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Plasmid DNA Residue (qPCR) Detection Kit (Gentamicin Resistance Gene)
Product Background
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) explicitly 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 during plasmid selection for viral production. Regulatory authorities require that the DNA content in the final product of cell expression should be minimized and quantified using highly sensitive methods. General Chapter 3407 of the Chinese Pharmacopoeia (Volume III) designates DNA probe hybridization, fluorescence staining, and quantitative PCR (qPCR) as the standard methods for detecting host cell DNA residues.
The detection linear range of this kit is 1×106 copies/μL - 1×101 copies/μL with a sensitivity of up to 5 copies/μL, which can meet the customer needs and quantify the DNA residue accurately and rapidly.
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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