ANTIBODY TO VEDOLIZUMAB ELISA

Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Vedolizumab (Entyvio®) in serum and plasma.

The solid phase (MTP) is coated by the drug Vedolizumab. Due to the assay design this test measures the free antibodies which are not bound to Vedolizumab. 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
Plate Size	96 Tests
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.

Entyvio® is a trademark of Takeda Pharmaceuticals Inc.

ANALYTICAL SENSITIVITY-THRESHOLD VALUE

The Detection Threshold for the assay is 2,5 ng/mL.

The assay sensitivity for undiluted clinical samples corresponds to 5 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-Vedolizumab antibodies in serum and plasma, the method has been

demonstrated to be highly (>0.99 %) linear from 0 to 150 ng/mL.

ASSAY PRECISION

Intra-assay CV:

Mean

CV (%)

150 <10

50 <10

15
<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.
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. 2015;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.

ANTIBODY TO VEDOLIZUMAB ELISA

ESSAY CHARACTERISTICS

REFERENCES

INSTRUCTIONS FOR USE

SAFETY DATA SHEET

BATCH/LOT INFORMATION

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Mean	CV (%)
150	<10
50	<10
15	<10