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ANTIBODY TO TRASTUZUMAB ELISA
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Trastuzumab (Herceptin®, Herclon®) in serum and plasma.
The solid phase (MTP) is coated by the drug Trastuzumab. Due to the assay design this test measures the free antibodies which are not bound to Trastuzumab. Results could be expressed in both qualitative and quantitative manner (nanogram per mililiter-ng/mL).
| Required Volume (µL) | 50 |
| Incubation Time (min) | 165 |
| Sample | Serum/Plasma |
| Package 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.
Herceptin® and Herclon® are trademarks Genentech Inc.
ESSAY CHARACTERISTICS
ANALYTICAL SENSITIVITY-THRESHOLD VALUE
The Detection Threshold for the assay is 15 ng/mL.
The assay sensitivity for undiluted clinical samples corresponds to 30 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-Trastuzumab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99)linear from 0 to 1000 ng/mL.
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 85-110% 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. Kang YK, Rha SY, Tassone P, Barriuso J, Yu R, Szado T, Garg A, Bang YJ. A phase IIa dose-finding and safety study of first-line pertuzumab in combination with trastuzumab, capecitabine and cisplatin in patients with HER2-positive advanced gastric cancer. Br J Cancer. 2014;111(4):660-6.
2. Sanford M. Subcutaneous trastuzumab: a review of its use in HER2-positive breast cancer. Target Oncol. 2014 Mar;9(1):85-94.
3. Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, Pienkowski T, Lichinitser M, Semiglazov V, Melichar B, Jackisch C. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012;13(9):869-78.
4. Leyland-Jones B, Colomer R, Trudeau ME, Wardley A, Latreille J, Cameron D, Cubedo R, Al-Sakaff N, Feyereislova A, Catalani O, Fukushima Y, Brewster M, Cortés J. Intensive loading dose of trastuzumab achieves higher-than-steady-state serum concentrations and is well tolerated. J Clin Oncol. 2010;28(6):960-6.
5. Baselga J, Carbonell X, Castañeda-Soto NJ, Clemens M, Green M, Harvey V, Morales S, Barton C, Ghahramani P. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J Clin Oncol. 2005;23(10):2162-71.
6. Hourcade-Potelleret F, Lemenuel-Diot A, McIntyre C, Brewster M, Lum B, Bittner B. Use of a population pharmacokinetic approach for the clinical development of a fixed-dose subcutaneous formulation of trastuzumab. CPT Pharmacometrics Syst Pharmacol. 2014 Jan 2;3:e87. doi: 10.1038/psp.2013.63.
7. Tokuda Y, Watanabe T, Omuro Y, Ando M, Katsumata N, Okumura A, Ohta M, Fujii H, Sasaki Y, Niwa T, Tajima T. Dose escalation and pharmacokinetic study of a humanized anti-HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. Br J Cancer. 1999;81(8):1419-25.
8. Goldenberg MM. Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, a novel agent for the treatment of metastatic breast cancer. Clin Ther. 1999;21(2):309-18.
9. Arpino G, Michelotti A, Truini M, Montemurro F, Russo S, Palumbo R, Zamagni C, Latorre A, Bruzzese D, Riccardi F, De Laurentiis M, Beano A, Biganzoli L, Zaniboni A, Laudadio L, Malagoli M, Bilancia D, Schettini F, Giuliano M, Cazzaniga ME, De Placido S. Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study. J Cancer Res Clin Oncol. 2015 Aug 25. [Epub ahead of print]
10. Laboissiere RS, Buzelin MA, Balabram D, De Brot M, Nunes CB, Rocha RM, Cabral MM, Gobbi H. Association between HER2 status in gastric cancer and clinicopathological features: a retrospective study using whole-tissue sections. BMC Gastroenterol. 2015;15(1):157.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION