Mycoplasma DNA Detection Kit (PCR-Fluorescence Probe Method) [HYM002]

The Mycoplasma DNA Detection Kit (PCR-Fluorescence Probe Method) is used in conjunction with the Mycoplasma DNA Sample Extraction and Purification Kit (Magnetic Bead Method) to detect the presence of mycoplasma contamination in Master Cell Banks, Working Cell Banks, virus seed lots, cell culture supernatants or cell suspension samples, and other biological products.

This kit utilizes fluorescent probe qPCR technology with primers and probes designed for conserved mycoplasma gene fragments. Based on sequence alignment results, it allows for the qualitative detection of approximately 200 mycoplasma species. The assay demonstrates high specificity, with no cross-reactivity observed for bacteria closely related to mycoplasma (e.g., E. coli, Clostridium, Streptococcus) or common engineered cells such as CHO, VERO, and HEK293. Validated in accordance with the mycoplasma detection requirements of EP 2.6.7, JP XVIII, and USP <77>, the limit of detection reaches 10 CFU/mL, complying with the sensitivity requirements of EP 2.6.7 for NAT methods as an alternative to culture methods.

Potential interference from common base media, PBS, fetal bovine serum, and common mycoplasma media in test sample matrices, as well as cells, bacteria, and fungi that may cross-react with mycoplasma DNA, does not affect the detection method.

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