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"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": "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).

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.

​​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.

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.

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Vial / Bottle	Cap	Label	Function / Description	Catalog Number	Content
1	orange	DNA Process Control Kit, DNA Process Control, conc.	Nuclease-resistant DNA concentrate in storage buffer	07 339 542 001	6 vials, 400 μl each
07 339 666 001	2 vials, 400 μl each
2	white	DNA Process Control Kit, DNA Process Control Diluent	DNA Process Control Diluent	07 339 542 001	3 bottles, 17 ml each
07 339 666 001	1 bottle, 17 ml
3	red	DNA Process Control Kit, qPCR Reaction Mix, 5x conc.	LightCycler® DNA Multiplex Master	07 339 542 001	3 vials, 880 μl each
07 339 666 001	1 vial, 880 μl
4	yellow	DNA Process Control Kit, DNA Process Control Detection Assay, 20x conc.	Primer/Probe Mix for detection of the DNA Process Control	07 339 542 001	6 vials, 120 μl each
07 339 666 001	2 vials, 120 μl each
5	white	DNA Process Control Kit, Water, PCR Grade	To adjust the final reaction volume	07 339 542 001	12 vials, 1 ml each
07 339 666 001	4 vials, 1 ml each

Vial / Bottle	Cap	Label	Function / Description	Catalog Number	Content
3	red	DNA Process Control Detection Kit, qPCR Reaction Mix, 5x conc.	LightCycler® DNA Multiplex Master	07 339 623 001	2 vials, 880 μl each
4	yellow	DNA Process Control Detection Kit, DNA Process Control Detection Assay, 20x conc.	Primer/Probe Mix for detection of the DNA Process Control	07 339 623 001	4 vials, 120 μl each
5	white	DNA Process Control Detection Kit, Water, PCR Grade	To adjust the final reaction volume	07 339 623 001	8 vials, 1 ml each

", "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" } ] } } ] }