Coronavirus COVID-19 IgM ELISA Assay Kit

Coronavirus COVID-19 IgM ELISA Assay Kit was developed and manufactured in the US

Size: 1×96 wells
Sensitivity: Cut-off control
Incubation Time: 1 Hour, 20 minutes
Sample Type: Serum
Species Sample: Human
Sample Size: 20 µL
Alternative Names: Serology, Coronavirus, COVID-19, Corona, Serological
IVD, CE-Marked

Controls Included

Cross Reactivity

Panels were studied with a minimum of five confirmed disease state samples with this serology assay. No interference was observed for the following disease or infectious agents:

• Anti-influenza A
• Anti-influenza B
• Hepatitis C (HCV)
• Antinuclear Antibodies (ANA)
• Respiratory Syncytial (RSV)

Assay Principle

The COVID-19 IgM ELISA Assay Kit is designed, developed, and produced for the qualitative measurement of the COVID-19 IgM antibody in serum samples. This COVID-19 serology ELISA assay utilizes the microplate based enzyme immunoassay technique.

Assay controls and samples, as well as the biotinylated COVID-19 specific peptide antigens are added to the microtiter wells of a microplate that was coated with a anti-human IgM specific antibody. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled streptavidin is added to each well. After an incubation period, an immunocomplex of ” Anti-hIgM antibody – human nCoV IgM antibody – HRP labeled COVID-19 antigen” is formed if there is novel coronavirus IgM antibody present in the tested materials. The unbound tracer antibody is removed by the subsequent washing step. HRP-labeled COVID-19 antigen tracer bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to the coronoavirus IgM on the wall of the microtiter well is proportional to the amount of the coronavirus IgM antibody level in the tested material.

Information for US Customers

During this crisis, steps are being taken to ensure that we can provide access to quality products for diagnostic testing. The Food and Drug Administration (FDA) has issued guidance which allows for distribution of the serological tests. At this time, the kits are released for sale in the United States under the provisions outlined in Section D of Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.

The kits are registered under product code QKO, the submission number is D376537.

Per the aforementioned guidance, the following statements are required:

• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
• Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• 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.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This kit is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.

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