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Chemiluminiscence kit for the determination of IgM antibodies against RBD, Spike S1 protein subunit, SARS-CoV-2 virus (COVID-19) in human serum or plasma.

Catalog Number: CL-CoRM100
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: COVID-19
Diagnostic panel: COVID-19
Respiratory Diseases
Vaccination Monitoring
  • Detection of IgM antibodies to Receptor-Binding Domain (RBD), a subunit of the Spike S1 protein of SARS-CoV-2
  • Intended for human serum and plasma
  • Recombinant antigen (rRBD), a subunit of the Spike S1 protein used

Coronaviruses belong to the family of enveloped RNA viruses. In humans, they cause diverse clinical pictures, from the common cold to severe respiratory syndromes (MERS, SARS, and COVID-19). SARS-CoV-2, the cause of COVID-19, is a respiratory virus discovered in 2019. It is primarily transmitted to an individual through close contact with an infected person, during which infectious droplets spread to the environment. Symptoms of COVID-19 are highly variable, ranging from none to life-threatening illness.

The SARS-CoV-2 virus contains four structural proteins: spike (S), nucleocapsid (N), envelope (E), and membrane (M) protein. Responding to the infection, the human immune system raises specific antibodies, starting with IgA and IgM. The IgG antibodies represent a later matured response. Serological tests play only a supporting role in COVID-19 diagnosis. However, they are effective in assessing the immune response of an individuum or population.

The used Receptor-Binding Domain (RBD) antigen, a subunit of the spike S1 protein, specifically binds to the angiotensin-converting enzyme 2 (ACE2) of the host cell. This bound highly correlates with the formation of neutralizing antibodies. In all vaccines developed so far, the spike protein is the antigenic substance (either as a protein or as an RNA / DNA sequence). Certainly, the anti-RBD antibodies are a valuable tool to monitor vaccination efficacy.

Technical specifications

Technical data
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Technical data

Assay time40 min
Assay stability30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
Sample matrix Serum, Plasma
Sample volume10 µL
Sample stability7 days at 2-8 °C, 24 months at -20 °C
Measuring range5 - 100 U/ml
Assay/kit contentReagent Cartridge with specific reagents for the assay, magnetic particles, calibrators
Complementary productsWash buffer, Anchor® Tips, Stackable cuvettes, Trigger solutions

The kits are CE-IVD certified and intended for professional use.

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Safety information

Declaration of conformity

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