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ANTIBODY TO NIVOLUMAB ELISA
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Nivolumab (Opdivo®) in serum and plasma.
The solid phase (MTP) is coated by the drug Nivolumab. Due to the assay design this test measures the free antibodies which are not bound to Nivolumab. 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.
Opdivo® is a trademark of Bristol Myers Squibb Company.
ESSAY CHARACTERISTICS
ANALYTICAL SENSITIVITY-THRESHOLD VALUE
The Detection Threshold for the assay is 5 ng/mL.
The assay sensitivity for undiluted clinical samples corresponds to 10 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-Nivolumab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 300 ng/mL.
ASSAY PRECISION
Intra-assay CV:
Mean
CV (%)
300 <10 100 <10 30 <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. Yamamoto N, Nokihara H, Yamada Y, et al., Phase I study of Nivolumab, an anti-PD-1 antibody, in patients with malignant solid tumors, Invest New Drugs,DOI 10.1007/s10637-016-0411-2.
2. Bajaj G, Wang X, Agrawal S, Gupta M, Roy A and Feng Y, Model-Based Population Pharmacokinetic Analysis of Nivolumab in Patients With Solid Tumors, CPT Pharmacometrics Syst. Pharmacol. 2016; 00, 00; doi:10.1002/psp4.12143; published online on 0 Month 2016.
3. Agrawal S, Statkevich P, Bajaj G, Feng Y, Saeger S,et al., Evaluation of Immunogenicity of Nivolumab Monotherapy and Its Clinical Relevance in Patients With Metastatic Solid Tumors, The Journal of Clinical Pharmacology, 2016; 00(0) 1–7. DOI: 10.1002/jcph.818
4. Wang C, Thudium K.B, Han M, et al, In Vitro Characterization of the Anti-PD-1 Antibody Nivolumab, BMS-936558, andIn Vivo Toxicology in Non-Human Primates, Cancer Immunol Res, 2014; 2(9); 846–56.
5. Agrawal S, Waxman I, Lambert A, Roy A, Darbenzio R, Evaluation of the potential for QTc prolongation in patients with solid tumors receiving nivolumab, Cancer Chemother Pharmacol, 2016; 77: 635–641.
6. Li Y, Fu T, Liu T, Guo H et al. Characterization of alanine to valine sequence variants in the Fc region of nivolumab biosimilar produced in Chinese hamster ovary cells, mAbs, 2016; 8:5, 951-960, DOI: 10.1080/19420862.2016.1172150
7. Brahmer JR, Drake CG, Wollner I, Powderly JD, Phase I Study of Single-Agent Anti–Programmed Death-1 (MDX-1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic Correlates, J Clin Oncol, 2010; 28: 3167-75
8. Wolchok JD, Kluger H, Callahan MK, Postow MA, et al. Nivolumab plus Ipilimumab in Advanced Melanoma, N Engl J Med 2013;369:122-33.
9. Scott LJ, Nivolumab: A Review in Advanced Melanoma, Drugs, 2015; 75: 1413–1424.
10. Kanda S, Goto K, Shiraishi H, Kubo E, Tanaka A, Utsumi H, Sunami K, Kitazono S, Safety and efficacy of nivolumab and standard chemotherapy drug combination in patients with advanced non-small-cell lung cancer: a four arms phase Ib study, Annals of Oncology, 2016; 27: 2242–50.
11. Kimura T, Fukushima S, Miyashita A, Aoi J, Jinnin M, Kosaka T,et al. Myasthenic crisis and polymyositis induced by one dose of nivolumab, Cancer Sci, 2016; 107: 1055–58.
12. Nakamura Y, Kitano S, Takahashi A, Tsutsumida A,et al. Nivolumab for advanced melanoma: pretreatment prognostic factors and early outcome markers during therap, Oncotarget, 2016; 7(47): 77404-77415.
13. Keating GM, Nivolumab: A Review in Advanced Squamous Non-Small Cell Lung Cancer, Drugs, 2015; 75: 1925–34.
14. Zhou GW, Xiong Y, Chen S, Xia F, Li Q, Hu J, Anti-PD-1/PD-L1 antibody therapy for pretreated advanced nonsmall-cell lung cancer: A meta-analysis of randomized clinical trials, Medicine, 2016; 95: 35.
15. Jung K, Zeng X, Bilusic M, Nivolumab-associated acute glomerulonephritis: a case report and literature review, BMC Nephrology 2016; 17: 188.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION