CE certified for diagnostic use. The COVID-19 (SARS-CoV-2) IgM ELISA is intended for the qualitative determination of IgM class antibodies against SARS-CoV-2 in human serum or plasma to support the diagnosis of COVID-19 disease and constitutes a supplement to direct pathogen detection. In addition, serology can be used to collect epidemiological information on the prevalence of SARS-CoV-2.
Significance of N-Protein in COVID-19 (SARS-CoV-2) ELISAs
A significant factor for the diagnostic specificity and sensitivity of COVID-19 ELISAs is which antigen is used for coating.
The DEMEDITEC COVID-19 (SARS-CoV-2) ELISAs use the SARS-CoV-2 nucleocapsid protein (N protein) as antigen for the detection of antibodies to SARS-CoV-2.
N protein is a highly conserved antigen which has the advantage that it is abundant during the course of corona infection and stronger immune response in comparison to other antigen can be observed. Studies using ELISAs with different antigens, structural protein (S1), Receptor Binding Domain (RBD) and N protein reveal that ELISAs coated with N protein antigen are more sensitive than S1 coated ELISAs in detecting antibodies in patients with mild course of disease and showed a stronger correlation with Plaque Reduction Neutralization Test (PRNT) titer. Although the N proteins show a high level of preservation with other corona viruses, cross-reactivity with other relevant corona viruses does not seem likely, as studies indicate no significant cross-reactivity with other viruses.
96 well ELISA microplate - separate strips
Diagnostic Specificity (normal blood donors) 100% (95% CI 97.26 - 100.0)
Diagnostic Sensitivity >12 days post symptoms onset 57.14%
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