AmoyDx® Novel Coronavirus (2019-nCoV) Detection Kit

AmoyDx® Novel Coronavirus (2019-nCoV) Detection Kit is a fast and sensitive real-time RT-PCR assay, which combines reverse transcription and PCR amplification in one-step procedure, intended use for qualitative detection of coronavirus SARS-CoV-2 with viral RNA extracted from human respiratory specimens. The kit simultaneously detects ORF1ab (open reading frame, ORF1ab) and N (Nucleoprotein) conserved regions of novel coronavirus, with an internal control system to monitor the whole PCR process.

Principles of the Procedure
The kit is based on real-time RT-PCR technology, combines reverse transcription and PCR amplification in one-step procedure. It’s designed for a specific amplification of the ORF1ab (open reading frame, ORF1ab) and N (Nucleoprotein, N) conserved regions of novel coronavirus SARS-CoV-2 in viral RNA. The targeted region is amplified by several specific primers and detected by fluorescence probes. A non-competitive internal control is included in nCoV RNA detection system to assess RNA quality and monitor the whole PCR procedure.
The kit is composed of nCoV Reaction Mix, nCoV Enzyme Mix and nCoV Positive Control.
1)  The nCoV Reaction Mix includes nCoV RNA detection system and an internal control system. It contains primers and FAM-labeled probe specific for ORF1ab gene of SARS-CoV-2, ROX-labeled probe specific for N gene of SARS-CoV-2, and VIC-labeled probe specific for internal control. The internal control system is designed for a housekeeping gene as reference gene to assess the RNA quality and monitor the accuracy of experimental operation, which may lead to false negative results.
2)  The nCoV Enzyme Mix contains the reverse transcriptase for reverse transcription of viral RNA and reference gene RNA into cDNA, the Taq DNA polymerase for PCR amplification and uracil-N-glycosylase to prevent PCR amplicon carryover contamination.
3)  The nCoV Positive Control contains nucleic acid template of ORF1ab and N genes of coronavirus SARS-CoV-2 and housekeeping gene.