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Product Information
| Product Name | Catalog No. | Product Specification | Storage Conditions |
| Mycoplasma Detection Kit (qPCR Method) | MY0001-50 | The kit contains 5x reaction buffer, enzyme, positive control, internal reference control, and DEPC-treated water. 50 tests/kit. | Transport and store at -20℃ Shelf life: 12 months. |
For rapid qualitative detection of Mycoplasma contamination in culture media, cell cultures, and biological products, with results available in 2 hours.
Can detect 8 types of Mycoplasma required by the European Pharmacopoeia EP2.6.7, Japanese Pharmacopoeia <G3>, United States Pharmacopeia <63>, and the Guiding Principles for Human Stem Cell Products 2023. The detection limit for oral Mycoplasma is 10 CFU/mL, 5GC/reaction for porcine Mycoplasma hyorhinis, 0.5fg/ reaction for Mycoplasma leachii and Mycoplasma salivarium, and 5fg/reaction for Mycoplasma fermentans and Mycoplasma arginini. Through sequence alignment, it can cover over 100 Mycoplasma DNA sequences.
Using two types of fluorescent probes, FAM and HEX, to detect mycoplasma target sequences and internal quality control respectively, with good specificity and the ability to exclude false negative results caused by PCR inhibitors in samples, and no cross-reactivity with human-derived cells such as stem cells, NK cells, and 293 cells.
Performance Validation I: Specificity
*The validation results indicate no cross-reaction with species closely related to mycoplasma on the evolutionary tree (such as Clostridium acetobutylicum, Lactobacillus acidophilus, and Streptococcus pneumoniae), as well as with other common bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Clostridium sporogenes, and Escherichia coli), fungi (Candida albicans and Aspergillus niger), and cellular DNA (DNA from NK cells, 293 cells, and stem cells).
*Three strains of closely related species, as recommended by the European Pharmacopoeia, were purchased in the form of calibrated suspensions with an initial concentration of 10⁹ CFU/mL. These suspensions were diluted to concentrations ranging from 10⁴ to 10² CFU/mL using DMEM medium, and then validated after nucleic acid extraction using our company's magnetic bead-based nucleic acid extraction kit.
The detailed information of the strains used is as follows:
The verification results showed no cross-reaction with the strains of the three closely related species, indicating good specificity of the test kit.
Performance Verification II: Limit of Detection and Sensitivity (Taking Mycoplasma Orale as an Example)
According to the Chinese Pharmacopoeia 2020 edition, the corresponding mycoplasma medium was purchased to culture Mycoplasma orale (ATCC23714). The culture was diluted to three dilutions of 10-3, 10-4, and 10-5, and incubated at 37℃ for 28 days. The results showed that the three tubes with a dilution of 10-5 were negative (no color change), while all others were positive. The sensitivity of the culture method reached 10-4, meeting the requirements of the Chinese Pharmacopoeia.
After extraction of samples with different concentrations, the test kit can stably detect samples diluted by a factor of 10-5, representing a 10-fold increase in sensitivity.
Performance Verification III: Repeatability and Stability Testing
Using the same batch of Mycoplasma detection kit, the same samples were extracted and validated in three different environments, divided into three groups. The results showed good consistency.
*For other related experimental validations, please refer to the "Technical White Paper" of Yocon Biotechnology's products.
Product Information
| Product Name | Catalog No. | Product Specification | Storage Conditions |
| Mycoplasma Detection Kit (qPCR Method) | MY0001-50 | The kit contains 5x reaction buffer, enzyme, positive control, internal reference control, and DEPC-treated water. 50 tests/kit. | Transport and store at -20℃ Shelf life: 12 months. |
For rapid qualitative detection of Mycoplasma contamination in culture media, cell cultures, and biological products, with results available in 2 hours.
Can detect 8 types of Mycoplasma required by the European Pharmacopoeia EP2.6.7, Japanese Pharmacopoeia <G3>, United States Pharmacopeia <63>, and the Guiding Principles for Human Stem Cell Products 2023. The detection limit for oral Mycoplasma is 10 CFU/mL, 5GC/reaction for porcine Mycoplasma hyorhinis, 0.5fg/ reaction for Mycoplasma leachii and Mycoplasma salivarium, and 5fg/reaction for Mycoplasma fermentans and Mycoplasma arginini. Through sequence alignment, it can cover over 100 Mycoplasma DNA sequences.
Using two types of fluorescent probes, FAM and HEX, to detect mycoplasma target sequences and internal quality control respectively, with good specificity and the ability to exclude false negative results caused by PCR inhibitors in samples, and no cross-reactivity with human-derived cells such as stem cells, NK cells, and 293 cells.
Performance Validation I: Specificity
*The validation results indicate no cross-reaction with species closely related to mycoplasma on the evolutionary tree (such as Clostridium acetobutylicum, Lactobacillus acidophilus, and Streptococcus pneumoniae), as well as with other common bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Clostridium sporogenes, and Escherichia coli), fungi (Candida albicans and Aspergillus niger), and cellular DNA (DNA from NK cells, 293 cells, and stem cells).
*Three strains of closely related species, as recommended by the European Pharmacopoeia, were purchased in the form of calibrated suspensions with an initial concentration of 10⁹ CFU/mL. These suspensions were diluted to concentrations ranging from 10⁴ to 10² CFU/mL using DMEM medium, and then validated after nucleic acid extraction using our company's magnetic bead-based nucleic acid extraction kit.
The detailed information of the strains used is as follows:
The verification results showed no cross-reaction with the strains of the three closely related species, indicating good specificity of the test kit.
Performance Verification II: Limit of Detection and Sensitivity (Taking Mycoplasma Orale as an Example)
According to the Chinese Pharmacopoeia 2020 edition, the corresponding mycoplasma medium was purchased to culture Mycoplasma orale (ATCC23714). The culture was diluted to three dilutions of 10-3, 10-4, and 10-5, and incubated at 37℃ for 28 days. The results showed that the three tubes with a dilution of 10-5 were negative (no color change), while all others were positive. The sensitivity of the culture method reached 10-4, meeting the requirements of the Chinese Pharmacopoeia.
After extraction of samples with different concentrations, the test kit can stably detect samples diluted by a factor of 10-5, representing a 10-fold increase in sensitivity.
Performance Verification III: Repeatability and Stability Testing
Using the same batch of Mycoplasma detection kit, the same samples were extracted and validated in three different environments, divided into three groups. The results showed good consistency.
*For other related experimental validations, please refer to the "Technical White Paper" of Yocon Biotechnology's products.
