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.
| Components | Shipping Condition | Unit Size | Detection Method |
| MyqPCR reaction buffer (2G) | -20℃, protect from light | 50 Reactions | Probe-based qPCR |
| MyPrimer & Probe MIX (2G) | |||
| Internal control (IC) (2G)* | -20℃ | ||
| Positive control (PC) (2G)* | |||
| DNA dilution buffer |
| Inclusivity | More than 180 species of Mycoplasma, Spiroplasma and Acholeplasma |
| Detection Limit | 10 CFU/mL or 1 genome copy/μL (Positive cut-off: 95%) |
| Specificity | No matrix-induced effect across different sample matrices and no cross-reactivity to nearly 30 types of cell lines |
| Robustness | Freeze-thaw stability over 5 cycles |
| Instrument suitability not limited to Thermo, Biorad, Roche, HZSKBio qPCR equipments | |
| Consistent LOC in different matrices |
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