Partnering With A Lab Can Be Key to Allergen Management

As expert users of detection methods, people who work in allergen analysis laboratories, particularly those in management positions, are often uniquely qualified to interpret results and advise on the suitability of different methods. Provision of such additional information is most often part of providing an analytical service, so do not be afraid to ask questions. More complex, time-consuming advisory services are sometimes dealt with through consultancy arrangements that (typically larger) analytical laboratories may provide. However, many relatively simple questions should be fully addressed by the lab as part of an analytical service.

You should be satisfied as to what an analytical report means, and what its implications are. Reports can appear complex and full of jargon to the uninitiated. Your lab should be able to tell you, in clear and plain language, what any problematic terms mean and what the implications might be. Much of the language may be standardized, and appear on most reports of the same type, regardless of which laboratory performs them. In some cases, different lab practices may result in terminology that you are not familiar with. For example, labs may subsample materials you send for analysis. A lab code for this subsample may be used in reporting. You should understand if this has occurred, and how such subsample names are derived.

Labs should be able to provide guidance on analytical methods that you perform yourself. Frequently, an allergen management plan may feature both in-house and lab-provided analyses. Lateral-flow devices, for example, are most often designed so that analysis may be performed entirely within a manufacturing facility. A good analytical lab should be able to inform you which in-house analyses to use within your allergen management plan, and how to perform them properly.

You should be confident that your analytical method is detecting the allergen it is meant to detect, and have some idea as to how sensitive it is. In theory, this should be simple. An egg detection method should detect egg, and measures of sensitivity (e.g., limit of detection and quantitation) should be available from the manufacturer of the method. However, methods differ widely in how they detect allergens in different types of food, or after processing (usually heating). Your lab may be able to provide information as to how your selected allergen detection method is likely to work in your individual circumstances.

A good first choice in finding this information is in validation reports from the kit manufacturer. It may be that the method was tested under conditions that are similar to those that you are testing under. If not, the analytical lab may have tested under similar conditions and be able to inform you of how well the method is likely to function.

If you are testing a “difficult” food matrix, or an extensively processed material, and no information on test performance already exists, it may wise to validate the method for your particular conditions. This will typically involve a “spike and recovery” type experiment where the method’s ability to detect a known amount of allergen in your food matrix is determined. Validation is more useful if you will be analyzing the same material many times using the same method, and you have reason to believe that the method is not functioning well. Your laboratory should be able to help you decide whether such a validation is necessary, and, if so, to design and conduct this type of validation with your input.

Allergen analysis may be more prone to interference and subject to interpretation than comparable chemical analyses. For the most part, this is due to the regulatory necessity of having to analyze for the presence of whole food, such as peanut or egg, rather than well-defined chemicals. It is also problematic that regulators do not stipulate levels at which allergens are deemed to be safe. The nuances of allergen detection make the relationship between food manufacturer and analyst more important than is the case for other food analyses. As with any relationship, communication is the key to success.