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The <Mycoplasma Test> (3301) in the Chinese Pharmacopoeia adopts the culture method and indicator culture method, which can effectively detect viable mycoplasma in biological products or cells but has poor detection timeliness. Compared with the culture method and indicator culture method specified in the Chinese Pharmacopoeia, <2.6.7> in the European Pharmacopoeia states that mycoplasma can be detected by amplifying nucleic acids extracted from test samples using specific primers. After appropriate validation, nucleic acid amplification technology (NAT) can replace the culture method and indicator cell culture method.
Independently developed by Junyan Bio, the Mycoplasma PCR Detection Kit uses polymerase chain reaction (PCR) technology to amplify and detect specific fragments in the 16S and 23S rRNA conserved regions of mycoplasma. This method can yield results within two hours, which not only saves time compared with the traditional culture method but also improves sensitivity and accuracy.
The Mycoplasma PCR Detection Kit can cover more than 100 mycoplasma species and has no cross-reactivity with common engineered cells and bacterial strains. UNG enzyme is added to this kit, which can effectively prevent contamination from PCR products.
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