Fact Sheet

VitalAmp - Mycoplasma Testing

Interest Group

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).

Applied Extraction

InviMag I/G Universal (Stratec Molecular GmbH), QiaAMP DSP Virus Spin Kit (Qiagen AG) and Venor GeM Sample Preparation Kit (Minerva Biolabs GmbH).

Process Control

Vital mycoplasma spike control, extraction and amplfication controls.

Sample Volume / PCR

10 µl.

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.

Regulatory Compliance

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.

Sample Requirements

Minimum: 1 to 5 ml, the input-related sensitivity of the assay decreases for sample quantities <1 ml per indicator culture.
Optimum: 2 units of 5 ml each, label as sample A and sample B (backup, please mark in accession form).

Order No.

Mycoplasma Testing ‘VitalAmp’      41-1014

Volume Discount Available

Yes, on request.

Additional Information

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.