IVD - Zestaw przeznaczony do użytku diagnostycznego.
Do wykorzystania w urządzeniach:
LightCycler 1.0 (brak możliwości wykorzystania kontroli wewnętrznej w tym urządzeniu),
Zestaw przeznaczony do analizy ludzkiego osocza oraz surowicy krwi.
ZIKV Super Mix
RT-PCR Enzyme Mix
Woda (Molecular Grade Water)
Kontrola wewnętrzna (Internal Control (IC))
ZIKV kontrola pozytywna (ZIKV Positive Control(1×107copies/ml))
1 fiolka, 350μl
1 fiolka, 28μl
1 fiolka, 400μl
1 fiolka, 30μl
1 fiolka, 30μl
The principle of the real-time detection is based on the fluorogenic 5’nuclease assay. During the PCR reaction, the DNA polymerase cleaves the probe at the 5’ end and separates the reporter dye from the quencher dye only when the probe hybridizes to the target DNA. This cleavage results in the fluorescent signal generated by the cleaved reporter dye, which is monitored real-time by the PCR detection system. The PCR cycle at which an increase in the fluorescence signal is detected initially (Ct) is proportional to the amount of the specific PCR product. Monitoring the fluorescence intensities during Real Time allows the detection of the accumulating product without having to re-open the reaction tube after the amplification.
Zika virus is enveloped and icosahedral with a non-segmented, single-stranded, positive sense RNA genome. It is most closely related to the Spondweni virus and is one of the two viruses in the Spondweni virus clade. The virus was first isolated in 1947 from a rhesus monkey in the Zika Forest of Uganda, Africa and was isolated for the first time from humans in 1968 in Nigeria. Common symptoms of infection with the virus include mild headaches, maculopapular rash, fever, malaise, conjunctivitis, and arthralgia. In 2009, it was proved that Zika virus can be sexually transmitted between humans.
The Zika Virus (ZIKV) real time RT-PCR Kit contains a specific ready-to-use system for the detection of the Zika Virus using RT-PCR (Reverse Transcription Polymerase Chain Reaction) in the real-time PCR system. The master contains a Super Mix for the specific amplification of the Zika Virus RNA. The reaction is done in one step real time RT-PCR. The first step is a reverse transcription (RT), during which the Zika Virus RNA is transcribed into cDNA. Afterwards, a thermostable DNA polymerase is used to amplify the specific gene fragments by means of PCR (polymerase chain reaction). Fluorescence is emitted and measured by the real time systems´ optical unit during the PCR. The detection of amplified Zika 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 defined as 1×107copies/ml is supplied which allow the determination of the gene load.
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