SARS-CoV-2 IgG/IgM Test Kit

【INTENDED USE】

The SARS-CoV-2 IgG/IgM Test Cassette is a lateral flow chromatographic immunoassay for the

qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or

plasma specimen.

【SUMMARY】

Early January 2020, a novel coronavirus (2019-nCoV) was identified as the infectious agent causing

an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in

December 2019.1

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other

mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.2 Six

coronavirus species are known to cause human disease.3 Four viruses — 229E, OC43, NL63, and

HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent

individuals.3 The two other strains — severe acute respiratory syndrome coronavirus (SARS-COV)

and Middle East respiratory syndrome coronavirus (MERS-COV) — are zoonotic in origin and have

been linked to sometimes fatal illness.4

Coronaviruses are zoonotic, meaning they are transmitted between animals and people.

Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and

breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute

respiratory syndrome, kidney failure and even death.5

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.