Microsart® Mycoplasma qPCR detection assays offer gold standard performance for your pharmaceutical QC processes.
Viable but non-culturable (VBNC) Mycoplasma can go undetected when using the traditional method of mycoplasma culturing, risking false-negative results. Our Microsart® qPCR kits offer a method for early detection of mycoplasma contamination. These kits are fast, highly specific, sensitive, and compliant with international guidelines.
Microsart® Mycoplasma qPCR detection kits: a rapid and guideline-compliant solution for Mycoplasma detection.
The New Gold Standard for Mycoplasma Detection with Microsart® Mycoplasma qPCR Kits
Avoid lengthy 28-day cultivation protocols with Microsart® Mycoplasma qPCR Kits. TaqMan® probes ensure the highest qPCR specificity without the need for a melting-curve analysis.
Microsart® AMP and ATMP Mycoplasma Kits are validated according to EP 2.6.7 for sensitivity, specificity, and robustness. They also fulfill the criteria of international authorities, such as USP and JP.
Validation standards for required mycoplasma species in Microsart® Mycoplasma qPCR kits are lyophilized to render them non-infectious. We provide step-by-step, matrix-specific validation guidance from Sartorius qPCR experts.
The ready-to-use master mix has the DNA for internal control already included. Avoid false-negative results and minimize the number of reactions you need to run.
Microsart® Mycoplasma qPCR kits can be used with any qPCR cycler able to detect the fluorescent dyes FAM® and ROX®. Our clear, color-coded reagents guide the user through the short and simple protocol. Lyophilized reagents ensure consistent quality without the need for freezer storage.
Three kits are available:
- For controlling raw materials, in-process testing, and lot release testing of finished products: Microsart® AMP Mycoplasma Kit
- For testing cell-based therapeutics (ATMPs) such as autologous chondrocyte transplants or CAR-T cells: Microsart® ATMP Mycoplasma Kit
- For detection of Mycoplasma DNA in cell culture supernatants in research and development labs: Microsart® RESEARCH Mycoplasma Kit
Application Note: Benchmarking of Two Mycoplasma Real-time PCR Kits suitable for Release Testing According EP 2.6.7
This benchmark study 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).
Resources
Microsart® ATMP Mycoplasma — Rapid Real-time PCR Mycoplasma Detection Kit for testing ATMPs
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