VIASURE SARS-CoV-2 Real-Time PCR Kit

GENERAL INFORMATION Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is the name given to the new coronavirus that originated in 2019 and is the causative agent of COVID-19 (the disease caused by the SARS-CoV-2 virus). The virus was originally known as the 2019-nCoV nomenclature. SARS-CoV-2 is a new coronavirus strain that has not been previously identified in humans. The genome of these viruses consists of single-stranded RNA protected by two protein coatings - nucleocapsid and capsid. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV. VIASURE SARS-CoV-2 Real Time PCR Detection Kit is a test kit for simultaneous detection of 2 genes of SARS-CoV-2 and to diagnose COVID-19 in combination with other clinical and epidemiological data. RNA was extracted from respiratory samples, and SARS-CoV-2 detection was performed by one-step Real-Time PCR. PRINCIPLE OF THE TEST The test is based on the protocol of work recommended by the China CDC (Center for Disease Control and Prevention) and uses primers and fluorescently labeled probes specific for fragments of ORF1ab and N genes. The kit is provided in a ready-to-use format that allows the test to be performed quickly and easily. All reagents were lyophilized and loaded into PCR tubes. Two steps are needed to start the assay - rehydrating the master mix and adding the isolated RNA. MATERIALS AND REAGENTS SENSITIVITY AND SPECIFITY The clinical features of the VIASURE SARS-CoV-2 PCR Detection Kit were tested by testing 100 respiratory samples (nasopharyngeal swab) from symptomatic patients with suspected COVID-19. The results obtained were compared with those of a molecular method used by the Spanish National Reference Center (Institute for Healthcare Carlos III (ISCIII)). The results are shown in the table below: The specificity of the test is confirmed by testing a panel consisting of various microorganisms, representing the most common respiratory pathogens. No cross-reactivity was detected between any of the following microorganisms tested: Compatible with the most common Real-Time PCR equipment CE-IVD MARKED