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Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kits
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Product Type:
Assay Kit
Assay Kit and Sample Preparation
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100 reazioni
Pezzo
Product Code. 30000681
missing translation for 'mfr': Applied Biosystems™ 4460623
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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 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.
Specifications
Specifications
| Content And Storage | • 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 |
| Descrizione | Detection for BioProduction process media, cells, raw materials |
| Da utilizzare con | 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) |
| Label or Dye | SYBR Green |
| Linea di prodotti | MycoSEQ™ |
| Product Type | Assay Kit |
| Quantità | 100 Reactions |
| Shipping Condition | Dry Ice |
| Da utilizzare con (applicazione) | Mycoplasma Detection |
Safety and Handling
Product Identifier
- MYCO DET.KIT/DISC POS.CTL EACH
- Pericolo
- Tossicità acuta Categoria 4
- PERICOLO A LUNGO TERMINE PER L'AMBIENTE ACQUATICO Cronico 3
- PERICOLO ACUTO PER L'AMBIENTE ACQUATICO Acuto 1
- Lesione oculare grave/irritazione oculare Categoria 1
- Lesione oculare grave/irritazione oculare Categoria 2
- Sensibilizzante delle vie respiratorie Categoria 1
- Corrosione/irritazione della pelle Categoria 1A
- Corrosione/irritazione della pelle Categoria 2
- Tossicità specifica per organi bersaglio (esposizione ripetuta) Categoria 2
- H302-Nocivo se ingerito.
- H314-Provoca gravi ustioni cutanee e gravi lesioni oculari.
- H315-Provoca irritazione cutanea.
- H318-Provoca gravi lesioni oculari.
- H319-Provoca grave irritazione oculare.
- H332-Nocivo se inalato.
- H334-Può provocare sintomi allergici o asmatici o difficoltà respiratorie se inalato.
- H373-Può provocare danni agli organi.
- H400-Molto tossico per gli organismi acquatici.
- H412-Nocivo per gli organismi acquatici con effetti di lunga durata.
- P260-Non respirare la polvere/i fumi/i gas/la nebbia/i vapori/gli aerosol.
- P261-Evitare di respirare la polvere/i fumi/i gas/la nebbia/i vapori/gli aerosol.
- P264-Lavare accuratamente dopo l'uso.
- P270-Non mangiare, né bere, né fumare durante l'uso.
- P271-Utilizzare soltanto all'aperto o in luogo ben ventilato.
- P273-Non disperdere nell'ambiente.
- P280-Indossare guanti/indumenti protettivi/Proteggere gli occhi/il viso.
- P284-¢Quando la ventilazione del locale è insufficiente! indossare un apparecchio di protezione respiratoria.
- P301+P312-IN CASO DI INGESTIONE accompagnata da malessere: contattare un CENTRO ANTIVELENI/medico/
- P301+P330+P331-IN CASO DI INGESTIONE: sciacquare la bocca. NON provocare il vomito.
- P302+P352-IN CASO DI CONTATTO CON LA PELLE: lavare abbondantemente con acqua/.
- P303+P361+P353-IN CASO DI CONTATTO CON LA PELLE (o con i capelli): togliere immediatamente tutti gli indumenti contaminati. Sciacquare la pelle/fare una doccia.
- P304+P340-IN CASO DI INALAZIONE: trasportare l'infortunato all'aria aperta e mantenerlo a riposo in posizione che favorisca la respirazione.
- P305+P351+P338-IN CASO DI CONTATTO CON GLI OCCHI: sciacquare accuratamente per parecchi minuti. Togliere le eventuali lenti a contatto se è agevole farlo. Continuare a sciacquare.
- P310-Contattare immediatamente un CENTRO ANTIVELENI/un medico .
- P312-Contattare un CENTRO ANTIVELENI/un medico/in caso di malessere.
- P330-Sciacquare la bocca.
- P332+P313-In caso di irritazione della pelle: consultare un medico.
- P337+P313-Se l'irritazione degli occhi persiste, consultare un medico.
- P342+P311-In caso di sintomi respiratori: contattare un CENTRO ANTIVELENI/un medico/ .
- P362+P364-Togliere tutti gli indumenti contaminati e lavarli prima di indossarli nuovamente.
- P363-Lavare gli indumenti contaminati prima di indossarli nuovamente.
- P391-Raccogliere il materiale fuoriuscito.
- P501b-Smaltire il prodotto/recipiente in conformità con le disposizioni locali/regionali/nazionali/internazionali.
- MIXTURE LIST-Contiene: Thiocyanic acid, Proteinase, tritirachium album serine, Glycerin, Hexadecyltrimethylammonium bromide
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