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제품 설명
Mycoplasma Real-time qPCR Detection Kit
제품 번호
40618ES25 / size: 25T
40618ES60 / size: 100T
제품 설명
MycAwayTM Mycoplasma Real-time qPCR Detection Kit is a product which can qualitative detect the mycoplasma contamination in the raw materials, cell bank, virus seeds, virual or cell harvesting solution and cells used in clinical treatment, etc. The kit uses the Taqman fluorescent probe (which included FAM and VIC) and the Multiple polymerase chain reaction (PCR) tools to detect the target and internal control separately. It covered over 169 species of the Mollicutes DNA, the specificity, detection limit and robustness of this kit are validated according to EP <2.6.7> which with high sensitivity, specificity, efficiency and safety. The detection limit is equals to and below 10 CFU/mL.
This product can be used in combination with MolPure® Magnetic Residual DNA Sample Preparation Kit (Cat#18461ES) which using the manual extracted method for the nucleic acid extraction. The nucleic acid in samples can also be automatically extracted by 48-Channel automatic nucleic acid extractor (Cat#80511ES) and MolPure® Mag48 Sample Preparation Kit FN (Cat#18467ES) (Please note, the kits which included Cat#18461ES and Cat#40618ES are full validated, please contact our technical support for detailed validation information). After the samples are pre-treated to remove the interference impurities and obtain purified nucleic acid, then a qPCR reaction perform by the Real Time PCR amplifier and the fluorescence signal of the probe will be collected and analyzed.
MycAwayTM Mycoplasma Real-time qPCR Detection Kit is based on the NAT method (nucleic acid amplification techniques), and its specificity, detection limit and durability are fully validated according to EP 2.6.7 and JP G3. Meanwhile, it covers the types of mycoplasma strains that are required to be validated by USP, WHO, ChP, etc. The performance of the kit is in line with the standards of Chinese and foreign laws and regulations as well as the standards of international authoritative organizations, which can help biopharmaceutical customers to obtain the acceptance of the clinical trial applications of their drug R&D projects from domestic and foreign pharmacological regulatory authorities.
NAT Method Mycoplasma qPCR Assay - Complete Solution
Cat.No. | 40618ES25 / 40618ES60 |
Size | 25T / 100 T |
Detection Limit | 10CFU/mL |
Detect method | qPCR method (Taqman fluorescent) |
Duration | 4 hours |
Fluorescent probe | FAM (Target channel);VIC (Internal channel) |
Covered mycoplasma | ≥169 |
Validation | Validated according to EP <2.6.7> |
This product should be stored at -25~-15℃ for 15 months.
*Upon receipt of the kit, please check whether all components are complete and immediately store them in -25~-15℃ condition if not perform the assay immediately. Please note 40618-B should be stored away from light.
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