Clostridium difficile Real Time PCR Kit
11 de septiembre de 2015
11 de septiembre de 2015
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E. Coli O157:H7 Real Time PCR Kit *CE Marked


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1. Intended Use
E. Coli O157:H7 real time PCR kit is used for the detection of E. Coli O157:H7 in stool or water
samples by using real time PCR systems.

2. Product Description
Enterohemorrhagic Escherichia coli (EHEC) O157:H7 is the serotype most commonly associated with
hemorrhagic colitis and the hemolytic uremic syndrome. It is phenotypically distinct from typical E.
coli, in that they do not ferment sorbitol and do not exhibit glucuronidase (GUD) activity. They are
also easily identified by their ability to production Shiga toxins (Stx) and by the presence of the
somatic O157 and the flagellar H7 antigens. As a result, these traits are extensively utilized in methods
used to isolate and detect O157:H7 in foods. However, new variant strains of EHEC, particularly
O157:H7, are being isolated more frequently from foods, animals and humans worldwide. These
include sorbitol-fermenting variants, strains that exhibit GUD, non-motile, toxigenic variants;
serological variants; toxin non-producing strains, etc. These variants carry most of the trait EHEC
virulence markers, so are potentially pathogenic and some have already been implicated in illness;
however, due to changes in trait genotypic and phenotypic markers, EHEC variants elude detection by
current testing methods.
E. Coli O157:H7 real time PCR kit contains a specific ready-to-use system for the detection of the E.
Coli O157:H7 using PCR (polymerase chain reaction) in the real-time PCR system. The master
contains reagents and enzyme for the specific amplification of the E. Coli O157:H7 DNA.
Fluorescence is emitted and measured by the real time systems´ optical unit during the PCR. The
detection of amplified E. Coli O157:H7 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 1×108copies/ml is supplied which allow the determination of the gene load.
For further information, please refer to section 9.3 Quantitation.

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