Zestaw RT-PCR do wykrywania wirusa 2019-nCoV
certyfikat medyczny CE-IVD

Opakowanie zawiera

50 testów/zestaw

Przeznaczone dla użytku profesjonalnego

The kit is a qualitative in vitro nucleic acid amplification assay to detect the new coronavirus identified in China in 2019 using Reverse transcription PCR in specimen of throat swab and Bronchoalveolar Lavage Fluid (BALF)from suspects.

In end of 2019, some pneumonia cases were reported in Wuhan, China and the pathogen was confirmed as a new strain. World Health organization has named the newly identified coronavirus as 2019-nCoV. Although more intensive researches must be conducted later to well understand the virus, in response to the emergency in disease control, simple and rapid kit is necessary to identify the virus timely and implement efficient interventions to contain the spread. The kit will qualitatively detect the nucleic acid of 2019-nCoV in specimen from suspects enabling to assess the infection situation of 2019-nCoV in suspects in clinical and public health practice.

Podstawowe zasady procedury

The kit is based on in vitro RT-PCR combining fluorescent probing. Primers and a sequence-specific fluorescence probes were designed tailored to high conservative region in 2019-nCoV genome. The probes are oligonucleotide attached fluorophores at the 5' end with FAM as reporter and 3’ end with quencher. In a meantime, specific primers and probes were developed as internal reference with fluorophores VIC/HEX attached at 5’ end as reporter. During the PCR procedures, the DNA polymerase cleaves the probe at the 5’ end and separates the reporter dye from the quencher dye when the probes hybridize 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. Monitoring the fluorescence intensities during Real Time allows the qualitative detection of 2019-nCoV in specimens.

Zestaw zawiera

Materiały wymagane, ale nie zawarte w zestawie

  • Reagents:TIANamp Virus RNA extraction Kit (DP315-R) manufactured by TIANGEN, or QIAamp Viral RNA Mini Kit (52904) by QIAGEN.
  • 1.5 mL RNase/DNase-free microcentrifuge tube, RNase/DNase-free tips for pipettes, 0.2mL 8-tube strips for real-time PCR, Bench centrifuge, Vortex mixer.
  • Notes:Components contained within a kit are intended to be used together. Do not mix components from different kit lots.

warunki przyznawania i okres ważności

  • The RT-PCR Kit should be stored at temperature lower than -18°C in dark. It is stable with shelf-life at 2-8 °C for 5 days and at -18°C for 6 months (tentative). Unpacked kit should avoid repeated thaw-freeze cycle (within 4 times)
  • The PCR Kit can be transported at -18°C in dark stable for 5 days. The manufacture date and shelf life would be provided in the labelling.

kompatybilne urządzenia

Applied Biosystems™ Real time PCR system 7500; SLAN-96P PCR system and other RT-PCR systems

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