• Indirect ELISA using recombinant spike subunit and nucleocapsid antigens
  • Low sample volume
  • Suitable for use on automated ELISA systems
  • Interchangeable reagents
  • Ready to use reagents
  • All incubations are at room temperature

The COVID-19 IgM assay is an in vitro diagnostic test intended for the detection of IgM antibodies to SARS-CoV-2 in human serum collected in certified laboratories and / or by healthcare workers at the point of care.

Since late December 2019, an outbreak of a novel coronavirus disease (initially known as 2019-nCoV and subsequently named COVID-19)1 was first reported in Wuhan, China2, which has subsequently spread becoming a global pandemic – as declared by the World Health Organisation (WHO) on 11th March, 2020. COVID-19 has caused significant impact on healthcare systems and caused societal disruption as the potential public health threat posed by COVID-19 is high3.  In general, COVID-19 is an acute resolved disease, but it can also be deadly, with a 2% case fatality rate.

SARS-CoV-2 is a single-stranded RNA coronavirus4. The viral infection causes a series of respiratory illnesses including severe respiratory syndrome, indicating the virus most likely infects respiratory epithelial cells and spreads mainly via the respiratory tract from human to human4. Coronaviruses are composed of several proteins including the spike (S), envelope (E), membrane (M), and nucleocapsid (N)5. The spike glycoprotein of SARS-CoV-2 is a trimeric protein with each 180 kDa monomer consisting of 2 subunits (S1 and S2) which facilitate attachment and binding to the target cell6.

Viral infections are characterised by elevations in specific IgM antibody levels 3 to 5 days after the onset of symptoms; the presence of these antibodies generally persists for 30 to 60 days. IgG levels also become elevated after 10 to 14 days and remain detectable for many years.

  1. Wu F, Zhao S, Yu B, et al. A new coronavirus associated with human respiratory disease in China. 2020; (published online Feb 3.)
  2. Huang C Wang Y Li X et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. 2020; 395: 497-506
  3. CDC (2020). Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
  4. Xiao F, Tang M, Zheng X, Liu Y, Li X, Shan H, Evidence for gastrointestinal infection of SARS-CoV-2, Gastroenterology (2020), doi: https://doi.org/10.1053/j.gastro.2020.02.055.
  5. Li, F., Li, W., Farzan, M., & Harrison, S. (2005). Structure of SARS coronavirus spike receptor-binding domain complexed with its 10.2210/pdb2ajf/pdb
  6. Ou, X., Liu, Y., Lei, X. et al. Characterization of spike glycoprotein of SARS-CoV-2 on virus entry and its immune cross-reactivity with SARS-CoV. Nat Commun 11, 1620 (2020).

ErbaLisa® COVID-19 IgG
COVID-19 IgG (automated for use on IDS instruments)