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Détails du produit
Product Specifications
Assay TypeCompetitive-ELISAAnalyteGentamicinFormat96T (8×12 strips)Regulatory StatusRUOSensitivity0.25 ng/mLStandard Curve Range0.25 ng/mL-8 ng/mLAssay Time1 hr 20 minSuitable Sample TypeFor the detection and quantitative determination of Gentamicin residues in plasmid DNA raw materials for cell and gene therap.Sample volume50 μLProduct Overview
Gentamicin ELISA Kit is based on the ELISA competitive method and is used to detect and quantitatively determine Gentamicin residues in plasmid DNA raw materials, proteins for CGT, vaccines, and other biological drugs. The kit is calibrated against NIFDC and USP standards to ensure accuracy and regulatory compliance, and is designed to provide a reliable solution for monitoring and controlling Gentamicin residues in the production of biological products, helping to ensure drug safety. It can also be used as a universal detection tool for the quantitative determination of Gentamicin.
Reconstitution
Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.
Storage
1. The kit is stable for 24 months from the date of manufacture if stored at 2°C to 8°C.
2. The reconstructed Gentamicin standard is stored at -70°C in at least 300ul per tube and cannot be frozen or thawed repeatedly.
3. Do not use reagents past their expiration date.
Materials Provided
IDComponentsSizeRES-A025-C01Gentamicin Coated Plate1 plate (8×12 strips)RES-A025-C02Gentamicin Standard0.1152 μgRES-A025-C03HRP-Anti-Gentamicin Antibody6 mLRES-A025-C041×Dilution Buffer50 mLRES-A025-C0520xWashing Buffer50 mLRES-A025-C06Substrate Solution12 mLRES-A025-C07Stop Solution7 mLACRO Quality Management System
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Typical Data
Please refer to DS document for the assay protocol.
Serial dilutions of gentamicin (from 8 ng/mL to 0.25 ng/mL) was added into gentamicin: anti-gentamicin binding reactions. The assay was performed according to the protocol dscribed below. Background was subtracted from data points prior to log transformation and curve fitting (QC tested).
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