Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kits

Product Code. 30000681

Brand: Applied Biosystems™ 4460623

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.

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
  
  
• 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)
• Label or Dye: SYBR Green
• Product Line: MycoSEQ™
• Product Type: Assay Kit
• Quantity: 100 Reactions
• Shipping Condition: Dry Ice
• For Use With (Application): Mycoplasma Detection

Safety and Handling

Product Identifier

• MYCO DET.KIT/DISC POS.CTL EACH

Signal Word

• Danger

Hazard Category

• Acute toxicity Category 4
• LONG-TERM AQUATIC HAZARD Chronic 3
• ACUTE AQUATIC Acute 1
• Serious eye damage/eye irritation Category 1
• Serious eye damage/eye irritation Category 2
• Respiratory sensitiser Category 1
• Skin corrosion/irritation Category 1 A
• Skin corrosion/irritation Category 2
• Specific target organ toxicity after repeated exposure Category 2

Hazard Statement

• H302-Harmful if swallowed.
• H314-Causes severe skin burns and eye damage.
• H315-Causes skin irritation.
• H318-Causes serious eye damage.
• H319-Causes serious eye irritation.
• H332-Harmful if inhaled.
• H334-May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• H373-May cause damage to organs.
• H400-Very toxic to aquatic life.
• H412-Harmful to aquatic life with long lasting effects.

Precautionary Statement

• P260-Do not breathe dust/fume/gas/mist/vapours/spray.
• P261-Avoid breathing dust/fume/gas/mist/vapours/spray.
• P264-Wash hands thoroughly after handling.
• P270-Do not eat, drink or smoke when using this product.
• P271-Use only outdoors or in a well-ventilated area.
• P273-Avoid release to the environment.
• P280-Wear protective gloves/protective clothing/eye protection/face protection.
• P284-¢In case of inadequate ventilation! wear respiratory protection.
• P301+P312-IF SWALLOWED: Call a POISON CENTER or doctor/physician/ if you feel unwell.
• P301+P330+P331-IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
• P302+P352-IF ON SKIN: Wash with plenty of water/soap.
• P303+P361+P353-IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/ shower.
• P304+P340-IF INHALED: Remove person to fresh air and keep comfortable for breathing.
• P305+P351+P338-IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
• P310-Immediately call a POISON CENTER/doctor/.
• P312-Call a POISON CENTER/doctor/if you feel unwell.
• P330-Rinse mouth.
• P332+P313-If skin irritation occurs: Get medical advice/attention.
• P337+P313-If eye irritation persists: Get medical advice/attention.
• P342+P311-If experiencing respiratory symptoms: Call a POISON CENTER/doctor/ .
• P362+P364-Take off contaminated clothing and wash it before reuse.
• P363-Wash contaminated clothing before reuse.
• P391-Collect spillage.
• P501b-Dispose of contents/container in accordance with local/regional/national/international regulations.

Supplemental information

• MIXTURE LIST-Contains : Thiocyanic acid, Proteinase, tritirachium album serine, Glycerin, Hexadecyltrimethylammonium bromide