1. Intended Use
Enterobacter sakazakii real time PCR kit is used for the detection of Enterobacter sakazakii in
enrichment broth of milk powder by using real time PCR systems.
2. Product Description
Enterobacter sakazakii is a Gram-negative rod-shaped pathogenic bacterium of the genus Enterobacter.
It is a rare cause of invasive infection with historically high case fatality rates (40–80%) in infants. It
can cause bacteraemia, meningitis and necrotising enterocolitis. E. sakazakii infection has been
associated with the use of powdered infant formula even after extended period of storage for more than
2 years. E. sakazakii was defined as a new species in 1980 by Farmer et al. 1980. DNA-DNA
hybridization showed that E. sakazakii was 53–54% related to species in two different genera,
Enterobacter and Citrobacter. However diverse biogroups were described and Farmer et al. suggested
that these may represent different species.
Enterobacter sakazakii real time PCR kit contains a specific ready-to-use system for the detection of
the Enterobacter sakazakii through polymerase chain reaction in the real-time PCR system. The master
contains reagents and enzymes for the specific amplification of the Enterobacter sakazakii DNA.
Fluorescence is emitted and measured by the real time systems´ optical unit during the PCR. The
detection of amplified Enterobacter sakazakii DNA fragment is performed in fluorimeter channel
FAM with the fluorescent quencher BHQ1. In addition, the kit contains a system to identify possible
PCR inhibition by measuring the HEX/VIC/JOE fluorescence of the internal control (IC). An external
positive control defined as 1×107copies/ml is supplied which allow the determination of the gene load.
For further information, please refer to section 9.3Quantitation.