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Product Details
Product Specifications
Assay TypeSandwich-ELISAAnalyteAAV3Format96TRegulatory StatusRUOSensitivity< 1.05E+08 capsids/mLStandard Curve Range3.35E+09 capsids/mL-1.05E+08 capsids/mLAssay Time2 hr 50 minSuitable Sample TypeFor the detection and quantitative determination of AAV3 capsid titration in AAV gene therapy product preparation processing.Sample volume100 μLProduct Overview
AAV3 Titration ELISA Kit is based on the sandwich-ELISA method and is used to detect and quantitatively determine the AAV3 capsid titration in AAV gene therapy product. 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
IDComponentsSizeAAV03-C01Pre-coated Anti-AAV3 Antibody Microplate1 plateAAV03-C02AAV3 Standard5.03E+10 capsidsAAV03-C03Biotin-Anti-AAV3 Antibody20 μgAAV03-C04Streptavidin-HRP50 μLAAV03-C0510×Washing Buffer50 mLAAV03-C062×Dilution Buffer50 mLAAV03-C07Substrate Solution12 mLAAV03-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.
Dilution Linearity
To assess the linearity of the assay, samples spiked with high concentrations of AAV3 were serially diluted with calibrator diluent to produce samples with values within the dynamic range of the assay.
Intra-Assay Statistics
Three samples of known concentration were tested ten times on one plate to assess intra-assay precision.
Inter-Assay Statistics
Three samples of known concentration were tested in three separate assays to assess inter-assay precision.
Recovery
Three AAV3 with different concentrations were tested to calculate the recovery rate.
Specificity
The specific binding of AAV-A003 to AAV1/2/3/5/6/8/9/dj serotypes was detected. The results showed that AAV-A003 only binds specifically to AAV3.
The specific binding of AAV-A003 to native/denatured AAV3 was detected. The results showed that AAV-A003 only binds specifically to native AAV3. (Denatured AAV3: 95℃ for 10min)
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