3M’s E. coli O157 assay gains NF Validation
It was found to be as or more effective than the EN ISO 16654 method for detecting E. coli O157 in raw beef meats, raw dairy products, raw fruits and vegetables.
The 3M Molecular Detection Assay 2 – E. coli O157 (including H7) test was introduced in 2016.
It combines isothermal DNA amplification and bioluminescence detection for pathogen testing.
Marie-Pierre Copin, 3M Food Safety’s European regulatory affairs specialist, said E. coli O157:H7 is one of the most commonly implicated Shiga-toxin producing E. coli associated with foodborne outbreaks.
“Globally, it is considered to be a significantly dangerous foodborne pathogen, so being able to offer a product that allows producers to be more confident that their food is safe and free of the pathogen is especially gratifying.”
The E. coli O157 test began with a comparison study in which a single lab tested the assay’s effectiveness compared to the reference method.
Then an inter-laboratory study saw 17 laboratories compare the test and reference method in accordance with the ISO 16140-2 standard.
The certificate is valid for four years. The assay was also recently granted First Action status through the Official Methods of Analysis program by AOAC International.
3M Food Safety’s molecular detection assays for Listeria, Listeria monocytogenes and Salmonella were backed by AFNOR Certification earlier this year.
In the May meeting, 135 alternative methods for microbiological food analysis were certified NF Validation: 102 according to EN ISO 16140: 2003 and 33 to EN ISO 16140-2: 2016.
Qiagen mericon Manual Listeria monocytogenes for detection in meats and dairy products was validated according to EN ISO 16140-2:2016.
Validation was extended for SALMA One Day (bioMérieux) to the analysis of infant formula powders and associated raw materials (50g) and ANSR for Listeria (Neogen Europe) for a modification on the amplification step with update of ANSR software to version 1.8.3.
Validation renewals (according to EN ISO 16140-2:2016) were also given to AdiaFood Cronobacter spp. (bioMérieux), AL Detection (Bio-Rad) and Qiagen mericon Salmonella.
