膜杰作
Star Staining
产品描述（Product Details）
| Assay Type | Competitive-ELISA |
| Analyte | Gentamicin |
| Format | 96T |
| Regulatory Status | RUO |
| Sensitivity | 0.25 ng/mL |
| Standard Curve Range | 0.25 ng/mL-8 ng/mL |
| Assay Time | 1 hr 20 min |
| Suitable Sample Type | For the detection and quantitative determination of Gentamicin residues in plasmid DNA raw materials for cell and gene therap. |
| Sample volume | 50 μL |
背景（Background）
Residues of gentamicin are prone to occur in the production process of biological products, which can easily lead to abnormal reactions in the human body. Therefore, the residual amount of gentamicin in biological products or semi-finished products of biological products should be strictly controlled.
应用说明（Application）
The kit is calibrated against the NIFDC and USP standard.
The kit is developed for the detection and quantitative determination of gentamicin residues in plasmid DNA raw materials and proteins for CGT, vaccine and other biological drugs. It is intended for research use only (RUO).
It is for research use only.
重构方法（Reconstitution）
Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.
存储（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.
组分（Materials Provided）
| ID | Components | Size |
| RES-A025-C01 | Gentamicin Coated Plate | 1plate |
| RES-A025-C02 | Gentamicin Standard | 0.1152ug |
| RES-A025-C03 | HRP-Anti-Gentamicin Antibody | 6mL |
| RES-A025-C04 | 1×Dilution Buffer | 50mL |
| RES-A025-C05 | 20xWashing Buffer | 50mL |
| RES-A025-C06 | Substrate Solution | 12mL |
| RES-A025-C07 | Stop Solution | 7mL |
原理（Assay Principles）
The Gentamicin quantitative detection kit adopts the indirect competitive ELISA method, and the pre-coated conjugated Gentamicin antigen on the microstrip competes with the residual Gentamicin in the sample to bind the enzyme-labeled anti-Gentamicin 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 0.25 ng/mL to 8 ng/mL.
典型数据-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).
