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ANTIBODY TO BEVACIZUMAB ELISA
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Bevacizumab (Avastin®) in serum and plasma.
The solid phase (MTP) is coated by the drug Bevacizumab. Due to the assay design this test measures the free antibodies which are not bound to Bevacizumab. 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.
Avastin® is a trademark of Genentech Inc./Roche.
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-Bevacizumab antibodies in serum and plasma, the method has been demonstrated to be highly linear.
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. Han K, Peyret T, Quartino A, Gosselin NH, Gururangan S, Daw NC, Navid F, Jin J, Allison DE. Bevacizumab dosing strategy in pediatric cancer patients based on population pharmacokinetic analysis with external validation. Br J Clin Pharmacol. 2015 Sep 7. doi: 10.1111/bcp.12778.
2. Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41.
3. Bunni J, Shelley-Fraser G, Stevenson K, Oltean S, Salmon A, Harper SJ, Carter JG, Bates DO. Circulating levels of anti-angiogenic VEGF-A isoform (VEGF-Axxxb) in colorectal cancer patients predicts tumour VEGF-A ratios. Am J Cancer Res. 2015 May 15;5(6):2083-9.
4. Imbs DC, Négrier S, Cassier P, Hollebecque A, Varga A, Blanc E, Lafont T, Escudier B, Soria JC, Pérol D, Chatelut E. Pharmacokinetics of pazopanib administered in combination with bevacizumab. Cancer Chemother Pharmacol. 2014 Jun;73(6):1189-96.
5. Stewart MW, Rosenfeld PJ, Penha FM, Wang F, Yehoshua Z, Bueno-Lopez E, Lopez PF. Pharmacokinetic rationale for dosing every 2 weeks versus 4 weeks with intravitreal ranibizumab, bevacizumab, and aflibercept (vascular endothelial growth factor Trap-eye). Retina. 2012 Mar;32(3):434-57.
6. Shields LB, Shelton BJ, Shearer AJ, Chen L, Sun DA, Parsons S, Bourne TD, LaRocca R, Spalding AC. Dexamethasone administration during definitive radiation and temozolomide renders a poor prognosis in a retrospective analysis of newly diagnosed glioblastoma patients. Radiat Oncol. 2015 Oct 31;10(1):222. doi: 10.1186/s13014-015-0527-0.
7. Li Q, Yan H, Zhao P, Yang Y, Cao B. Efficacy and Safety of Bevacizumab Combined with Chemotherapy for Managing Metastatic Breast Cancer: A Meta-Analysis of Randomized Controlled Trials. Sci Rep. 2015 Oct 27;5:15746. doi: 10.1038/srep15746.
8. Li E, Subramanian J, Anderson S, Thomas D, McKinley J, Jacobs IA. Development of biosimilars in an era of oncologic drug shortages. Drug Des Devel Ther. 2015;9:3247-55.
9. Tang N, Guo J, Zhang Q, Wang Y, Wang Z. Greater efficacy of chemotherapy plus bevacizumab compared to chemo- and targeted therapy alone on non-small cell lung cancer patients with brain metastasis. Oncotarget. 2015 Oct 20. doi: 10.18632/oncotarget.6184.
10. Ogata H, Kikuchi Y, Natori K, Shiraga N, Kobayashi M, Magoshi S, Saito F, Osaku T, Kanazawa S, Kubota Y, Murakami Y, Kaneko H. Liver Metastasis of a Triple-Negative Breast Cancer and Complete Remission for 5 Years After Treatment With Combined Bevacizumab/Paclitaxel/Carboplatin: Case Report and Review of the Literature. Medicine (Baltimore). 2015 Oct;94(42):e1756. doi: 10.1097/MD.0000000000001756.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION