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Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kits
Tienda Applied Biosystems Productos
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Tipo de producto:
Assay Kit
Assay Kit and Sample Preparation
Tamaño de la unidad:
100 reacciones
cada uno
Código de producto. 30000681
Marca: Applied Biosystems™ 4460623
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Descripción
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.
Especificaciones
Especificaciones
| Contenido y almacenamiento | • 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 |
| Descripción | Detection for BioProduction process media, cells, raw materials |
| Para utilizar 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) |
| Etiqueta o tinte | SYBR Green |
| Línea de productos | MycoSEQ™ |
| Tipo de producto | Assay Kit |
| Cantidad | 100 reacciones |
| Condiciones de envío | Dry Ice |
| Para utilizar con (aplicación) | Mycoplasma Detection |
Seguridad y manipulación
Nombre del producto
- MYCO DET.KIT/DISC POS.CTL EACH
- Peligro
- Toxicidad aguda Categoría 4
- PELIGRO ACUÁTICO A LARGO PLAZO Categoría 3
- PELIGRO ACUÁTICO AGUDO Categoría 1
- Lesión ocular grave/irritación ocular Categoría 1
- Lesión ocular grave/irritación ocular Categoría 2
- Sensibilizante respiratorio Categoría 1
- Corrosión o irritación cutáneas Categoría 1A
- Corrosión o irritación cutáneas Categoría 2
- Toxicidad específica para determinados órganos Categoría 2
- H302-Nocivo en caso de ingestión.
- H314-Provoca quemaduras graves en la piel y lesiones oculares graves.
- H315-Provoca irritación cutánea.
- H318-Provoca lesiones oculares graves.
- H319-Provoca irritación ocular grave.
- H332-Nocivo en caso de inhalación.
- H334-Puede provocar síntomas de alergia o asma o dificultades respiratorias en caso de inhalación.
- H373-Puede provocar daños en los órganos.
- H400-Muy tóxico para los organismos acuáticos.
- H412-Nocivo para los organismos acuáticos, con efectos nocivos duraderos.
- P260-No respirar el polvo/el humo/el gas/la niebla/los vapores/el aerosol.
- P261-Evitar respirar el polvo/el humo/el gas/la niebla/los vapores/el aerosol.
- P264-Lavarse concienzudamente tras la manipulación.
- P270-No comer, beber ni fumar durante su utilización.
- P271-Utilizar únicamente en exteriores o en un lugar bien ventilado.
- P273-Evitar su liberación al medio ambiente.
- P280-Llevar guantes/prendas/gafas/máscara de protección.
- P284-¢En caso de ventilación insuficiente,! llevar equipo de protección respiratoria.
- P301+P312-EN CASO DE INGESTIÓN: Llamar a un CENTRO DE TOXICOLOG A/médico/si la persona se encuentra mal.
- P301+P330+P331-EN CASO DE INGESTIÓN: Enjuagarse la boca. NO provocar el vómito.
- P302+P352-EN CASO DE CONTACTO CON LA PIEL: Lavar con abundante agua/.
- P303+P361+P353-EN CASO DE CONTACTO CON LA PIEL (o el pelo): Quitar inmediatamente todas las prendas contaminadas. Aclararse la piel con agua/ducharse.
- P304+P340-EN CASO DE INHALACIÓN: Transportar a la persona al aire libre y mantenerla en una posición que le facilite la respiración.
- P305+P351+P338-EN CASO DE CONTACTO CON LOS OJOS: Aclarar cuidadosamente con agua durante varios minutos. Quitar las lentes de contacto, si lleva y resulta fácil. Seguir aclarando.
- P310-Llamar inmediatamente a un CENTRO DE TOXICOLOG A/médico/.
- P312-Llamar a un CENTRO DE TOXICOLOG A/médico/si la persona se encuentra mal.
- P330-Enjuagarse la boca.
- P332+P313-En caso de irritación cutánea: Consultar a un médico.
- P337+P313-Si persiste la irritación ocular: Consultar a un médico.
- P342+P311-En caso de síntomas respiratorios: Llamar a un CENTRO DE TOXICOLOG A/médico/.
- P362+P364-Quitar las prendas contaminadas y lavarlas antes de volver a usarlas.
- P363-Lavar las prendas contaminadas antes de volver a usarlas.
- P391-Recoger el vertido.
- P501b-Eliminar el contenido/el recipiente en conforme a la reglamentación local/regional/nacional/internacional.
- MIXTURE LIST-Contém: Thiocyanic acid, Proteinase, tritirachium album serine, Glycerin, Hexadecyltrimethylammonium bromide
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