BioMérieux’s pathogen detection tech safeguards against nutraceutical contamination

09 Sep 2021 --- BioMérieux’s Gene-up Nutraplex Pro multiplex pathogen detection assay has received approval from the International Association Of Official Analytical Collaboration (AOAC) Research Institute Performance Tested Methods.

This demonstrates that the technology can effectively detect US Pharmacopeia (USP) pathogens in various nutraceuticals like herbals or dietary supplements.

“The pathogens, or often referred to as objective organisms, pose a significant risk to human health,” Ben Pascal, chief business officer of Invisible Sentinel, a BioMérieux company, tells NutritionInsight. 

“Many of the nutraceutical products are ready-to-eat, with no cooking step or kill step prior to consumption. Therefore, USP provides microbiological guidance on risk and testing protocols to ensure that the products we consume are safe and do not contain any of these objective organisms.”

Specifically, the assay offers nutraceutical products a novel 24-hour multiplex pathogen detection and PCR culture confirmation solution. 

It simultaneously detects Escherichia coli, Salmonella spp. and Staphylococcus aureus from a single universal enrichment.Gene-up Nutraplex Pro’s PCR-based confirmation method is equivalent to traditional culture confirmation.

Sizing up to gold standard
The AOAC validation demonstrates statistical equivalence to the US Food and Drug Administration (FDA) and USP reference methods, which Pascal says is the gold standard for nutraceutical testing. 

“The validation is a first of its kind for AOAC,” he notes. “This dual validation approach sets a higher standard for alternative methods in demonstrating their efficacy in testing complex nutraceutical matrices. 

“In fact, the Nutraplex Pro assay out-performed both FDA and USP in the AOAC independent validation.” 

Providing validation against two globally recognized reference methods allows nutraceutical players to maximize efficiency and flexibility without sacrificing data integrity and confidence in microbiological results, adds Ron Johnson, senior scientific affairs advisor at BioMérieux and former president of the AOAC. 

Wide compatibility
Various molecular technologies for microbiological safety exist in the marketplace, explains Pascal. However, there is no technology that combines the ability to detect multiple pathogen targets at the same time with a single enrichment available to the global nutraceutical community.

“The assay posed significant challenges in development, but the expertise of our R&D team coupled with the knowledge base from our partner Herbalife, allowed us to make this powerful tool a reality to the broader nutraceutical community.”

The France-based company has validated nearly 60 different raw and finished product nutraceutical items. Product categories including performance protein powders, botanicals, spices, pre-workout drinks, vitamin and mineral premixes, vitamins, thickening agents and gummies have been validated. 

“We have yet to find a product that the test is not compatible with. Importantly, this test was developed specifically to meet the needs and address the complexities of the products that fall under the nutraceutical industry,” notes Pascal. 

Ingredient transparency is a key touchpoint of the nutrition industry, with an investigation last month finding that half of turmeric extracts fail quality and labeling tests. In July, a new botanical partnership was formed to address the ongoing issues with adulteration in the dietary food supplements space.

By Katherine Durrell