Microsart® ATMP Sterile Release Detection Kit
Microsart® ATMP Sterile Release is designed to rapidly detect total bacteria and fungi in cell cultures, cell culture-derived biologicals, and ATMPs. The technology is based on real-time polymerase chain reaction (PCR).
Top Features of Microsart® ATMP Sterile Release
- Rapid detection of critical bacterial and fungal contaminants within three hours
- Designed for contamination control of ATMPs or short shelf-life applications
- The PCR kit is validated according to EP 5.1.6, EP 2.6.27, USP <1223>
- Lab research
- Quality control (QC)
Item no.: SMB95-1007
Get real-time results and streamline your laboratory workflow with the help of Microsart® ATMP Sterile Release.
Bacterial and fungal contaminants are common contamination elements, present in most cell culture facilities and tissue culture labs. The Microsart® ATMP Sterile Release is specially designed for hospitals, institutions and companies involved in testing for bacterial and fungal contamination according to EP 5.1.6, EP 2.6.27 and USP <1223>.
Bacteria and fungi are specifically detected by amplifying a highly conserved rRNA operon - a 16S rRNA coding region in the genome. The amplification is detected at 520 nm (FAM™ channel). The kit includes a ready-to-use Mastermix including primers and ROX/FAM™-labeled probes and the polymerase.
The Microsart® ATMP Sterile Release kit is a fast and easy-to-use real-time PCR. The total procedure from DNA extraction to the PCR result takes only a few hours. This speeds up laboratory testing times, allowing for an expedited workflow.
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 inhibition 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).
Sample Volume1 mL