KRIBIOLISA™ Atezolizumab (TECENTRIQ) ELISA

SKU: KBI1027 Category:

66,000.00

Enzyme Immunoassay for the estimation of Atezolizumab (TECENTRIQ) in serum and plasma.

Key features:
1. Developed using highly specific monoclonal anti-idiotypic antibodies in a sandwich assay format
2. Validated as per international bioassay validation guidelines
3. Recovery: 80-120%
4. Precision CV <10%

Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells








Description

Background:
Atezolizumab (trade name Tecentriq) is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). In 2015, it was in clinical trials as an immunotherapy for several types of solid tumors. It was under investigation by Genentech/Roche. In April 2016, Roche announced that atezolizumab had been granted fast track status for lung cancer by the FDA. In May 2018, Tecentriq was in combination with Avastin and standard chemotherapy for some patients with lung cancer was granted priority review.

Intended Use:
For Estimation of Atezolizumab (TECENTRIQ) in human serum and plasma. Please note the kit has not been optimized to be used for any other animal species. Should you require a specific sera tested, please connect with us at sales@krishgen.com for optimization.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Atezolizumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Atezolizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Atezolizumab antibody is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Atezolizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

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Additional information

Species

Human

Biomarker Estimation

measures free drug

Sample Type

Serum (100 ul), EDTA Plasma (100 ul), Heparin Plasma (100 ul), Citrate Plasma (100 ul)

Calibration Range

20 ng/ml ? 640 ng/ml

Sensitivity

80 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Atezolizumab (TECENTRIQ)

Cross Reactivity

< 0.5% cross-reactivity observed with related biomarker.

Interference

No significant interference observed with available related molecules.

Regulatory Status

Research Use Only

Research Area

Immune Checkpoints

Entez Gene ID

MPDL 3280A Human

Alternate Names / Synonyms

Atezolizumab

Alternate Drug Brand Names

Tecentriq

Drug Bank Accession Number

DB11595

ELISA Type

Direct Sandwich Assay

Storage Temperature

Store the unopened product at 2-8 Deg C. Opened products to be stored as per temperatures indicated on the datasheet.

Validation

The kit uses a biosimilar research grade standard / calibrator. The standard / calibrator has been validated against WHO/NIBSC standard and/or against commercially sourced innovator drug where available. Please refer to the IFU for more details.

Disclaimer

Trade name indicated is for reference purposes only. It does not reflect any licences or patent usage. The tradename is the registered trademark of the respective owners only.

Long Name

Protein Based Therapies – Monoclonal Antibody

Citations