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CE-marked ErbaLisa COVID-19

IgG and IgM Antibody ELISA kits.

erbalisa_logo-2.png

CE-marked ErbaLisa COVID-19

IgG and IgM Antibody ELISA kits.

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.

"We are very proud to be contributing towards the fight against COVID-19. Having a better understanding about the immunity of COVID-19 will help society move back towards normality."
Nikhil Vazirani / Managing Director Erba Mannheim

ErbaLisa COVID-19 IgG

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


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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

Developed and manufactured in the U.S.A.

Catalogue Number Product Name Format
IME00136 ErbaLisa COVID-19 IgG 96-well ELISA


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:
 

  Test Positive Test Negative
Confirmed Positive 57 1
Confirmed Negative 2 105

 

  • The diagnostic sensitivity is 98.3%.
  • The diagnostic specificity is 98.1%.
  • No interference was observed with Haemoglobin, Bilirubin, Biotin or IgM.
 
Intra-assay precision CV 5,29%
Inter-assay precision CV 6,37%


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.

ErbaLisa COVID-19 IgM

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

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

Developed and manufactured in the U.S.A.

Catalogue Number Product Name Format
IME00137 ErbaLisa COVID-19 IgM 96-well ELISA


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:
 

  Test Positive Test Negative
Confirmed Positive 30 0
Confirmed Negative 5 45

 

  • The diagnostic sensitivity is 100.0%.
  • The diagnostic specificity is 90.0%.
  • No interference was observed with Haemoglobin, Bilirubin, Biotin or IgG.
Intra-assay precision CV 8,10%
Inter-assay precision CV 8,22%


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.

Thank You For Your Interest In Our CE-marked COVID-19 ELISA kits. Please Submit the Below Form and Your Local Erba Mannheim Associate Will be in Contact Soon.

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