COVID-19 test kit One-Step

influenza Ainfluenza BSARS-COV-2

The kit is CE certified and intended for in vitro diagnostic use only. Principle The multiplex assay uses fluorescent probes and primers to detect three specific regions within the SARS-CoV-2 nucleocapsid (N) gene and the ORF1ab gene. β-globulin is used an internal control to monitor quality of the specimen and extraction process. Positive and negative controls are included. RNA isolated from patient samples can be directly used in the assay to be reverse transcribed and amplified quantitatively. The pseudoviral particles used as positive control act as control for the extraction process as well as the RT-PCR. Limit of Detection SARS-CoV2 (2019-nCoV ) ： 400 copies/mL. Influenza A virus ： 1.5 TCID50/mL. Influenza B virus ： 2.0 TCID50/mL.