Replication-competent Retrovirus (RCR) Detection Kit _ 41329ES yeasen
$1,485.00
In stock
SKU
41329ES50
Product Description
The Replication-competent Retrovirus (RCR) Detection Kit can be used to quantitatively analyze and detect the potential risk of Replication-competent Retrovirus (RCR) that may occur in a variety of cellular therapeutic products and gene therapy products associated with the use of r etrovirus vectors. This kit targets specific sequences on the retroviral vector to design specific primers, and adopts the principle of fluorescence quantitative PCR by probe method to rapidly and specifically detect the risk of replicative r etrovirus (RCR) . A nd the limit of quantification can be as low as 10 copies/μL, the limit of detection can be 0.3 copies/μL, it contains the RC R DNA Control (DNA quantitative reference product). The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES).
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
- 10
- 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
- RCR residual DNA
- without interference from other exogenous genomic DNA;
- Strong anti-interference:
- the introduction of internal quality control (IC) can exclude sample interference, abnormal reaction preparation and other factors, effectively avoiding false negatives.
Applications
- Residual
- RCR DNA
- test in biological products
Specifications
| Sensitivity | 10 copies/uL (range 5×101 ～ 5×106copies/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 specific sequences on the retroviral vector 2. |
| Linear Range | Assay Range Refer to the actual situation 5x101~5x106 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 RCR DNA without interference from other exogenous DNA 6. Sensitivity Limit of quantification Reliable quantification of the smallest concentrations of target substances 10 copies/μL Limit of detection Refer to the actual situation 0.3 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
- 41329ES50
- 41329ES60
- 41329-A
- RCR RT-qPCR Mix (Primer&Probe)
- 850 μL
- 1.7 mL
- 41329-B
- RCR RT-qPCR Enzyme Mix
- 100 μL
- 200 μL
- 41329-C
- Dilution Buffer
- 1.8 mL×2
- 1.8 mL×4
- 41329-D
- RCR Control (5×108
- copies
- /μL
- )
- 25 μL
- 50 μL
- 41329-E
- RCR IC*
- 50 μL
- 100 μL
- IC
- Internal control.
Storage
This product should be stored at -25~-15℃ for 2 years. The 41329 -A should be stored protected from light
Figures
Limit of quantification RCR DNA at concentrations of 5 ×101 copies/uL, 30 copies/uL, 20 copies/μL , 10copies/μL and 5 copies/uL were detected, with 10 replicates for each concentration, respectively. The results showed that the CV of RCR DNA was <20% at concentrations of 10 copies/μL and above. Therefore, the limit of quantification in the RCR DNA residue detection kits was 10 copies/μL for RCR Table 1 . Limit of quantification (LOQ) assay results for RCR DNA Repetition number Test item RCR (copies/μL) Quantity Return ratio 1 9.97 99.7% 2 9.47 94.7% 3 8.80 87.9% 4 9.51 95.1% 5 10.46 104.6% 6 8.91 89.1% 7 10.72 107.2% 8 9.88 98.8% 9 8.65 86.5% 10 10.96 109.6% Average value 9.73 CV 8.34% 1 10 copies/μL RC R DNA qPCR assay results Limit of detection The detection of RCR DNA 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.
3 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 Replication-competent Retrovirus (RCR) Detection Kit can reach 0. 3 copies/μL. Table 2. Limit of detection (LOD) assay results forRCR DNA Ct value Theoretical concentration RCR DNA (copies/μL) 0.3 0.2 0.1 Positive count / Total count 19/20 17/20 11/20 Detection rate 95% 85% 55%
Safety Data Sheet
- 41329_MSDS_HB250310.pdf
Manuals
- 41329_Manual_Ver.EN20250310.pdf
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