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DNA Process Control Kit

Nuclease-resistant Control DNA, Control DNA Detection Mix (primers and Cy5-labeled probe), and LightCycler® Multiplex DNA Master for monitoring the complete process of pathogen detection, from sample preparation to qPCR.

For general laboratory use. This product is not available in all territories due to different national regulations.

Product No. Pack Size
07339542001 600 reactions
Product No. Pack Size
07339666001 200 reactions

To order these products, please contact your Roche order management team.

Accurate and efficient qPCR detection of pathogen DNA in human samples can be challenging because of a) errors in the purification or qPCR processes, or b) co-purification of PCR inhibiting substances from many human samples. Both challenges may lead to ambiguous interpretations of negative results. The solution is a generic positive internal control that monitors the whole process, and not only the qPCR step, in order to rule out false-negative results.

  • Monitor your entire workflow of pathogen detection, from sample preparation to qPCR, by directly adding Roche nuclease-resistant DNA Process Control to the samples
  • Improve your data safety by ruling out false-negative results
  • Generate reproducible and reliable results with standardized controls manufactured under strict guidelines

Detect low copy number of DNA targets with higher sensitivity with a complete kit that includes a new 5x-concentrated multiplex master mix.


  • DNA Process Control, conc.
  • DNA Process Control Dilution Buffer
  • DNA Process Control Detection Mix (primers and Cy5-labeled hydrolysis probe)
  • LightCycler® Multiplex DNA Master
  • Water, PCR grade

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.

The generic internal Control DNA of the DNA Process Control Kit is a DNA sequence, encapsulated in a nuclease-resistant, inactivated and non-infectious lambda phage. Unlike naked DNA, the control DNA is protected and therefore better mimics cellular extraction processes. The synthetic Control DNA sequence does not match any mammalian sequence and does not interfere with the pathogen target DNA during isolation or qPCR. The robust LightCycler® Multiplex DNA Master supplied in the DNA Process Control Kit is designed to function under a variety of commonly used PCR reaction conditions in multiplex with pathogen targets.

Result Interpretation
In case of partial degradation of the sample DNA or co-extraction of PCR inhibiting substances, Cq’s for the target DNA can be lower than expected or may not give an interpretable PCR result. By using the DNA Process Control Kit, the target PCR result is then correlated to the expected result of the spiked-in Control DNA which should give a defined Cq value in the range of ≥30.

a) Pathogen test is negative: If the Control DNA PCR result is as expected, a false-negative result of the viral target DNA can be ruled out, and the process does not need to be repeated.

b) Pathogen test and Control DNA detection are negative: failures or problems in sample extraction, reverse transcription, or qPCR are likely, and the complete process must be repeated.