e-Myco™ VALiD Mycoplasma qPCR Detection Kit

Description

Fast and simple real-time PCR detection kit that replaces the direct method of mycoplasma negative testing

• Demonstrated the performance to satisfy the negative test of Mycoplasm based on nucleic acid amplification method of domestic, US and European Pharmacopoeia

• Suitable for process inspection before, during, and after manufacture of pharmaceuticals in regenerative medicine fields such as cell therapy and contamination monitoring

• High sensitivity (10 cfu / ml level) as an alternative to the direct method

• High specificity that does not detect other related microorganisms (including 3 strains related to domestic negative test validation)

• Closed pipe can be checked to prevent contamination by the result and use real-time PCR method to check the result within up to 3 hours of use

• Easy handling, minimizing deviation or contamination between experimenters

Mycoplasma is a serious contaminant commonly observed in cell culture. It is known that about 30-87% of cell cultures are infected with Mycoplasma. This can happen during the course of experiments (through humans), sometimes through animal-derived products (such as serum). Mycoplasma, unlike other germs, has no cell wall and can pass through the pore of the filter and can grow without being affected by antibiotics that inhibit cell wall synthesis. In addition, it is difficult to see under a microscope, and it affects the growth of contaminated cells but does not kill them. Therefore, culture is continuously performed without being aware of contamination by Mycoplasma.

e-Myco ™ VALiD-Q Mycoplasma qPCR Detection Kit is a product that amplifies a specific gene of Mycoplasma through PCR and detects Mycoplasma in real time using the fluorescence of the amplification product-specific probe. The Mycoplasma assay (culture method), which is currently used for quality control of cell therapy products, has a very long test period and is very short effective because it is made for testing of cell substrates used for the production of vaccines and monoclonal antibody drugs, which are produced in large quantities. Due to various limitations (sample volume, sample volume and media volume), it is difficult to apply existing test methods as they are during final quality control (shipping test).

This product is an e-Myco ™ VALiD-Q Mycoplasma qPCR Detection Kit, which is a successor to the existing e-Myco ™ VALiD Mycoplasma PCR Detection Kit. This product can be detected specifically. This product targets 16S Ribosomal RNA region of Mycoplasma and amplifies Mycoplasma target gene with high specificity and sensitivity, and Probe with complementary sequence to specific nucleic acid sequence inside target gene amplification product has a fluorescent color A fluorescent reporter dye is labeled and a quencher is labeled at the 3 ‘end, which is decomposed by DNA polymerase during amplification of the target gene. You can do it. This product has higher specificity than the PCR method because it is affected by the specificity of the probe along with the primer. In addition, it includes an internal positive control, which is designed to detect the IPC signal along with the target signal, ensuring the reliability of the analysis.

[How to use e-Myco ™ VALiD-Q Mycoplasma qPCR Detection Kit]

Applications

01 Monitoring Mycoplasma Contamination Before, During and After Cell Production

02 Contamination Management of Cell Lines

03 TA cloning for Mycoplasma detection in specimens and cell lines