MycoSHENTEK® Mycoplasma Hyorhinis Sensitivity Standard is designed to validate the robustness and sensitivity of nucleic acid amplification techniques (NAT) for the detection of mycoplasma.
Traditional culture methods for mycoplasma testing are time-consuming, especially for cell therapy products, because the testing cycle may exceed the product’s shelf life. Nucleic acid amplification technique, such as qPCR, offers rapid detection of mycoplasma contamination. According to the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP) and the Japanese Pharmacopoeia (JP), validated NAT methods are recommended to replace culture methods. According to EP 2.6.7, method sensitivity must reach 10 colony-forming units (CFU/mL) to replace culture methods and 100 CFU/mL to replace indicator cell culture methods.
The MycoSHENTEK® Mycoplasma Sensitivity Standards are non-infectious and are not intended for culture. Simply add the specified volume of sample matrix to the Sensitivity Standards to prepare the test solution for further use.
We also provide the MycoSHENTEK® Mycoplasma DNA Detection Kit and the MycoSHENTEK® Mycoplasma DNA Extraction Kit for Mycoplasma DNA extraction and qPCR detection assays.
MycoSHENTEK® Mycoplasma DNA Extraction Kit (2G)
MycoSHENTEK® Mycoplasma DNA Detection Kit (2G)
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