Lumipulse® G SARS-CoV-2 Ag

For in vitro diagnostic (IVD) use with the Lumipulse G system for detection and quantitative measurement of SARS-CoV-2 nucleocapsid protein antigen in human nasopharyngeal swab or saliva. As a diagnostic tool for the confirmation of a SARS-CoV-2 infection. 

The assay utilises proven CLEIA (chemiluminescent enzyme immunoassay) technology with results that are available in up to 35 minutes.

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CE marked
Lumipulse® G SARS-CoV-2 Ag Immunoreaction Cartridges

Product number 260340

3 x 14 Tests
Lumipulse® G SARS-CoV-2 Ag Calibrators

Product number 231869

4 x 4 Concentrations
Lumipulse SARS-CoV-2 Ag Sample Extraction Solution set for Nasopharynx swab

Product number 231883

20 Tests
Sample Extraction Solution

Product number 234921

4 x 40mL
Sample Extraction Solution set

Product number 234914

50 Tests
Please contact your local Fujirebio representative for the availability of this product in your country.
Lumipulse G CLIA analyzer cartridge close up LUMIPULSE G1200 fully automated CLEIA analyzer - cartridge loading

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    About SARS-CoV-2

    The 2019 novel coronavirus infection disease (COVID-19) is caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).1,2 In December 2019, the Health Commission of the City of Wuhan, Hubei Province, China, reported multiple pneumonia patients with unknown cause. On January 7th 2020, the World Health Organization (WHO) announced that the National Health Commission of China identified a new type of coronavirus, SARS-CoV-2.3 The WHO declared a COVID-19 pandemic on March 11th 2020 due to the worldwide spread of novel coronavirus infection.4

    To detect the virus, lower respiratory tract specimen, nasopharyngeal swab fluid and saliva of the patient are shown to be reliable samples for the detection of the SARS-CoV-2 virus.5,6 In general, the diagnosis of SARS-CoV-2 infection is made by molecular detection of the SARS-CoV-2 genes. Although nucleic acid-based tests can detect SARS-CoV-2 gene with high sensitivity, it is restricted by the needs of special equipment and turnaround time. Lumipulse G SARS-CoV-2 Ag is useful as a diagnostic tool for the confirmation of a SARS-CoV-2 infection by detecting the SARS-CoV-2 antigen.
     

    Assay principle:

    Lumipulse G SARS-CoV-2 Ag is an assay system, including a set of immunoassay reagents, for the quantitative measurement of SARS-CoV-2 antigen in specimens based on CLEIA technology7 by a specific two-step immunoassay method on the LUMIPULSE G System.
     

    References:

    1. Wu F, et al. A new coronavirus associated with human respiratory disease in China Nature, 579: 265-269, 2020.
    2. Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndromerelated coronavirus: classifying 2019-nCoV and naming it SARS-CoV-Nat Microbiol, 5: 536-544, 2020.
    3. WHO website ”Rolling updates on coronavirus disease(COVID-19)” (https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen) Medical Research and Development.
    4. WHO Director-General's opening remarks at the media briefing on COVID-19 - 11 March 2020 (https://www.who.int/dg/speeches/detail/who-director-general-sopening-remarks-at-the-media-briefing-on-covid-19---11-march-2020)
    5. Di Gennaro F, et al. Coronavirus Diseases (COVID-19) Current Status and Future Perspectives: A Narrative Review. Int J Environ Res Public Health, 17: 2690, 2020.
    6. Iwasaki S, et al. Comparison of SARS-CoV-2 detection in nasopharyngeal swab and saliva [published online ahead of print, 2020 Jun 4]. J Infect. 2020;S0163-4453(20)30349-2. doi:10.1016/j.jinf.2020.05.071.
    7. Nishizono I, et al. Rapid and sensitive chemiluminescent enzyme immunoassay for measuring tumor markers. Clin Chem, 37: 1639-1644, 1991.

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