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From: Food Quality & Safety magazine, December/January 2012

The Lab Revolution

How to speed results with advancements in microtechnology

by Regina Weaver

Now, more than ever, food manufacturers are looking to lab science for safe and speedy answers, especially when it comes to allergens. Food allergies are a public health liability that affects both business and the consumer. More than 12 million Americans have food allergies, and many more are underdiagnosed or ignored.

In fact, eight major allergens—fish, shellfish, peanuts, tree nuts, wheat, soy, egg, and dairy—designated by the Food Allergen Labeling and Consumer Protection Act (FALCPA) are responsible for more than 90% of all allergic reactions in the world.

Cross-contamination incidents, such as the Salmonella scare that caused the egg recall of 2010, are on the rise as well, and have renewed consumers’ unease with—and often distrust of—labels. As a result of this spike, manufacturers are feeling greater pressure to provide safe products, resulting in demands for more expedient testing results from quality assurance labs.

Although food lab scientists have myriad processes and technologies for food safety and quality assurance at their fingertips, the greatest improvements are being made to the systems already leading the industry: ELISA and PCR. When it comes to determining which of the two is better, or ideal, for integration, consider it on a case-by-case basis. Integrate one of these microtechnologies into your hazard analysis and critical control points program to increase testing turnaround and meet manufacturers’ deadlines, whether you are faced with allergens or bacteria.

ELISA Evolves

The enzyme-linked immunosorbent assay ELISA kit is a molecular biology industry standard—a rapid immunochemical test that uses components of the immune system and chemicals to detect potential allergic reactions in the body. Traditional food allergen detection uses ELISA to find protein. This common practice, which uses antibodies to detect antigens, is applied through the preparation of monoclonal antibodies, which detects their presence through the confirmation of an allergen. Every allergen has a specific protein that makes it unique, one that can cause a negative physical reaction when the body doesn’t recognize it.

Very often, ELISA can detect food allergens, although cross reactivity may occur and diminish the certainty of results. These kits are easy to operate and are generally low cost: between $2 to $11 per test. Because the ELISA is protein-based, it is proficient at determining the exact source of an allergen, such as dairy or wheat. Before the ELISA, the only option for conducting similar testing was with radioimmunoassay—a technique that uses radioactively labeled antibodies and requires expensive radioisotopes or counters. ELISA’s biggest benefit is the elimination of radioactive substances; the method is leading the way in lab innovation technology.

The ABCs of PCR

Polymerase chain reaction (PCR), another lab science favorite, analyzes even the smallest components of DNA through a screening process that takes mere days and provides nearly guaranteed accuracy.

It involves a simple two-part process: first, sample preparation and amplification, then detection. In the PCR process, screening is the noteworthy advancement in technology—previously, amplification of DNA involved cloning and plating bacteria, then a three-day incubation period followed by a manual count of the cells. Results were not available for weeks. Although it is a considerable expense up front at an average of $30,000, a PCR system, such as the automated BAX for screening Salmonella, requires less time, fewer personnel, and fewer chemicals—essentially paying for itself over time. Currently, members of the Association of Official Analytical Chemists have exclusive rights to access this procedure.

Although food lab scientists have myriad processes and technologies for food safety and quality assurance at their fingertips, the greatest improvements are being made to the systems already leading the industry: ELISA and PCR.

Additional advancements in PCR methods have noticeably improved avenues for analyzing DNA sequences, as well as the characterization of messenger RNA. Specifically within RNA detection, reverse transcription-PCR (RT-PCR) is the most sensitive technique on the market, enabling reproduction of RNA from just one cell. RT-PCR provides higher sensitivity and specificity than the traditional immunological testing and is another option for even more sensitive results. Most recently, PCR advancements have been made involving the use of a DNA chip to identify mycoplasma, bacteria, or viruses in biopharmaceutical research and production using specific genetic fingerprints. Overall, the greatest impacts PCR has on the industry are its DNA-based results accuracy and its ability to detect minute bacteria.

Allergy Swabs

Food manufacturers and processors must also rely on accurate, affordable testing to identify allergen risks. Food allergen detection tests are available to give companies the proof of performance they need. Among several different available methods, the allergy swab is a versatile option, because it detects the eight major allergens listed by the FALCPA; some swabs can even detect coconut, mustard, coffee, and red wine.

These self-contained, hand-held, highly sensitive protein tests are designed to detect residues to a level as low as 3 g or .01 parts per million. After equipment sanitization, the swab lifts any protein residuals and alerts the facility if any allergen presence remains. Its technology utilizes chemicals such as adenosine triphosphate to evaluate equipment surfaces as well as rinse water, raw material, and end products for signs of carryover. Taking only 10 minutes to evaluate and process samples, allergen swabs are particularly useful tools that can provide real-time results virtually anywhere.

Food Defense

Faster lab technology is partly driven by food defense. This post-production, post-lab process is a weighty contributor to the quality assurance and safety of the U.S. food supply. Food manufacturers and, ultimately, the science industry overall, play a significant role in the U.S. Department of Agriculture’s Food Safety and Inspection Service approach to addressing food defense. The three-pronged approach is divided as such: preparation and prevention, surveillance, and response. Mandatory preventative measures commonly include requisite, specific levels of seal strength to improve tamper resistance.

Furthermore, many policies and procedures are being reclassified and expanded upon—such as the National Center for Food Safety and Technology and newly formed Institute for Food Safety and Health—to better address this national issue. Manufacturing companies are looking at more rigorous and robust protocols to be applied once the product leaves its facility, specifically targeting the categories of tag seals and tamperproof boxes. Food defense scientists are developing applications that allow boxed products to disintegrate, shred, and/or turn a different color when packaging is breached illegally. Instead of focusing on the uncontrollable, utilize advancements in lab technology to minimize risks that can be controlled, those that affect quality and safety.

Global Audits

Most likely, the allergen and recall revolution will continue to grow throughout the global food industry as more regulations like the Food Safety Modernization Act increase the emphasis on product integrity and technological advancements. In turn, these technological advancements also focus more attention on the need for improved audit integrity. Instead of obtaining individual certifications—such as AIB sanitation and pest control, or GMA [Grocery Manufacturers Association]-safe traceability and manufacturing practices—the food safety industry is looking to create a global standard method, auditing all aspects of the process all the way down to documentation.

Forward-thinking companies and food brands are completing certifications with organizations such as the Safe Quality Food Institute, International Organization for Standardization, and British Retail Consortium to set better management systems in motion.

While post-production testing with allergy swabs, food defense, and global audit regulations are important and legitimize safety, allergen and bacteria management should be customary in food quality systems for high-quality assurance and speedy test results. The next steps are all but spelled out for the industry. Better management using the latest detection and testing technology, coupled with a streamlined and comprehensive global auditing standard, must be instituted to match current risks and regulations. n

Regina Weaver, director of quality assurance for Coalescence, has been in the food science and QA industry for more than 17 years. Before joining Coalescence, she developed her laboratory expertise in Columbus, Ohio, with Abbott Laboratories, Anheuser-Busch, and Cargill. Weaver can be reached by e-mail at or by phone at (614) 794-2008.



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