New MicroVal certification strengthens Bio-Rad’s leadership in food safety and molecular diagnostics
Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostics, has announced that the iQ-Check™ Enterobacteriaceae Kit has been officially validated by MicroVal for the real-time PCR detection of Enterobacteriaceae (EB) in infant formula, infant cereals (with and without probiotics), and related ingredients.
This validation confirms the kit’s reliability and performance for industrial microbiology laboratories that monitor hygiene and process control in food manufacturing—ensuring that even the most sensitive products meet strict global safety standards.
Ensuring safety from the earliest stage of nutrition
Enterobacteriaceae is a large family of Gram-negative bacteria that includes several critical foodborne pathogens such as Salmonella, Cronobacter, and pathogenic E. coli. The presence of these microorganisms serves as a key indicator of hygiene process effectiveness and prevention of recontamination during production.
The iQ-Check Enterobacteriaceae Kit provides a complete, flexible, and open solution for rapid EB detection using real-time PCR technology. Its streamlined workflow allows laboratories to efficiently verify sanitation efficiency, adjust quality control processes, and protect product integrity.
“Infant formula and related ingredients must be carefully managed, requiring strict testing and analyses before commercial release,” said Franck Edouard, Senior Marketing Director, Food Science Division, Bio-Rad Laboratories.
“Receiving MicroVal validation for our iQ-Check Enterobacteriaceae Kit demonstrates its wide applicability and reinforces Bio-Rad’s commitment to advancing food microbiology.”
About the validation process
MicroVal is an independent international certification body that validates and approves alternative microbiological methods for food and beverage analysis.
Validation of the iQ-Check Enterobacteriaceae method was performed under ISO 16140-2:2016 and MicroVal technical guidance, confirming its precision and accuracy for detecting Enterobacteriaceae in powdered infant products.
The latest study demonstrated excellent concordance with the reference method ISO 21528-1, validating the kit’s suitability for sample sizes up to 375 g. Evaluation parameters included sensitivity, relative detection level, inclusivity, and exclusivity.
In addition, Bio-Rad’s iQ-Check Free DNA Removal Solution was validated as part of the workflow—ensuring removal of non-viable cell DNA prior to PCR testing for superior accuracy.
Complementary validated methods
The iQ-Check Enterobacteriaceae Kit complements Bio-Rad’s other validated workflows, including the iQ-Check™ Salmonella spp. and iQ-Check™ Cronobacter solutions, extending the company’s comprehensive portfolio for food pathogen detection.
- MicroVal certificate: 2018LR80 (available on the MicroVal website)
- AOAC PTM validation: 082003 (for powdered infant formula and environmental samples)
Together, these methods provide manufacturers with robust, regulatory-ready tools to safeguard food quality and consumer health.
A commitment to global food safety
With this latest validation, Bio-Rad reinforces its position as a trusted partner in microbiological testing, delivering technologies that help laboratories meet international standards while accelerating turnaround time and improving data confidence.