Applied Biosystems™ MycoSEQ™ Mycoplasma gDNA Kits

Descripción

The MycoSEQ Mycoplasma gDNA Kit provides quantitative mycoplasma genomic DNA (gDNA) for use with the MycoSEQ Mycoplasma Detection Kit (Cat. No. 4460623 or 4460626). These kits provide gDNA from commonly referenced species, including those listed in the European Pharmacopeia chapter on mycoplasma, EP 2.6.7. Rapid mycoplasma testing methods such as the MycoSEQ Mycoplasma Detection assay are viable alternatives to traditional culture-based methods. This high-quality gDNA may be used during qualification and validation studies to establish limits of detection and specificity.

Features of the MycoSEQ Mycoplasma gDNA Kit include:
• Accurate titer, tested using independent methods of biochemical and nucleic acid testing (NAT) performance
• Identity confirmed through genotypic and phenotypic testing
• Lot-to-lot consistency

Components
• Each kit contains individual tubes of 1 mL gDNA in solution at 100 GC/μL concentration
• DNA dilution buffer is included with each kit and will be shipped separately
• Kit 1 (Cat. No. A49973): A. laidlawii, M. fermentans, M. hyorhinis, M. orale, M. arginini, M. pneumoniae
• Kit 2 (Cat. No. A49976): M. gallisepticum, M. synoviae, M. salivarium, M. hominis

Integrated workflow solution
MycoSEQ Mycoplasma gDNA Kits may be used with the MycoSEQ Mycoplasma Detection Kit as 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.