EDI™ Novel Coronavirus COVID-19 ELISA Kits

EDI™ Novel Coronavirus COVID-19 ELISA Kits
Enzyme Linked Immunosorbent Assays (ELISA) for the qualitative detection of the COVID-19 IgG and IgM in human serum.

Covid-19 IgG utilises an immunocomplex of “COVID-19 recombinant antigen - human anti-COVID 19 IgG antibody - HRP labeled
anti-human IgG tracer antibody" formed if there is coronavirus IgG antibody present in the tested samples.
Covid-19 IgM utilises an immunocomplex of “Anti-hIgM antibody - human COVID-19 IgM antibody - HRP labeled COVID-19 antigen" if there
is novel coronavirus IgM antibody present in the tested samples.

IgG is the most abundantly found immunoglobulin to be produced in response to an antigen and will be maintained in
the body after initial exposure for long term response.
Covid-19 IgG Assay has:
Sensitivity = 99.5%; Specificity = 99.5%
The combined cohort consisted of normal healthy patients with samples collected prior to the COVID-19 outbreak (N=624)
and RT-PCR confirmed positive patients(N=187).
Covid-19 IgG Assay has:
Sensitivity = 100%; Specificity = 95.5%
The combined cohort consisted of normal healthy patients with samples collected prior to the COVID-19 outbreak (N=233)
and RT-PCR confirmed positive patients(N=41).

Test results should not be the sole basis for clinical diagnosis and treatment and must be interpreted together with
other clinical information available to the physician in conjunction to other tests.
In the first week of the onset of the infection with the novel coronavirus (COVID-19) patients results may be negative for IgG.  In addition, patients with low immunity or other diseases that affect immune function, failure of important systemic organs, and use of drugs that suppress immune function can also lead to negative results of new coronavirus IgG.
In the first week of the onset or after four weeks of the infection novel coronavirus (COVID-19) patients may be negative for IgM.  In addition, patients with low immunity or other diseases that affect immune function, failure of important systemic organs, and use of drugs that suppress immune function can also lead to negative results of new coronavirus IgM.

For more information, prices and availability contact sales@clsdiagnostics.com

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