Novel Coronavirus COVID-19 IgM ELISA Kit


This kit is for in vitro diagnostics use only. The kit is detecting novel COVID-19 Nucleocapsid protein specific IgM antibody in human serum. It is for screening or to aid in the diagnosis of COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection. The assay is validated manually, but can be adapted to an automated instrument. The assay is for the qualitative detection only.

INTENDED USER This kit is for laboratory professional use or healthcare professionals.


This ELISA kit is designed, developed, and produced for the qualitative measurement of the COVID-19 IgM antibody in serum. This assay utilizes the “IgM capture” method on microplate based enzyme immunoassay technique. Assay controls and samples are added to the microtiter wells of a microplate that was coated with a anti-human IgM specific antibody. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled recombinant COVID-19 antigen is added to each well. After an incubation period, an immunocomplex of "Anti-hIgM antibody - human COVID-19 IgM antibody - HRP labeled COVID-19 antigen" is formed if there is novel coronavirus IgM antibody present in the tested materials. The unbound tracer antigen is removed by the subsequent washing step. HRP-labeled COVID-19 antigen tracer bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antigen bound to the coronavirus IgM on the wall of the microtiter well is proportional to the amount of the coronavirus IgM antibody level in the tested materials.

Technical Specifications

For in-vitro diagnostic use.