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AAV8 Titration ELISA Kit (Fast)

COADSMS
DS

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AAV-A008H-96tests
$670.00
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Product Details

  • Product Specifications

    Assay Type
    Sandwich-ELISA
    Analyte
    AAV8
    Format
    96T
    Regulatory Status
    RUO
    Sensitivity
    <1.94E+08 capsids/mL
    Standard Curve Range
    6.22E+09 capsids/mL-1.94E+08 capsids/mL
    Assay Time
    2 hr 20 min
    Suitable Sample Type
    For the detection and quantitative determination of AAV8 capsid titration in AAV gene therapy product preparation processing.
    Sample volume
    100 μL

  • Product Overview

    AAV8 Titration ELISA Kit (Fast) is based on the sandwich-ELISA method and is used to detect and quantitatively determine the AAV8 capsid titration in AAV gene therapy product winthin 2hr 20 min. The kit is designed to provide reliable solutions for the early development, production, and quality control of AAV gene therapy products.

  • Reconstitution

    Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.

  • 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.

  • Materials Provided

    ID
    Components
    Size
    AAV08H-C01
    Pre-coated Anti-AAV8 Antibody Microplate
    1 plate
    AAV08H-C02
    AAV8 Standard
    1.4E+10 capsids
    AAV08H-C03
    HRP-Anti-AAV8 Antibody
    15 μg
    AAV08H-C04
    10×Washing Buffer
    50 mL
    AAV08H-C05
    2×Dilution Buffer
    50 mL
    AAV08H-C06
    Substrate Solution
    12 mL
    AAV08H-C07
    Stop Solution
    7 mL

  • ACRO Quality Management System

    1. QMS(ISO, GMP)
    2. Quality Advantages
    3. Quality Control Process

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Performance Data

  • Typical Data 

    Please refer to DS document for the assay protocol.

    AAV8 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.

Validation

  • Dilution Linearity

    To assess the linearity of the assay, samples spiked with high concentrations of AAV8 were serially diluted with calibrator diluent to produce samples with values within the dynamic range of the assay.

    AAV8 DILUTION LINEARITY

  • Intra-Assay Statistics

    Three samples of known concentration were tested ten times on one plate to assess intra-assay precision.

    AAV8 INTRA-ASSAY STATISTICS

  • Inter-Assay Statistics

    Three samples of known concentration were tested in three separate assays to assess inter-assay precision.

    AAV8 INTER-ASSAY STATISTICS

  • Recovery

    Three AAV8 with different concentrations were tested to calculate the recovery rate.

    AAV8 RECOVERY

  • Specificity

    The specific binding of AAV-A008H to AAV1/2/3/5/6/8/9/dj serotypes was detected. The results showed that AAV-A008H only binds specifically to AAV8.

    AAV8 SPECIFICITY

    The specific binding of AAV-A008H to native/denatured AAV8 was detected. The results showed that AAV-A008H only binds specifically to native AAV8. (Denatured AAV8: 95℃ for 10min)

    AAV8 SPECIFICITY

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