Bosphore Novel Coronavirus (2019-nCoV) Detection Kit is a Real-Time PCR-based in vitro diagnostic medical device, IVD CE marked according to 98/79/EC Directive.
Bosphore Novel Coronavirus (2019-nCoV) Detection Kit detects and characterizes 2019-nCoV in human respiratory samples.
Fluorescence detection is accomplished using FAM and HEX filters. 2019-nCoV is detected by two regions of the virus in two separate reactions: E gene is used for screening purpose, where 2019-nCoV and also the closely related coronaviruses are detected, and the orf1ab target region is used to discriminate 2019-nCoV specifically. In the first PCR tube with PCR Master Mix 1, 2019-nCoV target region is amplified and fluorescence detection is accomplished using FAM filter. In the second PCR tube with PCR Master Mix 2, 2019-nCoV screening region (E gene) is amplified and fluorescence detection is accomplished using the FAM filter.
An internal control has been integrated into the kit in order to check RNA extraction, PCR inhibition and application errors. The amplification data of the internal control is detected with HEX filter in each tube. The internal control can be added either during RNA extraction or PCR step.