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The Trastuzumab ELISA kit is a validated tool for whole Trastuzumab and its biosimilar quantification in biological matrices for drug research and development.

產品概述

Product Description

Trastuzumab, also known as Herceptin, is a human epidermal growth factor receptor 2 (HER2) inhibitor for the treatment of breast cancer. Trastuzumab is a recombinant humanized IgG1 kappa monoclonal antibody. It binds to the extracellular domain of the HER2 protein on the on the surface of HER2-positive tumour cells with high affinity. Trastuzumab can suppress the cells growth and proliferation by blocking the ability of the cancer cells to receive chemical signals.
GenScript’s Trastuzumab Pharmacokinetic ELISA Kit had been comprehensively developed and validated for quantitative measurement of Trastuzumab in cynomolgus monkey serum and plasma, based on the ICH M10 and the FDA bioanalytical method validation guidance for industry. Its precision, accuracy, dilutional linearity, specificity, selectivity, stability, and hook effect were acceptable according to the guidances^[1-4]. The Trastuzumab ELISA kit is a validated tool for whole Trastuzumab and its biosimilar quantification in biological matrices for drug research and development.

產品簡介

LLOQ

1 ng/mL

ULOQ

64 ng/mL

Precision

Intra-assay: CV≤10%
Inter-assay: CV≤15%

Minimum required dilution (MRD)

1:40, validated non-human primate plasma

Kit Contents

Component	Quantity/Size	Part No.
Capture Plate	1 plate	Q1-80
Standard Stock	1 vial (50 μL)	Q1-10
Biotin Anti-Trastuzumab Antibody (11C4)	1 bottle (12 mL)	Q1-20
Streptavidin-HRP	1 bottle (12 mL)	Q1-30
Sample Dilution Buffer	1 bottle (60 mL)	Q1-60
20× Wash Solution	1 bottle (60 mL)	Q1-70
Stop Solution	1 bottle (6 mL)	A1-50
TMB Solution	1 bottle (12 mL)	A1-40
Plate Sealer	2 pieces	N/A

Storage

The unopened kit is stable for at least 12 months from the date of manufacture at 2°C to 8°C, and the opened kit is stable for up to 1 month from the date of opening at 2°C to 8°C.

原理

Assay Principle

Trastuzumab Pharmacokinetic ELISA Kit is a sandwich ELISA assay with a pair of anti-idiotypic monoclonal capture and detection antibodies. When standards or samples are added to the capture plate, the Trastuzumab in the sample can be captured on the plate coated with the anti-Trastuzumab capture antibody. Then the Biotin Anti-Trastuzumab Antibody is added to interact with the Trastuzumab bound on the plate. Streptavidin-HRP (Streptavidin-Horseradish Peroxidase conjugate) is added to interact with the Biotin Anti-Trastuzumab Antibody. After the washing steps, TMB Solution is added, resulting in the formation of blue color. The reaction is stopped by adding Stop Solution. Adding the Stop Solution changes the color from blue to yellow. The intensity of the color can be read at 450 nm and 630 nm by a microplate reader.
The quantity of Trastuzumab in the sample is precisely quantified against a Trastuzumab standard curve.

Reference

1. International Council for Harmonisation of TechnicalRequirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline,Bioanalytical Method Validation M10 (2019).
2. US FDA. Bioanalytical Method Validation Guidance for Industry (2018).
3. European Medicines Agency. Guideline on Bioanalytical Method Validation(2011).
4. DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalyticalmethod validation of ligand-binding assays to support.

圖例

Figure 1: Trastuzumab ELISA kit standard curve.
A set of Trastuzumab calibration standards from 1 ng/mL to 64 ng/mL was then diluted with Sample Dilution Buffer with a volume ratio of 1:40.

產品編號	L00970
規格	96 Tests 定制報價
數量
價格	￥4980


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Trastuzumab Pharmacokinetic ELISA Kit

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