FDA Collaborates to Gain Approval of Peanet Test Kits for Food Products FDA Collaborates to Gain Approval of Peanet Test Kits for Food Products
U.S. Food and Drug Administration

The Food and Drug Administration today announced that several test kit methods for the detection of peanut proteins in breakfast cereal, cookies, ice cream and milk chocolate have been approved as Performance Tested Methods by the Association of Official Analytical Chemists – INTERNATIONAL (AOAC). These test kits will provide a quick and reliable method for the food industry to detect more readily the presence of peanuts in food that is not labeled as containing peanuts, and can more effectively prevent these products from reaching consumers.

These test kits represent a significant step forward, because peanuts can cause severe and, in some cases, near fatal allergic reactions in some people. Nearly seven million Americans have food allergies of varying degrees of severity. Approximately 8% of children less than 3 years of age and 2% of the adult population are affected. Although any food may cause allergic reactions in selected individuals, 90% of all food allergic reactions are caused by eight foods: peanuts, eggs, milk, shellfish, wheat, soy, fish or tree nuts.

Three kits have been approved by the AOAC Research Institute as Performance Tested through a limited inter-laboratory study. They are: Biokits Peanut Assay, developed by Tepnel Biosystems Ltd, Flintshire, UK; RIDASCREEN FAST Peanut, developed by R-Biopharm AG, Darmstadt, Germany; and Veratox for Peanut, developed by Neogen Corp, Lansing, Mich.

Organizations that have limited laboratory facilities such as research and industrial food operations are the likely users of these kits. For example, use of these tests can assist organizations in rapidly determining whether their food processing operations are adequate to prevent the inclusion of peanut products in foods declared to be peanut-free. They can also use the tests to determine whether food processing plant cleanup operations are sufficient to avoid cross-contamination and whether the finished product is peanut-free.

The AOAC Research Institute and FDA completed their joint review and evaluation of the test kits in May 2003. An FDA laboratory prepared and distributed coded samples to three other participating laboratories. They were the Allergen Method Development Group of Health Canada in Ottawa, Canada; the National Food Processors Association laboratory in Washington, D.C.; and the FDA Regional laboratory in Jamaica, New York.

While there were some minor differences in the performance of the methods, all three test kit methods were approved by the AOAC and were proven to be reliable, i.e., 80% level of confidence, for the detection of peanut protein. Approximately 40 analyses can be performed with each kit, and the cost per kit ranges from $450 to $650. Users can decide which test kit method to use based on validated performance results, cost, time and ease of use.