Chemiluminescence kit for the determination of antigen SARS-CoV-2 Spike Glycoprotein S1 RBD + SARS-CoV-2 Nucleocapsid Protein in human serum and plasma

Coming soon
Catalog Number: CL-COVAg100
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: COVID-19
Diagnostic panel: COVID-19
Respiratory Diseases
Vaccination Monitoring
  • Detection of SARS-CoV-2 antigen, structural proteins of the virus
  • Screening test to identify COVID-19 infected individuals
  • Intended for human nasopharyngeal swab samples

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.

Efficient and timely testing for COVID-19 is not only required for individual patient management but at a population-level is a key component of public health efforts to control the pandemic. Whilst PCR testing remains the gold standard for diagnosing SARS-CoV-2 infection, antigen testing provides an important alternative. Antigen tests detect structural proteins of the SARS-CoV-2 virus. The following categories of people should be tested in both the public and private health sectors: hospitalized patients, any person with COVID-19 symptoms, and those who are close contacts of confirmed cases, including asymptomatic contacts.

The automated CLIA COVID-19 Antigen test is especially useful to investigate a high number of patients in hospitals and identify the positive ones.

Technical specifications

Technical data
Related Products

Technical data

Assay stability (on board)30 days
Sample matrix Serum, Plasma
Assay/kit contentReagent Cartridge with specific reagents for the assay, magnetic particles, calibrators
Complementary productsWash buffer, Anchor® Tips, Stackable cuvettes, Trigger solutions


References to CLIA COVID-19 RBD/NP Ag

  • Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3. Erratum in: Nature. 2020 Apr;580(7803):E7. PMID: 32015508; PMCID: PMC7094943.
    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.
    See more on PubMed
  • 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.
    See more on PubMed
  • 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.
    See more on PubMed
  • 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.
    See more on PubMed
  • 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.
    See more on PubMed
  • 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
  • Mattiuzzi C, Henry BM, Lippi G. Making sense of rapid antigen testing in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostics. Diagnosis (Berl). 2020 Nov 26:dx-2020-0131. doi: 10.1515/dx-2020-0131. Epub ahead of print. PMID: 33554523.
    See more on PubMed
  • Mina MJ, Parker R, Larremore DB. Rethinking Covid-19 Test Sensitivity - A Strategy for Containment. N Engl J Med. 2020 Nov 26;383(22):e120. doi: 10.1056/NEJMp2025631. Epub 2020 Sep 30. PMID: 32997903.
    See more on PubMed
  • Tang YW, Schmitz JE, Persing DH, Stratton CW. Laboratory Diagnosis of COVID-19: Current Issues and Challenges. J Clin Microbiol. 2020 May 26;58(6):e00512-20. doi: 10.1128/JCM.00512-20. PMID: 32245835; PMCID: PMC7269383.
    See more on PubMed

Do you want to learn more?
We're here for you

Please fill in
all fields
marked *
This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.
Find out more here.