I will never forget the face of a lab manager in a tech meeting who reported the very high CV she measured after using a certified ELISA kit. The kit was not certified for the material she had tested. Nor will I ever forget that several feed industries have a museum of LFD readers (each brand requiring its own reader, of course) because they couldn’t get good performance for certain raw materials, including mycotoxin screenings. Test kits and new portable analytical devices are very useful tools for food safety. But they often share a single problem: performance verification. The majority of companies in the food, beverage, and feed industries do not have the time and expertise to validate diagnostic products. Manufacturers conduct their own validations but rarely for all the matrices that end users will test. The most they provide you, if anything, is a “first party” report. Customers, however, need “third party” validation. Laboratories must be in accordance with ISO 17025 and if the kit is not certified by a third party for the test material they need to analyze, internal validation is mandatory. For microbiological tests (pathogens, etc.), there are several certified kits but there are very few for food contaminants and food fraud. The market is too small to allow a profitable return on investment. Because of this, everyone is unhappy. Industries and laboratories are forced to spend a lot of time on home-made verification or real validation and manufacturers can’t respond to every market demand. Only the producers of expensive chromatographic instruments are happy with this situation. When biochemical assays are weak, the winner is mass spectrometry or, at least, chromatography. Ah, I forgot, even consumers of food—all of us, that is—should be unhappy. If rapid on-site methods are not available, not used, or used with unreliable results, the risk of contaminated food is higher.Is it possible to change? Yes, we can. How? With cooperative efforts. We must take advantage of the internet and the attitude of younger generations to share knowledge. What exactly is the idea? We want to create a panel of experts that make a protocol for e-validation of test kits primarily using existing data. Is there more? Yes, of course. IT technologies need to guarantee data protection. The AOAC and AFNOR traditional approach is based on an “aseptic”, single independent laboratory verification exercise. The procedure is long (one year or so) and expensive. Affidia’s project for “e-coop-validation” has a goal of guaranteeing matrix verification in 6 months and at a more reasonable price. With this, more analyte-matrix combinations will be covered by certification and more test kits will be certified. Is anyone interested in being on our panel of experts for thisproject? We need representative from kit manufacturers, ISO 17025 certification bodies, and food industries that have experience in validation exercises to design the validation protocol. Contact us if you’re interested in being part of this exciting new venture.
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