The Covid-19 RNA Vs 2 Multiplex Real-Time RT-PCR kit coded COV19RNALYO.CE is intended for the specific qualitative detection of SARS-CoV-2 in human samples (see chapter H) by simultaneous retrotranscription and amplification of specific target region of Sars-CoV-2 genome (RdRp gene and N gene). In the same reaction tube an endogenous human gene is used as extraction/amplification reaction control (Internal Control). The kit has been adapted for the use on the Real-Time Thermacyclers and ABI 7500 Sequence Detection System® (Software SDS version 1.3.1, Applied Biosystems™*) and CFX96 Real-Time System (Software CFX manager version 1.7, Biorad™**)
NTRODUCTION
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death. Respiratory disease caused by the novel coronavirus, first detected in Wuhan City, China, has been named coronavirus disease 2019 (COVID-19) and the virus has been named SARS-CoV-2.
The SARS-CoV-2 virus is a betacoronavirus, like MERS-CoV and SARS-CoV; they are enveloped, positive-sense, single-stranded RNA viruses of zoonotic origin.
COV19RNA.CE RT-PCR assays is able to detect viral RNA reducing sample handling steps, providing fast results and a really low risk of cross-contamination for the sample under evaluation.
RINCIPLE OF THE TEST
The COV19RNALYO.CE Kit is based on a Real Time chemistry which uses specific Primers and Probes.
The SARS-CoV-2 RNA, recovered from the biological sample under investigation through an extraction step, is retrotranscribed and amplified using the Real Time amplification system. The Multiplex RT-PCR is based on a one-tube reaction performed for each sample. The multiplex assay is specifically targeting two regions of the SARS-CoV-2 (RdRp and N) and an endogenous (GAPDH) Internal Control (IC). The Endogenous IC extracted, retrotranscribed and amplified meanwhile, serves as an Collection/Extraction/Amplification control for each individually processed specimen aiming to the identification of good respiratory sample collection and the eventually identification of reaction inhibitors.
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