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ANTIBODY TO USTEKINUMAB ELISA
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Ustekinumab (Stelara®) in serum and plasma.
The solid phase (MTP) is coated by the drug Ustekinumab. Due to the assay design this test measures the free antibodies which are not bound to Ustekinumab. 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.
Stelara® is a trademark of Janssen Biotech.
ESSAY CHARACTERISTICS
ASSAY SENSITIVITY-THRESHOLD VALUE
The sensitivity of the assay is 2 ng/mL with the standards supplied.
The assay sensitivity for undiluted clinical samples corresponds to 4 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-Ustekinumab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 100 ng/mL.
ASSAY PRECISION
Intra-assay CV:
Mean
CV (%)
100 <10 30 <10 10 <10
Inter-assay CV: <10%.
ASSAY RECOVERY
Recovery rate was found to be 85-110% 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. Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI–IM-UNITI Study Group, Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016;375(20):1946-1960.
2. Zhu Y, Wang Q, Frederick B, Bouman-Thio E, Marini JC, Keen M, Petty KJ, Davis HM, Zhou H., Comparison of the pharmacokinetics of subcutaneous ustekinumab between Chinese and non-Chinese healthy male subjects across two Phase 1 studies. Clin Drug Investig. 2013;33(4):291-301.
3. Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, Li S, Wang Y, Mendelsohn AM, Song M, Zhu Y, Rahman P, McInnes IB; PSUMMIT 1 Study Group., Maintenance of Clinical Efficacy and Radiographic Benefit Through Two Years of Ustekinumab Therapy in Patients With Active Psoriatic Arthritis: Results From a Randomized, Placebo-Controlled Phase III Trial. Arthritis Care Res (Hoboken). 2015;67(12):1739-49.
4. Lamb YN, Duggan ST., Ustekinumab: A Review in Moderate to Severe Crohn's Disease. Drugs. 2017; 77(10):1105-1114.
5. Smolen JS, Agarwal SK, Ilivanova E, Xu XL, Miao Y, Zhuang Y, Nnane I, Radziszewski W, Greenspan A, Beutler A, Baker D., A randomised phase II study evaluating the efficacy and safety of subcutaneously administered ustekinumab and guselkumab in patients with active rheumatoid arthritis despite treatment with methotrexate. Ann Rheum Dis. 2017; 76(5): 831-839.
6. Deepak P, Loftus EV Jr., Ustekinumab in treatment of Crohn's disease: design, development, and potential place in therapy. Drug Des Devel Ther. 2016;10:3685-3698. eCollection 2016.
7. Lebwohl M, Yeilding N, Szapary P, Wang Y, Li S, Zhu Y, Reich K, Langley RG, Papp KA., Impact of weight on the efficacy and safety of ustekinumab in patients with moderate to severe psoriasis: rationale for dosing recommendations. J Am Acad Dermatol. 2010; 63(4): 571-9.
8. Menting SP, van den Reek JM, Baerveldt EM, de Jong EM, Prens EP, Lecluse LL, Wolbink GJ, Van der Kleij D, Spuls PI, Rispens T. The correlation of clinical efficacy, serum trough levels and antidrug antibodies in ustekinumab treated patients with psoriasis in a clinical-practice setting. Br J Dermatol. 2015; 173(3): 855-7
9. van Bezooijen JS, van Doorn MBA, Schreurs MWJ, Koch BCP, Te Velthuis H, Prens EP, van Gelder T., Prolongation of Biologic Dosing Intervals in Patients With Stable Psoriasis: A Feasibility Study. Ther Drug Monit. 2017; 39(4): 379-386.
10. Chiu HY, Chu TW, Cheng YP, Tsai TF., The Association between Clinical Response to Ustekinumab and Immunogenicity to Ustekinumab and Prior Adalimumab. PLoS One. 2015; 10(11):e0142930. doi: 10.1371/journal.pone.0142930. eCollection 2015.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION