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Product Specifications
Assay TypeCompetitive-ELISAAnalyteGentamicinFormat96T (8×12 strips)Regulatory StatusRUOSensitivity0.1 ng/mLStandard Curve Range0.1 ng/mL-3.2 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 (High Sensitivity) 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 the 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.
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
IDComponentsSizeRES-A079-C01Gentamicin Coated Plate1 plate (8×12 strips)RES-A079-C02Gentamicin Standard0.1152 μgRES-A079-C03HRP-Anti-Gentamicin Antibody6 mLRES-A079-C041×Dilution Buffer50 mLRES-A079-C0520xWashing Buffer50 mLRES-A079-C06Substrate Solution12 mLRES-A079-C07Stop Solution7 mLACRO Quality Management System
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Data Display
Typical Data
Please refer to DS document for the assay protocol.
Detection of Gentamicin by competitive ELISA Assay
Immobilized Gentamicin antigen competes with the residual Gentamicin in the sample to bind the enzyme-labeled anti-Gentamicin monoclonal (QC tested). For each experiment, a standard curve needs to be set for each micro-plate, and the specific OD value may vary depending on different laboratories, testers, or equipments. The following example data is for reference only.
Intra-Assay Statistics
Three samples of known concentration were tested ten times on one plate to assess intra-assay precision , Intra-Assay Precision CV≤15%.
Inter-Assay Statistics
Three samples of known concentration were tested in ten separate assays to assess inter-assay precision, Inter-Assay Precision CV≤15%.
Accuracy
Three samples of different concentration were tested ten times to assess Accuracy , Accuracy recovery rate 75-120%.
Interference effect
We have conducted interference effect test about frequently-used buffers, they have excellent buffer compatibility. For specific buffers, it is recommended that you verify recovery to determine the minimum dilution ratio.
Specificity
When 500 μg/mL ampicillin, tetracycline and chloramphenicol were added into the sample diluent, no cross-reactivity was observed
High, medium and low concentrations of BSA were added to MDCK( 2×106 cells/mL), HEK293( 3.5×106 cells/mL) , CHO( 2×106 cells/mL) and T-lymphocyte( 2.15×106 cells/mL) the recovery rate of BSA was used as the specific validation index.
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