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产品概述（Product Overview）
Plasmid resDNA Quantitation Kit is designed for quantitative detection of residual plasmid DNA in biopharmaceutical productions (cells, viruses, etc.). Based on real-time quantitative PCR (qPCR) method, this kit makes detection the residual DNA rapid and reliable. The lower limit of quantitation is 40 copies/µL using the Linearize DNA Control in the assay. All procedures are typically in less than 4 hours.
Use the kit after you extract residual DNA from test samples. For achieving the better DNA recovery, it is recommended to use the resDetect™ resDNA Sample Preparation Kit (Magnetic Beads) (Cat. No. OPA-R005) in combination.
产品特性（Features）
- High sensitivity for optimal product safety: LLOQ is 40 copies/µL using Linearize DNA Control in this assay
- High specificity: No cross-reactivity with unrelated DNA
- Validation: ICH Q2(R2) as validation of analytical procedures
- High-quality: This kit is manufactured in ISO 13485 standard facility.
应用说明（Application）
The kit is used for quantitative detection of residual Plasmid DNA in biopharmaceutical production.
For use in quality control/manufacturing process only.
It is for research use only.
技术参数（Technical Specifications）
使用提示（Attention）
If your experimental workflow involves host cell DNA sample preparation, please use the recommended sample preparation kits listed in the table. This ensures that the buffers used during both sample preparation and residual DNA quantitation remain consistent, supporting reliable and accurate results.
组分（Materials Provided）
IDComponentsSizeOPA-R009-01Plasmid Primer & Probe Mix550 μLOPA-R009-022×qPCR Master Mix1.6 mLOPA-R009-03Circular DNA Control 2×10⁸ copies/μL50 μLOPA-R009-04Linearize DNA Control 4×10⁸ copies/μL50 μLOPA-R009-05DNA Dilution Buffer1.5 mL×3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.
Figure 1 High sensitivity and broad dynamic range using the Plasmid resDNA Quantitation Kit. (A) Typical analysis results of obtained with Linearize DNA control Standard 1 (4×10⁶ copies/µL) to 6 (4×10 copies/µL). (B) The standard curve of the Linearize DNA control 10-fold dilution series. PCR efficiency should be 90-110%. (C) Typical analysis results of obtained with Circular DNA control Standard 1 (2×10⁶ copies/µL) to 5 (2×10² copies/µL). (D) The standard curve of the Circular DNA control 10-fold dilution series. PCR efficiency should be 90-110%.
To evaluate the specificity of assay using Plasmid resDNA Quantitation Kit, no template samples spiked with unrelated DNA were tested. Results shown in the following Table. Unrelated DNA (HEK293, CHO, Vero, Pichia pastoris, and MDCK) were detected in assay, however the values of Mean were outside the range of standard curve (4×106 copies/µL to 4×10 copies/µL).
To evaluate the recovery of assay using Plasmid resDNA Quantitation Kit, three different concentrations of DNA samples were tested. Results shown in the following Table. All samples had recoveries between 80%-110%.
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