Bio-Rad Laboratories Inc. has announced that its iQ-Check Enterobacteriaceae Kit has received MicroVal certification for the real-time polymerase chain reaction (PCR) detection of Enterobacteriaceae in infant formula, infant cereal with and without probiotics, and related ingredients. MicroVal is the international certification organization for the validation and approval of alternative methods for the microbiological analysis of food and beverages.

Enterobacteriaceae, often used as indicators for hygiene process criteria, is a large family of gram-negative bacteria that encompasses important foodborne pathogens including Salmonella, Cronobacter, and pathogenic Escherichia 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 Enterobacteriaceae 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 grams (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.

The method is complementary to Bio-Rad’s iQ-Check Salmonella 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).