Mycoplasma Experience is now offering two real time Real Time PCR protocols aimed at cell cultures and Cell Therapy or Advanced Therapy Medicinal Products (ATMPs) for rapid mycoplasma testing. We hold a MHRA license, allowing us to carry out regulatory tests on therapeutic clinical products. See here for a copy of our license.
The test
DNA is extracted from the test article using the Qiagen EZ2 Connect Instrument.
Real time amplification of samples is carried out in optical reaction plates with TaqMan® probes using the Venor®Gem qEP mycoplasma detection kit (Minerva biolabs) OR the MycoTOOL Real-
Rapid Microbiological Mycoplasma Testing -
Protocol 1 -
Suitable for Cell Therapy or Advanced Therapy Medicinal Products (ATMPs)
This test may be included for an early result whilst Cultural Mycoplasma Tests are ongoing.
Both the Venor®Gem qEP test kit and the MycoTOOL kit used comply fully with the requirements of European Pharmacopoeia 2.6.7 and we have further validated the sensitivity of our protocol to 10cfu/mL. See here for data. A validation will be required for all new sample types to be tested. Please contact us for costings.
In addition to the standard positive controls, the test will include three positive low number spike controls in the test matrix to confirm absence of matrix inhibition.
Price: One test -
Protocol 2-
The standard protocol for rapid mycoplasma detection by Real Time PCR in cell cultures or other non-
Price: 1 sample -
2 samples -
3-
Over 8 samples-
Transport of Samples To Our Laboratory
Samples can be sent independently, or we can arrange to send a cool box out to you and collect it by courier for delivery to us, or you can use your own packaging and we can just arrange courier collection.
Full Sample transport service -
Collection of your sample container only -
Mycoplasma Experience Ltd. Phone: 01883 740185 Email: mexp@mycoplasma-