Personal allergen testing devices – can they be trusted?
Adrian Rogers of Romer Labs says emphatically 'no'.
Adrian Rogers has been a Senior Research Scientist Romer Labs for the last eight years. He is responsible for research and development within Romer's allergen competence center based in the UK.
Before joining Romer Labs, Adrian was an R&D Scientist involved in the development of ELISA and Lateral Flow immunoassays for the detection of food allergens. Adrian is a microbiologist by training and has 17 years experience in the development of immunoassays, 15 years of which have been spent developing test kits for the detection of food allergens.
Over the years Adrian has been involved in a number of food allergy projects including EuroPrevall, an EU funded multidisciplinary integrated project which investigated the prevalence of food allergy across Europe. He is currently a member of the University of Manchester's Food and Health Network allergy cluster and co-ordinated Romer Labs’ contribution to the “Innovate UK Knowledge Transfer Project”, with the University of Manchester looking at improving soya allergen analysis.
Earlier this year he blogged about what he call the 'Sexy Black Allergen Detection Boxes' that are being offered to coeliacs and allergy sufferers for use when eating out.
Ok I think it is time to write about something that has been bugging me for a while. The growing trend for Personal Allergen Detection Devices.
First the positives.
I am all for new tech that helps make life easier and safer. In fact I am a little jealous that these guys have managed to secure so much funding to create their sexy black allergen detection boxes.
You see I have been developing tests like these for years but have never had the spare cash needed to even think of creating such devices.
The test kits I create are sold direct to the food industry, private contract labs and public analysts. No existing food allergen diagnostic kit manufacture would ever consider selling their products to the public for personal use.
Not suitable or safe
Nope. In my view they are not suitable or safe for personal use.
Take the NIMA Sensor.
The chemistry used to make the allergen detection possible is exactly the same as the one that many allergen test kit companies use, a special immunoassay called a Lateral Flow Device.
At this point I hear the sound of your eyes glazing over – 'I don't know what that is' – 'all too sciencey for me'. Well if you have ever used or seen a home pregnancy test then you know what I am talking about. That little strip of plastic that makes you hold your breath for an eternity is a Lateral Flow Device (LFD) and the NIMA sensor works in exactly the same way just with a flashy, literally, front end.
How do they work?
Life would be very boring if we all ate the same foods. There is an almost infinite variability in the makeup of the food we eat. While variety is the spice of life when it comes meal time, this same variety can pose many challenges when it comes to analysing the foods we eat for allergens by immunoassay based methods.
Processing, pH, fat content, salt content, polyphenols can all influence whether the test can find an allergenic protein in a food – which is why it is essential to validate an immunoassay method with a wide variety of different and challenging matrices.
Validate Validate Validate Validate Validate Validate Validate Validate Validate Validate Validate
Basically in the industry we test the Lateral Flow Devices (LFDs) we create as much as we can to know what they can and almost more importantly, what they can't be used for. When it comes to testing food with LFDs we actually recommend that you should validate for every type of food for which a company will be using the devices.
We do this by adding a known amount of allergen into a sample and seeing how much of that allergen we get back out again when we run the test. There is no way that you can do this with a food you are about to eat in a restaurant.
Which bit to test?
Another major issue is choosing which bit of the food to test.
The NIMA sensor recommends a pea sized amount but that is a very small sample size if you want to make sure your whole plate of food is safe to eat. @RonaldNiemeijer sums this issue up really well in his article here.
If you want to make sure that the meal you are about to eat is really safe, you need to pop it in a blender and whizz it all up before testing. Of xourse this will mean that you will spend your whole life drinking your meals through a straw.
At the moment the NIMA sensor is being marketed to the Coeliac community to test for gluten contamination. For hands on, real world NIMA testing information please follow @GFWatchdog adn see their report here.
Planned peanut and milk sensors
But NIMA are also launching a peanut sensor (in 54 days from the date this piece was written) and have plans to start producing tests to look for milk. This brings me out in a cold sweat.
We sell LFDs to be part of a tool kit approach that companies can use in conjunction with their allergen management control plans. If there is a problem with the test then they have a backup or can contact us directly before they have issues. This type of support would not be available for these personal allergen detection devices.
I am worried that such devices may lead to a false sense of security for the allergic individual which unfortunately may have severe if not fatal consequences. And it woudl appear that NIMA have similar concerns – see their legal disclaimer:
'THE PRODUCT IS NOT A MEDICAL DEVICE; IS NOT REGULATED OR APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION; AND IS NOT DESIGNED TO DETERMINE WHETHER YOU WILL HAVE AN ALLERGIC REACTION OR SENSITIVITY TO THE FOODS THAT YOU TEST.
SOMEONE WITH A SEVERE ALLERGY SHOULD NOT RELY ON THE PRODUCT TO IDENTIFY THE PRESENCE OF ALLERGENS.
THE PRODUCT IS INTENDED TO BE USED WITH THE NIMA ONE-TIME-USE CAPSULES AND THE NIMA MOBILE APPLICATION TO DETERMINE WHETHER A THRESHOLD LEVEL OF GLUTEN IS IN THE FOOD SAMPLE THAT YOU TEST, AND IS LIMITED TO THAT SAMPLE, WHICH MAY NOT BE REPRESENTATIVE OF THE FOOD SERVING AS A WHOLE.
THE PRODUCT IS NOT A SUBSTITUTE FOR MEDICAL CARE OR ADULT SUPERVISION. THE PRODUCT IS NOT INTENDED FOR USE IN WHICH ERRORS OR FAILURE COULD LEAD TO PERSONAL INJURY OR DEATH.'
Errrrr...... So, exactly, is the point of the device then???????
The Allergy Amulet
This is not due to come to market until later in 2018 and is based on rather different science. (See their website here for details.)
However, the issue of actually ensuring that the sample of a particular dish or food that you test is the one that contains the allergen remains the same whichever device you are proposing to use.