MycoSHENTEK® Mycoplasma DNA Detection Kit (2G) is used, together with MycoSHENTEK® Mycoplasma DNA Extraction Kit (2G), to qualitatively determine whether there is mycoplasma, spiroplasma, or acholeplasma contamination in master cell bank, working cell bank, virus seed stock, or cell culture-derived products, etc. The integrated system has been fully validated per European Pharmacopoeia Chapter 2.6.7 and Japanese Pharmacopoeia XVII, at a detection limit of 10 CFU/mL.

The detection kit uses real-time PCR technology to detect more than 200 species of Mycoplasma, Spiroplasma and Acholeplasma with high specificity. It has been validated in a variety of matrices, as well as on non-mycoplasma species, production cells, and engineered bacteria and fungi.