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ANTIBODY TO ETANERCEPT ELISA
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Etanercept (Enbrel®) in serum and plasma.
The solid phase (MTP) is coated by the drug Etanercept. Due to the assay design this test measures the free antibodies which are not bound to Etanercept. Results could be expressed in both qualitative and quantitative manner (nanogram per mililiter-ng/mL).
| Required Volume (µL) | 50 |
| Incubation Time (min) | 135 |
| Sample | Serum, Plasma |
| Package Size | 96 |
| Results in | Qualitative & Quantitative (ng/mL) |
| Shelf Life (years) | 2 |
Intended Use: This kit has been developed for the detection of anti-drug antibodies in research and diagnostic uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
Enbrel® is a trademark of Amgen.
ESSAY CHARACTERISTICS
ANALYTICAL SENSITIVITY-THRESHOLD VALUE
The Detection Threshold for the assay is 20 ng/mL.
The assay sensitivity for undiluted clinical samples corresponds to 40 ng/mL. Because the serum or plasma samples are instructed to be diluted at two-fold (1:2) before starting the assay.
ASSAY RANGE
For anti-Etanercept antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 1000 ng/mL.
ASSAY PRECISION
Intra-assay CV:
Mean
CV (%)
1000 <10 300 <10 100 <10
Inter-assay CV: <10%.
ASSAY RECOVERY
Recovery rate was found to be 85-115% using native serum and plasma samples spiked with exogenous Anti Drug Antibody (ADA) positive samples.
AUTOMATION
The ImmunoGuide ADA ELISA 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.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION