Intended Use

This product is intended for the qualitative detection of novel coronavirus (SARS-CoV-2) in respiratory samples. Detection results can be used to aid clinical diagnosis of Coronavirus Disease 2019 (COVID-19).

Components

2019-nCoV PCR Buffer - 96 tests

PCR Enzyme Mix - 96 tests

2019-nCoV Positive Control - 48 tests

2019-nCoV Negative Control - 48 tests

2019-nCoV Internal Control - 96 tests

Package Insert - 1 copy

Product mechanism

This product contains four pairs of PCR primers, four fluorescent probes, RNA reverse transcriptase, DNA polymerase, dNTP, magnesium ion, and other chemicals for viral RNA detection. It targets the RNA-dependent RNA polymerase (RdRp) gene, Nucleocapsid (N) gene, and Envelop (E) gene of 2019-nCoV simultaneously in one single test tube. The testing process runs in the following three steps: 1) Reverse-transcribe viral RNA into viral DNA. 2) Amplify viral DNA to measurable amount. 3) Report the amount of DNA amplicons through probe hybridization. Besides, this product also includes a internal control and external control to monitor its performance during transportation and storage.

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