Reliable, reproducible, easy testing -
why wait days to get results?

The GeneDisc Rapid Microbiology System helps to provide microbial test data in as little as two hours, using a simple to use, robust and cost effective platform based on quantitative Polymerase Chain Reaction (qPCR) technology. Using the GeneDisc Rapid Microbiology System represents an attractive alternative to existing microbiological methods.

Current Applications

The current portfolio of tests covers:

• Biopharmaceuticals
  Testing for the key indicator organisms cited in the pharmacopoeial chapters such as USP <62>/EP 2.6.13/JP 35.2 and USP <51>. These organisms are Escherichia coli, Salmonella spp., Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and Burkholderia cepacia.

• Food Industry
  Testing for key food-borne pathogens, such as Salmonella and Listeria, as well as pathogenic strains of Escherichia coli
  (O157 and non-O157 STEC).

• Water Safety
  Quantification of Legionella and Pseudomonas aeruginosa in critical water systems, and testing of bathing water for E. coli, Enterococcus faecalis and Pseudomonas aeruginosa, with results available in hours.

How The GeneDisc® Rapid Microbiology System Works

The system consists of three key components - the GeneDisc DNA Extractor, GeneDisc plate and GeneDisc Cycler. The GeneDisc DNA Extractor is used to prepare samples for analysis, based on four simple steps (filtration, sonication, heating and DNA purification). The GeneDisc plate is a two-part molded device approximately the same diameter as a DVD. The upper part of the disc incorporates a hollow central hub divided into either 6, 9 or 12 separate sectors, depending on the specific plate/application. The GeneDisc Cycler is a small-footprint device, with a sliding door at the front through which the GeneDisc plates are then loaded.

Each GeneDisc plate hub sector is connected by micro-channels to 6, 4 or 3 wells respectively, depending on the number of sectors incorporated into the plate. Liquid added to a hub sector flows through these microchannels into the wells. Either 6, 9 or 12 samples samples per plate can be tested, corresponding to the number of plate sectors.

When a test is run, the barcode from each GeneDisc plate is scanned by a reader built into the front of the GeneDisc Cycler. For quantitative assays, the liquid reagent also carries a unique barcode – part of both plate and reagent barcodes must match, or the instrument will not run. These controls ensure accurate, precise and highly reproducible data, using a very simple format that requires no significant user skills or training.

Testing Overview

Samples are first filtered, and the filter is then placed into buffer. The GeneDisc DNA Extractor may then be used to release DNA from any bacteria present by lysing cells, then to purify any DNA released. Samples and additional reagent (a Master Mix, containing polymerase and deoxynucleotides) are added to the upper hub of the GeneDisc plate.

A cap and interconnected hose (part of the GeneDisc Cycler instrument) are fitted to the hub and a vacuum is applied by the instrument. This vacuum causes the liquid loaded into the hub to flow uniformly into the wells. Mineral oil is added and the vacuum step repeated. This seals the plate and prevents sample evaporation during testing.

The plate is then placed into the GeneDisc Cycler. Inside, there are heating devices required for the qPCR reaction, an optical system for measuring fluorescence and control systems.

Features and Benefits

• Simplicity - limited user input required to run tests; patented instrument and consumable design allows highly simplified operation
• Speed - results available within hours, ensuring timely decisions during manufacturing cycle
• Security - unique, closed system provides reproducible results - ideal for routine QC operation
• Savings - attractive pricing, with cost savings based on lean manufacturing and improved quality control
• Support - a full package of training, servicing, calibration, repair and technical support is available