Bacterial DNA Detection Kit (PCR-fluorescent Probe Method) [HYM008]

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

This kit utilizes fluorescent probe qPCR technology, with primers and probes designed for conserved bacterial gene fragments. Based on sequence alignment results, it allows for the qualitative detection of tens of thousands of bacterial species. The assay demonstrates high specificity, with no cross-reactivity observed for mycoplasma species closely related to bacteria (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 10 CFU/mL, complying with pharmacopoeial sensitivity requirements for NAT methods.

Cross-reactivity: Mycoplasmas (Mycoplasma pneumoniae, Mycoplasma oris, Mycoplasma hyopneumoniae, Mycoplasma synoviae, Mycoplasma arginine, Mycoplasma gallisepticum, Mycoplasma leyi, Spiroplasma, etc.), fungi (Candida albicans, Aspergillus brasiliensis, Aspergillus niger) , and engineered cells (Vero cells, HEK293 cells, 293T cells, CHO-K1 cells) do not cause cross-reactions.

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