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AAV5 Titration ELISA Kit (Fast)

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  • 产品参数(Product Specifications)

    Assay Type
    Sandwich-ELISA
    Analyte
    AAV5
    Format
    96T
    Regulatory Status
    RUO
    Sensitivity
    < 1.70 E+08 capsids/mL
    Standard Curve Range
    1.09 E+10 capsids/mL-1.70 E+08 capsids/mL
    Assay Time
    2 hr 20 min
    Suitable Sample Type
    For the detection and quantitative determination of AAV5 capsid titration in AAV gene therapy product preparation processing.
    Sample volume
    100 uL

  • 产品概述(Product Overview)

    AAV5 Titration ELISA Kit(Fast) is based on ELISA sandwich method and designed to detect and quantitative determine of AAV5 capsid titration in AAV gene therapy product preparation processing. It contains AAV5 empty capsids and a pair of antibodies against AAV5. Results are obtained by four parameter logistic curve that were parallel to the standard curves obtained. The verification results indicate that this kit can be used for the quantitative determination of AAV5 capsid titration.

  • 应用说明(Application)

    AAV5 Titration ELISA Kit(Fast) was developed for the detection and quantitative determination of AAV5 capsid titration in AAV gene therapy product preparation processing.

    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)

    The unopened kit is stable for 12 months from the date of manufacture if stored at 2°C to 8°C.

    The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.

  • 组分(Materials Provided)

    ID
    Components
    Size
    AAV05H-C01
    Pre-coated Anti-AAV5 Antibody Microplate
    1 plate
    AAV05H-C02
    AAV5 Standard
    8.7 E+10 capsids
    AAV05H-C03
    HRP-Anti-AAV5 Antibody
    20 μg
    AAV05H-C04
    10xWashing Buffer
    50 mL
    AAV05H-C05
    2xDilution Buffer
    50 mL
    AAV05H-C06
    Substrate Solution
    12 mL
    AAV05H-C07
    Stop Solution
    7 mL

  • 原理(Assay Principles)

    This assay kit employs a standard sandwich-ELISA format, providing a rapid detection of AAV5 capsid. The kit consists of Pre-coated Anti-AAV5 Antibody Microplate and AAV5 Standard,HRP-Anti-AAV5 Antibody and buffers.

    Your experiment will include 5 simple steps:

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

    b) Add your sample to the plate, take the AAV5 capsid as Control sample. The samples and Control sample are diluted by Dilution Buffer.

    c) Add the HRP-Anti-AAV5 Antibody diluted by Dilution Buffer to the plate.

    d) Wash the plate and add TMB.

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

  • 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.

     AAV5 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.

验证
  • 批内差异(Intra-Assay Statistics)

    Three samples of known concentration were tested twenty times on one plate to assess intra-assay precision, Intra-Assay Precision CV<10%.

     AAV5 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<10%.

     AAV5 INTER-ASSAY STATISTICS
  • 回收率(Recovery)

    Three AAV5 capsid with different concentrations were tested to calculate the recovery rate.

     AAV5 RECOVERY
  • 专属性(Specificity)

    The specific binding of AAV-A005H to AAV1/2/3/8/9/dj serotypes was detected. The results showed that AAV-A005H only binds specifically to AAV5.

     AAV5 SPECIFICITY

    The specific binding of AAV-A005H to native/denatured AAV5 was detected. The results showed that AAV-A005H only binds specifically to native AAV5. (Denatured AAV5: 95℃ for 10min)

     AAV5 SPECIFICITY

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背景介绍

The adeno-associated virus (AAV) is a small (25 nm), non-enveloped virus of the parvoviridae family, including 12 different AAV serotypes. In the parvoviridae family it belongs to the genus dependoparvovirus, because it needs the presence of a helper virus for replication and assembly. The icosahedral AAV capsid composed of the capsid proteins VP1, VP2 and VP3 contains a linear, single-stranded DNA genome of 4.7 kb.

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