GMO Test Kits (background & industry information)

List and Product Pages of GMO Kits


Background and Industry Information



Detecting Transgenic Markers(GMO)
In a very short period of time, advances in genetic engineering have created tremendous potential for rapid introduction of desired traits in a myriad of food and feed crops. Although the technologies for identification and isolation of specific gene sequences are highly sophisticated and precise, the techniques for inserting desired genes in a plant's DNA are still evolving. They require extensive testing to confirm that the desired gene transfers have been made and that resulting seed stock will express the desired traits at adequate levels.

There are a number of genetically engineered ("GE") foods in the marketplace, consumers, government agencies, and food retailers in many countries are rapidly gaining awareness and voicing concerns. In some cases, they are demanding labeling -- for the ability to distinguish genetically modified organisms or foods ("GMOs or GE foods") from other, "natural" foods. In some areas, such as parts of Europe and the Pacific Rim, some consumer groups are seeking to ban GMOs altogether until the potential corollary effects are better understood. Threshold levels are being established in some countries to set maximum levels for GMOs in certain foods or crops.

Labeling requires knowledge of the genetic status of all ingredients and segregation and identity preservation (IP) of GMO and non-GMO ingredients as they move through the grain distribution channels and into food production. This segregation requires tracing back to the seed level and upward through the processing and distribution chain to retail consumption. Testing for genetic markers also includes testing crops during the growing cycle to ensure that no cross- pollination occurs between GE seeds and non-GE seeds of the same crop.

To date, the largest applications of genetic engineering in agriculture have concentrated on the high volume crops: corn, soybeans, cotton, alfalfa and canola. The principal modifications have centered on two different aspects of pest control: i) introduction of a protein produced by the Bacillus thurigiensis (Bt) bacteria into seeds for ingrained insecticide protection, and ii) resistance to the synthetic herbicides such as glyphosate (RoundUp®) in so-called RoundUp Ready seeds or glyphosinate in LibertyLink® seeds. There have been numerous different insect resistant varieties developed utilizing unique Bt gene segments, and thereby expressing different and specific proteins including Cry1Ab, Cry1Ac, Cry1C, Cry1F, Cry2A, Cry3B, Cry34 and Cry9C. Regardless of the protein expressed, these different Bt varieties enable the plant to produce its own internal protection against pests such as the European corn borer in the case of corn plants, or against the boll weevil in the case of cotton plants. Similarly, Bt varieties have been developed for other crops such as potatoes and rice. The herbicide tolerant varieties on the other hand, render the plant resistant to powerful herbicides such as glyphosate (RoundUp) or glyphosinate (Liberty®). This enables the grower to apply herbicides in a more targeted and efficient manner without harming the crop.

Some of these varieties have received regulatory approvals in different countries by International regulatory agencies for specific applications, while others await final resolution and action. Concerns in Europe and parts of Asia have slowed the process of regulatory approvals, which has created the need for further segregation of grain and food ingredients destined for export, in order to comply with different international restrictions.


EnviroLogix Assays
Click here for detailed information on our GMO Test Kits

While the objectives of detecting transgenic markers in seeds, plants and crops can vary from one user to the next, EnviroLogix' assays are equally suited to confirm the presence of desired traits or to detect the presence of unwanted gene modifications. Our current kits are designed to detect the predominant forms of genetic seed modification now on the market, which include different expressions of the Bacillus thuringiensis (Bt) insecticide, Herculex®, YieldGard®, Roundup Ready®, and LibertyLink® herbicide tolerance in corn, cotton, soybeans, alfalfa, canola and other grains, seeds, seedlings and mature tissue.

A "96-well ELISA plate" form of the assay is designed for quantitative, high volume, laboratory based testing where certain immunoassay equipment is on-hand and useful in large-scale screening and documentation. The lateral flow membrane formats are also suitable for high volume screening, but are especially designed for use in the field, with no additional equipment or facilities required. For more information, choose Test Kit Formats or GMO Test Kits.


EnviroLogix is continuously working on tests for measuring gene expression for other traits of interest. Contact us to learn about these additional product developments or to discuss your specific needs in this area.

While an assay may have been developed primarily to test for gene expression in a young leaf, for example, it may also be effective in other stages of plant development. The product insert will indicate validated samples. We can also provide Application Guides for other samples.



USDA/GIPSA Guidelines for Handling Biotech Grain
The USDA and FDA have established sampling and testing guidelines to assist the industry in going about the task of testing grain throughout the system, as well as all seed lots destined for planting in 2001. The USDA/GIPSA has established a system for validating the claims of test kit manufacturers and certifying those tests for official use. The USDA/GIPSA has established guidelines which deal with various aspects of handling biotech grain. http://www.gipsa.usda.gov/GIPSA/webapp?area=home&subject=grpi&topic=rd-bi

The EnviroLogix test kits for Starlink have all been certified by the USDA and have been included in the official Directives issued by the USDA and FDA related to Starlink testing.


USDA Directive 9181.1 - Testing for Starlink Corn
This Directive can be found at: http://151.121.3.117/biotech/starlink/starlink.htm

The QuickStix strips have been validated by the USDA to detect 1 kernel in 800 (0.125%) in 5 minutes.


USDA Certificate of Performance for EnviroLogix QuickStix to Detect 1 kernel in 800 in 5 minutes
Click to view the USDA Certificate of Perfomance
The test procedure involves grinding a well-mixed and representative sample of corn or seed and adding water and mixing to extract the protein. The extracted sample is transferred to a reaction vial and the QuickStix strip is inserted into the reaction vial. The sample will automatically migrate up the strip and a test line will appear if the sample contains the Cry9C protein. A control line will appear above the test line area to indicate that the test functioned properly. The second line, or control line will appear regardless of whether or not the sample contained Cry9C protein. Thus, two lines would indicate a valid positive result, and one line (the control line) would indicate a negative result.

This actual photo is of typical reactions. The line intensity varies with the amount of Cry9C in the sample. Whether used to confirm gene expression for seed producers, crop consultants and growers, or to verify claims of non-GMO status for grain suppliers, food and grain processors and distributors, the EnviroLogix assays can provide low-cost, rapid and reliable screening. These kits detect the expressed proteins in seed, early growth and mature plant tissue. The 96-well ELISA plate assay is designed for high volume, quantitative testing where laboratory facilities are available.


USDA/GIPSA Certificate of Performance for EnviroLogix Cry9C ELISA Plate Kit
Click to view the USDA Certificate of Perfomance
The USDA/GIPSA has also certified the performance of the EnviroLogix Cry9C ELISA Plate Kit, which can detect 1 kernel in 10,000 or 0.01% Starlink corn in ground grain, flour, corn meal, or grits.


USDA/GIPSA Certificate of Performance for EnviroLogix QuickStix Kit for Roundup Ready Bulk Soybeans
Click to view the USDA Certificate of Performance
This QuickStix test has been certified by the Grain Inspection, Packers and Stockyards Administration (GIPSA) unit of the U.S. Department of Agriculture as meeting performance claims of detecting 1 Roundup Ready soybean in a 1000 soybean sample (0.1%).


Managing the Challenge of Grain Separation
As consumer groups in European, some Asian markets and, more recently, in the US continue to resist genetically modified food products, grain producers and handlers are faced with the daunting challenge of separating their grain throughout the supply chain.

Traditional approaches, which rely largely on knowing your producers and what they are growing, may not be enough. What everyone would like is a simple test that could quickly and accurately differentiate GMO from non-GMO grain, and ideally further identify approved varieties from non-approved varieties. Unfortunately, the "magic bullet" doesn't yet exist, and given the dynamic nature of international approvals, the feasibility of that ultimate test seems unlikely, as it would be targeting a constantly moving target. The solutions - at least for the present - will have to rely on a combination of knowledge of the source of supply, some reliance on the growers' declaration of content, and rapid screening tests, perhaps followed by PCR confirmation.

Despite not having all the diagnostic tools desired, it is possible to better manage the challenge of segregating corn grain using rapid, simple and reliable new tests for detecting Bt varieties. EnviroLogix is actively working to develop rapid tests for all commercially available varieties of crops.


Sampling Strategies - A Crucial Element
Perhaps the most important aspect of any grain-testing program is obtaining a representative sample from the truck or barge being tested. The USDA has outlined guidelines for effective sampling of grain document entitled:

Inspecting Grain: Practical Procedures for Grain Handlers
This guidance document can be viewed at the following USDA website: Inspecting Grain

Section I of the document addresses the importance of proper sampling techniques in order to obtain representative grain samples. They recommend taking at least two probe samples from lots that are 600 bushels or less. For larger lots, draw at least three probe samples. Probe samples should be drawn at random locations from grain sampled at rest, using hand or mechanical probes. Refer to the USDA website above for further information on representative sampling methods, techniques and materials.

Once a representative sample is obtained it will be helpful to obtain a smaller yet representative sub-sample for use in the test. A splitter can be used to randomly separate the probe sample(s). By repeatedly taking one of the resulting split samples and re-running it through the splitter, the sample can be reduced to a manageable size for grinding and blending, while still maintaining the representativeness of the original sample.

Alternatively, if using a larger capacity grinder, the entire probe sample can be ground and a representative sample taken from the uniform ground probe sample.

For further reading: GIPSA Publication Library


USDA/GIPSA Sample Planner Excel Spreadsheet
The USDA/GIPSA has developed a useful tool to assess the probabilities associated with detecting different concentrations of GM varieties in a sample based on different assumptions and sub-sample sizes. USDA Worksheet

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