Bench Top POC Microbial Detection Instrument Uses Lateral Flow and Magnetic Particle Technologies

The Envisio(TM) Microbial Detection System was designed to detect multiple pathogens (Salmonella, E. Coli, and Listeria) in the food processing industry. The instrument employs a disposable cassette that uses para-magnetic microparticles, which bind to target microbes during the test cycle. Test results are displayed and a hard copy is provided via an internal printer. The benefits of magnetic particle detection are sensitivity, speed, and low cost.

It was the first commercial application of the MagnaBiosciences MAR(TM) Assay Development System (ADS), a patented platform capable of performing detection of chemical and biologic agents for research and diagnostics. We developed the assay cassette and magnetic detector, and converted the existing system from a lab instrument to a functional and portable module.

Afterward, the Omnica team combined the just-perfected technology with reagent chemistries from Eastman® into an innovative and manufacturable package. We were responsible for the concepting, industrial design, mechanical/electronic engineering, and software development. This includes circuit design, enclosures, design documentation, and formal transfer to manufacturing. We also built and prototyped the test and demo units.

Envisio(TM) Microbial Detection System

· Device is tailored for high-volume test sites.

· System has its own built-in CPU and printer.

· Automatically calibrates each time it is turned on

· Reliable and proven technology detects E.coli 0157

· Simple, one button operation - results in less than 30 seconds.

· Successful example of parallel development effort.

Magnetic Assay Reader (MAR(TM))

· Quantitative results via magnetic particle detection

· MAR(TM) compatible assays are easily adapted
from enzyme-linked immunoabsorbent (ELISA), and lateral flow assay formats.

· Integrated barcode reader - scalable data matrix

· Robust, power efficient, and easily manufacturable

· Sensitivity 10-1000 times better than visual assays

· Configurable to the needs of specific applications.

Miniature Barcode Reader

We developed a miniature barcode reader to make the best use of existing data matrix barcode technology.

The challenge was to build the smallest possible reader that correctly interpreted and relayed critical information even if the printed barcode was blemished or distorted. It is the size of a postage stamp - small er th an any commercially available barcode reader - and is easily manufactured.

The reader communicates information in the data matrix barcode (the size of a fingernail) to a printer, and to the assay detector in the microbe detection instrument.

· Special optical lens and custom LED light source.

· Effective and robust error correction algorighms.

· Weighs one tenth of an ounce.

Disposable Sample Cassette

This high-volume disposable cassette is an integral part of the Omnica-developed MAR(TM) system. We designed the cassette, prototyped tooling and first articles, and built assembly and test fixtures.

· Total amount of analyte is measured in one volumetric measurement.

· Measurements of each analytical region (up to 6) is performed in 15 seconds.

· Can be used with solid phase and flow assays, and multi-analyte panels.

· Compatible with many small-volume assay formats such as microdots (<1mm diameter) or lines (0.5 mm x 5 mm)

· Usable with film substrates with an overall thickness of less than 0.50 mm.

· Measurements are linear over a range of at least 4 orders of magnitude.

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