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Coronaviruses are a large family of viruses which may cause illness in animals or humans. SARS-CoV-2 is an enveloped, single-stranded RNA virus of the β genus. The virus can cause mild to severe respiratory illness with other associated symptoms, and has spread globally.
This COVID-19 assay is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology intended for the qualitative detection of nucleic acid from the SARS-CoV-2 viral RNA in direct nasal, nasopharyngeal or throat swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2RNA is generally detectable in respiratory samples during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
NAAT's can use many different methods to amplify nucleic acids and detect the virus.
This test is a Loop mediated isothermal amplification (LAMP) using : Nicking Enzyme Amplification Reaction (NEAR) is a method for in vitro DNA / RNA amplification like the polymerase chain reaction (PCR). NEAR is isothermal, replicating DNA/RNA at a constant temperature using a polymerase (and nicking enzyme) to exponentially amplify the DNA/RNA at a temperature range of 55 °C to 59 °C.