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SARS Coronavirus(SARS-CoV) Real Time RT-PCR Kit *CE Marked


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1. Intended Use
SARS Coronavirus (SARS-CoV) real time RT-PCR kit is used for the detection of SARS
Coronavirus in sputum, gargle or PBMC from non-heparin anticoagulation by real time PCR

2. Product Description
Severe acute respiratory syndrome (SARS) is a respiratory disease in humans which is caused by
the SARS coronavirus (SARS-CoV). There has been one near pandemic to date, between
November 2002 and July 2003, with 8,096 known infected cases and 774 deaths (a mortality rate
of 9.6%) worldwide being listed in the World Health Organization’s (WHO) April 21, 2004
concluding report. SARS-CoV is positive-strand, enveloped RNA viruse, with diameters of
between 60 and 130 nm. The SARS-CoV genome appears to be equidistant from those of all
known coronaviruses, ~30,000 nt. Viral RNA were found in sputum, nasopharyngeal aspirates,
stool, plasma.
SARS Coronavirus (SARS-CoV) real time RT-PCR kit contains a specific ready-to-use system for
the detection of the SARS virus by Reverse Transcription Polymerase Chain Reaction(RT-PCR) in
the real-time PCR system. The master contains a Super Mix for the specific amplification of SARS
virus RNA. The reaction is done in one step real time RT-PCR. The first step is a reverse
transcription (RT), during which the SARS virus RNA is transcribed into cDNA. Afterwards, a
thermostable DNA polymerase is used to amplify the specific gene fragments by means of
polymerase chain reaction(PCR). Fluorescence is emitted and measured by the real time systems´
optical unit during PCR. The detection of amplified SARS virus 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 (1×107copies/ml) contained, allows the
determination of the gene load. For further information, please refer to section 9.3 Quantitation.

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