resDetect™ Kanamycin ELISA Kit

Product Specifications

Product Overview

resDetect™ Kanamycin ELISA Kit is based on the ELISA sandwich method and is used to detect and quantitatively determine Kanamycin residues in plasmid DNA raw materials, proteins for CGT, vaccines, and other biological drug preparations. The kit is calibrated against the USP standard to ensure accurate assay results and is designed to provide a reliable solution for CAR-T product quality assessment during drug development and CMC quality control stages. It can also be used as a universal detection tool for the quantitative determination of Kanamycin.

Reconstitution

Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.

Storage

1. Unopened kit should be stored at 2℃-8℃ upon receiving.

2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.

3. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.

Materials Provided

Assay Principles

The Kanamycin quantitative detection kit adopts the indirect competitive ELISA method, and the pre-coated conjugated kanamycin antigen on the microstrip competes with the residual kanamycin in the sample to bind the enzyme-labeled anti-kanamycin monoclonal antibody, and then uses a microplate reader to detect the absorbance value by adding TMB substrate, and the absorbance value is negatively correlated with the content of kanamycin in the sample. The kit takes only about one hour and 20 minutes to operate and has a linear range of 0.5 ng/mL to 40.5 ng/mL.

ACRO Quality Management System

1. QMS(ISO, GMP)
2. Quality Advantages
3. Quality Control Process