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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 / bottle	Cap	Label	Function / description	Content
1	white	Workflow Negative Control	To exclude false-positive results.	1 vial, 700 μL
2	white	Dilution Buffer	For preparation of DNA standard dilutions.	5 vials, 1 mL each
3a	red	FastStart 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
3b	red	FastStart Reaction Mix, 5x conc.	1 vial, 600 μL
4	purple	DNA Stock Solution	50 μg/mL solution.	1 vial, 40 μL
5	blue	MgCl2, M-grade, 25 mM	For preparation of master mix.	1 vial, 200 μL
6	green	Detection Mix, 10x conc.	Primers and FAM-labeled detection probe with BHQ2 Quencher.	1 vial, 200 μL
7	white	PCR Negative Control	To exclude false-positive results.	1 vial, 100 μL
8	white	PCR 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" } ] } } ] }