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PCR


Mycoplasma Experience is now offering two real time (RT)-PCR protocols aimed at cell cultures and Cell Therapy Products.


The test

DNA is extracted from 200uL of test article using the Roche “MagNA Pure Compact” robot.

Real time amplification of samples is carried out in optical reaction plates by Scorpions® technology using a PCR Mycoplasma test kit from Promokine (Promocell) or TaqMan® probes using the Venor®Gem qEP mycoplasma detection kit for QPCR (Minerva biolabs) in a Roche LightCycler® 480.


Protocol 1

Suitable for Cell Therapy Products

May be included for an early result whilst Cultural Tests are ongoing.

The Venor®Gem qEP test kit use complies 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.

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:   £230.00 for one test

             £110.00 for each additional sample processed concurrently


Protocol 2

Standard protocol for cell cultures. A PCR run will only be performed with a minimum of eight samples.

Price:   £30.00 per test

Where PCR is requested for fewer than 8 samples, the charge will be £65.00 per sample.

The sample transport service, if used, will be charged at £20.