Product Description

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.

Key Features and Values

• 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

Scientific Description

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 11^th 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.

Publications