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产品参数（Product Specifications）
Assay TypeSandwich-ELISAAnalyteAAV8Format96TRegulatory StatusRUOSensitivity<1.94E+08 capsids/mLStandard Curve Range6.22E+09 capsids/mL-1.94E+08 capsids/mLAssay Time2 hr 20 minSuitable Sample TypeFor the detection and quantitative determination of AAV8 capsid titration in AAV gene therapy product preparation processing.Sample volume100 μL产品概述（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.
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）
IDComponentsSizeAAV08H-C01Pre-coated Anti-AAV8 Antibody Microplate1 plateAAV08H-C02AAV8 Standard1.4E+10 capsidsAAV08H-C03HRP-Anti-AAV8 Antibody15 μgAAV08H-C0410×Washing Buffer50 mLAAV08H-C052×Dilution Buffer50 mLAAV08H-C06Substrate Solution12 mLAAV08H-C07Stop Solution7 mL质量管理控制体系（QMS）
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数据展示
典型数据-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.
稀释线性（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.
批内差异（Intra-Assay Statistics）
Three samples of known concentration were tested ten times on one plate to assess intra-assay precision.
批间差异（Inter-Assay Statistics）
Three samples of known concentration were tested in three separate assays to assess inter-assay precision.
回收率（Recovery）
Three AAV8 with different concentrations were tested to calculate the recovery rate.
专属性（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.
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)
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