SteriSEQ Rapid Sterility Testing Assay Kit

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Applied Biosystems SteriSEQ Rapid Sterility Testing Assay

Central to the SteriSEQ Rapid Sterility Testing System is its robust, multiplexing qPCR assay. Leveraging the high performance of trusted TaqMan chemistry, the SteriSEQ Assay can detect more than 16,000 bacterial species plus 2,600 species of fungi* and can detect contamination in raw materials and in-processing samples in cell densities up to 1e6 cells.

Key assay features:

  • Fast—Delivers actionable results in less than 5 hours, enabling rapid contamination detection of in-process and raw materials, helping expedite the release of your cell therapy product
  • Sensitive—Detects bacterial and fungal species at 5–25 genome copies per reaction
  • Specific—Designed specifically for bacteria (16S rRNA) and fungi (18S rRNA), with no known cross-reactivity to in-process byproducts or sample matrix effects
  • Efficient—Helps minimize use of sample material by simultaneously testing for bacteria and fungi, preserving precious cells for final product
  • Accurate—Discriminatory positive control helps eliminate false positives and an internal positive control helps ensure PCR reaction consistency in the samples

 *Based on in-silico testing

The SteriSEQ Rapid Sterility Testing Kit includes:

2X Master Mix Plus

Assay Mix

Discriminatory Positive Control

DNA Dilution Buffer

Partial panel of species detected by the SteriSEQ kit

  • Aspergillus brasiliensis
  • Staphylococcus aureus
  • Burkholderia cepacia
  • Candida albicans
  • Lactobacillus acidophilus
  • Ralstonia pickettii
  • Bacillus subtilis
  • Lactobacillus delbrueckii
  • Cryptococcus neoformans
  • Clostridium sporogenes 
  • Niallia circulans
  • Komagataella pastoris
  • Pseudomonas aeruginosa
  • Afipia felis

Learn more about the use of rapid, qPCR-based sterility testing for cell therapy production

This application note details specificity experiments for the six species listed in the USP <71> guidelines for sterility testing, as well as category 2 bacterial and fungal species. It illustrates how the SteriSEQ Rapid Sterility Testing Kit can be used for in-process testing to help ensure confidence in the cell therapy bioprocessing workflow.
 

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For Research Use Only. Not for use in diagnostic procedures.