Mycoplasma DNA Detection Kit (PCR-Fluorescence Probe Method)

This kit is based on the fluorescence quantitative PCR method. Primer probes are designed for the conserved sequences of mycoplasma and are used in conjunction with the Baorui Biological Nucleic Acid Extraction or Purification Kit I (magnetic bead method) to rapidly and qualitatively detect potential mycoplasma in production raw materials, cell banks, virus seeds, virus or cell harvest fluids, and therapeutic cells.

Comprehensive verification of detection limit, specificity and durability was carried out strictly in accordance with the relevant requirements of EP 2.6.7 for mycoplasma detection. It 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.

1. Detection limit (refer to the content of the performance verification report)

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 24 5CFU/mL samples of all strains are positive, meeting the requirement that at least 23 out of 24 tests have positive results.

Table 1 Strain Information and Sensitivity Verification

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 Mycoplasma amplification curve

Figure 2 Internal standard amplification curve

2. Summary of the performance of the reagent kit products
Table 3 Performance Verification Contents and Conclusions of Mycoplasma qPCR Detection Kit

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