Applied Biosystems™ MycoSEQ™ Plus Mycoplasma Detection Kits

Beschreibung

The MycoSEQ™ Plus Mycoplasma Detection Kit is a TaqMan™-based quantitative PCR (qPCR) kit for the detection of mycoplasma in complex bioproduction samples. Designed and tested using criteria often applied toward rapid mycoplasma detection in biotherapeutic manufacturing cell culture lot release, the MycoSEQ Plus kit enables results that meet or exceed guidance on sensitivity and specificity expectations as described in European Pharmacopoeia (E.P. 2.6.7, 2007), US Pharmacopoeia (US63) and Japanese Pharmacopoeia. When used with a suitable sample preparation method, the MycoSEQ Plus kit can detect less than 10 CFU/mL or the genomic equivalent of 10 GC/mL.

This multiplexed assay enables predicted simultaneous screening of over 200 species of Mycoplasma target, discriminatory detection of an assay specific control template, and internal PCR control with no cross-reactivity to closely-related bacterial species.

Features of the MycoSEQ Plus Mycoplasma Detection Kit
• Provides results in less than 1 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
• 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
• May be used in conjunction with culture-based methods by providing preliminary results while waiting for results from the 28-day test

PrepSEQ nucleic acid extraction kits offer a robust and easy workflow to overcome complex matrix challenges to ensure the required sensitivity. Use MycoSEQ Plus Mycoplasma Detection Kit with PrepSEQ 1-2-3 Nucleic Acid Extraction Kit (Cat. No. A57925) for manual extractions, or MycoSEQ Plus Mycoplasma Detection Kit with PrepSEQ Express Nucleic Acid Extraction Kit (Cat. No. A57926) for automated extraction using the Automate Express Nucleic Acid Extraction System.

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 Plus 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, which offer manual or automated sample preparation approaches, 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 Plus 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.