Running an unvalidated program or product is like betting your life’s savings on a horse because you overheard a “surefire tip” outside the racetrack, or driving around without any mirrors.
To put it less dramatically: Skipping validation is asking for problems. But what does validation mean, how much is necessary, and what’s the best way to include it in your plans?
In order to start understanding validation, we must first break it down into two main categories: Product validation and process validation. From there, it’s important to look at whether something has been broadly validated for general use, and whether it has been narrowly validated for use in your specific situation. That last question is where people often struggle: How can we ensure this product or process is validated for use in the way that we plan to use it?
Validating an on-site allergen test kit requires a few different layers of research and testing. Taking the time to carefully design and vet a validation process may seem tedious, and it may require some additional up-front costs—but in the long run, it’s the only way to ensure you are spending your money on a test kit that works. And if you’re using an allergen test kit that doesn’t actually detect allergens in your facility—best-case scenario, you’re wasting money and time. Worst-case scenario, you’re headed straight for a recall and you won’t see it coming until your customers get sick.
If you are buying a test to determine the absence or presence of allergens in your facility (specific or general), you’ll likely ask the kit manufacturer if the test kit has been validated. This validation can come in many forms, most commonly:
- Third party validation (eg., AOAC)
- Internally produced validation documents or whitepapers
- Published studies
A product with more validation (third-party certifications, studies, whitepapers) isn’t necessarily better than a product with less. It may have simply been on the market longer or be produced by a company that allocates its funding differently. However, validation documents can be very comforting when reviewing a product, as they provide a starting point for your own research. When you are reviewing validation data, ask yourself a few questions:
- Does this data cover products like mine?
- Are the ingredients similar (raw meat, ice cream, spices, etc.)?
- Are the preparation processes similar (heat, fermentation, etc.)?
- Does this data cover an environment like mine?
- Will the tests be run the same way in my facility as in the data?
- Is the contamination being introduced in a way and amount that feels realistic to the risk factors I know about in my facility?
- Does the data mention any complicating factors (and do I need to care about them)?
- Are there ingredients known to cross-react or cause false negatives?
- Are there processes known to change the LOD or cause false negatives?
- If I am aware of limitations with other similar test kits, are those limitations addressed in the data for this test kit as well?
To give an example, let’s imagine you make premium ice cream and are reviewing allergen test kits that look for peanuts and almonds in product, in rinsewater and on surfaces. You’ll want to ask questions like:
- How does the kit perform in a high-fat environment?
- Does the validation data cover product, rinsewater and surfaces?
- Are there ingredients in our facility that are called out as cross-reactive (or otherwise troublesome)?
- Do our ingredients get exposed to temperatures, pH levels, or other processes that impact the LOD?
You might learn, for example, that one of the matrices tested in validation was ice cream. If so: Wonderful! That’s a vote of confidence and a great starting point. Or maybe you learn that the kit in question isn’t recommended for matrices that include an ingredient in your formulation. If so: That’s equally wonderful! Now you know you need a different solution. Or maybe the instructions on your current peanut test kit indicate that heavily roasted peanuts have a higher detection limit than raw peanuts, but this new test kit only has data for raw peanuts. If so: OK! You have more research to do, and that’s fine too.
In short: Pre-existing product validation data is a helpful starting point for determining whether or not an allergen test kit MIGHT work well in your facility—but it doesn’t eliminate the need for you to run your own internal validation study.
Once you’ve identified an allergen test kit that you want to use in your facility, you’ll want to prove that it can work to identify contamination in your specific environment. This is where a more narrowly tailored validation comes into play. Your test kit provider may have resources available to help you design an internal validation. Don’t be afraid to ask for help! A reputable test kit provider should care not just about making the sale, but also about making your food safer.
Before you even order a new test kit, you should have a good idea of how your validation process is going to work. It’s important to have both the study design and study outcome on file. Here are some possible additions for your internal validation study:
Validating that an allergen test kit can reliably prove your surfaces are clean of said allergen:
- Test the surface prior to cleaning, after the allergen in question has been run. Do you see positive results? If not, then a negative result after cleaning is essentially meaningless.
- Test the surface after cleaning. Do you see negative results? If not, it could mean a problem with your cleaning process—or a strange interference. Both require further research.
- If your products encounter multiple surfaces (eg., stainless steel and also ceramic), test them all with before and after testing.
Validating that an allergen test kit can reliably prove your rinsewater is free of said allergen:
- Test water from the beginning of the cleaning cycle as well as the end. Do you see a change in results, from positive to negative?
- If you don’t ever see the allergen present in your rinsewater, you may want to “spike” a sample by adding a small amount of the product that contains the allergen into the rinsewater you’ve collected. Could it be that something in your cleaning protocol or some aspect of your matrix is affecting the detection limit?
Validating that an allergen test kit can reliably prove your ingredients or finished products are free of said allergen:
- Test a product that you know contains the allergen but is otherwise similar. Keep in mind that some allergen test kits can be overloaded and can show false negatives if too much allergen is present in the sample—if you aren’t sure whether the test kit you are trialing has this limitation, ask your supplier. Do you see a positive?
- Have you encountered batches of your product with accidental cross-contamination from the allergen in question? If so, and you have some of that batch archived, run a test on it. Would this kit have identified the problem?
- Do you have a batch or lot of product that has been analyzed by a third-party lab? If so, do your results in-house match the lab’s results?
- Run—or ask a lab to run—a spiked recovery. This is especially important if there is no pre-existing data on how the test kit works against your specific matrices.
- Some test kit manufacturers can provide this service for you—you would simply need to send them the product, and they can add various amounts of allergen into the product and confirm that the test kit shows positive results.
- Some kit manufacturers or other suppliers can send you standards that have known quantities of allergen in them. You can mix these into your product and run tests, and confirm that you get positive results when expected.
- You may want to simply do this on your own, by adding small quantities of the allergen into the sample and running tests. However, take care to be especially careful with your documentation in case questions arise down the line.
- No matter how the spiked recovery is being run, consider these two factors:
- Be sure you’re including what could be a realistic amount of contamination—if you’re concerned about catching 25ppm of allergen, loading up your sample with 2000ppm won’t necessarily help you prove anything.
- The matrix of your allergen-containing foods is just as important as the matrix of your allergen-free foods. If your allergen has been fermented, roasted, pressurized, etc. —your spike needs to be processed in the same way. If you aren’t sure how to think about your matrices, this previous Allergen Alley post is a good starting place.
Once you’ve proven that the test kit in question can in fact show positive results when traces of allergen are present, you can confidently and comfortably incorporate it into your larger allergen control plan. If your matrices change, you’ll want to re-validate whatever’s new.
While it can be tempting to rely on a kit’s general validation, taking the extra step to validate your unique matrices is an essential part of a truly robust food safety plan. If you’re stumped for how to begin, contact your kit provider—after all, you share the same goals: Safe, allergen-free food for consumers who rely on you to keep themselves and their families healthy and well fed.