bioMérieux assay achieves AOAC approval for nutraceuticals

The real-time PCR solution for pathogen detection detects <>E. coli, Salmonella spp. and Staphylococcus aureus from a single universal enrichment in 24 hours

The bioMérieux Gene-Up Nutraplex Pro multiplex pathogen detection assay has achieved AOAC Research Institute performance tested methods approval (PTM 082103). The validation reportedly demonstrated statistical equivalence to the FDA and US Pharmacopeia (USP) reference methods for the detection of USP pathogens in comparative studies with various nutraceutical matrices including nutrients, herbals and dietary supplements.

“AOAC validation, demonstrating statistical equivalence to the FDA and USP reference methods, provides flexibility and confidence to nutraceutical companies,” said Adam Joelsson, Director of R&D, Technology, bioMérieux. “Ensuring a rapid, novel 24 hour multiplex pathogen detection and PCR culture confirmation solution in nutraceutical products.”

The real-time PCR solution for pathogen detection detects <>E. coli, Salmonella spp. and Staphylococcus aureus from a single universal enrichment in 24 hours, the company says.

“The AOAC approval of Gene-Up Nutraplex Pro is a significant milestone in our ability to serve the nutraceutical industry,” said Ron Johnson, Senior Scientific Affairs Advisor at bioMérieux, and former President of the AOAC. “Providing validation against two globally recognised reference methods allows our customers – and the nutraceutical market-at-large – to maximise efficiency and flexibility without sacrificing data integrity and confidence in microbiological results.”

AOAC is a global standardisation organisation that certifies analytical test methods. Its performance tested methods designation is recognised by the US Department of Agriculture, the FDA, and global regulatory agencies.

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