The public's health has been put at risk by pathogens in food, affecting more than one in six Americans. The need for a faster testing solution is profound. Utilizing technology invented at Kent State University and Northeast Ohio Medical University,  Crystal Diagnostics is proud to unveil a rapid testing system which makes testing for multiple pathogens possible in one test.  The Crystal Diagnostics MultiPath System™– cassette, reader and software – saves time, provides accuracy and hyper-functionality through multi-pathogenic testing.

Technology Description

The device consists of two components:
The first component  is a consumable “Cassette” designed with appropriate test controls and the capacity to simultaneously evaluate a single sample for 3 different pathogenic bacteria. The food sample is processed, mixed with an antibody specific to the microbe(s) of interest and combined with a liquid crystals solution.

The second component of the system is a “Reader device.” The cassette is inserted in the reader and the liquid crystal caused to form an aligned matrix. If the pathogen of interest is present, the liquid crystal  matrix will be disrupted. This disruption will be recognized via digital imaging, and the result is output to an iPad or other device.

Sample processing involves homogenizing the food to release the microbes.  Since there is zero regulatory tolerance for food pathogens such as  E.coli, all current technologies culture food samples to ensure that the lowest numbers of contaminating bacteria can grow to a detectable concentration.

The liquid crystals, the antibody (antibodies) for the target pathogen(s) and the sample, are mixed and then injected into the three test cells via ports on the cassette.  The cassette is inserted into the reader and the test proceeds automatically to provide a positive/negative detection.

Meaningful Advantages

The company's technology offers very compelling advantages to the food industry:

First, the positive/negative time-to-result exclusive of sample preparation is ≤ 30 minutes, which the company expects to be able to reduce still further. Related to lettuce and hamburger, two commodities with large volume and large risk, even when accounting for sample preparation, we project a time saving of at least 25%, as compared to the most commonly used competitive “rapid” detection. To shippers of fresh product, the inventory savings due to reduction in hold time, and the resulting enhancement of freshness, is very meaningful. It may, in some cases, allow for an extra day of sell-by date coding.

Second, the most commonly used technology (other than culturing) detects a single pathogen in each test: for example, the 0157:H7 strain of E.coli. CDx's technology will detect this strain of E.coli, plus the so-called “Big Six” strains, as well as the new strain that appeared in Germany, in a single test. This, along with competitive or better reliability and sensitivity, is perhaps the most compelling advantage of the company's technology, as it promises simplification and speed, along with cost savings to the user, while likely offering added pricing flexibility to the company.

Third, false positives and negatives are reduced as a result of the protection provided by the two control cells.  Inaccurate tests increase product cost. False positives require extended product holds while retesting is accomplished. False negatives, on the other hand, represent a more serious problem for food producers, because of the expense of recall lawsuits and loss of reputation.