Sartorius Microsart™ ATMP Mycoplasma

Description

Fast detection of Mycoplasma contamination in Advanced Therapy Medicinal Products (ATMP) is very important. With the Microsart™ ATMP Mycoplasma, testing time can be reduced from weeks to just three hours. Additionally, the TaqMan™ probe adds high specificity to the PCR system and minimizes result interpretation. The Microsart™ ATMP Mycoplasma has been effectively validated according EP 2.6.7 in combination with EP 2.6.21 with respect to the detection limit for all listed Mycoplasma species, specificity and robustness for autologous cell transplants (e.g. chondrocytes).

Efficient Applications Mycoplasma are present in most cell culture facilities and tissue culture labs. It is estimated that Mycoplasma are responsible for up to 60% of cell culture contamination. The Microsart™ ATMP Mycoplasma real-time PCR kit is specially designed for hospitals, institutions and companies involved in testing Mycoplasma contamination according to EP 2.6.7 in cell-based therapeutics. It can be used to directly detect Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) in cell cultures and cell culture-derived biologicals, ATMPs.

High Performance Mycoplasma are detected explicitly by amplifying a highly conserved rRNA operon, or more precisely, a 16S rRNA coding region in the mycoplasma genome. The mycoplasma-specific amplification is detected at 520 nm (FAM™ channel). The kit includes a ready-to-use Mastermix containing polymerase, primers and FAM™- and ROX™ - labeled probes, which allow specific detection of mollicute species and an internal control. A detection limit of less than 10 CFU/mL for all Mycoplasma species mentioned in the European Pharmacopoeia fulfills its requirements for sensitivity and specificity and robustness.

Contamination Prevention The kit contains dUTP instead of dTTP, so the option is available to degrade amplicons from previous analyses using uracil-DNA glycosylase (UNG). Thus, the occurrence of false-positive results can be minimized. UNG is not included in the kit. The internal amplification control detects False-negative results due to PCR inhibitors or improper DNA extraction. The Internal Control DNA can be added directly to the PCR master mix to act as a PCR control or monitor the extraction process. The amplification of the internal control is detected at 610 nm (ROX™ channel). Using uracil-DNA glycosylase (UNG), the kit contains dUTP instead of dTTP to degrade amplicons from previous analysis by using uracil-DNA glycosylase (UNG). This minimizes the occurrence of false-positive results.