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产品概述（Product Overview）
E. coli residual DNA quantitative Kit is designed for quantitative detection of residual E. coli DNA in biopharmaceuticals (Antibodies, CAR cell, Vaccines, etc.). Based on real-time quantitative PCR (qPCR) method, this kit makes detection the residual DNA from E. coli bacteria rapid and reliable. The lower limit of quantitation is 3 fg/µL. All procedures are typically in less than 4 hours. Use the kit after extracting host cell DNA from test samples. For achieving the better DNA recovery, it is recommended to use the resDNA Sample Preparation Kit (Magnetic Beads) (Cat. No. OPA-R005) in combination.
产品特性（Features）
- High sensitivity for optimal product safety: LLOD (1 fg/µL) for detection of residue host cell DNA
- 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 E. coli 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-O002-012×qPCR Master Mix1.0 mL×2OPA-O002-02E. coli Primer & Probe Mix700 μLOPA-O002-03E. coli DNA Control（3ng/μL）100 μLOPA-O002-04Dilution Buffer1.5 mL×3OPA-O002-05DNase/RNase-free Water1.0 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.
Figure 1. High sensitivity and broad dynamic range using the E. coli residual DNA quantitative Kit. (A) Typical analysis results obtained with Standard 1 (300 pg/μL) to 6 (3 fg/μL). (B) The standard curve of the 10-fold dilution series. PCR efficiency should be 90-110%.
Figure 2. Assay specificity. Standard curves generated using 10-fold serial dilution of E. coli genomic DNA (included in the kit).
Figure 3. Consistent quantitation across a broad range of fragment sizes. Standard curves were generated using a 10-fold serial dilution of gDNA and fragmented DNA. Fragmented DNA was generated by sonicating total E. coli genomic DNA (8min, 13min, 20min). Fragmentation of the DNA was confirmed by agarose gel analysis.
Figure 4. The standard curve for ACRO and Brand T demonstrates near-optimal amplification efficiency, approaching 100%, whereas the standard curve for Brand H exhibits an amplification efficiency below 90%.
Figure 5. Recovery efficiency was validated using four distinct E. coli DNA sample types: intact genomic DNA (180 pg and 1.8 pg) and fragmented DNA (180 pg and 1.8 pg). ACRO products demonstrated consistent recovery rates ranging from 90% to 100% across all sample conditions.
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