Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

- Introduction
  - Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.
    
    Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.
- Advantages
  - One-tube technology, extraction within 30minutes
    
    Up to 96 samples at one time
    
    Simple operation process, no need long term staff training
    
    Room temperature nucleic acid lysis, No heating
    
    Direct sample types include: Nasal, Throat, and Nasopharyngeal swabs
    
    Enhance screening efficiency
    
    Internal control: human housekeeping gene RNase P
- Parameters
  - Technology: One-tube fast test/ Mag-beads
    
    Sensitivity: 200copies/mL
    
    Lysis: Room temperature lysis
    
    Sample types: Alveolar lavage fluid; throat swab, sputum
    (varys in different registration version)
- Certificates
  - CE-IVD, NMPA, FDA-EUA, Brazil ANVISA etc.
    
    FDA-EUA: Instruction for Use and fact sheet for healthcare providers, fact sheet for patients are available at https://www.fda.gov/medical-devices/emergency-situations