Benchmarking of two mycoplasma real-time PCR kits suitable for release testing according EP 2.6.7

In this application note, Sartorius compares the capabilities of two different qPCR kits for the detection of Mycoplasma, namely, the Sartorius Microsart^® ATMP Mycoplasma qPCR kit and the CellSafe MycoQSearchTM qPCR kit. The EP 2.6.7 required sensitivity of 10 CFU / mL of selective species is tested using three different Sartorius Microsart^® Validation Standards (Acholeplasma laidlawii, Mycoplasma orale, Mycoplasma pneumoniae) and one CellSafe Standard (Mycoplasma arginini). Despite some differences in the overall qPCR performance between the benchmarked products, mainly the different shipping conditions and the number of pipetting steps are crucial. The Sartorius qPCR kit shows a higher sensitivity (detected 16 / 16 positive) than the CellSafe qPCR kit (detected 12 / 16 positive).