Equivalency of PCR-Based Rapid Sterility Testing and the Compendial Culture Method According to Ph. Eur. 2.6.1., JP 4.06 and USP <71>
In this study, we compared the microbial detection capability of the Microsart® ATMP Bacteria and Microsart® ATMP Fungi Real-time PCR kits with the compendial sterility test. We spiked samples, using 6 different bacterial (Bacillus subtilis, Staphylococcus aureus, Clostridium sporogenes, Pseudomonas aeruginosa, Streptococcus pyogenes, and Pseudomonas protegens) and 2 fungal (Candida albicans and Aspergillus brasiliensis) species at concentration levels between 2.5 CFU/mL and 198 CFU/mL, and compared our results to the growth-based method performed in parallel at an external contract lab, according to Ph. Eur. 2.6.1, JP 4.06 and USP <71>2,3,4. Our results show full equivalency of Microsart® ATMP Bacteria and Microsart® ATMP Fungi with the compendial method. Moreover, the Microsart® ATMP Fungi detected Candida albicans
with higher sensitivity.