The device is based on isothermal amplification method and enzyme digestion probe technology, and selected SARS-CoV-2 N gene as the target region, designed the probe and specific primers. A large number of target sequence’s copies were generated in the reaction system during the isothermal amplification. When the probe hybridizes to the complementary sequence, it is cleaved and fluorescence is emitted. The device detects and analyzes fluorescence signal and automatically report result.

The device automatically detects and analyzes fluorescence signal, reporting results with indicator lights. The assay includes internal control for monitoring of sample collection, processing, and amplification to reduce false negative results.