VitalAmp - Mycoplasma Testing
ATMP manufacturer, pharmaceutical industry, media manufacturer.
Utilizing the cell culture enhancement step as recommended by EP 2.6.7 a minute amount of vital mycoplasma can be detected. Most mycoplasma species can be propagated in cell culture to titers easily detectable by the subsequent qPCR.
Recommended Sample Material
Cell cultures, cell culture compatible materials (non-cytotoxic).
Cell culture enrichment on VERO cells followed qualitative Real-Time PCR.
Applied PCR System
Microsart ATMP Mycoplasma (Sartorius Biotech GmbH).
InviMag I/G Universal (Stratec Molecular GmbH), QiaAMP DSP Virus Spin Kit (Qiagen AG) and Venor GeM Sample Preparation Kit (Minerva Biolabs GmbH).
Vital mycoplasma spike control, extraction and amplfication controls.
Sample Volume / PCR
Average Turnaround Time
6-8 days after sample receipt.*
Sensitivity of Method
1 to 10 CFU – the sensitivity can be vary depending on matrix and input quantity. A sensitivity of 10 CFU must be confirmed for questions relevant to the release by method validation.
QPCR system is EP 2.6.7 compliant. Indicator cell conformity has been shown for standard materials; for other materials, individual validation may be required to demonstrate the efficiency of the preanalytical process in terms of sensitivity. Please contact us for more information.
QPCR system is manufacturer-validated, the indicator cell method must be validated for the respective matrix.
Mycoplasma Testing ‘VitalAmp’ 41-1014
Volume Discount Available
Yes, on request.
Please note: repetitions which are not caused by our laboratory are subject to additonal charges. *Testing can be started on certain days due to experimental setup, please contact us for further information.