ErbaLisa COVID-19 IgM

CE-marked Enzyme Immunoassay (ELISA) kit for the detection of IgM antibodies to SARS-CoV-2 in human serum.

 

Main Features:

Number of tests: 96

Principle: Indirect ELISA using recombinant Spike (S) subunit and Nucleocapsid (N) antigens

Tracer: HRP-Labelled Anti-human IgM

Assay format: Semi-quantitative

Total incubation time: 50 minutes

Sample type: Serum

Sample volume: 10 μL

Sample Size: 100 μL (1:21 Dilution)

Reading wavelength: 450nm

Storage: 2-8ºC

Built for convenience:

Ready to use reagents

Removable strips

Break-apart wells

All incubation steps at room temperature

Interchangeable reagents

Calibrator and Controls included

Ready for automation

1:21 sample dilution can be performed validated on microwell plate

 

Performance characteristics:

30 serum samples collected from previously RT-PCR confirmed COVID-19 patients were tested. 50 normal  healthy patients with samples collected before COVID-19 outbreak (prior to December 2019) were tested. The results are as follows:

 

Validation conducted in the USA.

 

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.

Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.