Mycoplasma Standards
Mycoplasma Standards are defined reference materials for the validation, verification, and performance monitoring of NAT-based mycoplasma detection methods. They are used for the determination of the limit of detection (LoD), as external positive controls (EPC), and as extraction and inhibition controls (EIC), and support pharmacopoeia-compliant NAT-based mycoplasma testing in accordance with EP 2.6.7 (12.2), USP <77>, and JP 18 G3.
Depending on the application, both non-infectious, inactivated mycoplasma particles (CFU-based standards) and purified nucleic acids with defined genome copy numbers (GC-based standards) are available.
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