The novel coronavirus is an RNA virus, which is composed of proteins and nucleic acids. The virus invades the host (human)body, enters cells through binding site corresponding receptor ACE2, and replicate in host cells, causing the human immune system to respond to foreign invaders and produce specific antibodies. Therefore, the vial nucleic acids and antigens,and specific antibodies against novel coronavirus can theoretically be used as specific biomarkers for the detection of the novel coronavirus. For nucleic acid detection, RT-PCR technology is the most commonly used.
Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit is intended to be used to achieve qualitative detection of SARS_CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs,sputum and BALF from patients in association with an FDA/CE IVD extraction system and the designated PCR platforms listed above .
The kit is intended for use by laboratory trained personnel