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Bacillus Diphtheriae Real Time PCR Kit *CE Marked


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1. Intended Use
Bacillus Diphtheriae real time PCR Kit is used for the detection of Bacillus Diphtheriae by real time
PCR systems in samples like nasal and pharyngeal secretions, sputum, C.S.F. and etc.

2. Product Description
Bacillus Diphtheriae, also known as Bacillus diphtheriae and Klebs-Löffler bacillus, is a pathogenic
bacterium that causes diphtheria. C. diphtheriae is a facultatively aerobic Gram positive organism,
characterized by non-encapsulated, non-sporulated, immobile, straight or curved rods with a length of 1
to 8 μm and width of 0.3 to 0.8 μm, which form ramified aggregations in culture (looking like «Chinese
characters»). The bacterium may contain polymetaphosphate aggregates called Volutin granules. It is
pathogenic only in humans. Many strains of C. diphtheriae produce diphtheria toxin, a proteic exotoxin
which inhibit protein synthesis and thus is responsible for the signs of diphtheria. However, not all
strains are toxigenic; the ability to produce the exotoxin is conferred on the bacterium when it is
infected by a bacteriophage. Bacillus Diphtherae real time PCR kit contains a specific ready-to-use
system for the detection of Bacillus Diphtherae by polymerase chain reaction (PCR) in the real-time
PCR system. The master contains reagents and enzymes for the specific amplification of the Bacillus
Diphtherae DNA. Fluorescence is emitted and measured by the real time systems´ optical unit during
PCR. The detection of amplified Bacillus Diphtherae DNA fragment is performed in fluorimeter
channel FAM with the fluorescent quencher BHQ1. DNA extraction buffer is available in the kit. An
external positive control(1×107copies/ml) contained, allow the determination of the gene load. For
further information, please refer to section 9.2 Quantitation.

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