Serum, Plasma, COVID-19
Store the complete kit at 2–8°C. Under these conditions, the kit is stable until the expiration date (see label on the box)
Calculation of Index of Positivity
Limit of Detection
Limit of Analytical sensitivity is 1:32 (binary dilution)
CV = 5.76 %
CV = 6.62 %
European Union: for in vitro diagnostic use. Rest of the world: for research use only! The total assay time is less than 2 hours. For the detection of IgM antibodies against S1 RBD protein of SARS-CoV-2 virus in human blood.
Diagnostic specificity: 95.1%.
Diagnostic sensitivity: 97.5%
Assay format is 96 wells. Components of the kit are provided ready to use or concentrated. The kit contains Positive Control, Negative Control and Cut-off control material to calculate the index of positivity.
Since December 2019, outbreak of SARS-CoV-2 (COVID-19) infection has become a major epidemic threat in China and brought back the attention of pathogenic coronavirus to the spotlight. Spike protein is an envelopeanchored protein that mediates the recognition and binding of SARS-CoV-2 to host cells. S1 can be further cleaved by the host protease into two subunits called S1 and S2, wherein the S1 polypeptide contain a receptor binding domain (RBD) crucial for the specific recognition and interaction with human receptor ACE2, which is the first and the most essential step for the virus infection. EIA COVID 19 RBD IgM kit is a highly sensitive and specific ELISA kit for the precision detection and calculation of index positivity of anti-S1RBD IgM class antibodies in human blood.