CLIA COVID-19 RBD IgM
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.
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This kit in detail
- 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
Description
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 data
- Assay time: 40 min
- Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
- Sample matrix: Serum, Plasma
- Sample volume: 10 μL
- Sample stability: 7 days at 2-8 °C, 24 months at -20 °C
- Measuring range: 5 – 100 U/ml
- Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
- Note: The kits are CE-IVD certified and intended for professional use. Date of delivery on request.
Specifications
- Catalog Number: CL-CoRM100
- Size: 100 tests
- Regulatory status: CE IVD
- Clinical topic: COVID-19
- Diagnostic panel: COVID-19 Respiratory Diseases Vaccination Monitoring
- Producer: TestLine Clinical Diagnostics s.r.o.
References
- 33519745,33132005,33247109,32350462
- Reagent Cartridge with specific reagents for the assay
- magnetic particles
- calibrators
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Safety information
Product brochure
Declaration of conformity
Frequently paired with this kit
Other assays and instruments lab teams add alongside the CLIA COVID-19 RBD IgM.
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