Polymerase chain reaction (PCR) techniques provide a faster path to sterility results than the compendial culture method by amplifying microbial DNA. However, standard quantitative PCR (qPCR) approaches amplify the entire sample in a single reaction, meaning that ubiquitous bacterial DNA in reagents can elevate the baseline signal beyond a defensible cycle threshold (Ct) cutoff.
Digital PCR (dPCR) isolates background interference using a partition-based architecture that contains trace contaminants in individual nano-wells, allowing teams to establish a statistically grounded limit of blank. This Sartorius application note provides the experimental data to evaluate that baseline for the Cyclus® dPCR Tool Box, demonstrating detection at approximately 10 CFU/mL.
Download the application note to:
- Review the mathematical baseline required to differentiate true sample signals from inherent reagent noise
- Evaluate detection performance against compendial bacterial and fungal targets relevant under EP 2.6.27
- Examine how partition-based architecture prevents ambient environmental DNA from inflating bulk readings
