Introduction
Components | Shipping Condition | Unit Size | Product Line | Detection Method |
E. coli DNA Control | -20℃ | 100 Reactions | SHENTEK™ | Probe-based qPCR |
qPCR Master MIX | -20℃ | – | – | – |
DNA Dilution Buffer (DDB) | -20℃ | – | – | – |
E. coli Primer&Probe MIX (Incl IPC) | -20℃, protect from light | – | – | – |
Overview
SHENTEK™ Residual E. coli DNA Quantitation Kit is used to quantitate residual E. coli host cell DNA in different stages of biopharmaceutical products, from in-process samples to final products. This kit uses duplex real-time PCR technology to perform rapid, specific, and reliable quantitation assay at the fg level. IPC(Internal Positive Control) is included in the E. coli Primer&Probe MIX to evaluate the performance of each PCR reaction. For extraction information, please refer to the SHENTEKTM Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191-E).
Specification
Range | 3.00E+02 to 3.00E-02 pg/μL, R2=0.99968, AE=97.5% |
Accuracy | Recovery = 50%-150%, CV<30% |
LOQ | 0.03 pg/μL |
LOD | 0.003 pg/μL |
Precision | CV <30% |
Robustness |
Freeze-thaw stability over 5 cycles Instrument suitability not limited to Thermo, Biorad, HZSKBio qPCR equipments |
Related Products
Residual Host Cell DNA Sample Preparation Kit – SHENTEK®
Documents
User Guide
Assay Validation Summary
Assay Validation Report (on Request)
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