Thermo Fisher, 4460623, MycoSEQ™ Mycoplasma Detection Kits

Name: MycoSEQ™ Mycoplasma Detection Kits
Brand: Thermo Fisher
SKU: 4460623

Product Type: Assay Kit, Unit Size: 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 h

Catalog Number: 4460623

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Category

Molecular Identification Kits

TagsPCR Equipment and Supplies PCR Supplies Real Time PCR Products Real Time PCR Reagents and Kits

CollectionsThermo Fisher PCR Equipment & Supplies: Instruments, Master Mixes & Plastics Thermo Fisher Clinical Analyzers & Instruments for Diagnostic Labs Thermo Fisher General Lab Supplies for Daily Workflows — Nalgene, Nunc, Samco & Matrix

Description

Product Type: Assay Kit
Unit Size: Each
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 testThe 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.

Specifications

General

Description	Detection for BioProduction process media, cells, raw materials
For Use With	QS5 0.1 mL Block or 7500 FAST, using sample preps PrepSEQ™ 1-2-3 Nucleic Acid Extraction Kit (Cat. No. 4452222), or PrepSEQ™ Express Nucleic Acid Extraction Kit (Cat. No. 4466351)
Product Line	MycoSEQ
Product Type	Assay Kit
Quantity	100 Reactions
Shipping Condition	Dry Ice
For Use With (Application)	Mycoplasma Detection
Label or Dye	SYBR Green
Unit Size	Each

FAQs

Question: What does MycoSEQ detect?

Answer:Mycoplasma nucleic acids using real-time PCR.

Question: Is sample preparation important?

Answer:Yes. Use validated extraction and preparation appropriate to the tested matrix.

Question: Does a positive PCR result prove viable contamination?

Answer:No. PCR detects nucleic acids and does not alone establish viability.

Application Note

MycoSEQ™ Mycoplasma Detection Kit supports rapid molecular screening for mycoplasma contamination in cell-culture and bioprocess samples. Its real-time PCR workflow detects target mycoplasma nucleic acids following suitable sample preparation. Researchers and quality-control laboratories can use the assay as part of a broader contamination-control strategy for raw materials, cell banks, in-process samples and related matrices where validated. The kit is associated with the MycoSEQ testing workflow; compatible extraction procedures, instruments, controls and acceptance criteria must be established for the sample type. An amplification-based result does not by itself demonstrate whether an organism remains viable.

Ordering

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