Contaminated ATMPs pose life-threatening risks for immunocompromised patients who need rapid QC results prior treatment. For PCR-based Mycoplasma detection a unique combination of highest specificity and more control with less pipetting is available.

European pharmacopeia EP 2.6.7 stipulates a rapid qPCR-based detection of Mycoplasma species, which is applicable for the rapid release testing of ATMPs

Sartorius cares for patient safety and the effort that QC staff puts into ATMP testing. The validated Microsart® ATMP Mycoplasma Kit combines several technical features to benefit Kit-users and Patients

• Mycoplasma detection within 3 hours
• Comprehensive qPCR kit validation based on EP 2.6.7 for compliant final release testing
• Highest Specificity by TaqMan™ probes
• One well provides two results: 1. Mycoplasma contamination result (FAM™ channel) and 2. PCR inhibition control (ROX™ channel) in one pipetting step (duplex-assay)
• Maximal reliability of the result with up to 75% less pipetting effort compared to single assays
• Non-infectious validation standards are already pre-quantified with 10 CFU/ml and ready-to-use for matrix-specific validation studies without any risk of cross-contamination.