The test results are for clinical reference only and cannot be used as a basis for confirming or eliminating cases. Operators should have experience of professional training in gene amplification or molecular biology method testing, and have relevant qualifications for laboratory operations. The laboratory should have reasonable biological safety precautions and protective procedures.

In this kit, primers and probes of real-time fluorescent PCRtechnology are designed to the conserved and specific regions of theORF1ab and N genes of 2019-nCoV, respectively. During PCRamplification, the probe binds to the template, and the 5'-end reportergroup of the probe is cleaved by the Taq enzyme (5'→3' exonucleaseactivity), thereby moving away from the quenching group to generatea fluorescent signal. The real-time amplification curve isautomatically plotted based on the detected fluorescence signal, andthe sample Ct value is calculated. FAM and HEX fluorophores arelabeled to ORF1ab gene and N gene probes in 2019-nCoV-PCRreaction solution. By using one test, qualitative detection of the abovetwo genes of 2019-nCoV can be performed simultaneously.

The kit is provided with an internal control (IC), which is a human housekeeping gene fragment, and is labeled with a ROX fluorescentgroup.