Cronobacter sakazakii, which before 2007 was named Enterobacter sakazakii is an opportunistic Gram-negative, rod-shaped, pathogenic bacterium that can live in very dry places. The majority of Cronobacter sakazakii cases are adults but low-birth-weight preterm neonatal and older infants are highest at risk. The disease is associated with a rare cause of invasive infection infants with historically high case fatality rates (40–80%).
In infants it can cause bacteraemia, meningitis and necrotizing enterocolitis. Most neonatal C. sakazakii infections cases have been associated with the use of powdered infant formula with some strains able to survive in a desiccated state for more than two years. However, not all cases have been linked to contaminated infant formula. In November 2011, several shipments of Kotex tampons were recalled due to a Cronobacter (E. sakazakii) contamination. There also was a study done where they found the strands of pathogen in 12% of field vegetables and 13% of hydroponic vegetables.
All Cronobacter species, except C. condimenti, have been linked retrospectively to clinical cases of infection in either adults or infants. However multilocus sequence typing has shown that the majority of neonatal meningitis cases in the past 30 years, across 6 countries have been associated with only one genetic lineage of the species Cronobacter sakazakii called ‘Sequence Type 4’ or ‘ST4’, and therefore this clone appears to be of greatest concern with infant infections.
In Regulation (EC) 2073/2005, the European Commission states that Salmonella and Cronobacter are the microorganisms of greatest concern in infant formula, formula for special medical purposes and follow-on formula. The lethality rate caused by neonatal Cronobacter infections is between 40-80 %.
The foodproof® Cronobacter Detection LyoKit is based on the real-time PCR technology, which is well-established in the food industry. The kit enables the detection of all species of genus Cronobacter. It uses the same primer and probes for Cronobacter detection as the according to ISO 16140 MicroVal validated foodproof® Enterobacteriaceae plus Cronobacter Detection Kit.