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Vial / Bottle	Cap	Label	Function / Description	Catalog Number	Content
1	purple	RNA Process Control Kit, RNA Process Control, conc.	Nuclease-resistant RNA concentrate in storage buffer	07 099 592 001	6 vials, 10 μl each
07 099 622 001	2 vials, 10 μl each
2	colorless	RNA Process Control Kit, RNA Process Control Diluent	RNA Process Control Diluent	07 099 592 001	3 bottles, 17 ml each
07 099 622 001	1 bottle, 17 ml
3	blue	RNA Process Control Kit, RT Enzyme Solution, 200x conc.	LightCycler® Multiplex RNA Virus Master	07 099 592 001	3 vials, 28 μl each
07 099 622 001	1 vial, 28 μl
4	red	RNA Process Control Kit, RT-qPCR Reaction Mix, 5x conc.	LightCycler® Multiplex RNA Virus Master	07 099 592 001	3 vials, 880 μl each
07 099 622 001	1 vial, 880 μl
5	yellow	RNA Process Control Kit, RNA Process Control Detection Assay, 20x conc.	Primer/Probe Mix for detection of the RNA Process Control	07 099 592 001	6 vials, 120 μl each
07 099 622 001	2 vials, 120 μl each
6	white	RNA Process Control Kit, Water, PCR Grade	To adjust the final reaction volume	07 099 592 001	12 vials, 1 ml each
07 099 622 001	4 vials, 1 ml each

Vial / Bottle	Cap	Label	Function / Description	Catalog Number	Content
3	blue	RNA Process Control Detection Kit, RT Enzyme Solution, 200x conc.	LightCycler® Multiplex RNA Virus Master	07 099 606 001	2 vials, 28 μl each
4	red	RNA Process Control Detection Kit, RT-qPCR Reaction Mix, 5x conc.	LightCycler® Multiplex RNA Virus Master	07 099 606 001	2 vials, 880 μl each
5	yellow	RNA Process Control Detection Kit, RNA Process Control Detection Assay, 20x conc.	Primer/Probe Mix for detection of the RNA Process Control	07 099 606 001	4 vials, 120 μl each
6	white	RNA Process Control Detection Kit, Water, PCR Grade	To adjust the final reaction volume	07 099 606 001	8 vials, 1 ml each

", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "The RNA Process Control Kit is a tool to control for potential failures of sample preparation, amplification, detection, and handling errors. The product is intended for use with a variety of sample materials (e.g., blood, serum, stool, urine) and a variety of viral RNA targets.
The RNA Process Control Kit is intended for general laboratory use. Any use of the product for in vitro diagnostic tests is the sole responsibility of the operator and must be validated by the operator, following the relevant national regulations.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "The RNA Process Control Kit contains a nuclease-resistant RNA that can be added at various steps during the nucleic acid purification of viral RNA detection workflows. Successful detection of this control RNA serves as a positive control, verifying the functionality of the RNA purification as well as the detection using RT-qPCR.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "en", "Value": "Two major outcomes can occur during a typical detection workflow for viral RNA 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 RNA Process Control Assay amplicon has been designed to have no significant homologies to any other known sequence. The RNA Process Control Detection Assay primers and probe are added in a low concentration to further lower any possible competition effects in multiplex reactions.
The RNA Process Control concentrate is adjusted carefully to achieve a robust Cq value within one specified workflow. Different sample materials and workflows may require adjusted dilution of the RNA Process Control concentrate.

The RNA Process Control Kit is designed for the detection of an endogenous heterologous control (RNA Process Control) during a sample purification procedure and is compatible with either the MagNA Pure 96 Instrument, MagNA Pure LC 2.0 Instrument, MagNA Pure Compact Instrument, or the High Pure Purification Kit.

The RNA 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 RNA Process Control working solution contains a constant amount of nuclease-resistant RNA⁽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 RNA viruses.

1. The strictly monitored production and quality processes in conjunction with the easy-to-use workflow ensure that constant amounts of the control RNA are added to each and every sample.
2. The RNA 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 RNA 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, HEX, 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 RNA Process Control as well as any target-specific parameter is detected in a RT-qPCR reaction.

• In monoplex reactions in single wells, the RNA Process Control must be positive.
• In multiplex reactions, the RNA Process Control detection must be positive in all target-negative samples. In target-positive samples, the RNA Process Control may be out-competed by the target-specific assay and a negative control result is allowed.

Any failure of the RNA Process Control Detection Assay in target-negative samples indicates an erroneous purification/detection workflow and the sample must be retested.

1. RNA 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 RNA with other sample endogenous nucleic acids.
3. The sample eluates are used for RT-qPCR reactions.
   – The RNA Process Control Detection Assay specifically detects the internal control.
   – Lab-developed assays assess the status of other targets in the sample material.

Since the RNA 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": "Nuclease-resistant Control RNA, Control RNA Detection Mix (Cy5-labeled probe and primers), and LightCycler^® Multiplex RNA Virus Master for monitoring the complete process of virus detection, from sample preparation to RT-qPCR.", "Country": "XG", "Code": "Positioning", "Name": "Positioning" }, { "Language": "en", "Value": "Two major outcomes can occur during a typical detection workflow for viral RNA 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.", "Country": "XG", "Code": "Background Information", "Name": "Background Information" } ] } } ] }