Replication-competent AAV Serotype 2 (rcAAV2) Detection Kit _ 41327ES yeasen
$1,485.00
In stock
SKU
41327ES50
Product Description
The Replication-competent AAV Serotype 2 (rcAAV2) Detection Kit is designed to quantitatively analyze and detect the potential risk of Replication Competent Adeno-associated Virus (rcAAV) in a variety of gene therapy, oncology and vaccine development products using recombinant adeno-associated viral vectors with AAV2 serotype. This kit is based on the principle of fluorescent probe quantitative PCR, and uses qPCR to detect rAAV terminal repeat sequence (ITR) (i.e. Reference gene) and rcAAV linked sequence (i.e. Target gene) respectively, realizing the quantitative detection of rAAV and rcAAV at the same time. The kit also contains DNA quantitative references for the reference gene and the target gene (rcAAV2 Reference&Target DNA Control) Before using this kit, make sure that the sample to be tested also meets the following conditions: 1. The serotype of the adeno-associated virus in the sample to be tested is AAV2;
2. The ITR sequence of the recombinant adeno-associated viral vector rAAV in the sample to be tested needs to be matched with the ITR sequence of rAAV2 as described below: >rAAV-2/N ITR sequence TTGGCCACTCCCTCTCTGCGCGCTCGCTCGCTCACTGAGGCCGGGCGACCAAAGGTCGCCCGACGCCCGGGCTTTGCCCGGGCGGCCTCAGTGAGCGAGCGAGCGCGCAGAGAGGGAGTGGCCAACTCCATCACTAGGGGTTCCT
Features
- Compliance with regulations:
- the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards;
- Guarantee of quality:
- the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory;
- High sensitivity:
- the lower limit of quantification (LLOQ) was
- 2
- copies/uL;
- High precision:
- high intra-batch reproducibility CV <10%, small inter-batch variation i.e. intermediate precision CV <15%;
- Strong specificity:
- specific detection of
- rcAAV2 residual DNA
- without interference from other exogenous genomic DNA;
- Strong anti-interference:
- the introduction of internal quality control (Reference) can exclude sample interference, abnormal reaction preparation and other factors, effectively avoiding false negatives.
Applications
- Residual
- rcAAV2 DNA
- test in biological products
Specifications
| Sensitivity | 2 copies/uL (rang: Referenceand Target are all 2×101 ～ 2×106copies/μL ） Assay Time ~1.5 hours Assay Principle Fluorescent probe qPCR method Required Instruments Real-time fluorescence quantitative PCR system Product Performance Product Performance Validation Program Reference standards or requirements YEASEN 1. Standards for the kit Homemade standards are available Plasmid DNA containing Reference gene and Target gene 2. |
| Linear Range | Assay Range Refer to the actual situation 2x101~2x106 copies/μL R2 ≥0.98 ≥0.99 and above Slope -3.1~-3.8 -3.1~-3.6 Amplification Efficiency 84%~109% 90%~109% 3. Accuracy Recovery Rate 50%~150% 70%~130% and above 4. Precision Repeatability CV≤15% ＜ 10% Intermediate precision CV≤15% ＜ 15% 5. Exclusivity No interference with DNA from other sources Specific detection of rcAAV2 DNA without interference from other exogenous DNA 6. Sensitivity Limit of quantification Reliable quantification of the smallest concentrations of target substances 2 copies/μL Limit of detection Refer to the actual situation 0.125 copies/μL 7. Durability Reagent Stability Evaluating the effect of different storage temperatures on reagent performance 2~8°C for 30 days and 37°C for 14 days, and repeated freeze-thaw 10 times, the kit amplification efficiency is in the range of 90%~109%, R2≥0.99 and above Instrument Compatibility Kits are used on different devices without affecting the test results Compatible with many types of qPCR Instruments (eg. Bio-Rad CFX96 Optic Module, Thermo Scientific ABI 7500, ABI Quant Studio 5) |
Components
- Components No.
- Name
- 41327ES50
- 41327ES60
- 41327-A
- rcAAV2 qPCR Mix
- 300 μL×2
- 600 μL×2
- 41327-B1
- rcAAV2 Reference Primer&probe Mix
- 200 μL
- 400 μL
- 41327-B2
- rcAAV2 Target Primer&probe Mix
- 200 μL
- 400 μL
- 41327-C
- DNA Dilution Buffer
- 1.8 mL×2
- 1.8 mL×4
- 41327-D
- rcAAV2 Reference&Target DNA Control (2×108
- copies
- /μL
- )
- 50 μL
- 100 μL
Storage
This product should be stored at -25~-15℃ for 2 years. Both 41327 -A , 41327-B1 and 41327 -B 2 should be stored protected from light
Figures
Limit of quantification rcAAV2 DNA at concentrations of 2 ×101 copies/uL, 10 copies/uL, 5 copies/μL , 2 copies/μL and 1 copies/uL (with Target DNA and Reference DNA) were detected, with 10 replicates for each concentration, respectively. The results showed that the CV of rcAAV2 DNA was <20% at concentrations of 2 copies/μL and above. Therefore, the limit of quantification in the rcAAV2 DNA residue detection kits was 2 copies/μL. Table 1 . Limit of quantification (LOQ) assay results for rcAAV2 DNA Repetition number Test item Target (copies/μL) Reference (copies/μL) Quantity Return ratio Quantity Return ratio 1 2.34 117.01 % 1.97 98.63 % 2 2.13 106.26 % 1.92 96.22 % 3 2.06 103.24 % 2.45 122.39 % 4 1.99 99.43 % 2.15 107.52 % 5 1.93 96.26 % 1.78 89.14 % 6 1.93 96.56% 2.35 117.72 % 7 2.27 113.69% 1.80 90.16 % 8 2.38 119.10% 1.65 82.39 % 9 2.41 120.73% 1.88 94.25 % 10 1.85 92.43 % 1.83 91.40 % Average value
2.13 1.98 CV 9.83% 13.87% 1 2 copies/μL rcAAV2 DNA qPCR assay results Limit of detection The detection of Target and Reference at various concentration points under the quantitative limit, combined with the blank limit requirements, yields the detection limit of the reagent kit. The results show that at concentrations of 0.125 copies/μL and above, in 20 repeated wells, ≥19 wells are detected (i.e., the detection rate is ≥95%). Therefore, the detection limit of the replicative adeno-associated virus serotype 2 (rcAAV2) detection reagent kit can reach 0.125 copies/μL. Table 2. Limit of detection (LOD) assay results for rcAAV2 DNA Ct value Theoretical concentration Target (copies/μL) Reference (copies/μL) 0.25 0.125 0.0625 0.25 0.125 0.0625 Positive count / Total count 20/20 19/20 18/20 20/20 19/20 Detection rate 100% 95% 90% 100% 95%
Safety Data Sheet
- 41327_MSDS_HB250310.pdf
Manuals
- 41327_Manual_Ver.EN20250310.pdf
Reviews
Write Your Own Review
Related Products
Check items to add to the cart or
