The Cyclus®RT-qPCR Kit is specifically designed for use in QC and GMP laboratories. Compared to classical culture methods, it reduces detection time from several weeks to ≤ 3 hours and enables reliable release testing of biopharmaceuticals and ATMPs. The PCR-based method offers the advantage of detecting both culturable and non-culturable mycoplasmas, making it superior to traditional culture tests.
Detection is based on amplification of a highly conserved 16S rRNA coding region in the mycoplasma genome, enabling reliable identification of all mycoplasma, acholeplasma, and spiroplasma species listed in EP 2.6.7(12.2), as well as over 130 additional mollicutes. By combining reverse transcriptase and DNA polymerase, both RNA (as cDNA) and DNA are amplified, significantly increasing sensitivity. The assay has been validated according to current regulatory requirements EP 2.6.7 (12.2, meeting criteria for specificity, robustness, and sensitivity with detection limits of ≤ 10 CFU/ml and < 100 GC/ml. Positive control as well as internal and process controls further ensure the reliability of results and provide maximum security in routine testing.
