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MycoSEQ™ Mycoplasma Detection Kits
The MycoSEQ Mycoplasma Detection Kit is a real-time mycoplasma PCR assay designed and validated to meet the requirements of European Pharmacopeia Chapter 2.6.7 for use as a nucleic acid amplification technique (NAT).
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| Catalog Number | Product Type |
|---|---|
| 4460626 | Assay Kit and Sample Preparation |
| 4460623 | Assay Kit |
Catalog number 4460626
Price (USD)
4,870.00
Each
Product Type:
Assay Kit and Sample Preparation
Price (USD)
4,870.00
Each
The MycoSEQ Mycoplasma Detection Kit is a real-time mycoplasma PCR assay designed and validated to meet the requirements of European Pharmacopeia Chapter 2.6.7 for use as a nucleic acid amplification technique (NAT). The PCR primers were designed for mycoplasma detection using a proprietary bioinformatics pipeline to detect >90 mycoplasma species with high specificity and no cross-reactivity to closely-related bacterial species. The assay's sensitivity has been demonstrated by internal and external validations to detect 10 CFU/mL or the genomic equivalent as recommended by regulatory guidance.
Features of the MycoSEQ Mycoplasma Detection Kit include:
• Easy to use, results in less than one day
• Includes a unique discriminatory positive control to differentiate a true positive result from a potential cross-contamination positive call
• Includes protocols for various methods, including lot release and in-process testing
• Live mycoplasma is not needed: MycoSEQ Mycoplasma Detection Kit does not contain any live mycoplasma and does not require use of live mycoplasma for validation
• Can be used with gDNA, inactivated mycoplasma, or live mycoplasma
• May be used as an alternative to the standard 28-day culture test
• Can be used in conjunction with culture-based methods by providing preliminary results while waiting for results from the 28-day test
The PrepSEQ nucleic acid extraction module included in MycoSEQ Mycoplasma Detection Kit, with PrepSEQ sample preparation (Cat. No. 4460626) offers a robust and easy workflow to overcome complex matrix challenges to ensure the required sensitivity. For other recommended sample prep options, see the Integrated workflow solution section.
Also available but not included with the detection kit: MycoSEQ gDNA kits (Cat. No. A49973 and A49976), containing purified genomic DNA from various mycoplasma species, may be used as positive test material during method development.
Integrated workflow solution
The MycoSEQ Mycoplasma Detection Kit is part of an integrated workflow for adventitious agent, impurity and contaminant testing during biopharmaceutical manufacturing. The entire workflow, including PrepSEQ Sample Preparation Kits together with qPCR analysis, can provide results in under 5 hours. (Please note complex matrices may require additional upfront processing steps, as described in various available protocols.)
MycoSEQ kit performance has been tested and confirmed on the Applied Biosystems 7500 Fast Real-Time PCR System and the Applied Biosystems QuantStudio 5 Real-Time PCR System. Data analysis using AccuSEQ Real-Time PCR Detection Software provides accurate quantitation and security, audit, and e-signature capabilities to help enable 21 CFR Pt 11 compliance.
• Easy to use, results in less than one day
• Includes a unique discriminatory positive control to differentiate a true positive result from a potential cross-contamination positive call
• Includes protocols for various methods, including lot release and in-process testing
• Live mycoplasma is not needed: MycoSEQ Mycoplasma Detection Kit does not contain any live mycoplasma and does not require use of live mycoplasma for validation
• Can be used with gDNA, inactivated mycoplasma, or live mycoplasma
• May be used as an alternative to the standard 28-day culture test
• Can be used in conjunction with culture-based methods by providing preliminary results while waiting for results from the 28-day test
The PrepSEQ nucleic acid extraction module included in MycoSEQ Mycoplasma Detection Kit, with PrepSEQ sample preparation (Cat. No. 4460626) offers a robust and easy workflow to overcome complex matrix challenges to ensure the required sensitivity. For other recommended sample prep options, see the Integrated workflow solution section.
Also available but not included with the detection kit: MycoSEQ gDNA kits (Cat. No. A49973 and A49976), containing purified genomic DNA from various mycoplasma species, may be used as positive test material during method development.
Integrated workflow solution
The MycoSEQ Mycoplasma Detection Kit is part of an integrated workflow for adventitious agent, impurity and contaminant testing during biopharmaceutical manufacturing. The entire workflow, including PrepSEQ Sample Preparation Kits together with qPCR analysis, can provide results in under 5 hours. (Please note complex matrices may require additional upfront processing steps, as described in various available protocols.)
MycoSEQ kit performance has been tested and confirmed on the Applied Biosystems 7500 Fast Real-Time PCR System and the Applied Biosystems QuantStudio 5 Real-Time PCR System. Data analysis using AccuSEQ Real-Time PCR Detection Software provides accurate quantitation and security, audit, and e-signature capabilities to help enable 21 CFR Pt 11 compliance.
For Research Use Only. Not for use in diagnostic procedures.
Specifications
DescriptionDetection for BioProduction process media, cells, raw materials
For Use WithQS5 0.1 mL Block or 7500 FAST
Product LineMycoSEQ™
Product TypeAssay Kit and Sample Preparation
Quantity100 Reactions
For Use With (Application)Mycoplasma Detection
Label or DyeSYBR Green
Unit SizeEach
Contents & Storage
MycoSEQ Mycoplasma Detection Kit
• Power SYBR Green PCR Master Mix (2X), store at -15°C to -25°C on receipt, 2°C to 8°C after first use, protected from light
• Mycoplasma Real-Time PCR Primer Mix (10X), -15°C to -25°C on receipt, 2°C to 8°C after first use
• Discriminatory Positive/Extraction Control, -15°C to -25°C
• Negative control, -15°C to -25°C on receipt, 2°C to 8°C after first use
PrepSEQ 1-2-3 Mycoplasma Nucleic Acid Sample Extraction Kit
• Cell Fractionation Buffer, store at 2°C to 8°C
• RNase Cocktail Enzyme Mix, -15°C to -25°C
• Lysis Buffer, 18°C to 25°C
• Wash Buffer Concentrate, 18°C to 25°C
• Elution Buffer, 18°C to 25°C
• Proteinase K Buffer, 18°C to 25°C
• Magnetic Particles, 18°C to 25°C
• Proteinase K, -15°C to -25°C
• Power SYBR Green PCR Master Mix (2X), store at -15°C to -25°C on receipt, 2°C to 8°C after first use, protected from light
• Mycoplasma Real-Time PCR Primer Mix (10X), -15°C to -25°C on receipt, 2°C to 8°C after first use
• Discriminatory Positive/Extraction Control, -15°C to -25°C
• Negative control, -15°C to -25°C on receipt, 2°C to 8°C after first use
PrepSEQ 1-2-3 Mycoplasma Nucleic Acid Sample Extraction Kit
• Cell Fractionation Buffer, store at 2°C to 8°C
• RNase Cocktail Enzyme Mix, -15°C to -25°C
• Lysis Buffer, 18°C to 25°C
• Wash Buffer Concentrate, 18°C to 25°C
• Elution Buffer, 18°C to 25°C
• Proteinase K Buffer, 18°C to 25°C
• Magnetic Particles, 18°C to 25°C
• Proteinase K, -15°C to -25°C
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Notice to Purchaser: The purchase of this product conveys to the purchaser the limited, non-transferable right to use the purchased amount of the product (a) to perform internal research for the sole benefit of the purchaser; and (b) for environmental testing, quality control/quality assurance testing, food and agricultural testing, including reporting results of purchaser's activities in environmental testing, quality control/quality assurance testing, food and agricultural testing for a fee or other commercial consideration. No other right is hereby granted expressly, by implication, or by estoppel. This product is for environmental testing, quality control/ quality assurance testing, food and agricultural testing and research purposes only. The purchase of this product does not grant the purchaser any additional rights, including (without limitation) the right to transfer or resell the product in any form or the right to use the product as a therapeutic agent or diagnostics test component. For information on obtaining additional rights, please contact outlicensing@thermofisher.com, Licensing and Commercial Supply, Thermo Fisher Scientific, 5823 Newton Drive, Carlsbad, CA, 92008, United States.
'Frequently asked questions (FAQs)
Very often mycoplasma contamination cannot be removed from the culture so it should be discarded. You may have a unique culture that you prefer not to discard and would like to try to clean it. Ciprofloxacin and Plasmocin have reportedly been used for this application. If interested in a protocol or directions for use, check with the antibiotic supplier or published literature. Note that mycoplasma are very difficult to remove from culture and spread easily so the treated cultures should be quarantined until clear of mycoplasma, and your laboratory should be thoroughly cleaned.
Find additional tips, troubleshooting help, and resources within our Cell Culture Support Center.