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The Rapid Mycoplasma qPCR Detection Kit is a cutting-edge solution designed for the rapid, qualitative detection of Mycoplasma contamination in culture media, cell cultures, and biological products. Results are available in just 2 hours, enabling fast and reliable contamination monitoring. The kit can detect 8 types of Mycoplasma as required by major pharmacopoeias such as the European Pharmacopoeia EP2.6.7, Japanese Pharmacopoeia , and United States Pharmacopeia <63>, as well as the Guiding Principles for Human Stem Cell Products 2023.
Rapid Detection: Provides results in just 2 hours.
Comprehensive Detection: Detects 8 types of Mycoplasma, including those required by international standards.
High Sensitivity: Detects Mycoplasma at concentrations as low as 10 CFU/mL for oral Mycoplasma, 0.5 fg/reaction for Mycoplasma leachii and salivarium, and 5 fg/reaction for Mycoplasma fermentans and arginini.
Specificity: No cross-reactivity with human-derived cells (such as stem cells, NK cells, and 293 cells).
Dual Fluorescent Probes: Uses FAM for Mycoplasma target sequences and HEX for internal quality control, enhancing specificity and eliminating false negatives.
Compliance: Meets the requirements of several pharmacopoeias and guidelines.
Oral Mycoplasma: Detectable at 10 CFU/mL.
Porcine Mycoplasma hyorhinis: Detectable at 5 GC/reaction.
Mycoplasma leachii & Mycoplasma salivarium: Detectable at 0.5 fg/reaction.
Mycoplasma fermentans & Mycoplasma arginini: Detectable at 5 fg/reaction.
Coverage: The kit covers over 100 Mycoplasma DNA sequences through sequence alignment.
The kit has been validated to show no cross-reactivity with closely related species such as Clostridium acetobutylicum, Lactobacillus acidophilus, and Streptococcus pneumoniae, as well as common bacteria like Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli.
It also does not react with fungi like Candida albicans or Aspergillus niger and is highly specific to Mycoplasma DNA.
Chinese Pharmacopoeia Standard: The kit successfully detects Mycoplasma orale at concentrations as low as 10⁻⁵ dilution, offering 10 times greater sensitivity compared to traditional culture methods.
The kit showed excellent consistency in three different environments during validation, ensuring reliable performance across various test conditions.
Storage Conditions: Store at -20°C for optimal stability.
Shelf Life: 12 months from the date of manufacture.
Kit Contents: The kit contains 5x reaction buffer, enzyme, positive control, internal reference control, and DEPC-treated water.
Test Quantity: Each kit includes 50 tests.
Sample Collection: Collect the sample to be tested.
Nucleic Acid Extraction: Extract nucleic acids using the company’s magnetic bead-based extraction kit.
PCR Amplification: Perform the PCR amplification using the provided reaction buffer and enzyme.
Result Interpretation: The presence of Mycoplasma is indicated by fluorescence signal detection for Mycoplasma target sequences (FAM probe) and internal quality control (HEX probe).
The Rapid Mycoplasma qPCR Detection Kit complies with the following international standards:
European Pharmacopoeia EP2.6.7
Japanese Pharmacopoeia
United States Pharmacopeia <63>
Guiding Principles for Human Stem Cell Products 2023
The Rapid Mycoplasma qPCR Detection Kit is a powerful tool for detecting Mycoplasma contamination in various biological products and cell cultures. With its high sensitivity, specificity, and rapid results, this kit is an ideal solution for researchers and manufacturers aiming to ensure the quality and safety of their biological products.
The Rapid Mycoplasma qPCR Detection Kit is a cutting-edge solution designed for the rapid, qualitative detection of Mycoplasma contamination in culture media, cell cultures, and biological products. Results are available in just 2 hours, enabling fast and reliable contamination monitoring. The kit can detect 8 types of Mycoplasma as required by major pharmacopoeias such as the European Pharmacopoeia EP2.6.7, Japanese Pharmacopoeia , and United States Pharmacopeia <63>, as well as the Guiding Principles for Human Stem Cell Products 2023.
Rapid Detection: Provides results in just 2 hours.
Comprehensive Detection: Detects 8 types of Mycoplasma, including those required by international standards.
High Sensitivity: Detects Mycoplasma at concentrations as low as 10 CFU/mL for oral Mycoplasma, 0.5 fg/reaction for Mycoplasma leachii and salivarium, and 5 fg/reaction for Mycoplasma fermentans and arginini.
Specificity: No cross-reactivity with human-derived cells (such as stem cells, NK cells, and 293 cells).
Dual Fluorescent Probes: Uses FAM for Mycoplasma target sequences and HEX for internal quality control, enhancing specificity and eliminating false negatives.
Compliance: Meets the requirements of several pharmacopoeias and guidelines.
Oral Mycoplasma: Detectable at 10 CFU/mL.
Porcine Mycoplasma hyorhinis: Detectable at 5 GC/reaction.
Mycoplasma leachii & Mycoplasma salivarium: Detectable at 0.5 fg/reaction.
Mycoplasma fermentans & Mycoplasma arginini: Detectable at 5 fg/reaction.
Coverage: The kit covers over 100 Mycoplasma DNA sequences through sequence alignment.
The kit has been validated to show no cross-reactivity with closely related species such as Clostridium acetobutylicum, Lactobacillus acidophilus, and Streptococcus pneumoniae, as well as common bacteria like Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli.
It also does not react with fungi like Candida albicans or Aspergillus niger and is highly specific to Mycoplasma DNA.
Chinese Pharmacopoeia Standard: The kit successfully detects Mycoplasma orale at concentrations as low as 10⁻⁵ dilution, offering 10 times greater sensitivity compared to traditional culture methods.
The kit showed excellent consistency in three different environments during validation, ensuring reliable performance across various test conditions.
Storage Conditions: Store at -20°C for optimal stability.
Shelf Life: 12 months from the date of manufacture.
Kit Contents: The kit contains 5x reaction buffer, enzyme, positive control, internal reference control, and DEPC-treated water.
Test Quantity: Each kit includes 50 tests.
Sample Collection: Collect the sample to be tested.
Nucleic Acid Extraction: Extract nucleic acids using the company’s magnetic bead-based extraction kit.
PCR Amplification: Perform the PCR amplification using the provided reaction buffer and enzyme.
Result Interpretation: The presence of Mycoplasma is indicated by fluorescence signal detection for Mycoplasma target sequences (FAM probe) and internal quality control (HEX probe).
The Rapid Mycoplasma qPCR Detection Kit complies with the following international standards:
European Pharmacopoeia EP2.6.7
Japanese Pharmacopoeia
United States Pharmacopeia <63>
Guiding Principles for Human Stem Cell Products 2023
The Rapid Mycoplasma qPCR Detection Kit is a powerful tool for detecting Mycoplasma contamination in various biological products and cell cultures. With its high sensitivity, specificity, and rapid results, this kit is an ideal solution for researchers and manufacturers aiming to ensure the quality and safety of their biological products.
