Product Details
Product Specifications
Assay TypeSandwich-ELISAAnalyteNucleaseFormat96T (8×12 strips)Reactivity/Regulatory StatusRUOSensitivity<25 pg/mLStandard Curve Range25 pg/mL-800 pg/mLAssay Time3 hr 20 minSuitable Sample TypeFor the quantitative determination the residue of nuclease in biologicals.Sample volume100 μLProduct Overview
resDetect™ GENIUS™ Nuclease ELISA Kit (Residue Testing) is based on the ELISA sandwich method and is used to detect and quantitatively determine GENIUS™ Nuclease residues in biological products. It is designed to provide a reliable solution for quality assessment of biological products during drug development and CMC quality control stages. Additionally, it can be used as a universal detection tool for the quantitative determination of GENIUS™ Nuclease.
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
IDComponentsSizeCRS031-C01Pre-coated Anti-Nuclease Antibody Microplate1 plate (8×12 strips)CRS031-C02Nuclease Standard5 μgCRS031-C03Biotin-Anti-Nuclease Antibody20 μgCRS031-C04Streptavidin-HRP50 μLCRS031-C0510×Washing Buffer50 mLCRS031-C062×Dilution Buffer50 mLCRS031-C07Substrate Solution12 mLCRS031-C08Stop Solution7 mLACRO Quality Management System
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Performance Data
Typical Data
Please refer to DS document for the assay protocol.

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.

resDetect™ GENIUS™ Nuclease ELISA Kit (Residue Testing) (Cat. No. CRS-A031) can detect the nuclease in different culture supernatant with similar curve and sensitivity.

resDetect™ GENIUS™ Nuclease ELISA Kit (Residue Testing) (Cat. No. CRS-A031) can detect the nuclease from different culture supernatant and was free from the matrix effects.

resDetect™ GENIUS™ Nuclease ELISA Kit (Residue Testing) (Cat. No. CRS-A031) can detect the nuclease from different manufacturers, a nuclease levels differ from manufacturer to manufacturer.
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 three separate assays to assess inter-assay precision, Inter-Assay Precision CV≤15%.

Recovery
Three Nuclease with different concentrations were tested to calculate the recovery rate.

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