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MicroSEQ Microbial Identification System

Used in top pharmaceutical companies worldwide, the Applied Biosystems MicroSEQ Rapid Microbial Identification System is an ideal solution for environmental monitoring, contamination investigation, root cause analysis, raw materials testing, and microbial identification in small-molecule and biopharmaceutical manufacturing, and service laboratories.

The MicroSEQ Rapid Microbial ID System combines the benefits of PCR and DNA sequencing technologies to enable highly accurate results.

  • Accurate and specific: Phylogenetic approach, based on the sequencing of the 16S rRNA gene for bacteria or the D2 region of the large subunit ribosomal DNA for fungi, delivers high discrimination power
  • Designed based on regulatory guidelines: Follows approaches recommended by regulatory agencies such as ICH, USP, EUP, and JP, for accurate contamination identification
  • Rapid time-to-results: ~5 hrs from colony to identification, allowing in-process testing
  • Wide range of organisms: Software using our large and comprehensive validated libraries for bacteria and fungi
  • Streamlined workflow: Standardized, simple and easy-to-validate workflow
  • Support network: Worldwide technical and validation support, detailed training and implementation guidance

Genotypic microbial identification—a proven technology

Accurate identification of isolates is required to support active environmental monitoring programs within pharmaceutical manufacturing facilities and to implement accurate Corrective and Preventive Actions (CAPAs) for products and processes to help reduce the risk of contamination. The comparative gene sequence analysis of ribosomal DNA (rDNA) has been shown to have the highest accuracy of microbial identification system technologies and has been considered the widely-trusted standard for microbial identification for over a decade.

  • Identification is based on DNA, offering the highest potential for unambiguous results
  • Outcome of the results is not dependent on culture conditions
  • Highly accurate due to excellent discrimination power between organisms having similar phenotypic characteristics

The Applied Biosystems MicroSEQ Rapid Microbial Identification System, based on comparative rDNA sequencing of the 16S region (for bacteria) or the LSU D2 region (for fungi), is a widely-used genotypic method for rapid and accurate microbial identification.

“Genotypic methods have been shown to be more accurate and precise than traditional biochemical and phenotypic techniques. These methods are especially valuable for investigations into failures (e.g., sterility test; media fill contamination).” 

 

U.S. Food and Drug Administration. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice U.S. Food and Drug Administration. FDA, October 2004.

Webinar: Microbial identification via DNA‑sequencing method to support risk mitigation

The utilization of microorganism identification through DNA sequencing provides an in-depth and comprehensive view of the variety of organisms that may pose a risk to controlled environments or final product. This webinar discusses the standards requiring characterization, identification, and techniques of a genotypic microbial identification method.

Go from culture to answer in less than 5 hours

Streamlining every step in the microbial identification process, the MicroSEQ System combines the advantages of MicroSEQ ID Software with easy sample preparation reagents and protocols, MicroSEQ bacterial and fungal application kits, and trusted thermal cyclers and sequencing systems. To facilitate optimal performance and system-wide integration, we develop and test all components of the system together.

 

A single, standardized procedure is used for identifying both bacterial and fungal isolates, giving you results from colony to identification in less than five hours.

Easy PCR-ready template preparation

The Applied Biosystems PrepMan Ultra Sample Preparation Reagent was developed for the rapid preparation of DNA template from gram-negative pathogens for use in PCR amplification reactions. It has been used to prepare PCR-ready template from a wide variety of different sources, including bacteria, yeast, filamentous fungi, from a plate or from liquid culture, mammalian tissue smears, human cells (buccal swab), and mammalian whole blood. It offers a simple rapid protocol, helping reduce time-to-results.

All-inclusive reagent kits and libraries

Specific and easy-to-use, MicroSEQ kits provide all the reagents needed for robust microbial identification. Complementary PCR and Sequencing kits have been tested and internally validated to meet or exceed regulatory guidelines. There are several kits and corresponding data libraries to choose from—covering more than 12,000 strain types of bacteria and fungi.

 

Precise PCR control

The Applied Biosystems VeritiPro Thermal Cycler offers proven reliability with advanced temperature control technology and connectivity. Take advantage of next-level PCR optimization with the precision offered by VeriFlex temperature control technology.

 

Simple, flexible sequencing platforms

The Applied Biosystems SeqStudio Series of genetic analyzers offer the high quality and reliable performance of Sanger sequencing and fragment analysis that scientists need, while leveraging design improvements and technological advances for increased flexibility, easier operation, enhanced connectivity, and remote serviceability.

 

Fast, accurate data analysis

Unlock the power of precise bacterial and fungal sequence identification with MicroSEQ Identification Software 4.0, tailored for the Applied Biosystems SeqStudio genetic analyzers. Experience advanced analysis, packed with features that elevate your workflow while supporting compliance with 21 CFR Part 11 regulatory standards.

 

Webinar: Methods for Rapid Microbial Testing & Identification: When and How                                                                   

Brochure: MicroSEQ Rapid Microbial Identification System                                                                                                    

Application note: Microbial identification using the MicroSEQ system on the SeqStudio Genetic Analyzer

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