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Infectious Serology · COVID-19 RBD CLIA
TestLine Distributed by Goffin Diagnostics

CLIA COVID-19 RBD IgA

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

CLIA CE-IVD TestLine 1 Package (100 Tests)
Technique
CLIA
Brand
TestLine
Packaging
1 Package (100 Tests)
Diagnostic Panel
COVID-19, Respiratory Diseases, Vaccination Monitoring
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Runs on KleeYa® Automated CLIA Analyser See the analyser and everything it runs

Quote-based, no public pricing. Add to your quote and our specialists put together a proposal with the right documentation, typically within 24 hours.

Product details

This kit in detail

  • Detection of IgA 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: 30 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-CoRA100
  • 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
Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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