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  7. Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kits

Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kits

Code produit 30000672 Tous les produits Applied Biosystems Produits
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Type de produit:
Assay Kit
Assay Kit and Sample Preparation
Conditionnement:
1 pièce
100 réactions
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Code produit Type de produit unitSize
30000672 Assay Kit and Sample Preparation 100 réactions
30000681 Assay Kit 1 pièce
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Code produit 30000672 Fournisseur Applied Biosystems™ Code fournisseur 4460626

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Description

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 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.

TRUSTED_SUSTAINABILITY

Spécification

Contenu et stockage 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
Description Detection for BioProduction process media, cells, raw materials
À utiliser avec QS5 0.1 mL Block or 7500 FAST
Marqueur ou colorant SYBR Green
Gamme de produits MycoSEQ
Type de produit Assay Kit and Sample Preparation
Quantité 100 réactions
À utiliser avec (application) Mycoplasma Detection

Usage exclusivement réservé à la recherche. Ne pas utiliser pour des procédures de diagnostic.

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