Technology – Molecular Assay using Isothermal Amplification of SARS-CoV-2
Sampling – Nasopharyngeal Swab
Limit of Detection – 75 copies SARS-CoV-2 RNA per µL
Operation – Bio sampling, buffer solution, assay exposure, heating, automated detection
Reporting – Automated Detection and reporting with MobileDetect App on iOS and Android
True Positive Accuracy – 100%
True Negative Accuracy – 95%*
*Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient decisions. Negative results can result from poor sample collection, or if collected sample is below the Limit of Detection.
Reagent 1 – -20°C
Reagent 2 – -20°C
Positive Control – -80°C
Reagents should be stored at -20°C when not preparing assay. Ensure entire aliquot of Reagent or Control is thawed before preparing the assay.