FLU-COVID RT-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. FLU-COVID RT-PCR Kit is an in vitro diagnostics kit for the qualitative simultaneous detection and differentiation of the RNA of the Influenza A (FluA), Influenza B (FluB) and/or SARS-CoV-2 viruses, starting from purified RNA from human clinical samples of different origin, such as nasopharyngeal and oropharyngeal swabs and bronchoalveolar lavages (BAL). Target genes: SARS-CoV-2 N gene, FluA matrix protein, FluB matrix protein Types of influenza virus identified: Influ enza A Universal Subtype H1N1 (pandemic 2009) (Swine flu) Subtype H3 (incl. H3N2 Hong Kong) Influenza B: Victoria and Yamagata lineages. PRINCIPLE OF THE TEST The FLU-COVID RT-PCR Kit is a multiplexed assay based on reverse transcription and Real Time polymerase chain reaction. The Master mix contains three sets of primers and probes designed to detect the RNA from Influenza A virus, Influenza B and SARS-CoV-2 viruses. It also includes primers and probes to detect the human RNaseP gene in clinical samples or control samples. The oligonucleotides used as primers and probes were selected in evolutionarily conserved regions. With this test it is possible to differentiate between Influenza A virus, Influenza B virus and SARS-CoV-2 virus in a single assay. MATERIALS AND REAGENTS Master Mix RNAse/DNAse free water FLU-COVID Positive control Negative control PERFORMANCE CHARACTERISTIC Diagnostic sensitivity - 100% Diagnostic specificity - 100% Analytical sensitivity - 10 copy per amplification tube CE-IVD