Bio-Rad’s iQ-Check Enterobacteriaceae Kit validated for detection of Enterobacteriaceae in infant formula and cereals

Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostics products, today announced that MicroVal, the international certification organization for the validation and approval of alternative methods for the microbiological analysis of food and beverages, has approved iQ-Check^™ Enterobacteriaceae Kit for the real-time PCR detection of Enterobacteriaceae (EB) in infant formula, infant cereal with and without probiotics, and related ingredients.

Enterobacteriaceae, often used as indicators for hygiene process criteria, is a large family of gram-negative bacteria that encompasses well-known food pathogens including Salmonella Cronobacter, or pathogenic E. coli. Presence of the pathogens provides an indicator of process effectiveness to eliminate or neutralize biological contaminants and supports prevention of recontamination. The iQ-Check Enterobacteriaceae Kit is a complete, flexible, and open solution for EB detection, enabling industrial microbiology laboratories to control and effectively adjust quality assurance procedures.

MicroVal is an independent international certification organization that provides a standardized method validation system for the microbiological analysis of food and beverages. By certifying that proprietary testing methods perform as well as internationally recognized reference methods, MicroVal certification ensures acceptance of new testing methods by regulatory and governing bodies in the food trade. Validation of the iQ-Check Enterobacteriaceae method was carried out according to the ISO-16140-2:2016 and MicroVal technical guidance, confirming its capabilities to accurately detect common pathogens in infant formula and cereals.

The latest study for the iQ-Check Enterobacteriaceae method demonstrated excellent concordance to the reference method, ISO 21528-1, validating the kits for use in infant formula and cereal testing up to 375 g. The kit was evaluated on parameters including sensitivity, relative level of detection, inclusivity and exclusivity. In addition, Bio-Rad’s iQ-Check Free DNA Removal Solution was validated as part of the workflow to remove free/dead cell DNA from the samples before PCR testing.

Infant formula and their related ingredients must be very carefully managed, requiring strict testing and analyses prior to commercial launch, with a strong focus on Enterobacteriaceae.

Receiving MicroVal validation for our iQ-Check Enterobacteriaceae Kit for infant formula and cereal demonstrates the wide applicability of our iQ-Check kits, further cementing our position as leaders in food science."

Franck Edouard, Senior Marketing Director, Food Science Division, Bio-Rad Laboratories

The method is complementary to Bio-Rad’s iQ-Check Salmonella spp. and iQ-Check Cronobacter Solution. The certificate (2018LR80) is available on the MicroVal website. The iQ-Check Enterobacteriaceae Kit is also AOAC PTM validated for powdered infant formula and environmental samples (certificate 082003).