New Coronavirus (COVID-19) IgG/IgM Rapid Test Device

Package Insert

Specimens: Whole Blood/Serum/Plasma

Version: 06

Effective Date: 2020-06

For professional in vitro diagnostic use only.

The novel coronaviruses( New Coronavirus) belong to the β genus. COVID-19 is an acute respiratory infectious

disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main

source of infection; asymptomatic infected people can also be an infectious source . Based on the current

epidemiological investigation ,the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations

include fever, fatigue and dry cough. Nasal congestion, runny nose sore throat, myalgia and diarrhea are found

in a few cases.

New Coronavirus (COVID-19) IgG/IgM Rapid Test Device is a lateral flow immunoassay for the simultaneous

detection and differentiation of IgG anti–COVID-19 virus and IgM anti-COVID-19 virus in human whole blood,

serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis

of infection with COVID-19 viruses. Any reactive specimen with New Coronavirus (COVID-19) IgG/IgM Rapid

Test Device must be confirmed with alternative testing method(s).  

 

 

 Package information