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VEDOLIZUMAB ELISA (MAB-BASED)
Enzyme immunoassay for the specific and quantitative determination of free Vedolizumab (Entyvio®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Vedolizumab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
| Required Volume (µL) | 10 |
| Incubation Time (min) | 105 |
| Sample | Serum or Plasma |
| Plate Size | 96 Tests |
| Sensitivity (ng/mL, 10x) | 0-1000 |
| Detection Limit (ng/mL) | 2 |
| 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.
Entyvio® is a trademark of Takeda Pharmaceuticals Inc.
ESSAY CHARACTERISTICS
SPECIFICITY
There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 24 different native human sera. All produced OD450/620 nm valuesless than the mean OD of standard D. In addition, binding of Vedolizumab to the solid phase is inhibited by recombinant human alpha4beta7 integrin protein in a concentration dependent manner. Therefore, the ImmunoGuide Vedolizumab ELISA (mAb-based) measures the biologically active free form of Vedolizumab, i.e. not pre-occupied by human alpha4beta7 integrin antigen. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Bevacizumab, Cetuximab, Tocilizumab, Rituximab, and Nivolumab at concentrations up to 100 µg/mL. All produced mean OD450/620 nm values (ranged from 0.035 to 0.058) less than standard D.
SENSITIVITY
The lowest detectable level that can be clearly distinguished from the zero standard is 4 ng/mL 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 2 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:500 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 Vedolizumab.
AUTOMATION
The ImmunoGuide Vedolizumab ELISA (mAb-based) is suitable also for being used by an automated ELISA processor.
REFERENCES
1. Williet N, Boschetti G, Fovet M, Di Bernado T, Claudez P, Del Tedesco E, Jarlot C, Rinaldi L, Berger A, Phelip JM, Flourie B, Nancey S, Paul S, Roblin X., Association Between Low Trough Levels of Vedolizumab During Induction Therapy for Inflammatory Bowel Diseases and Need for Additional Doses Within 6 Months., Clin Gastroenterol Hepatol. 2016: S1542-3565(16)31121-1. doi: 10.1016/j.cgh.2016.11.023.
2. Wyant T, Leach T, Sankoh S, Wang Y, Paolino J, Pasetti MF, et al., Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results., Gut. 2014;64(1):77-83.
3. Wang MC, Zhang LY, Han W, Shao Y, Chen M, Ni R, Wang GN, Wei FX, Zhang YW, Xu XD, Zhang YC., PRISMA--efficacy and safety of vedolizumab for inflammatory bowel diseases: a systematic review and meta-analysis of randomized controlled trials., Medicine (Baltimore). 2014; 93(28):e326. doi: 10.1097/MD.0000000000000326.
4. Poole RM., Vedolizumab: first global approval. Drugs. 2014;74(11):1293-303.
5. Milch C, Wyant T, Xu J, Parikh A, Kent W, Fox I, Berger J, Vedolizumab, a monoclonal antibody to the gut homing α4β7 integrin, does not affect cerebrospinal fluid T-lymphocyte immunophenotype, Journal of Neuroimmunology, 2013; 264(1–2): 123–126.
6. Bruce E. Sands, Brian G. Feagan, Paul Rutgeerts, Jean-Frédéric Colombel, William J. Sandborn, Richmond Sy, Geert D’Haens et al., Effects of Vedolizumab Induction Therapy for Patients With Crohn’s Disease in Whom Tumor Necrosis Factor Antagonist Treatment Failed, Gastroenterology 2014;147:618–627.
7. Soler D, Chapman T, Yang LL, Wyant T, Egan R, Fedyk ER., The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases., J Pharmacol Exp Ther. 2009;330(3):864-75.
8. Rosario M, French JL, Dirks NL, Sankoh S, Parikh A, Yang H, Danese S, Colombel JF, Smyth M, Sandborn WJ, Feagan BG, Reinisch W, Sands BE, Sans M, Fox I. Exposure-Efficacy Relationships for Vedolizumab Induction Therapy in Patients with Ulcerative Colitis or Crohn's Disease. Crohns Colitis. 2017 Feb 17. doi: 10.1093/ecco-jcc/jjx021. [Epub ahead of print]
9. Sands BE, Sandborn WJ, Van Assche G, Lukas M, Xu J, James A, Abhyankar B, Lasch K. Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naïve to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy. Inflamm Bowel Dis. 2017;23(1):97-106.
10. Cohen LB, Nanau RM, Delzor F, Neuman MG. Biologic therapies in inflammatory bowel disease., Transl Res. 2014;163(6):533-56.
11. Rosario M, Wyant T, Leach T, Sankoh S, Scholz C, Parikh A, Fox I, Feagan BG. Vedolizumab Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability Following Administration of a Single, Ascending, Intravenous Dose to Healthy Volunteers. Clin Drug Investig. 2016;36(11):913-923.
12. Amiot A, Grimaud JC, Peyrin-Biroulet L, Filippi J, Pariente B, et al. Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group.; Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif.. Effectiveness and Safety of Vedolizumab Induction Therapy for Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2016;14(11):1593-1601.
13. Loftus EV Jr, Colombel JF, Feagan BG, Vermeire S, Sandborn WJ, Sands BE, Danese S, D'Haens GR, Kaser A, Panaccione R, Rubin DT, Shafran I, McAuliffe M, Kaviya A, Sankoh S, Mody R, Abhyankar B, Smyth M. Long-term Efficacy of Vedolizumab for Ulcerative Colitis. J Crohns Colitis. 2016 Sep 28. pii: jjw177. [Epub ahead of print].
14. Dulai PS, Singh S, Jiang X, Peerani F, Narula N, Chaudrey K, Whitehead D, Hudesman D, Lukin D, Swaminath A, Shmidt E, Wang S, Boland BS, Chang JT, Kane S, Siegel CA, Loftus EV, Sandborn WJ, Sands BE, Colombel JF. The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn's Disease: Results From the US VICTORY Consortium. Am J Gastroenterol. 2016;111(8):1147-55.
15. Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015;42(2):188-202.
16. Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2016 Feb 18. pii: gutjnl-2015-311079. doi: 10.1136/gutjnl-2015-311079. (Epub ahead of print)
17. Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, et al.; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013;369(8):711-21.
18. Fedyk ER, Wyant T, Yang LL, Csizmadia V, Burke K, Yang H, Kadambi VJ. Exclusive antagonism of the α4 β7 integrin by vedolizumab confirms the gut-selectivity of this pathway in primates. Inflamm Bowel Dis. 2012;18(11):2107-19.
19. Feagan BG, Greenberg GR, Wild G, Fedorak RN, Paré P, McDonald JW, Cohen A, Bitton A, Baker J, Dubé R, Landau SB, Vandervoort MK, Parikh A. Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin. Clin Gastroenterol Hepatol. 2008;6(12):1370-7.
20. Yajnik V, Khan N, Dubinsky M, Axler J, James A, Abhyankar B, Lasch K. Efficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn's Disease Patients Stratified by Age. Adv Ther. 2017;34(2):542-559.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION