Description
The Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing Kit is a TaqMan™ based qPCR solution for rapid detection of bacterial and fungal contamination in complex bioproduction samples. Designed for cell therapy manufacturing workflows, it delivers results in under 5 hours while preserving valuable sample material through simultaneous bacteria and fungi testing. The kit detects 5–25 genome copies per reaction and is designed to meet or exceed sensitivity and specificity guidance in European Pharmacopoeia 2.6.27 and USP <1071>. It also includes built-in controls to support result accuracy and PCR consistency.