Intended Use:
This assay kit is used for in vitro qualitative detection of the N gene and ORF1ab gene of novel coronavirus SARS-CoV-2 in nasal swab samples from suspected pneumonia cases of SARS-CoV-2 infection and suspected cluster cases and other persons requiring diagnosis or differential diagnosis of SARS-CoV-2 infection.
Testing Principle
This assay kit is based on isothermal amplification technology and enzyme digestionprobe technology.The SARS-Cov-2 N gene and ORF1ab gene were selected as the amplification target region in designing the specific probe and primers. A large number of copies of the target sequence were generated in the reaction system during theisothermal amplification process. When the probe hybridizes to the complementary sequence, it is cleaved and fluorescence is emitted. The Integrated Nucleic Acid TestingDevice detects and analyzes the fluorescence signal automatically, reporting a negative,positive or invalid result.