Validation certifies that test kits are equivalent to or better than standard reference methods in detecting the target pathogens in food as well as in samples from the food processing environment, excluding primary production samples.
The pathogen test kits were introduced in 2015 with technology that combines isothermal DNA amplification and bioluminescence detection.
Second generation tests
They use a workflow that is 30% faster than first generation assays thanks to lysis chemistry that uses nanotechnology and features a color-change indicator.
All assays can be run simultaneously and the user can test up to 96 samples in each run.
Marie-Pierre Copin, 3M Food Safety’s European regulatory affairs specialist, said the validation for Listeria and Listeria monocytogenes took one year and around nine months for Salmonella.
“They are validated for all food and environmental samples following ISO 16140 part 2. The expert lab [Adria Développement] tested 400-500 types of food and environmental samples including dust, water and process water.”
Copin said the kit was compared to the ISO standard for Salmonella 65:79 and Listeria and Listeria monocytogenes to ISO 11290 part 1 detection.
“The time to result for most food categories is 24 hours, for Listeria and Listeria monocytogenes it can be 48 hours with a second enrichment,” she added.
“For Salmonella we also have a protocol that takes 10 hours for raw meat products.
“It is very important for [customers] to have third party validation and in addition in European regulation for food microbiological criteria when you want to produce results showing your products have been tested you must mention either the ISO standard or a method validated in comparison with the ISO standard.”
Time to result
It takes 35 minutes to process 96 samples and start the instrument run. Positive results are identified in 15 minutes so can be seen in less than one hour after enrichment.
Negative results are identified at the end of the 75-minute instrument run so total time to result is less than two hours after enrichment.
The NF Validation certification process begins with a method comparison study in which an expert lab tests the technology’s effectiveness versus standard methods.
Then an inter-laboratory study compares the efficacy of the new test and reference method under defined conditions of reproducibility and repeatability.
AFNOR Certification is accredited by Cofrac for activities under the NF Validation mark.
All three assays have previously been designated by AOAC International as Official Methods.
The Official Methods of Analysis program consists of a multi-laboratory validation of the method, and review by an expert panel.
Lisa Monteroso of 3M Food Safety’s regulatory affairs team, said: “As the food safety landscape changes and regulatory requirements become more stringent, these certifications reaffirm our products’ high level of performance and provide our customers with additional data to support method implementation.”