ErbaLisa COVID-19: CE-marked Enzyme Immunoassay (ELISA) kits for the detection of IgG and IgM antibodies to SARS-CoV-2 in human serum.
 

Erba Mannheim has developed reliable and automation-friendly COVID-19 ELISA kits, allowing for comprehensive and accurate IgG and IgM antibody assessment. Our solid phase assays use proven technology, and total incubation time is 50 min at room temperature with a simple one step serum dilution. ErbaLisa COVID-19 assays are built for superior performance and reliable interpretation of results.

 

ErbaLisa COVID-19 IgG

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

 

Main Features:

Number of tests: 96

Principle: Indirect ELISA using recombinant Spike subunit antigen

Tracer: HRP-Labelled Anti-human IgG

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 directly on microwell plate

 

Performance characteristics:

58 serum samples collected from previously RT-PCR confirmed COVID-19 patients were tested. 107 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 and Italy.

 

This kit has been granted Notification Status by the FDA, under product code QKO.

Our submission number is D386770. In the first 14 days of the onset of infection with SARS-CoV-2 patient results may be negative for IgG antibodies.

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.