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| Product Name | E. coli Residual DNA Quantification Kit |
| Catalog No. | MDKPK-0027 |
| Description | A one-tube probe qPCR kit for sensitive quantitative detection of residual E. coli host-cell DNA in biopharmaceutical intermediates and finished products. |
| Intended Use | Residual E. coli host-cell DNA testing during development, manufacturing and quality control of biological products and pharmaceuticals. |
| Principle / Technology | Target-specific probe qPCR quantifies E. coli genomic DNA using a calibrated reference-DNA series. |
| Detection Method | Fluorescent probe-based real-time PCR. |
| Sample Type | Biological-product and pharmaceutical intermediates, semi-finished materials and finished products after suitable residual-DNA preparation. |
| Performance Range / Specifications | Linear range: 0.03–300 pg/µL; reported R² 1.00 and amplification efficiency 100.10%; qPCR run time below 1 hour. |
| Sensitivity / LOD | Reported detection down to 3 fg/µL; quantification limit 0.01 pg/µL with replicate CV below 15%. |
| Specificity | No detected interference from tested Pichia pastoris, Vero or CHO genomic DNA at background levels up to 100 ng. |
| Reaction Conditions / Protocol | Add prepared sample to the one-tube probe qPCR reagent system and quantify against the supplied reference series. |
| Components / Formulation | One-tube E. coli-specific probe qPCR detection reagent system with DNA reference standards and controls. |
| Storage Conditions | Store at −30 to −15°C. |
| Package Specifications | 100 reactions. |
| Product Form | One-tube residual host-cell DNA qPCR kit. |
| Quality Control | Reference standards are calibrated against a national E. coli DNA reference standard; linearity, amplification efficiency, quantification limit and specificity are assessed. |
| Key Features | Femtogram-level detection; broad linear range; high host specificity; less than 1-hour qPCR workflow; one-tube operation. |
| Shipping Conditions | Ship at or below 0°C. |
| Compatibility | Suitable for residual-DNA testing of E. coli-derived biopharmaceutical materials and compatible sample-preparation workflows. |
For research use only, not for clinical use.
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