This kit is designed for the quantitative detection of the size distribution of Human residual host cell DNA fragments in intermediates, semi-finished and finished products of various biological products.
This kit adopts the principle of PCR fluorescent probe method to quantitatively detect the size distribution of human residual host cell DNA fragments in the sample. The kit features three different amplified fragments (99 bp, 200 bp and 307 bp), and the Human DNA quantification reference is used to make standard curves for different amplified fragments respectively, and the fragment distribution of Human residual DNA in the sample is analyzed through the ratio of different sizes of fragments.
The kit is a rapid, specific and reliable device, with the minimum detection limit reaching fg level.
| Specification | 300 Reactions |
Assay range | 3.00×101~3.00×105 fg/μL |
Limit of quantitation | 3.00×101 fg/μL |
Precision | CV%≤15% |
| Validity period | 18 months |
| Storage conditions | -20℃ |
| LOQ | 30 fg/μL |
| LOD | 30 fg/μL |
| IND Filing | OK |
Residual DNA Fragment（≥99bp）Detection
| Standard | Ct Value | Ct-IPC value | |||
| Concentration (fg/μl) | Log10 (Concentration) | Ct Value | Mean value | Ct-IPC value | Mean value |
| 3.00E+05 | 5.48 | 21.66 | 21.66 | 22.96 | 22.8 |
| 3.00E+04 | 4.48 | 25.06 | 25.06 | 22.67 | |
| 3.00E+03 | 3.48 | 28.61 | 28.61 | 22.81 | |
| 3.00E+02 | 2.48 | 31.85 | 31.85 | 22.7 | |
| 3.00E+01 | 1.48 | 34.74 | 34.74 | 22.86 | |
| Amplification efficiency | 101.19% | ||||
Residual DNA Fragment（≥200bp）Detection
| Standard | Ct Value | Ct-IPC value | |||
| Concentration | Log10 | Ct Value | Mean value | Ct-IPC value | Mean value |
| (fg/μl) | (Concentration) | ||||
| 3.00E+05 | 5.48 | 23.23 | 23.23 | 23.09 | 23.06 |
| 3.00E+04 | 4.48 | 26.8 | 26.8 | 23.08 | |
| 3.00E+03 | 3.48 | 30.16 | 30.16 | 22.99 | |
| 3.00E+02 | 2.48 | 33.49 | 33.49 | 23.13 | |
| 3.00E+01 | 1.48 | 36.77 | 36.77 | 23 | |
| Amplification efficiency | 97.76% | ||||
Residual DNA Fragment（≥307bp）Detection
| Standard | Ct Value | Ct-IPC value | |||
| Concentration | Log10 | Ct Value | Mean value | Ct-IPC value | Mean value |
| (fg/μl) | (Concentration) | ||||
| 3.00E+05 | 5.48 | 23.98 | 23.98 | 23 | 22.99 |
| 3.00E+04 | 4.48 | 27.98 | 27.98 | 22.99 | |
| 3.00E+03 | 3.48 | 31.31 | 31.31 | 23.04 | |
| 3.00E+02 | 2.48 | 34.4 | 34.4 | 22.88 | |
| 3.00E+01 | 1.48 | 37.79 | 37.79 | 23.02 | |
| Amplification efficiency | 96.68% | ||||
1-805-304-6109 
info@hillgene.com 
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