Description
The HEK293 Host Cell Residue DNA Size Analysis Kit is designed for the quantitative analysis of HEK293 residual DNA fragments of various lengths in intermediates, semi-finished products, and final products of biological preparations.
This kit utilizes the qPCR fluorescence probe principle to specifically and rapidly detect HEK293 DNA residues both below and above 200 base pairs, with a quantification limit as low as 10 fg/μL. It also includes the HEK293 DNA Control (DNA quantitative reference). This kit can be used in conjunction with the company's magnetic bead-based residual DNA sample preparation kits (Cat#18461ES).
Feature
- Compliance with regulations: the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards;
- Guarantee of quality: the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory;
- High sensitivity: the limit of quantification can reach 10 fg/μL level;
- High precision: high intra-batch repeatability and low inter-batch variation;
- Strong exclusivity: specific detection of residual DNA in HEK293 cells without interference from other exogenous genomic DNA;
- Strong anti-interference: adding UDG enzyme, digesting routine product aerosol contamination, preventing non-specific amplification.
Application
Residual HEK293 Host Cell DNA Size test in biological products.
Specification
Sensitivity |
10 fg/μL (range 30 fg/μL~300 pg/μL) |
Assay Time |
~1.5 hours |
Assay Principle |
Fluorescent probe qPCR method |
Required Instruments |
Real-time fluorescence quantitative PCR system |
Components
Components No. |
Name |
41316ES70-EN |
41316ES74-EN |
41316-A |
HEK293 qPCR Mix |
0.75 mL×4 |
1.5 mL×4 |
41316-B1 |
HEK293 Primer&Probe Mix-82 |
250 μL |
500 μL |
41316-B2 |
HEK293 Primer&Probe Mix-133 |
250 μL |
500 μL |
41316-B3 |
HEK293 Primer&Probe Mix-227 |
250 μL |
500 μL |
41316-B4 |
HEK293 Primer&Probe Mix-515 |
250 μL |
500 μL |
41316-C |
DNA Dilution Buffer |
1.8 mL×2 |
1.8 mL×4 |
41316-D |
HEK293 DNA Control (30 ng/μL) |
25 μL |
50 μL |
Storage
This product should be stored at -25~-15℃ for 2 years.
Both 41316-A and 41316-B1&B2&B3&B4 all should be stored protected from light.
Figures
- Limit of quantification
The primer probes for the four fragments, 82bp, 133bp, 227bp and 515bp, were used to detect HEK293 DNA at 30fg/μL, 20fg/μL, 10fg/μL (i.e. 0.01pg/μL), with 10 replicates for each concentration, respectively. The results showed that at concentrations of 10fg/μL (i.e., 0.01pg/μL) and above, the CVs of the four fragments were <20%, and the backcalculated ratios were all between 70% and 130%, so the limits of quantification of the four fragments of the HEK293 Residual DNA Fragmentation Analysis Kit were all 10fg/μL (i.e., 0.01pg/μL).
Repetition number 重复次数
Test item |
HEK293 DNA (fg/μL) |
|||||||
82bp |
133bp |
227bp |
515bp |
|||||
Quantity |
Return ratio |
Quantity |
Return ratio |
Quantity |
Return ratio |
Quantity |
Return ratio |
|
1 |
0.011 |
110% |
0.009 |
90% |
0.010 |
95% |
0.009 |
88% |
2 |
0.009 |
91% |
0.009 |
93% |
0.009 |
86% |
0.009 |
93% |
3 |
0.011 |
107% |
0.009 |
95% |
0.009 |
87% |
0.009 |
88% |
4 |
0.011 |
112% |
0.010 |
97% |
0.009 |
92% |
0.009 |
93% |
5 |
0.011 |
108% |
0.010 |
95% |
0.009 |
87% |
0.010 |
99% |
6 |
0.009 |
94% |
0.010 |
102% |
0.009 |
90% |
0.010 |
98% |
7 |
0.010 |
97% |
0.009 |
93% |
0.009 |
87% |
0.009 |
87% |
8 |
0.010 |
100% |
0.011 |
111% |
0.010 |
101% |
0.009 |
91% |
9 |
0.010 |
102% |
0.010 |
102% |
0.008 |
83% |
0.009 |
94% |
10 |
0.010 |
100% |
0.009 |
90% |
0.008 |
84% |
0.010 |
101% |
Average value |
0.010 |
\ |
0.010 |
\ |
0.090 |
\ |
0.008 |
\ |
CV% |
7% |
\ |
7% |
\ |
8% |
\ |
14% |
\ |
Table 1. Limit of quantification (LOQ) detection results of four fragments of 82bp, 133bp, 227bp and 515bp
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The product is for research purposes only and is not intended for therapeutic or diagnostic use in humans or animals. Products and content are protected by patents, trademarks, and copyrights owned by Yeasen Biotechnology. Trademark symbols indicate the country of origin, not necessarily registration in all regions.
Certain applications may require additional third-party intellectual property rights.
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