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Plasmid Residual DNA(qPCR)Detection Kit (Kanamycin Resistance Gene)
Product Introduction
In May 2022, the Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products issued by the Center for Drug Evaluation (CDE) clearly stated that viral vectors such as AAV, which easily package non-vector DNA into viral particles, should consider the potential risk of foreign DNA packaging into viral particles when selecting packaging plasmids. Regulatory authorities stipulate that the DNA content in the final products of cell expression should be as low as possible, and highly sensitive methods must be used for quantification. General Chapter 3407 of the Chinese Pharmacopoeia (2020 Edition, Volume III) specifies that the methods for detecting host cell DNA residue include DNA probe hybridization, fluorescent staining, and quantitative PCR (qPCR).
The kit has a linear range of 1×106 copies/μL - 1×101 copies/μL and a sensitivity of up to 5 copies/μL, meeting customers’ requirements for residue detection sensitivity. It enables accurate and rapid quantification of plasmid DNA residues.
Performance Specifications
Linear Range: 1×106 copies/μL - 1×101 copies/μL
Standard Curve Linearity:
R² ≥ 0.980
Amplification Efficiency 90% ≤ Eff (%) ≤ 110%
CV < 15% for all concentration detection values
Accuracy (Spiked Recovery): 70%–130%
Limit of Quantification: 5 copies/μL, CV ≤ 20%, measurement deviation ≤ |±20%|
Precision (repeatability): Ten replicates each for high and medium concentration reference samples, with coefficient of variation (CV) <15%
Negative control compliance rate: NTCs must yield Undetermined results or Ct values >35
Compatible instruments (including but not limited to): ABI QuantStudio 5, ABI 7500, etc
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