[PRODUCT NAME]  

SARS-CoV-2 Variant Test (Real-time PCR) 

[PACKING SPECIFICATIONS] 

48 T/kit

[INTENDED USE]  

The SARS-CoV-2 Variant Test (Real-time PCR) is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative differentiation of SARS-CoV-2 variants in pharyngeal swab, nasal swab and plasma from confirmed SARS-CoV-2 patient. Differentiation is done according to the detection of mutations N501Y, HV69-70del, K417N, E484K, K417T, D614G on Spike region from the SARS-CoV-2 genome.

The SARS-CoV-2 Variant Test (Real-time PCR) is intended for use as an aid in the clinical diagnosis of SARS-CoV-2 variants. The results could not be used as the sole basis for treatment.

The SARS-CoV-2 Variant Test (Real-time PCR) is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

[PRINCIPLE OF TEST] 

6 principal mutations of the SARS-CoV-2 in S protein genes including N501Y, HV69-70del, K417N, E484K, K417T and D614G are the targets of the kit. Specific primers were designed to amplify highly conservative segments containing these mutations. Specific labeled probes were designed to hybridize to the mutated amplicons, but not to the wild-type. When mutation is present in an amplicon, during the PCR extension step, 5’exonuclease activity of Taq polymerase cuts 5’ end fluorophore from the probe, making it free in reaction system, so as to separate from the shielding of 3’ end fluorescent quencher, which enables it to accept photo-stimulation to emit fluorescence that can be detected with instruments, so as to detect mutations N501Y, HV69-70del, K417N, E484K, K417T and D614G on Spike gene of the SARS-CoV-2 automatically in a fully closed reaction system.

 Internal control (IC) is designed with a region from a housekeeping gene (beta-actin). Amplification of targets and IC takes place simultaneously in the same reaction. The IC is used for monitoring whether the process has proceeded correctly for each sample.