Mycoplasma DNA Detection Kit (PCR-Fluorescence Probe Method)

This kit is based on the fluorescence quantitative PCR method and is designed with primer probes targeting the conserved sequences of mycoplasma. It is used in conjunction with Zhuhai Baorui Biotechnology Co., LTD. 's nucleic acid extraction or purification Kit I (magnetic bead method) for rapid qualitative detection of potential mycoplasma contamination in production raw materials, cell banks, virus seeds, virus or cell harvest fluids, and therapeutic cells.

This kit has been comprehensively verified in terms of detection limit, specificity and durability in strict accordance with the relevant requirements of EP 2.6.7 for mycoplasma detection, and can detect the equivalent genome of 5 CFU/mL or as recommended by regulatory guidelines. It simultaneously covers the mycoplasma strain types required for verification in USP, JP, WHO, ChP, etc.

Product item NumberBP-QN08-50、BP-QN22-50

Since the reagent kits with item numbers BP-QN08-50 and BP-QN22-50 only differ in the internal standard fluorescence channels, only the reagent kit with item number BP-QN08-50 is used for display below:

1. Detection limit

The common 10 mycoplasma standard strains (5CFU/mL) were extracted and detected 24 times respectively, and a total of 24 detection data were obtained. NCS and NTC samples are tested simultaneously in each experiment.

The results show that the NCS and NTC results are qualified. The test results of all 24 5CFU/mL samples are positive, meeting the requirement that at least 23 out of 24 tests have positive results.

Table 1 verifies strain information and sensitivity detection

For oral Mycoplasma orale at a concentration of 5 CFU/mL, three tests were conducted, with 8 replicates each time. The total test results met the requirement that ≥23 test results were positive among 24 tests. The following shows the data from one of the three experiments:

Table 2 shows the test results of oral mycoplasma detected by the kit


Figure 1 Amplification diagram of mycoplasma detection

2. Summary of the performance of the reagent kit products

Table 3 Performance Verification Contents and Conclusions of Mycoplasma qPCR Detection Kit

Note: The above data is for reference only. For specific product performance indicators, please refer to the performance verification report of the corresponding item number.