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resDetect™ GENIUS™ Nuclease ELISA Kit (Residue Testing)

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  • 产品参数(Product Specifications)

    Assay Type
    Sandwich-ELISA
    Analyte
    Nuclease
    Format
    96T(8×12 strips)
    Reactivity
    /
    Regulatory Status
    RUO
    Sensitivity
    <25pg/mL
    Standard Curve Range
    25 pg/mL-800 pg/mL
    Assay Time
    3 hr 20 min
    Suitable Sample Type
    For the quantitative determination the residue of nuclease in biologicals.
    Sample volume
    100 uL

  • 产品概述(Product Overview)

    resDetect™ GENIUS™ Nuclease ELISA Kit (Residue Testing) is based on the ELISA sandwich method and is used to detect and quantitatively determine GENIUS™ 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™.

  • 应用说明(Application)

    resDetect™ GENIUS™ Nuclease ELISA Kit was developed for the detection and quantitative determination of nuclease in samples from downstream processing where nuclease is used as a process or purification aid.

    The  limitation of detectable dose (LOD) of Cat. No. CRS-A016 was determined as 2.733 pg/mL.

    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)

    2-8℃

  • 组分(Materials Provided)

    ID
    Components
    Size
    CRS031-C01
    Pre-coated Anti-Nuclease Antibody Microplate
    1 plate(8×12 strips)
    CRS031-C02
    Nuclease Standard
    5 μg
    CRS031-C03
    Biotin-Anti-Nuclease Antibody
    20 μg
    CRS031-C04
    Streptavidin-HRP
    50 μL
    CRS031-C05
    10×Washing Buffer
    50 mL
    CRS031-C06
    2×Dilution Buffer
    50 mL
    CRS031-C07
    Substrate Solution
    12 mL
    CRS031-C08
    Stop Solution
    7 mL

  • 原理(Assay Principles)

    This assay kit employs a standard sandwich-ELISA format, providing a rapid detection of Nuclease. The kit consists of Pre-coated Anti-Nuclease Antibody Microplate and Nuclease Standard and Biotin-Anti-Nuclease Antibody and Streptavidin-HRP and buffers.

    Your experiment will include 6 simple steps:

    a) Bring all reagents to room temperature(20℃-25℃) before use.

    b) Add your sample to the plate and take the Nuclease as standard. The samples and standard are diluted by Dilution Buffer.

    c) Add the Biotin-Anti-Nuclease Antibody diluted by Dilution Buffer to the plate.

    d) Wash the plate and add the Streptavidin-HRP diluted by Dilution Buffer to the plate.

    e) Wash the plate and add TMB.

    f) Stop the substrate reaction by adding diluted acid. Absorbance (OD) is calculated by the absorbance at 450 nm minus the absorbance at 630 nm to remove background disturbance before statistical analysis. The OD Value reflects the amount of bound protein.

  • 质量管理控制体系(QMS)

    1. 质量管理体系(ISO, GMP)
    2. 质量优势
    3. 质控流程

产品展示

  • 典型数据-Typical Data

    Please refer to DS document for the assay protocol.

     Nuclease TYPICAL DATA

    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.

  •  Nuclease TYPICAL DATA

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

  •  Nuclease TYPICAL DATA

    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.

  •  Nuclease TYPICAL DATA

    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.

验证
  • 批内差异(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%.

     Nuclease INTRA-ASSAY STATISTICS
  • 批间差异(Inter-Assay Statistics)

    Three samples of known concentration were tested in three separate assays to assess inter-assay precision, Inter-Assay Precision CV≤15%.

     Nuclease INTER-ASSAY STATISTICS
  • 回收率(Recovery)

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

     Nuclease RECOVERY

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背景介绍

Nucleases are enzymes that degrade nucleic acids, either DNA or RNA. It has been used for the preparation of nuclear extracts by digesting DNA and releasing nuclear proteins intimately associated with DNA. It has also been designed for removing RNA and DNA in biotechnological processing. Thus, the amount of residual nuclease in biological products should be detected and limited.

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