Fungal DNA Detection Kit (PCR-Fluorescent Probe Method) [HYM005]

The Fungal DNA Detection Kit (PCR-Fluorescence Probe Method) is used in conjunction with the Fungal and Bacterial DNA Extraction and Purification Kit (Magnetic Bead Method) to qualitatively detect the presence of fungal contamination in cells, cell products, vaccines, and other products.

This kit utilizes fluorescent probe qPCR technology, with primers and probes designed for conserved fungal gene fragments. Based on sequence alignment results, it allows for the qualitative detection of thousands of fungal species. The assay demonstrates high specificity, with no cross-reactivity observed for mycoplasma species closely related to fungi (e.g., Mycoplasma orale, Mycoplasma hyorhinis, Mycoplasma pneumoniae) or common engineered cells such as CHO, VERO, and HEK293. Validated in accordance with relevant regulatory requirements, the limit of detection reaches 5 CFU/mL, complying with pharmacopoeial sensitivity requirements for NAT methods as an alternative to culture methods.

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