VIASURE SARS-CoV-2 Real Time PCR Detection Kit is designed for the specific identification and differentiation of 2019 Novel Coronavirus (SARS-CoV-2) in respiratory samples from patients with signs and symptoms of COVID-19 infection.

This test is intended for use as an aid in the diagnosis of SARS-CoV-2 in combination with clinical and epidemiological risk factors. RNA is extracted from respiratory specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for SARS-CoV-2.

The detection is done in one step real time RT format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well. The isolated RNA target is transcribed generating complementary DNA by reverse transcriptase which is followed by the amplification of a conserved region of ORF1ab and N genes for SARS-CoV-2 using specific primers and a fluorescent-labeled probe.

In December 2019, some people that worked at or lived around the Huanan seafood market in Wuhan, Hubei Province, China, have presented pneumonia of unknown cause. Deep sequencing analysis of the respiratory samples indicated a novel coronavirus, which was named firstly 2019 novel coronavirus (2019-nCoV) and lately SARS-CoV-2.

Diagnosis of SARS-CoV-2 is performed detecting conventional causes of pneumonia early and detected by next-generation sequencing or real-time RT-PCR methods. Several assays that detect the SARS-CoV-2 have been are currently available, such as China CDC (“gene targets, ORF1ab and N”), Charité – Germany (“gene targets, RdRP, E”) or US CDC (“three targets in N gene”).

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