden L, Demengeot J. A preliminary algorithm introducing immunogenicity assessment in the management of patients with RA receiving tumour necrosis factor inhibitor therapies. Ann Rheum Dis. 2014 Jun;73(6):1138-43.

    9. Mahil SK, Arkir Z, Richards G, Lewis CM, Barker JN, Smith CH. Predicting treatment response in psoriasis using serum levels of adalimumab and etanercept: a single-centre, cohort study. Br J Dermatol. 2013 Aug;169(2):306-13.

    10. Sivamani RK, Goodarzi H, Garcia MS, Raychaudhuri SP, Wehrli LN, Ono Y, Maverakis E. Biologic therapies in the treatment of psoriasis: a comprehensive evidence-based basic science and clinical review and a practical guide to tuberculosis monitoring. Clin Rev Allergy Immunol. 2013;44(2):121-40.

    11. Hutmacher MM, Nestorov I, Ludden T, Zitnik R, Banfield C. Modeling the exposure-response relationship of etanercept in the treatment of patients with chronic moderate to severe plaque psoriasis. J Clin Pharmacol. 2007;47(2):238-48.

    12. Yim DS, Zhou H, Buckwalter M, Nestorov I, Peck CC, Lee H. Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis. J Clin Pharmacol. 2005 Mar;45(3):246-56.

    13. Andrick BJ, Schwab AI, Cauley B, O'Donnell LA, Meng WS. Predicting Hemagglutinin MHC-II Ligand Analogues in Anti-TNFα Biologics: Implications for Immunogenicity of Pharmaceutical Proteins. PLoS One. 2015 Aug 13;10(8):e0135451. doi: 10.1371/journal.pone.0135451

    14. Emery P, Vencovský J, Sylwestrzak A, Leszczyński P, Porawska W, Baranauskaite A, Tseluyko V, Zhdan VM, Stasiuk B, Milasiene R, Barrera Rodriguez AA, Cheong SY, Ghil J. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2015 Jul 6. pii: annrheumdis-2015-207588. doi: 10.1136/annrheumdis-2015-207588.

    15. Arstikyte I, Kapleryte G, Butrimiene I, Venalis A. Influence of Immunogenicity on the Efficacy of Long-Term Treatment with TNF α Blockers in Rheumatoid Arthritis and Spondyloarthritis Patients. Biomed Res Int. 2015;2015:604872. doi: 10.1155/2015/604872.

    16. Baldo BA. Chimeric fusion proteins used for therapy: indications, mechanisms, and safety. Drug Saf. 2015;38(5):455-79.

    17. 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.

    18. Senabre-Gallego JM, Santos-Ramírez C, Santos-Soler G, Salas-Heredia E, Sánchez-Barrioluengo M, Barber X, Rosas J; AIRE-MB group. Long-term safety and efficacy of etanercept in the treatment of ankylosing spondylitis. Patient Prefer Adherence. 2013;7:961-72.

    19. Hunt L, Emery P. Etanercept in the treatment of rheumatoid arthritis. Expert Opin Biol Ther. 2013;13(10):1441-50.

    20. Jamnitski A, Bartelds GM, Nurmohamed MT, van Schouwenburg PA, van Schaardenburg D, Stapel SO, Dijkmans BA, Aarden L, Wolbink GJ. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann Rheum Dis. 2011;70(2):284-8.

  • INSTRUCTIONS FOR USE

    Download

  • SAFETY DATA SHEET

    Download

  • BATCH/LOT INFORMATION

    Download

Contact Us

bottom of page