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Product Details
Product Overview
E1A resDNA Quantitation Kit is designed for quantitative detection of residual E1A 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. 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 resDNA Sample Preparation Kit (Magnetic Beads) (Cat. No. OPA-R005) in combination.
Features
- High sensitivity for optimal product safety: LLOQ (40 copies/µL) for detection of residue 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 E1A DNA in biopharmaceutical production.
For use in quality control/manufacturing process only.
It is for research use only.
Technical Specifications
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.
Materials Provided
IDComponentsSizeOPA-R008-01E1A Primer & Probe Mix550 μLOPA-R008-022×qPCR Master Mix1.6 mLOPA-R008-03Linearize DNA Control 4×10⁸ copies/μL50 μLOPA-R008-04DNA Dilution Buffer1.5 mL×3ACRO 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 E1A resDNA Quantitative Kit. (A) Typical analysis results obtained with Standard 1 (4×10⁶ copies/µL) to 6 (4×10 copies/µL). (B) The standard curve of the 10-fold dilution series. PCR efficiency should be 90-110%.
To evaluate the specificity of assay using E1A resDNA Quantitation Kit, no template samples spiked with unrelated DNA were tested. Results shown in the following Table. Unrelated DNA (E. coli, CHO, Vero, and Pichia yeast) were not detected in assay, and the value of MDCK was outside the range of standard curve (4×10⁶ copies/µL to 4×10 copies/µL).
To evaluate the recovery of assay using E1A resDNA Quantitation Kit, three different concentrations of DNA samples were tested. Results shown in the following Table. All samples had recoveries between 95%-104%.
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