SHENTEK® Residual Human DNA Quantitation Kit (2G) is used to quantitate residual Human host cell DNA of biopharmaceutical products in different stages, from in-process samples to final products. This kit utilizes duplex quantitative PCR (qPCR) technique to performs a rapid, specific, and reliable quantitation assay at femtogram (fg) level. Internal Positive Control (IPC) is included in the Human Primer&Probe MIX to evaluate the performance of each PCR reaction. For extraction information, please refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191) .
| Components | Shipping Condition | Unit Size | Detection Method |
| Human DNA Control | -20℃ | 100 Reactions | Probe-based qPCR |
| qPCR Master MIX | -20℃, protect from light | ||
| Human Primer&Probe MIX (Incl IPC) | |||
| DNA Dilution Buffer (DDB) | -20℃ |
| Range | 3x10-2-3x102 pg/μL (3x10-1-3x103 pg/reaction), R2=0.999677, E=94.4% |
| Accuracy | Recovery = 65.9% - 97.7%, CV<30% |
| LOQ | 0.03 pg/μL (0.3 pg/reaction) |
| Precision | 5.1%-7.9% (CV≤30%) |
| Specificity | No cross-reactivity with CHO, E.coli and NS0&SP2/0 gDNA |
| Robustness | Freeze-thaw stability over 5 cycles |
| Instrument suitability not limited to Thermo 7500, Biorad CFX-96, SHENTEK-96S qPCR equipments |
SHENTEK® Residual Host Cell DNA Sample Preparation Kit
SHENTEK® Residual Human DNA Quantitation Kit
SHENTEK® Residual Human DNA Size Analysis Kit (2G)
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