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CLIA COVID-19 RBD IgG

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

Available
Catalog Number: CL-CoRG100
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: COVID-19
Diagnostic panel: COVID-19
Respiratory Diseases
Vaccination Monitoring
CLIA COVID-19 RBD IgG
  • Detection of IgG 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
References
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Technical data

Assay time30 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 - 1000 U/ml
Assay/kit contentReagent Cartridge with specific reagents for the assay, magnetic particles, calibrators
Complementary productsWash buffer, AnchorĀ® Tips, Stackable cuvettes, Trigger solutions
Note

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

References

References to CLIA COVID-19 RBD IgG

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    See more on PubMed
  • Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3. PMID: 32015507; PMCID: PMC7095418.
    See more on PubMed
  • Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. PMID: 32074444; PMCID: PMC7121626.
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  • Burbelo PD, Riedo FX, Morishima C, Rawlings S, Smith D, Das S, Strich JR, Chertow DS, Davey RT, Cohen JI. Sensitivity in Detection of Antibodies to Nucleocapsid and Spike Proteins of Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Coronavirus Disease 2019. J Infect Dis. 2020 Jun 29;222(2):206-213. doi: 10.1093/infdis/jiaa273. PMID: 32427334; PMCID: PMC7313936.
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  • Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2. PMID: 32123347; PMCID: PMC7095448.
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  • Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, Sun R, Wang Y, Hu B, Chen W, Zhang Y, Wang J, Huang B, Lin Y, Yang J, Cai W, Wang X, Cheng J, Chen Z, Sun K, Pan W, Zhan Z, Chen L, Ye F. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol. 2020 Sep;92(9):1518-1524. doi: 10.1002/jmv.25727. Epub 2020 Apr 13. PMID: 32104917; PMCID: PMC7228300.
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  • Wölfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Müller MA, Niemeyer D, Jones TC, Vollmar P, Rothe C, Hoelscher M, Bleicker T, Brünink S, Schneider J, Ehmann R, Zwirglmaier K, Drosten C, Wendtner C. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 May;581(7809):465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1. Erratum in: Nature. 2020 Dec;588(7839):E35. PMID: 32235945.
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  • Walls AC, Park YJ, Tortorici MA, Wall A, McGuire AT, Veesler D. Structure, Function, and Antigenicity of the SARS-CoV-2 Spike Glycoprotein. Cell. 2020 Apr 16;181(2):281-292.e6. doi: 10.1016/j.cell.2020.02.058. Epub 2020 Mar 9. Erratum in: Cell. 2020 Dec 10;183(6):1735. PMID: 32155444; PMCID: PMC7102599.
    See more on PubMed
  • Dai L, Gao GF. Viral targets for vaccines against COVID-19. Nat Rev Immunol. 2021 Feb;21(2):73-82. doi: 10.1038/s41577-020-00480-0. Epub 2020 Dec 18. PMID: 33340022; PMCID: PMC7747004.
    See more on PubMed

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