SARS-CoV-2 / SARS-CoV Multiplex REAL-TIME PCR Detection 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. SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit is a test kit intended for detection and diagnostic of COVID-19. The SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit is designed to detect SARS-CoV-2 (COVID-19, 2019-nCoV) and SARS-like coronaviruses in human biological samples based on the Real-Time RT-PCR method. Samples are human biological materials: nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, sputum. PRINCIPLE OF THE TEST The PCR-mix contains four target-specific probes bearing reporter fluorescent dyes (Fam, Hex, Rox and Cy5) and quencher molecules. Once hybridized to a target sequence, the probes become activated and the fluorescence emittion increases proportionally to target sequence amplification. The kit includes the Internal control (RNAIC), which is intended to assess the quality of the RNA extraction and polymerase chain reaction. DNA probe used for the detection of the SARS-CoV-like coronaviruses product amplification includes fluorescent dye Fam. DNA probe used for the detection of the SARS-CoV-2 (E-gene) product amplification includes fluorescent dye Rox. DNA probe used for the detection of the SARS-CoV-2 (N-gene) product amplification includes fluorescent dye Cy5. DNA probe used for the detection of the internal control amplification product includes the fluorescent dye Hex. The application of four fluorescent dyes makes it possible to register the results of different amplification reactions taking place simultaneously in one tube. MATERIALS AND REAGENTS Paraffin sealed PCR-mix RT-PCR-buffe Enzyme Taq/RT Mineral oil Internal control (RNA-IC) Positive control RESULTS INTERPRETATION PERFORMANCE CHARACTERISTIC Number of samples - 192; Diagnostic sensitivity - 100% Diagnostic specificity - 100% Analytical sensitivity - 10 copy per amplification tube