• SARS-CoV-2

    ELISA test systems from EUROIMMUN

Anti-SARS-CoV-2 ELISA IgG

  • Specific detection of IgG antibodies against SARS-CoV-2 using the S1 domain of the spike protein including the immunologically relevant receptor binding domain (RBD)
  • RBD represents important target antigen for virus neutralising antibodies
  • Excellent performance and good correlations with neutralisation tests confirmed in external studies
  • Programmes for vaccine development worldwide are based on the spike protein as the antigen
  • Fully automated processing and evaluation possible
  • Also validated for the use of dried capillary blood (dried blood spots – DBS) as alternative sample material; fully automated DBS processing possible

Customer comments and testimonials about this ELISA

 

ProductIg classFormatIncluded controlsOrder no.Status
ELISA IgG96 x 01
96 x 20
pos. control, neg. controlEI 2606-9601 G
EI 2606-9620 G*
CE-marked
FDA EUA

*Optimized for processing with the EUROLabWorkstation ELISA

Performance data

Days after onset of symptoms or pos. direct detection nSensitivity (Prevalence)*
≤ 108743,7 %
≥ 107294,4 %

*Borderline results were not included. To determine the diagnostic sensitivity, samples from patients with confirmed SARS-CoV-2 infection were analysed. The sensitivity therefore corresponds to the prevalence of antibodies against SARS-CoV-2 in COVID-19 infected persons.

It is possible that no antibodies have formed yet in the persons who tested negative. In some isolated cases the onset of antibody secretion was detected only after a period of 4 – 6 weeks post onset of symptoms.

Paneln Specificity*
Blood donors849 99.5%
Pregnant women199 99.5%
Children74 100%
Older patients97 100%
Other human coronaviruses23 100%
Influenza
(fr. vaccinated, incl. follow ups)
40 100%
Acute EBV infection &
heterophile antibodies
22 100%
Rheumatoid factor40 100%
Total134499.6%

*Borderline results were not included


Anti-SARS-CoV-2 NCP ELISA (IgG)

  • Sensitive detection of IgG antibodies against SARS-CoV-2 using the nucleocapsid protein
  • Antigen with the strongest immune dominance in the coronavirus family
  • Optimised specificity of the ELISA due to the use of a modified nucleocapsid protein (NCP) that only contains diagnostically relevant epitopes
  • Fully automated processing and evaluation possible
  • Also validated for the use of dried capillary blood (dried blood spots – DBS) as alternative sample material; fully automated DBS processing possible

   

ProductIg classFormatIncluded controlsOrder no.Status
ELISA IgG96 x 01
96 x 20
pos. control, neg. controlEI 2606-9601-2 G
EI 2606-9620-2 G*
CE-marked

*Optimized for processing with the EUROLabWorkstation ELISA

Performance data

Days after onset of symptoms or pos. direct detectionnSensitivity (Prevalence)*
≤ 101580.0 %
> 105694.6 %

*Borderline results were not included. To determine the diagnostic sensitivity, samples from patients with confirmed SARS-CoV-2 infection were analysed. The sensitivity therefore corresponds to the prevalence of antibodies against SARS-CoV-2 in COVID-19 infected persons.

Paneln Specificity*
Blood donors849 99.8 %
Pregnant women99 100 %
Children74 100 %
Older patients97 99.0 %
Other human coronaviruses27 100 %
Influenza
(fr. vaccinated, incl. follow ups)
40 100 %
Acute EBV infection &
heterophile antibodies
22 100 %
Rheumatoid factor40 100 %
Total124899.8 %

*Borderline results were not included.


Anti-SARS-CoV-2 NCP ELISA (IgM)

  • Sensitive detection of IgG antibodies against SARS-CoV-2 using the nucleocapsid protein
  • Antigen with the strongest immune dominance in the coronavirus family
  • Optimised specificity of the ELISA due to the use of a modified nucleocapsid protein (NCP) that only contains diagnostically relevant epitopes
  • Fully automated processing and evaluation possible
  • Also validated for the use of dried capillary blood (dried blood spots – DBS) as alternative sample material; fully automated DBS processing possible

   

ProductIg classFormatIncluded controlsOrder no.Status
ELISA IgM96 x 01pos. control, neg. controlEI 2606-9601-2 MCE-marked

*Optimized for processing with EUROIMMUN Analyzer I / I-2P and Sprinter XL

Performance data

Days after onset of symptoms or pos. direct detectionnSensitivity (Prevalence)*
≤ 101788.2 %
11 - 1517

70,6 %

16 - 252853,6 %
26 - 351145,5 %
36 - 45650,0 %
≥ 461711,8 %

*Borderline results were not included. To determine the diagnostic sensitivity, samples from patients with confirmed SARS-CoV-2 infection were analysed. The sensitivity therefore corresponds to the prevalence of antibodies against SARS-CoV-2 in COVID-19 infected persons.

Paneln Specificity*
Blood donors449 99.1 %
Pregnant women99 96,9 %
Children74 100 %
Older patients97 100 %
Influenza
(fr. vaccinated, incl. follow ups)
40 100 %
Acute EBV infection &
heterophile antibodies
22 81,8 %
Rheumatoid factor40 100 %
Total82198.6 %

*Borderline results were not included.


Anti-SARS-CoV-2 ELISA IgA

  • Sensitive ELISA for the determination of IgA against SARS-CoV-2
  • Use of the S1 domain of the spike protein as the antigen
  • For monitoring of the immune response after positive direct pathogen detection
  • Fully automated processing and evaluation possible

   

ProductIg classFormatIncluded controlsOrder no.Status
ELISAIgA96 x 01
96 x 20
pos. control, neg. controlEI 2606-9601 A
EI 2606-9620 A
CE-marked

Performance data

Days after onset of symptoms or pos. direct detectionnSensitivity (Prevalence)*
≤ 101788.2 %
11 - 609696.9 %
> 601384.6

*Borderline results were not included. To determine the diagnostic sensitivity, samples from patients with confirmed SARS-CoV-2 infection were analysed. The sensitivity therefore corresponds to the prevalence of antibodies against SARS-CoV-2 in COVID-19 infected persons.

PanelnSpecificity*
Blood donors849 98.2 %
Pregnant women99 97.0 %
Children104 100 %
Older patients97 99.0 %
Other human coronaviruses11 100 %
Influenza
(fr. vaccinated, incl. follow ups)
40 100 %
Acute EBV infection &
heterophile antibodies
22 90.5 %
Rheumatoid factor40 100 %
Total126298.3 %

*Borderline results were not included


Options for automated processing of the EUROIMMUN ELISA

1. EUROIMMUN Automation Solutions:

EUROLabWorkstation ELISA, Analyzer I, Analyzer I-2P and Sprinter XL

For further information on our automation options, please contact our experts of product management for instruments and software.


2. Processing on all common open ELISA platforms