Novel coronavirus antibody, COVID-19 IgM/IgG Test Kit
This novel coronavirus disease COVID-19 IgM IgG Test Kit is based on lateral flow immunoassay to detect IgM/IgG antibodies of SARS-COV-2. It can be used as an aiding tool for RT-PCR testing. Clinical diagnosis shall be done according to the doctor.
This product is CE marked according to EU IVD Directive 98/79/EC
This product is not registered in China NMPA, not for sale in China.
This product has been submitted for registration in German DIMDI.
This product has been submitted for FDA EUA review.
Read carefully the kit manual before test.
This kit is for professional use only, not for home testing.
Clinical diagnosis of COVID-19 shall be done by doctor.
Component of the COVID-19 IgM IgG Test Kit
- COVID-19 Rapid Test Card, 50pcs,
- Disposable micropipette tips, 50pcs,
- Sample buffer, 2pcs
- Kit manual, 1 pc
Significance of tesing IgG/IgM in blood/serum/plas
- IgM is produced in the beginning of infection, indicates an early stage of the disease
- IgG is produced after a period of infection, indicates the infection is ongoing or was infected.
- Combination of IgG/IgM indicates the infection is ongoing
- Clinical diagnosis shall be determined by RT-PCR/CT scanning.
Background of novel coronavirus and COVID-19
Coronaviruses (CoV) are a large family of viruses that cause illness, ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). A novel coronavirus (nCoV, also known as SARS-CoV-2) is a new strain that has not been previously identified in humans. The disease caused by this novel coronavirus is then named Coronavirus Disease 2019(COVID-19) by WHO.
Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.
More information can be found on WHO website, CDC website.