COVID-19 IgG/IgM Rapid Test Kit

INSTRUCTION FOR USE

Please read the instruction manual carefully before performing the test. Follow the instructions and do not modify the process. Strict adherence to the guidel avoid misleading results and achieve optimal performance of PCL COVID19 IgG/IgM Rapid Gold.

PRODUCT NAME

PCL COVID19 IgG/IgM Rapid Gold

INTENDED USE

PCL COVID19 IgG/IgM Rapid Gold is an in vitro diagnostic medical device for qualitative detection of IgG and IgM antibodies of COVID19 infection in human serum, plasma, venous blood and capillary blood.

CONCEPT

COVID19 is a respiratory disease caused by a new type of coronavirus (SARS-CoV-2) virus first identified in December 2019 in Wuhan, China [1]. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath, and more. In severe cases, the infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and death. Coronaviruses are a group of viruses that cause symptoms from common cold to more serious illnesses such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV) [2].

PRINCIPLE OF THE PROCEDURE

This product (PCL COVID19 IgG/IgM Rapid Gold) is an in-vitro diagnosis kit that makes use of immunochromatogra method that combines antigen-antibody reaction and chromatogra for qualitative detection of COVID19 IgG and IgM in human serum, plasma, venous blood, and capillary blood.