Rapid Microbiology System

Transcription

1 USD 2667 The GeneDisc Rapid Microbiology System Reliable, reproducible, easy testing

2 User Benefits and Current Applications Why Wait Days to Get Results? The GeneDisc Rapid Microbiology System helps to provide 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. Novel design features of this technology address key customer needs, including: 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. Simplicity: Limited user input is 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 Service: A full package of training, servicing, calibration, repair and technical support is available for system. The GeneDisc Rapid Microbiology System refore represents an attractive alternative to existing microbiological methods. Current Applications The current portfolio of tests covers: Biopharmaceuticals Testing for key indicator organisms cited in pharmacopoeial chapters such as USP <62>/EP /JP 35.2 and USP <51>. These organisms are Escherichia coli, Salmonella spp., Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and Aspergillus brasiliensis. 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). 2

3 The GeneDisc Rapid Microbiology System: System Components The GeneDisc DNA Extractor Used for sample preparation The GeneDisc plate Consumable item in which assays are run. Two of key reagents necessary for assay ( primers and probe) are contained in wells of GeneDisc plate, ready for use. The GeneDisc Cycler Performs assay and records results How System Works 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 same diameter as a DVD. The upper part of disc incorporates a hollow central hub divided into eir 6, 9 or 12 separate sectors, depending on specific plate/application. The lower part of plate contains 36 molded sample wells and micro-channels. Each hub sector is connected by micro-channels to 6, 4 or 3 wells respectively, depending on number of sectors incorporated into plate. Liquid added to a hub sector flows through se microchannels into wells. Eir 6, 9 or 12 samples samples per plate can be tested, corresponding to number of plate sectors. Incorporation of key reagents into GeneDisc plate during manufacturing allows shipment at ambient temperature and storage at 4 C, instead of freezing at -20 C or below (as is typical). This adds user convenience, by minimizing risk of reduced reagent activity due to temperature cycling during freezing and thawing of liquid reagents. Master Mix reagent (supplied for use as an individual tube per plate) is used to run qpcr assays and prevents contamination risks which are inherent in or multi-use formats. Each GeneDisc plate sector contains a positive control well. During a test, GeneDisc Cycler compares positive control data with a stored reference value. If measurements are not within defined limits, that test is automatically invalidated. There is also a negative control well in each sector. Individual batches of reagent and GeneDisc plate are co-qualified during production and ir performance forms part of traceable batch records. For traceability, assembled GeneDisc plates carry printed labels with product description, well identifier numbers and a unique barcode. When a test is run, barcode from each GeneDisc plate is scanned by a reader built into front of GeneDisc Cycler. For quantitative assays, liquid reagent also carries a unique barcode part of both plate and reagent barcodes must match, or 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. 3

4 Testing Overview The current test method for quantitative assays is based on filterable samples. Pall also offers assays for certain non-filterable samples, and is developing additional tests. Samples are first filtered, and filter is n placed into buffer. The GeneDisc DNA Extractor may n be used to release DNA from any bacteria present by lysing cells, n to purify any DNA released. Samples and additional reagent (a Master Mix, containing polymerase and deoxynucleotides) are added to upper hub of GeneDisc plate. A cap and interconnected hose (part of GeneDisc Cycler instrument) are fitted to hub and a vacuum is applied by instrument. This vacuum causes liquid loaded into hub to flow uniformly into wells. Mineral oil is added and vacuum step repeated. This seals plate and prevents sample evaporation during testing. The plate is n placed into GeneDisc Cycler. The GeneDisc Cycler is a small footprint (roughly 510 mm x 300 mm x 260 mm) device, with a sliding door at front through which samples are loaded. Inside, re are heating devices required for qpcr reaction, an optical system for measuring fluorescence and control systems. 4

5 1. Scan barcode to validate GeneDisc plate and test 2. Add test sample to GeneDisc plate The qpcr reaction (along with specific aspects of GeneDisc Cycler) is described in Pall publication USTR 2728, and is summarized in Figure 1 of that document. Briefly, at elevated temperature, double-stranded DNA separates into two strands. A fluorescently-labeled probe binds to one strand and small DNA sequences called primers (specific to a small region of DNA) bind to both strands. This bound probe incorporates a quencher that blocks label from fluorescing. A polymerase enzyme copies two DNA strands. The bound probe is consumed during this process and fluorescent group is released. Therefore, if a specific DNA sequence is present and amplified, fluorescent signal from probe will increase during reaction. This increasing fluorescent signal is used to quantify presence of specific DNA sequence. To run a test, GeneDisc plate is fitted to a drive within GeneDisc Cycler, where it rotates during test. The optical system within instrument is used to measure any fluorescent signal generated during testing. Data is recorded and analyzed using software stored within instrument. Cycle parameters are stored in firmware within instrument. These parameters are not user-accessible but can be user-reprogrammed using security locked files, sent to user by Pall. This allows user flexibility and security of key operational parameters and thus reliability of data generated. 3. Transfer sample to well 4. Load plate into GeneDisc Cycler 5

6 Technical Information Below are brief technical specifications for GeneDisc DNA Extractor and GeneDisc Cycler. This and or important information is also included in Instructions For Use supplied with instruments. Pall provides full technical support for se instruments, including servicing and calibration. GeneDisc DNA Extractor Part Number European model US model Physical Dimensions Weight Cabinet Working space EGDDE01EU EGDDE01US 75 kg (165 lb) approx. (H x W x D) 915 x 950 x 670 mm (36 x 37.5 x 26 in.) Cabinet and touch screen plus ventilation and wiring clearance H x W x D* 915 x 1370 x 670 mm (36 x 54 x 26 in.) * Requires a work surface minimum depth 500 mm (20 in.), capable of supporting a weight of at least 80 kg (176 lb) Electrical Data Voltage Power consumption EGDDE01EU 230 V AC, 50 Hz EGDDE01US 110 V AC, 60 Hz EGDDE01EU 4 A nominal EGDDE01US 8 A nominal Ultrasonic Bath Maximum ultrasound level in operation with lysis rack in place 80 db. Four ultrasonic transducers operating at 40 khz, total 320 W maximum. Environmental Conditions The instrument is designed for indoor use under following environmental conditions: Altitudes Up to 2,000 m (6,500 ft) Temperatures +5 C to +40 C Maximum relative humidity 80% for temperatures up to +31 C, decreasing to 50% at +40 C, with no condensation Electricity mains supply voltage fluctuations up to 10% of nominal voltage, with transient overvoltages typically present Splash Protection Control pad Cabinet Storage Conditions Ambient temperatures GeneDisc Cycler Part Number EGDCU2C Physical Dimensions Weight: Unit IP30 IPX3-20 C to +70 C. Relative humidity in range 10% to 90%, with no condensation 15 kg (33 lb) approx. (H x W x D) 200 x 550 x 260 mm (7.8 x 21.6 x 10.2 in.) Electrical Data Voltage V, Hz Power Consumption 312 VA (24 V, 13 A) Connections USB ports for: Or User interface ports Barcode reader Remote controller Spare for optional Flash drive or or accessory Ernet port not currently in use Vacuum port not currently in use UV light 15 W UVC tube This is a user maintainable component 6

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