Cyclus® dPCR Tool Box Bacteria Fungi for Rapid Sterility Testing | Application Note

Authors: Lisa Hollstein, Michel Gerke, Dr. Alexandra Müller-Scholz, Dr. Robert Hertel, Dr. Diana Patzelt | Last updated: November 2025

Cyclus dPCR Bacteria Fungi Tool Box kit front view of the box opened with vials visible and angeled position of the cover

Resource overview

This application note examines the use of the Cyclus® dPCR Tool Box Bacteria Fungi for rapid sterility testing of cell and gene therapy products and other short-shelf-life products. The kit combines broad-range bacterial and fungal assays with internal controls for reliable analysis by digital PCR. Testing with spiked cell samples demonstrated detection of low levels of microbial contamination and established background limits for interpreting bacterial and fungal results.


Key takeaways:

  1. Rapid molecular detection of bacterial and fungal contamination
  2. Broad-range 16S and 18S assays with integrated controls
  3. Evaluation in a cell-based product matrix using digital PCR
     

Resource details:

  • Document type: Application note
  • Page count: 6
  • Read time: 11 minutes

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