Anti-Cetuximab ELISA Kit (DEIABL204)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Size
96T
Sample
Serum, plasma
Species Reactivity
N/A
Intended Use
CD Quantitative Antibodies to Cetuximab ELISA has been especially developed for the quantitative analysis of antibodies to cetuximab in serum and plasma samples.CD Quantitative Antibodies to Cetuximab ELISA is optimized with reference drug.
Contents of Kit
1.Microtiter Plate, 1 x 12 x 8 Microtiter plate
2.Standard A-E, 1 mL (each)
Standard A: 500 ng/mL
Standard B: 250 ng/mL
Standard C: 125 ng/mL
Standard D: 62.5 ng/mL
Standard E: 0 ng/mL
3.Controls, 1 mL (each) Control low and high levels
4.Assay Buffer, 1 x 50 mL Assay buffer
5.Conjugate, 1 x 12 mL Horse radish peroxidase conjugated probe
6.Confirmation Reagent, 1 x 12 mL Confirmation reagent
7.Substrate, 1 x 12 mL TMB substrate solution
8.Stop Buffer, 1 x 12 mL TMB stop solution
9.Wash Buffer, 1 x 50 mL Wash buffer (20x)
10.Foil, 2 x 1 Adhesive Foil
Storage
The kit is shipped at ambient temperature (10-30°C) and should be stored at 2-8°C for long term storage. Keep away from heat or direct sunlight. The strips of microtiter plate are stable up to the expiry date of the kit in the broken, but tightly closed bag when stored at 2-8°C.
Precision
Intra-assay and inter-assay CVs <30%
Cut-off
Cut-off values must be calculated/set or verified according to scientific standards by the users/laboratories.
Sensitivity
Sensitivity: The lowest detectable level (Lowest detection limit, LOD) that can be distinguished from the zero standard is 6.2 ng/mL.
Functional sensitivity (Limit of quantification-LOQ): 62.5 ng/mL
General Description
Cetuximab is an epidermal growth factor receptor binding FAB. Cetuximab is composed of the Fv (variable; antigen-binding) regions of the 225 murine EGFr monoclonal antibody specific for the N-terminal portion of human EGFr with human IgG1 heavy and kappa light chain constant (framework) regions.
Cetuximab binds to the epidermal growth factor receptor (EGFr) on both normal and tumor cells. EGFr is over-expressed in many colorectal cancers. Cetuximab competitively inhibits the binding of epidermal growth factor (EGF) and TGF alpha, thereby reducing their effects on cell growth and metastatic spread.
Therapeutic drug monitoring (TDM) is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens. The indications for drug monitoring include efficacy, compliance, drug-drug interactions, toxicity avoidance, and therapy cessation monitoring. Additionally, TDM can help to identify problems with medication compliance among noncompliant patient cases. Biologic medicinal products (biologics) have transformed treatment landscapes worldwide for patients with haematological or solid malignancies with the 21st century. Today, as data exclusivity periods of first wave biologics approach expiration/have expired, several biosimilar products (i.e., biologics that are considered to be similar in terms of quality, safety and efficacy to an approved 'reference' biologic) are being developed or have already been approved for human use.
Like all biologics, biosimilars are structurally complex proteins that are typically manufactured using genetically engineered animal, bacterial or plant cell culture systems. As a consequence of this molecular complexity and the proprietary nature of the manufacturing process, which will inevitably result in the use of different host cell lines and expression systems as well as related differences in manufacturing conditions, it is not possible to manufacture exact copies of a reference biologic.
When administered to patients, all therapeutic proteins have the potential to induce an unwanted immune response (i.e., to stimulate the formation of antidrug antibodies [ADAs]). The impact of immune responses can range from no apparent effect to changes in pharmacokinetics, loss of effect and serious adverse events. Furthermore, the immunogenicity profile of a biologic can be significantly altered by even small differences in its manufacturing process that are accompanied by a change in product attributes, as well as differences in dosing schedules, administration routes or patient populations.
CD ELISA kits can be used for drug level and anti-drug antibodies measurements
Standard Curve
Calibration curve (Linearity, Dilutional linearity): r2>0.95.This is only an example. Assay conditions will change in every assay and do not use this curve for your assay calculations.

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References


Price, TJ; Segelov, E; et al. Current opinion on optimal treatment for colorectal cancer. EXPERT REVIEW OF ANTICANCER THERAPY 13:597-611(2013).
Fornaro, L; Lonardi, S; et al. FOLFOXIRI in combination with panitumumab as first-line treatment in quadruple wild-type (KRAS, NRAS, HRAS, BRAF) metastatic colorectal cancer patients: a phase II trial by the Gruppo Oncologico Nord Ovest (GONO). ANNALS OF ONCOLOGY 24:2062-2067(2013).

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