Description
Hansenula polymorpha Host Cell DNA Residue Detection Kit is used for the quantitative analysis of Hansenula polymorpha host cell DNA residuce in intermediate samples, semi-finished and finished products of various biological products.
This kit adopts Taqman fluorescent probe and the polymerase chain reaction (PCR) method, which has fg level minimum detection limit and can specifically and quickly detect the residual Hansenula polymorpha cell DNA. The kit needs to be used together with the the Residual DNA Sample Preparation Kit (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 3 fg/μL level;
- High precision: high intra-batch repeatability and low inter-batch variation;
- Strong exclusivity: specific detection of residual DNA in Hansenula polymorpha cells without interference from other exogenous genomic DNA;
- Strong anti-interference: add internal control (IC), easy to exclude sample interference, reaction preparation abnormalities and other factors.
Application
Residual Hansenula polymorpha Host Cell DNA test in biological products.
Specification
|
Sensitivity |
3 fg/μL (range 30fg/μL~300pg/μL) |
|
Assay Time |
~1.5 hours |
|
Assay Principle |
Fluorescent probe qPCR method |
|
Required Instruments |
Real-time fluorescence quantitative PCR system |
Components
|
Components No. |
Name |
41317ES50-EN |
41317ES60-EN |
|
41317-A |
Hansenula polymorpha qPCR Mix |
0.75 mL |
1.5 mL |
|
41317-B |
Hansenula polymorpha Primer&Probe Mix |
200 μL |
400 μL |
|
41317-C |
DNA Dilution Buffer |
1.8 mL×2 |
1.8 mL×4 |
|
41317-D |
Hansenula polymorpha DNA Control (30 ng/μL) |
25 μL |
50 μL |
|
41317-E |
IC* |
50 μL |
100 μL |
*IC：Internal control.
Storage
This product should be stored at -25~-15℃ for 2 years.
Both 41317-A and 41317-B should be stored protected from light.
Figures
- Limit of quantification
Hansenula polymorpha DNA was detected at 30 fg/uL, 10 fg/uL, 5 fg/uL, and 3 fg/uL, with 10 replicates for each concentration. The results showed that at concentrations of 3fg/uL and above, the CV was <20%, i.e., the limit of quantification for DNA residues in Hansenula host cells was 3fg/uL.
|
Repetition number Test item |
Hansenula polymorpha DNA (fg/uL) |
|
|
Quantity |
Return ratio |
|
|
1 |
3.25 |
108.33% |
|
2 |
2.69 |
89.67% |
|
3 |
3.41 |
113.67% |
|
4 |
3.46 |
115.33% |
|
5 |
2.98 |
99.33% |
|
6 |
2.81 |
93.67% |
|
7 |
2.89 |
96.33% |
|
8 |
2.79 |
93.00% |
|
9 |
3.35 |
111.67% |
|
10 |
2.80 |
93.33% |
|
Average value |
3.04 |
\ |
|
CV% |
9.64% |
\ |
Table 1. Limit of quantification (LOQ) assay results for Hansenula polymorpha yeast DNA
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