Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to COVID19 in human plasma and sera.

The kit is intended for the monitoring of the immune response to COVID-19 in the early stage of the infection as an additional marker to PCR.

For “in vitro” diagnostic use only.



Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China and has since then caused a global pandemic. SARS-CoV-2 is a positive-sense single-stranded RNA virus and belongs to the Betacoronavirus Genus, which also includes SARS CoV (2003) and MERS CoV (2012). Same as all other coronaviruses, the genome of SARS-CoV-2 (2019-nCoV) encodes the spike protein, the envelope protein, the membrane protein, and the nucleocapsid protein. Those who are infected with COVID-19 may have little to no symptoms. Symptoms of COVID-19 are similar to a cold or flu and may take up to 14 days to appear after exposure to SARS-CoV-2. Symptoms have included: fever, cough, difficulty breathing, pneumonia in both lungs.

In severe cases, infection can lead to death. Current tests for SARS-CoV-2 look for genetic material of the virus in oral swabs, using the polymerase chain reaction (PCR). PCR only give a positive result when the virus RNA is still present.

Enzyme-linked immunosorbent assays (ELISAs) are more rapid,

easily automatable and simple tests respect PCR, providing additional markers of early COVID-19 infection. COVID19 IgM