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

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