{ "ProductData": { "ID": "3.5.9.5.3.3", "ProductType": "Others", "BrandName": "DNA Process Control Kit", "ProductNameAddition": "Includes DNA Process Control, Control Assay, and multiplex master mix for monitoring the whole workflow, from nucleic acid extraction to qPCR.", "RegulatoryDisclaimer1": "For general laboratory use.", "DisclaimerGroup1": "GPR", "RegulatoryDisclaimer2": "", "DisclaimerGroup2": null, "RegulatoryDisclaimer3": "This product is not available in all territories due to different national regulations.
This document is not intended for use in the USA.", "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "DNA Process Control Kit" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07339542001_im_en.png", "ImageType": "Image main" }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "StructureNodeStatus": "valid", "NodeName": "DNA Process Control", "NodeID": "06-0003" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "StructureNodeStatus": "valid", "NodeName": "Controls", "NodeID": "90-000-00" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "StructureNodeStatus": "valid", "NodeName": "Research Lab", "NodeID": "150-00" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "StructureNodeStatus": "valid", "NodeName": "Molecular", "NodeID": "100" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "170-00" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999-00" } ] }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "StructureNodeStatus": "valid", "NodeName": "DNA Process Control", "NodeID": "06-0003" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "StructureNodeStatus": "valid", "NodeName": "Controls", "NodeID": "90-000-00" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "StructureNodeStatus": "valid", "NodeName": "Research Lab", "NodeID": "150-00" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "StructureNodeStatus": "valid", "NodeName": "Molecular", "NodeID": "100" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "170-00" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999-00" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07339542001", "MaterialDescription": "DNA Process Control Kit", "RegisteredProductName": "DNA Process Control Kit", "GTIN": "04038377029450", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "1 kit", "PackSizeDescPIM360": "6 x 96 DNA Control reactions and 600 qPCR reactions of 20 μL final volume each", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" }, { "MaterialNum": "07339666001", "MaterialDescription": "DNA Process Control Kit Trial Pack", "RegisteredProductName": "DNA Process Control Kit", "GTIN": "04038377029443", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "1 kit", "PackSizeDescPIM360": "2 x 96 DNA Control reactions and 200 qPCR reactions of 20 μL final volume each", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" }, { "MaterialNum": "07339623001", "MaterialDescription": "DNA Process Control Detection Kit", "RegisteredProductName": "DNA Process Control Detection Kit", "GTIN": "04038377029436", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "1 refill kit for the DNA Process Control detection only.", "PackSizeDescPIM360": "400 qPCR reactions of 20 μL final volume each.", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "INS_445", "BrandName": "LightCycler® 480 Instrument II", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "417", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "230", "StructureGroupPath": "LightCycler", "StructureGroupName": "LightCycler", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "300-00", "StructureGroupPath": "RT-PCR/qRT-PCR", "StructureGroupName": "RT-PCR/qRT-PCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "170-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "160-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "055", "StructureGroupPath": "Laboratory developed testing", "StructureGroupName": "Laboratory developed testing", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "530", "StructureGroupPath": "Sequencing", "StructureGroupName": "Sequencing", "StructureNodeStatus": "valid" } ] }, { "ProductID": "INS_2691", "BrandName": "LightCycler® 96 Instrument", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "6274", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "230", "StructureGroupPath": "LightCycler", "StructureGroupName": "LightCycler", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "300-00", "StructureGroupPath": "RT-PCR/qRT-PCR", "StructureGroupName": "RT-PCR/qRT-PCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "530", "StructureGroupPath": "Sequencing", "StructureGroupName": "Sequencing", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "170-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "055", "StructureGroupPath": "Laboratory developed testing", "StructureGroupName": "Laboratory developed testing", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Store the kits at –15 to –25°C.", "Country": "XG", "Code": "Storage Conditions (Product)", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "kit", "Country": "XG", "Code": "Form of Supply", "Name": "Form of Supply" }, { "Language": "en", "Value": "The Control DNA of the DNA Process Control Kit combines a number of important features required for unambiguous qPCR result interpretation. Nuclease-resistant Control DNA is added directly to the sample with a defined copy number input and is used to control the complete workflow, from DNA extraction to qPCR. The co-isolated Control DNA is detected in a multiplex qPCR reaction together with the target pathogen parameter(s).  Detailed protocols for use with the MagNA Pure Instruments, other nucleic acid isolation kits and LightCycler® Instruments are given in the \"Instructions for Use\" document. The performance with a large variety of human sample materials, such as blood, plasma, and serum, and a number of pathogen modular assays, has been extensively evaluated.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "
Background Information
Two major outcomes can occur during a typical detection workflow for DNA targets. The sample can be either positive or negative. Whereas a positive detection also verifies the functionality of workflow components, a negative test outcome could be due either to a true negative sample or to a failure of critical workflow components and thus be a false negative. To rule out the possibility of workflow failures, a positive control that is similar to the target material but inert to the target detection is supplied in this kit and can be used in the workflow.

In order to prevent any cross-reaction with sample-derived nucleic acids or target-specific detection systems, the DNA Process Control Assay amplicon has been designed to have no significant homologies to any other known sequence. The DNA Process Control Detection Assay primers and probe are added in a low concentration to further lower any possible competition effects in multiplex qPCR amplifications.
The DNA Process Control concentrate is formulated to achieve a robust Cq value within one specified workflow. Different sample materials and workflows may require adjusted dilution of the DNA Process Control concentrate.

The DNA Process Control Kit is designed for the detection of an endogenous heterologous control (DNA Process Control) during a sample purification procedure when using:
– either a MagNA Pure System together with a dedicated reagent kit (for automated isolation),
– or a High Pure Nucleic Acid Isolation Kit (for manual isolation).

How this Product Works
The DNA Process Control Kit provides a non-competitive internal control to monitor nucleic acid purification and detection processes in order to prevent false-negative results. The DNA Process Control working solution contains a constant amount of nuclease-resistant DNA(1) that can be added to a large variety of sample materials without impairing the purification of other sample intrinsic nucleic acid(2), such as from DNA viruses.

  1. The strictly monitored production and quality processes in conjunction with the easy-to-use workflow ensure that constant amounts of the control DNA are added to each and every sample.
  2. The DNA Process Control has a unique and completely artificial sequence that makes primer competition with any other target parameters less likely. The primer and the probe of the DNA Process Control are designed to only amplify and detect the unique sequence. The Cy5-labeled probe ensures that other target-specific assays with common dyes such as FAM, Yellow 555, or Red 610 can be combined in multiplex setups.
​​
Test Principle
The control is added to the sample material and co-purified with all other sample endogenous nucleic acids. After purification, the DNA Process Control as well as any target-specific parameter is detected in a qPCR reaction.
  • In monoplex reactions in single wells, the DNA Process Control must be positive.
  • In multiplex reactions, the DNA Process Control detection must be positive in all target-negative samples. In target-positive samples, the DNA Process Control may be out-competed by the target-specific assay and a negative control result is allowed.
Any failure of the DNA Process Control Detection Assay in target-negative samples indicates an erroneous purification/detection workflow and the sample must be retested.

The key steps in the process are:
  1. DNA Process Control working solution is added to the sample material.
  2. The protective coat of the internal control is lysed during the extraction process, thus enabling co-purification of the control DNA with other sample endogenous nucleic acids.
  3. The sample eluates are used for qPCR reactions.
    – The DNA Process Control Detection Assay specifically detects the internal control.
    – Laboratory-developed assays assess the status of other targets in the sample material.
    Since the DNA Process Control is added to all samples, its successful detection proves the correct sample processing as well as the functionality of the generic detection reagents.
", "Country": "XG", "Code": "Principle", "Name": "Principle" }, { "Language": "en", "Value": "Includes DNA Process Control, Control Assay, and multiplex master mix for monitoring the whole workflow, from nucleic acid extraction to qPCR.", "Country": "XG", "Code": "Product Characteristics", "Name": "Product Characteristics" }, { "Language": "en", "Value": "The DNA Process Control Kit contains a nuclease-resistant DNA that can be added at various steps during the nucleic acid purification of DNA detection workflows. Successful detection of this control DNA serves as a positive control, verifying the functionality of the DNA purification as well as the detection using quantitative PCR (qPCR). It also contains the LightCycler® Multiplex DNA Master optimized for multiplex reactions, ensuring performance for up to 4 targets plus the internal process control.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "en", "Value": "
DNA Process Control Kit
Vial / BottleCapLabelFunction / DescriptionCatalog NumberContent
1orangeDNA Process Control Kit,
DNA Process Control, conc.
Nuclease-resistant DNA concentrate in storage buffer07 339 542 0016 vials,
400 μl each
07 339 666 0012 vials,
400 μl each
2whiteDNA Process Control Kit,
DNA Process Control Diluent
DNA Process Control Diluent07 339 542 0013 bottles,
17 ml each
07 339 666 0011 bottle,
17 ml
3red  DNA Process Control Kit,
qPCR Reaction Mix, 5x conc.
LightCycler® DNA Multiplex Master07 339 542 0013 vials,
880 μl each
07 339 666 0011 vial,
880 μl
4yellowDNA Process Control Kit,
DNA Process Control Detection Assay, 20x conc.
Primer/Probe Mix for detection of the DNA Process Control07 339 542 0016 vials,
120 μl each
07 339 666 0012 vials,
120 μl each
5whiteDNA Process Control Kit,
Water, PCR Grade
To adjust the final reaction volume07 339 542 00112 vials,
1 ml each
07 339 666 0014 vials,
1 ml each
DNA Process Control Detection Kit
Vial / BottleCapLabelFunction / DescriptionCatalog NumberContent
3redDNA Process Control Detection Kit,
qPCR Reaction Mix, 5x conc.
LightCycler® DNA Multiplex Master07 339 623 0012 vials,
880 μl each
4yellow DNA Process Control Detection Kit,
DNA Process Control Detection Assay, 20x conc.
Primer/Probe Mix for detection of the DNA Process Control07 339 623 0014 vials,
120 μl each
5white DNA Process Control Detection Kit,
Water, PCR Grade 
To adjust the final reaction volume07 339 623 0018 vials,
1 ml each
The DNA Process Control Detection Kit can only be used in combination with the DNA Process Control that is contained in the DNA Process Control Kit.
", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "from 20 minutes (High Pure) up to 50 – 60 minutes for a typical run on the MagNA Pure 96 Instrument with 96 samples", "Country": "XG", "Code": "Assay Time", "Name": "Assay Time" } ] } } ] }

DNA Process Control Kit

Includes DNA Process Control, Control Assay, and multiplex master mix for monitoring the whole workflow, from nucleic acid extraction to qPCR.

DNA Process Control Kit

Ordering Information

Overview

Technical Documents

Access Material Data Sheets, Certificates of Analysis, and other product documentation.

After clicking above, you will be redirected to eLabDoc, where you can choose your local country.

Instruments

...
    ...
    error errorMessage
    Sorry, we couldn't find the content you are looking for
    Please try again later