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Chemiluminescence kit for the determination of IgG antibodies against SARS-CoV-2 virus nucleocapsid protein (COVID-19) in human serum or plasma.

Catalog Number: CL-CoNM100
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: COVID-19
Diagnostic panel: COVID-19
Respiratory Diseases
  • Detection of IgM antibodies to Nucleocapsid Protein (NP) of SARS-CoV-2
  • Intended for human serum and plasma
  • Nucleocapsid recombinant antigen (rNP) 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.

Nucleocapsid protein (NP) encapsulates viral genomic RNA and forms a major component of the viral structure. NP is a highly antigenic epitope, which is highly conserved and does not change when the virus is mutated. In patients who have had COVID-19 infection, the anti-NP antibodies are usually measured at higher levels than antibodies to other SARS-CoV-2 proteins.

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.


References to CLIA COVID-19 NP IgM

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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.
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  • 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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  • 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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