The right answer, every time

Transcription

1 MICROSEQ MICROBIAL IDENTIFICATION SYSTEM The right answer, every time Definitive identification of bacterial and fungal isolates.

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3 Accuracy adds confidence. When microbial contamination poses problems, you need a highly accurate identification system that you can depend on. To provide that level of confidence, a growing number of pharmaceutical, food, and public health laboratories rely on DNA sequencing, the new gold standard for microbial identification. Experts agree that DNA sequencing is faster, more accurate, and more reproducible than phenotypic or biochemical identification methods. It provides the definitive information you need to control contamination and reduce risks associated with production downtime. Genotypic methods have been shown to be more accurate and precise than traditional biochemical and phenotypic methods. These methods are especially valuable for investigations of failures (sterility test; media fill contamination). Guidance for industry Sterile Drug Products Produced by Aseptic Processing. USFDA, September 2004, Pharmaceutical cgmps The MicroSeq Microbial Identification system was developed specifically for automated microbial DNA sequencing. Using the MicroSeq system, you can identify thousands of microbial species, including bacteria, yeasts, molds, and fungi.

4 FAST, ACCURATE IDENTIFICATION The answer is in the DNA If microbial DNA sequencing is the gold standard for microbial identification, the gold standard for microbial DNA sequencing is the MicroSeq system. By combining the latest in DNA sequencing technology with powerful analysis software, and a simplified workflow, the MicroSeq system makes it easier than ever to get accurate, reproducible results. Get better results, faster than ever The MicroSeq system identifies bacteria by automatically sequencing the universal 16S ribosomal RNA (rrna) gene the objective basis for bacterial taxonomic classification in Bergey s Manual. Fungi are identified by sequencing the D2 region of the 26S rrna gene. After sequencing the rrna gene, the MicroSeq system automatically compares the results to validated sequences in the MicroSeq microbial libraries and provides a list of closest matches. The results are ranked according to genetic distance from the sample and displayed on the system monitor along with a phylogenetic tree. MicroSeq Software automatically matches unknown samples to the % match or closest match in the MicroSeq Library based on sequence alignment and phylogenetic tree. Simple Work Flow with RESULTS IN LESS THAN 5 HOURS From sample preparation to final result, the complete MicroSeq System combines proven performance and ease of use with the robust reliability of Applied Biosystems components. Colony or culture Only a small number of cells needed Extract DNA Using a simple sample preparation procedure Perform PCR & cycle sequencing Using pre-configured reagent kits

5 Validated coverage on thousands of species Validated MicroSeq sequence libraries are provided with the MicroSeq system for both bacterial and fungal identification. The MicroSeq bacterial library includes entries for over 1700 species, including gram-negative non-fermenters, Bacillus, Coryneforms, Mycobacteria, and Staphylococcus. The library for fungal species includes over 1000 entries. Both libraries are continually updated and expanded with new entries. The libraries support sequence polymorphisms and include bacterial Category A biothreat agents. You can also create custom libraries for species of interest and add sequences from new or proprietary strains. 100% ACCURATE, 100% OF THE TIME In a comparison of bacterial identification methods, the MicroSeq System was the only commercially available system found to be 100% accurate with 100% reproducibility at identifying 18 American Type Culture Collection (ATCC) strains of organisms most frequently encountered in pharmaceutical manufacturing environments. One simple procedure for every sample With the MicroSeq System you can identify microbial species in less than 5 hours using a simple workflow that requires minimum hands-on time. No previous DNA sequencing or genotyping experience is required, and a single, standardized procedure is used for all bacterial and fungal isolates. No prior knowledge of organism required No gram stain necessary No biochemical testing No previous experience needed From: Alexander R, Clements JA, Guest R, Leiper K, et al. The sixth New Technologies Forum on Rapid Methods in Microbiology. Royal Pharmaceutical Society. Feb Automatic DNA sequencing Load your samples and walk away Automatic analysis & identification Using powerful, easy-to-use MicroSeq software Time to results Less than 5 hours

6 INTEGRATED SYSTEM A complete solution The MicroSeq system combines all the instrumentation, reagents, sequence libraries, and software required for automated microbial DNA sequencing. Each component of the system is quality-controlled and validated to work together making it easier for you to get accurate, reliable, and reproducible results. SIMPLIFIED SAMPLE PREPARATION RELIABLE PCR FAST, EASY, AUTOMATED DNA SEQUENCING The PrepMan Ultra Reagent makes it easy to prepare samples from colony or culture. Applied Biosystems PCR instruments provide reproducible and ultra-reliable results and are available in a range of configurations to meet your lab s needs. Applied Biosystems genetic analyzers offer advanced automation, exceptional ease of use, and industry- leading performance for fast, accurate results. Different system configurations are available to meet low, medium, and high throughput requirements.

7 ANSWERS YOU CAN TRUST MicroSeq ID Analysis Software includes all the tools you need to identify microorganisms using validated sequences of bacterial and fungal type strains in the MicroSeq Libraries. CONVENIENT REAGENT KITS MicroSeq S Bacterial Identification Kit includes reagents for identifying bacteria based on sequencing 500 basepairs (bp) of the 16S RNA gene. The MicroSeq Full Gene 16S Bacterial Identification Kit includes reagents for identifying bacteria based on the sequence of the entire 16S RNA gene. The MicroSeq D2LSU Fungal Identification Kit includes reagents for identifying fungi based on sequencing of nuclear ribosomal DNA. Comprehensive validation support MicroSeq system components are optimized and validated to work together. In addition, all entries in the MicroSeq libraries are validated to ensure accurate identification. The libraries include only correctly identified organisms and quality controlled sequences derived from type strains of preeminent culture collections. The MicroSeq software includes features for 21 CFR Part 11 compliance, and Applied Biosystems provides all MicroSeq customers with comprehensive IQ/OQ/PQ validation support.

8 Support you can depend on Whenever and wherever you need it When you purchase the MicroSeq Microbial Identification System, you have access to the one of the world s most extensive technical service and support organizations. We take great pride in providing you with specialized training, service, and applications assistance from knowledgeable professionals who offer expert support in your laboratory, over the phone, and on-line. For more information about the MicroSeq Microbial Identification System, please call the Sales Office nearest you or visit NOTICE TO PURCHASER: LIMITED LICENSE, Thermostable Enzyme Use of the MicroSeq S rdna Bacterial Identification Kit, MicroSeq Full Gene 16S rdna Bacterial Identification Kit and MicroSeq D2 rdna Fungal Identification System is covered by one or more of the following US patents and corresponding patent claims outside the US: 5,079,352, 6,127,155, 5,476,774, 5,219,727, 6,677,152 (claims 1-23) and 5,773,258 (claims 1-10). The purchase price of these products includes a limited, non-transferable immunity from suit under the foregoing patent claims for using only this amount of product solely in environmental testing, quality control/quality assurance testing, food and agricultural testing, including reporting results of purchaser s activities for a fee or other commercial consideration, and also for the purchaser s own internal research. No right under any other patent claim is conveyed, expressly, by implication, or by estoppel to the purchaser by the purchase of these products. Further information on purchasing licenses may be obtained by contacting the Director of Licensing, Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404, USA. Notice to Purchaser About Limited License The MicroSeq S rdna Bacterial Identification Kit, MicroSeq Full Gene 16S rdna Bacterial Identification Kit and MicroSeq D2 rdna Fungal Identification System are sold pursuant to a limited sublicense from Amersham International plc under one or more U.S. Patent Nos. 5,498,523 4,994,372, U.S. Patent Application Serial Nos. 08/ / and corresponding foreign patents and patent applications. The purchase of these kits (reagent) includes a limited non-exclusive sublicense (without the right to resell, repackage or further sublicense) under such patent rights to use this reagent for DNA sequencing or fragment length analysis solely with an Applied Biosystems commercial automated sequencing machine or other authorized DNA sequencing machines that have been authorized for such use by Applied Biosystems, or for manual DNA sequencing. No license is hereby granted for use of these kits, or the reagents therein, in any other automated sequencing machine. Such sublicense is granted solely for research or other uses that are not unlawful. No other license is granted expressly, impliedly, or by estoppel. For information concerning the availability of additional license to practice the patented methodologies, contact: Amersham Life Science, Inc., Vice President, Regulatory Affairs, P.O. Box 22400, Cleveland, Ohio Patents are pending in countries outside the United States. Applied Biosystems, AB (Design), MicroSeq and PrepMan are registered trademarks and Applera is a trademark of Applera Corporation or is subsidiaries in the US and/or certain other countries Applied Biosystems. All rights reserved. Printed in the USA, 03/2006 Publication 116BR Headquarters 850 LIncoln Center Drive Foster City, CA USA Phone Toll Free International Sales For our office locations please call the division headquarters or refer to our Web site at