Mycoplasma qPCR
The Ph.Eur. 2.6.7 guidance states that nucleic acid amplification techniques (NAT) can be used to test for mycoplasma when a complementary test is required or can be used as an alternative. For example when the test sample is a cytotoxic viral suspension, or when under special circumstances the regulatory authority has approved this technique for product lot release after the review of special risk-based analysis. In addition, the FDA state that PCR for the detection of Mycoplasma can be applied to products with a limited shelf life.

Vitrology’s regulatory compliant in-house Mycoplasma qPCR will be released in 2008 and is designed to detect the presence of mycoplasma in biological materials. With qPCR testing, results are obtained in less than half the time of culture-based methods. Vitrology’s primer and probe set is designed to a highly conserved Mycoplasma region allowing specific detection of a wide range of mycoplasma species with high sensitivity and specificity.

The qPCR assay is designed to detect, and is not limited to the following species:

Click here for literature references.