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Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kits
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Type de produit:
Assay Kit
Assay Kit and Sample Preparation
Conditionnement:
1 pièce
100 réactions
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 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.
Spécification
Spécification
| Contenu et stockage | • 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 |
| Description | Detection for BioProduction process media, cells, raw materials |
| À utiliser avec | 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) |
| Marqueur ou colorant | SYBR Green |
| Gamme de produits | MycoSEQ™ |
| Type de produit | Assay Kit |
| Quantité | 100 réactions |
| Conditions d’expédition | Dry Ice |
| À utiliser avec (application) | Mycoplasma Detection |
Sécurité et traitement
Identifiant produit
- MYCO DET.KIT/DISC POS.CTL EACH
- Dangers
- Toxicité aiguë Catégorie 4
- TOXICITÉ À LONG TERME POUR LE MILIEU AQUATIQUE Chronique 3
- TOXICITÉ AIGUË POUR LE MILIEU AQUATIQUE Aiguë 1
- Lésion oculaire grave/irritation oculaire Catégorie 1
- Lésion oculaire grave/irritation oculaire Catégorie 2
- Sensibilisant respiratoire Catégorie 1
- Corrosion cutanée/irritation cutanée Catégorie 1A
- Corrosion cutanée/irritation cutanée Catégorie 2
- Toxicité spécifique pour certains organes cibles à la suite d'une exposition répétée Catégorie 2
- H302-Nocif en cas d'ingestion.
- H314-Provoque des brûlures de la peau et des lésions oculaires graves.
- H315-Provoque une irritation cutanée.
- H318-Provoque des lésions oculaires graves.
- H319-Provoque une sévère irritation des yeux.
- H332-Nocif par inhalation.
- H334-Peut provoquer des symptômes allergiques ou d'asthme ou des difficultés respiratoires par inhalation.
- H373-Risque présumé d'effets graves pour les organes.
- H400-Très toxique pour les organismes aquatiques.
- H412-Nocif pour les organismes aquatiques, entraîne des effets néfastes à long terme.
- P260-Ne pas respirer les poussières/fumées/gaz/ brouillards/vapeurs/aérosols.
- P261-Éviter de respirer les poussières/fumées/gaz/brouillards/vapeurs/ aérosols.
- P264-Se laver soigneusement après manipulation.
- P270-Ne pas manger, boire ou fumer en manipulant ce produit.
- P271-Utiliser seulement en plein air ou dans un endroit bien ventilé.
- P273-Éviter le rejet dans l'environnement.
- P280-Porter des gants de protection/des vêtements de protection/un équipement de protection des yeux/ du visage.
- P284-¢Lorsque la ventilation du local est insuffisante! porter un équipement de protection respiratoire.
- P301+P312-EN CAS D'INGESTION: appeler un CENTRE ANTIPOISON/médecin / en cas de malaise.
- P301+P330+P331-EN CAS D'INGESTION: rincer la bouche. NE PAS faire vomir.
- P302+P352-EN CAS DE CONTACT AVEC LA PEAU: Laver abondamment à l'eau/.
- P303+P361+P353-EN CAS DE CONTACT AVEC LA PEAU (ou les cheveux): Enlever immédiatement tous les vêtements contaminés. Rincer la peau à l'eau/Se doucher.
- P304+P340-EN CAS D'INHALATION: transporter la personne à l'extérieur et la maintenir dans une position où elle peut confortablement respirer.
- P305+P351+P338-EN CAS DE CONTACT AVEC LES YEUX: rincer avec précaution à l'eau pendant plusieurs minutes. Enlever les lentilles de contact si la victime en porte et si elles peuvent être facilement enlevées. Continuer à rincer.
- P310-Appeler immédiatement un CENTRE ANTIPOISON/un médecin/ .
- P312-Appeler un CENTRE ANTIPOISON/un médecin/en cas de malaise.
- P330-Rincer la bouche.
- P332+P313-En cas d'irritation cutanée: consulter un médecin.
- P337+P313-Si l'irritation oculaire persiste: consulter un médecin.
- P342+P311-En cas de symptômes respiratoires: Appeler un CENTRE ANTIPOISON/un médecin/ .
- P362+P364-Enlever les vêtements contaminés et les laver avant réutilisation.
- P363-Laver les vêtements contaminés avant réutilisation.
- P391-Recueillir le produit répandu.
- P501b-Éliminer le contenu/récipient conformément à la réglementation locale/régionale/nationale/internationale.
- MIXTURE LIST-Contient: Thiocyanic acid, Proteinase, tritirachium album serine, Glycerin, Hexadecyltrimethylammonium bromide
Usage exclusivement réservé à la recherche. Ne pas utiliser pour des procédures de diagnostic.
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