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Product Details
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 resDetect™ resDNA Sample Preparation Kit (Magnetic Beads) (Cat. No. OPA-R005) in combination.
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.
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.
Technical Specifications
Attention
If your experimental process requires sample preparation, please purchase and conduct the experiment using the sample preparation kits recommended in the table to ensure that the buffers used in both the sample preparation and resDNA detection are consistent.
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 mLACRO Quality Management System
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Performance Data
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 amplification efficiency of standard curve (ACRO and Competitor T) is close to 100%, while the amplification efficiency of standard curve (Competitor H) is less than 90%.
Figure 5. Validation of the recovery in four different E. coli DNA samples (gDNA 180 pg, gDNA 1.8 pg, Fragmented DNA 180 pg, Fragmented DNA 1.8 pg). Results show that the recovery using the ACRO products are between 90 and 100%.
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