food safety pathogen testing

High False Negative Rates For Pathogen Food Safety Testing

Even in best case scenarios, food safety testing labs are still averaging greater than 6% FALSE NEGATIVES on pathogen testing. Is this acceptable?

Continuing on the theme of pathogen diagnostics and observations from the recent IAFP meeting in Indianapolis, this blog looks at proficiency testing (PT) for pathogen analysis, and the recent finding by the the American Proficiency Institute (API) of a 6.6% false-negative rate on food safety PT samples (14-year average for the 1999-2012 period).

While at IAFP I met with Heather Jordan, who directs food PT programs at the American Proficiency Institute. API proficiency testing programs are used at many food labs in conjunction with lab accreditation programs. Proficiency testing is done at food plant labs (FPLs) and corporate labs, as well as at food contract testing labs (FCLs) as a way to demonstrate quality results in their food micro and chemistry testing.

More Proficiency Tests But Less Proficiency?

In fact, the use of PTs is increasing in food labs, which is probably tied in part to the push for lab accreditation by FSMA and non-government groups like GFSI.

Yet it seems to me that the current use of PTs doesn’t go far enough to enable an FPL or FCL to demonstrate overall laboratory competency, and gain or maintain accreditation (ISO 17025).

In most labs, PTs are done just a few times a year. And really, they test the competency of the lab technician and protocols used in analyzing the PT samples. They are not a holistic measure of the lab and its ability to consistently generate quality results on every test run by every operator in the lab.

In a previous life I ran a group of environmental testing labs, which also are required to run PT samples during the year. From this experience, I know that lab personnel are aware that PTs are in-house: The sample-receiving group logs them in, and then alerts management. As a result, the best operators usually are assigned to run the PTs. This kid-glove treatment is not representative of day-to-day practices and processes. If we really want to validate and accredit the proficiency of an entire lab, shouldn’t every operator be tested on all protocols in use?

Plus, if labs know when they are running PT samples, and likely have their best operators running them, shouldn’t there be few, if any, false-negative or false-positive results?

Surprisingly, that’s not what the API research found…

API Study: “Performance Accuracy for Food Pathogens Remains Problematic”

In a retrospective study, “Pathogen Detection in Food Microbiology Laboratories: An Analysis of Proficiency Test Performance,” API analyzed the results from 39,500 food proficiency tests conducted between 1999 and 2012 to see how U.S. labs are doing in detecting or ruling out contamination of four common food pathogens.

Over the 14-year period, “False negative results ranged from 3.3% to 14.0% for E. coli O157:H7; 1.9% to 10.6% for Salmonella spp; 3.4% to 11.0% for L. monocytogenes; and 0% to 19.8% for Campylobacter spp.” Most concerning is that while both false positive and false negative rates were down in the last year of the study, the cumulative false negative rate for the 14-year period was 6.6%.

As we know, false positive results (in which a sample that does not contain pathogens is incorrectly shown as positive) are a nuisance. But false negative test results—which fail to detect true pathogenic organisms in the sample—are not unacceptable.

API, false negative, proficiency test, pathogen

The cumulative average false positive rate was 3.1%, less than half of the false negative rate for the same period.

The objective of the study—and, I would think, of proficiency testing in general—is to demonstrate improvement in lab performance year over year. The results of the API report concluded to the contrary, however: “Performance accuracy for food pathogens remains problematic with the recent cumulative trend showing a slight decrease for false positive and false negative results.”

Performance accuracy for food pathogens remains problematic with the recent cumulative trend showing a slight decrease for false positive and false negative results.

Clearly if false negatives happen in proficiency programs, they happen in the course of regular testing at food labs. I’m told that many FCLs and FPLs rely on other parts of their QA systems to make sure testing is being conducted properly. Even so, the documentation of ongoing and unacceptably high false negative rates in PT testing is a big concern for everyone.

It also points to a number of follow-on questions:

  • Would the false negative and false positive results be even higher if every technician, rather than the best operator, performed the analysis?
  • PT samples are created in only a couple of sample matrices. Would results be even worse if performed on the myriad of sample matrices present in the food industry?
  • What are the performance results among all of the pathogen methods available? Are some methods better than others when measured in real world conditions? Do the more complex protocols of some pathogen diagnostic systems result in poorer PT performance results?
  • Would PT results and, even more important, lab proficiency improve if the frequency of PTs increased, and were required of every technician involved with real food samples?
  • How can proficiency testing be used to isolate problem areas, whether in the pathogen diagnostic method or the competency of lab operators and processes?
  • Is the performance data different between food contract labs and food plant labs? And are all FCLs are equal, or are some more able to deliver quality results?

 

For example you can buy medications that fights bacterial infections. These medicaments will not treat several infection such as the common cold. Some pharmacies offer to their consumers Viagra. Possibly you know about price of viagra or viagra price. Medicines, like Viagra, sure, is going to change your life. Also known as impotence is defined as the failure to maintain an erection suitable for intercourse. Currently for men of any age, it can be an early warning symptom for earnest illnesses, so it’s essential for your overall health, not just your sexual relationship, to see a sex therapist if you experience erection disfunction. Why it happen? What kinds of professionals treat sexual soundness problems in men?

Tagged , , , , ,

Food Contract Labs Are Taking a Big Bite Out of Food Safety Testing

In the past 5 years, food contract labs (FCLs) have shown a compound annual growth rate (CAGR) that exceeds overall growth in the food safety testing market. Clearly, FCLs are taking market share from food plant labs (FPLs).

As covered in last week’s blog, the 40,000 food plants worldwide are finding the running of in-plant food labs to be increasingly complex. Faced with FSMA and the possible requirement of lab accreditation, particularly for analysis of food safety compliance samples, more and more food companies are questioning the role and scope of their food plant labs (FPLs)—and considering alternatives.

One alternative is to utilize a food contract lab (FCL) for all compliance samples while continuing to analyze other food safety samples at the FPL. Another is to shut down the food plant lab entirely and utilize FCLs for all food safety test analysis. Yet a third is to have a food contract lab locate a ‘lab-in-a-box’ just outside the food plant or to have the FCL take over the food plant lab operations.

Salmonella, food safety testing, food contract lab

Strategic Consulting, Inc. (SCI) has been monitoring food safety testing for 15+ years, and has documented this shift in business from FPLs to outside labs. Based on data from SCI’s thousands of interviews with food plant QA/QC managers, there is a clear trend in food plants to send samples outside for analysis. The following chart is based on SCI interviews with U.S. food plants regarding where Salmonella samples are analyzed. In 2013, 61% of U.S. food plants sent Salmonella samples outside for analysis. Just twelve years ago, in 2001, the reverse was true, and 63% of the U.S. food plants did the analysis at food plant labs.

At one point all food plants had laboratories. In the 1970s, a few entrepreneurs began what has now grown into a thriving food contract lab industry. Many of the early entrepreneurs established outside laboratories with their own expertise as the foundation. Acting as subject matter experts and consultants, these scientist-entrepreneurs provided knowledge that helped their food industry clients solve food safety issues. Many of the early food contract labs were microbiology-based, due to industry needs and the lower cost of entry for micro versus other types of testing. These early FCLs grew through personalized service, expert consulting, scientific proficiency and strong client relationships. Over time, FCLs added basic chemistry services as necessary to support the needs of food company clients.

food contract lab, food safety testing

According to Strategic Consulting’s newest market research report, Food Contract Lab Report, there are 2,350 FCLs worldwide and they generated revenues of more than $3.0 billion in 2013. In fact, over the past five years, the food contract lab industry has shown a compound annual growth rate (CAGR) that exceeds overall growth in the food safety testing market. Clearly, FCLs are taking market share from the food plant labs.


Food Contract Lab Market

The FCL growth rate varies slightly by geographic region and business area (microbiology, chemistry, services) but frankly, all areas are growing well.

FCL Geographic Region Analysis

  • Europe is the largest region based on total FCL revenues, but is showing slower growth than other geographic regions. Chemistry revenues remain strong in the EU.
  • North America is second in total revenues, but is catching the EU, driven by large increases in microbiology revenues.
  • Asia and the rest of the world (ROW) have the smallest total revenues but the greatest growth potential of the four geographic regions.

FCL Business Area Analysis

  • The microbiology business area is second in total revenues but growing quickly, with increases in both routine micro and pathogen analysis.
  • Chemistry is the largest business area but slowing in growth compared to the other business areas.
  • Currently the smallest, the Services business area is growing quite quickly due to increasing demand from food companies.

The future for food contract laboratories looks strong, and five years out, SCI expects FCLs to have continued their growth in market share. FSMA will push companies outside the U.S. (OUS) to utilize accredited labs for compliance testing, which will drive rapid growth for FCLs particularly in the markets in Asia and Latin America.

Next: The evolving nature of the food contract lab business.

 

 

 

 

For example you can buy medications that fights bacterial infections. These medicaments will not treat several infection such as the common cold. Some pharmacies offer to their consumers Viagra. Possibly you know about price of viagra or viagra price. Medicines, like Viagra, sure, is going to change your life. Also known as impotence is defined as the failure to maintain an erection suitable for intercourse. Currently for men of any age, it can be an early warning symptom for earnest illnesses, so it’s essential for your overall health, not just your sexual relationship, to see a sex therapist if you experience erection dysfunction. Why it happen? What kinds of professionals treat sexual health problems in men?

Tagged , , , , , , ,

Food Safety Testing Market in Europe to Top $1 Billion in Five Years

According to Food Micro—6, a new market research report from Strategic Consulting, Inc., food safety microbiology testing in the EU will reach close to 350 million tests in 2016, at which point the market should top $1 billion in value.

Woodstock, VT February 9, 2012 — Europe is a substantial market for food microbiology testing. With a population of over 500 million, the 27 countries of the European Union (EU) conducted an estimated 275 million food safety microbiology tests in 2011, according to Food Micro, Sixth Edition: Food Microbiology Testing in Europe (Food Micro—6), a new market report from Strategic Consulting, Inc. In comparison, there were 213 million such tests conducted in the US in 2010.

EU Food Safety Test Volume 2005 - 2011

EU Food Safety Test Volume 2005 - 2011

Food Micro—6 is the first definitive report to focus exclusively on the European food microbiology testing market, and reviews the methods, technologies, companies, regulations and trends shaping food safety testing in Europe.

According to Tom Weschler, president of Strategic Consulting and lead author of Food Micro-6, “Food safety microbiology testing in the EU will approach 350 million total tests in 2016, at which point the market should top $1 billion in value.” Given these numbers and other factors, the European food safety testing market must be examined and understood, Weschler says. “A resurgence in public awareness in the wake of the 2011 E. coli outbreak in Germany, and the continued focus of the European Food Safety Authority on EU-wide systems, could drive test volumes even higher.”

A resurgence in public awareness in the wake of the 2011 E. coli outbreak in Germany, and the continued focus of the European Food Safety Authority on EU-wide systems, could drive test volumes even higher.

In preparing this new and comprehensive review of the European food microbiology testing market, Strategic Consulting (SCI) conducted more than 175 detailed interviews in 11 European countries accounting for 77% of all agricultural/food value-added in the European Union. Because of this primary research with food-processing plants throughout Europe, Food Micro—6 is able to offer new, detailed data on European food safety testing such as test volumes, methods used for routine and pathogen testing, and costs per test performed. Differences in testing practices are analyzed for the meat, dairy, fruits/vegetables, and processed food segments. Variations within countries are outlined, and expected changes in future testing practices are discussed.

“Routine” microbiology tests used in the food processing industry in Europe to indicate the presence of microorganisms in the plant or food product include total bacteria, E. coli, Staphylococcus, yeast and molds. In 2011, these routine tests numbered 225.4 million. The balance of food microbiology tests in Europe were 49.9 million “pathogen” tests, which look for specific microbes such as Salmonella, Listeria, L. mono, Campylobacter, and E. coli O157.

Food Micro—6 also profiles the leading diagnostic companies competing in the food safety testing market including a discussion of new technologies and market strategies. Food Micro—6 includes company profiles for Becton-Dickinson, BioControl, bioMérieux, Bio-Rad, BIOTECON, DuPont Qualicon, Foss A/S, Idaho Technology, Life Technologies (ABI), Merck Millipore, 3M, Neogen, Pall Corporation, QIAGEN, Roka Bioscience, R-Biopharm, SDIX and Thermo Fisher.

Food Micro—6 is a companion report to Food Micro, Fifth Edition: Microbiology Testing in the U.S. Food Industry (Food Micro—5), published by SCI in 2011, which reviews the current practices and changes impacting food safety testing at 9,350 U.S. food processing plants.

Strategic Consulting has published six reports to date reviewing quality and safety testing in the food industry. The food sector represents almost 50% of the total industrial microbiology testing market, and is more than double the size of any other industrial segment including pharmaceutical, personal care products, beverage, environmental, and industrial processes. SCI market research reports are widely accepted by leading diagnostic manufacturers and investors as highly credible analyses of the industry.

For more information about Food Micro, Sixth Edition: Food Microbiology Testing in Europe, call Strategic Consulting’s U.S. office at 802-457-9933.

###

Strategic Consulting, Inc. (SCI) provides market reports and business consulting for industrial diagnostics companies delivering microbiology-based products for quality and safety testing in food, beverages, pharmaceuticals, personal care products, environmental water, and industrial-process water. With more than 75 combined years of international management in the industrial marketplace, SCI’s principals have proven success in working with venture capital backed start-ups, publicly traded companies, technology acquisitions, and transformation of underachieving companies. For more information on Strategic Consulting, Inc. and its current market reports, visit www.strategic-consult.com or call 802-457-9933. Follow SCI president and industry expert, Tom Weschler, on LinkedIn or Twitter @tomweschler.

 

For example you can buy medications that fights bacterial infections. These medicaments will not treat several contagion such as the common cold. Some pharmacies offer to their consumers Viagra. Possibly you know about price of viagra or viagra price. Medicines, like Viagra, sure, is going to change your life. Also known as impotence is defined as the failure to maintain an erection suitable for intercourse. Currently for men of any age, it can be an early warning symptom for earnest illnesses, so it’s essential for your overall soundness, not just your sexual relationship, to see a sex therapist if you experience erection disfunction. Why it happen? What kinds of professionals treat sexual soundness problems in men?

Tagged , , , , , ,

Requirements for Food Safety Pathogen Testing Systems Changing

The overall increase in food safety pathogen testing combined with the concentration of testing in corporate and contract laboratories will dramatically change product requirements for pathogen detection systems.

As discussed in my last post, the increasing trend in food safety testing is to send samples to an outside food testing laboratory rather than conduct pathogen analysis in the food processing plant. In this post I want to quantify the implications of this concentration of analysis in contract testing labs, and to discuss the resulting impact on product requirements for pathogen detection systems. read more…

Tagged ,