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Limit of Quantification (LOQ): 5 pg/mL", "Country": "XG", "Code": "Sensitivity", "Name": "Sensitivity" }, { "Language": "en", "Value": "Escherichia coli DNA is quantified using a real-time PCR assay. The PCR-based assay is sensitive and specific for DNA from E. coli cells and not subject to detection of human or environmental DNA that might be introduced during sample handling.", "Country": "XG", "Code": "Specificity", "Name": "Specificity" }, { "Language": "en", "Value": "
Vial / bottleCapLabelFunction / descriptionContent
1whiteWorkflow Negative ControlTo exclude false-positive results.1 vial,
700 μL
2whiteDilution BufferFor preparation of DNA standard dilutions.5 vials,
1 mL each
3aredFastStart Enzyme• Ready-to-use hot start PCR reaction mix.
• Contains FastStart Taq DNA Polymerase, reaction buffer, uracil-N-glycosylase, and dNTP mix (with dUTP instead of dTTP).
1 vial,
30 μL
3bredFastStart Reaction Mix, 5x conc.1 vial,
600 μL
4purpleDNA Stock Solution50 μg/mL solution.1 vial,
40 μL
5blueMgCl2, M-grade, 25 mMFor preparation of master mix.1 vial,
200 μL
6greenDetection Mix, 10x conc.Primers and FAM-labeled detection probe with BHQ2 Quencher.1 vial,
200 μL
7whitePCR Negative ControlTo exclude false-positive results.1 vial,
100 μL
8whitePCR Water M-grade
  • For preparation of working solution.
  • For preparation of master mix.
1 vial,
1 mL
", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "Each lot of the Residual DNA E. coli Kit is function tested using the LightCycler® 480 Instrument II. PCR is performed on a dilution series of DNA amplified using the PCR protocol of the Residual DNA E. coli Kit.", "Country": "XG", "Code": "Quality Control", "Name": "Quality Control" }, { "Language": "en", "Value": "Quantitative detection of residual DNA from E. coli in products derived from fermentation processes.", "Country": "XG", "Code": "Product Characteristics", "Name": "Product Characteristics" }, { "Language": "en", "Value": "The kit is used as a final drug release test to detect the amount of residual host cell DNA (E. coli).", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Country": "XG", "Code": "CB - Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "The Roche Residual DNA E. coli Kit, based on proven real-time qPCR technology, makes testing of residual DNA from E. coli bacteria fast and reliable. It allows for high-confidence testing across a broad range of sample types, from in-process samples to bulk drug substance. The kit has a high sensitivity (LOD 1 pg/mL [10 fg/reaction]) and has been developed to meet WHO requirements. These characteristics are largely due to highly pure DNA-free buffers and enzymes supplied with the assay. An optimized sample preparation protocol for excellent DNA Recovery (min 80%) is available.
The PCR-based assay is sensitive and specific for DNA from E. coli cells and not subject to detection of human or environmental DNA that might be introduced during sample handling.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "en", "Value": "For the testing of cell culture samples for the absence of residual host cell DNA from E. coli bacteria.", "Country": "XG", "Code": "Positioning", "Name": "Positioning" }, { "Language": "en", "Value": "
  • Ready-to-use reagents jump start your assay.
  • High Quality: Standardized manufacturing according to ISO 13485. Change notification also available.
", "Country": "XG", "Code": "Benefits", "Name": "Benefits" }, { "Language": "en", "Value": "The PCR-based assay is sensitive and specific for DNA from E. coli cells and not subject to detection of human or environmental DNA that might be introduced during sample handling.
Stability: At -15 to -25°C within specification range for 24 months.", "Country": "XG", "Code": "Specification", "Name": "Specification" }, { "Language": "en", "Value": "Limit of Detection (LOD): 1 pg/mL
Limit of Quantification (LOQ): 5 pg/mL", "Country": "XG", "Code": "Properties", "Name": "Properties" } ] } } ] }

Residual DNA E. coli Kit

Kit for determination of residual DNA E.coli

Residual DNA E.coli Kit