AffiPCR® SARS CoV 2 Real Time PCR

Target Disease Type: Respiratory Infections

Specific Application: Coronavirus

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SARS-CoV-2 RT-PCR (CE) V435-100FRT DataSheet

INTRODUCTION

Coronaviruses are a large family of ribonucleic acid (RNA) viruses capable of infecting humans and a number of animal species. In humans, coronaviruses may cause a range of illnesses, from the common cold to severe acute respiratory syndrome (SARS) .

The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), known also as 2019 novel coronavirus (2019-nCoV), is a positive-sense single-stranded RNA virus. It is contagious in humans and is the cause of the ongoing pandemic of coronavirus disease 2019 (COVID-19) that has been designated a Public Health Emergency of International Concern by the World Health Organization (WHO) .

The earliest case of infection currently known is thought to have been found on November 2019. The virus subsequently spread to all provinces of China and to more than one hundred other countries in Asia, Europe, North America, South America, Africa, and Oceania. On 11th March 2020 the WHO has officially declared it a pandemic.

INTENDED USE

SARS-CoV-2 Real-TM is Real-Time PCR test for the qualitative detection of SARS-CoV-2 (COVID-19 virus, 2019-nCoV) RNA in clinical samples.

PRINCIPLE OF ASSAY

SARS-CoV-2 Real-TM Test is based on three major processes: isolation of virus RNA from specimens, reverse transcription of the RNA, Real Time amplification of the cDNA. The reverse transcription and amplification are performed in a single, one step reaction. Coronavirus detection by the polymerase chain reaction (PCR) is based on the amplification of pathogen genome specific region using specific primers and detection via fluorescent dyes. These dyes are linked with probes of oligonucleotides which bind specifically to the amplified product. The real-time PCR monitoring of fluorescence intensities allows the accumulating product detection without reopening of reaction tubes after the PCR run.

SARS-CoV-2 Real-TM is a multiplex Real-time PCR assay that detects and identifies the causative agent of the new coronavirus disease (COVID-19) using three targets: E gene and N gene specific for SARS-CoV-2 and region of E gene common for all SARS-like coronaviruses (SARS-CoV, SARS-CoV-2) .

SARS-CoV-2 Real-TM PCR kit is a multiplex Real Time PCR kit with four simultaneous reactions – amplification of the SARS-like coronaviruses, including SARS-CoV, SARS-CoV-2 (FAM channel) ; SARS-CoV-2 E-gene (ROX channel) ; SARS-CoV-2, N-gene (Cy5 channel) as well as amplification of nucleic acid sequence of the Internal Control-RNA in HEX channel, which allows to exclude inhibition and nucleic acids extraction issues.