This kit is used to quantitate Human DNA residues of different fragment sizes at varying stages of biopharmaceutical products, from in-process samples to final products.
The SHENTEK® Residual Human DNA Size Analysis Kit (2G) utilizes real-time PCR technique to perform rapid and specific quantitation of residual human DNA fragments in samples. It is designed to amplify four different fragments (75 bp, 122 bp, 244 bp and 562 bp) for the accurate determination of their size distribution at the femtograms (fg) level.
For extraction information, please refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191).
Size: 4 × 100 Reactions
| Components | Shipping Condition | Unit Size | Detection Method |
| Human DNA Control | -20℃ | 4×100 Reactions | Probe-based qPCR |
| qPCR Reaction Buffer | -20℃, protect from light | ||
| Human Primer&Probe MIX-75 | |||
| Human Primer&Probe MIX-122 | |||
| Human Primer&Probe MIX-244 | |||
| Human Primer&Probe MIX-562 | |||
| IPC MIX | |||
| DNA Dilution Buffer (DDB) | -20℃ |
| Range | 75bp: 0.03 pg/μL-300 pg/μL, R2=0.999 |
| 122bp: 0.03 pg/μL-300 pg/μL, R2=0.998 | |
| 244bp: 0.03 pg/μL-300 pg/μL, R2=0.998 | |
| 562bp: 0.03 pg/μL-300 pg/μL, R2=0.996 | |
| Accuracy | 75bp: Recovery = 76.4%-80.1% , CV<40% |
| 122bp: Recovery = 83.5%-103.3% , CV<40% | |
| 244bp: Recovery = 80.5%-107.7% , CV<40% | |
| 562bp: Recovery = 94.5%-124.7% , CV<40% | |
| LOQ | 0.03 pg/μL, CV<40% |
| Precision | CV<40% |
| Robustness | Freeze-thaw stability over 4 cycles |
| Instrument suitability not limited to Thermo, SHENTEK qPCR equipments |
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