SARS-CoV-2 Antigen Quantitative ELISA Assay Kit

The SARS-CoV-2 Antigen Quantitative ELISA Assay Kit is for Research Use Only and not for use in diagnostic procedures

Size: 1×96 wells
Incubation Time: 2 hours 30 minutes
Sample Type: Serum, heparin plasma, EDTA plasma and citrate plasma.
Sample Size: 50 µl

Controls Included

Assay Principle

The SARS-CoV-2 Antigen Quantitative ELISA uses the principle of the double antibody sandwich method to detect SARS-CoV-2 N protein in human serum or plasma. Anti-SARS-CoV-2 N protein antibody was used to prepare microplates in advance. Add the biotin-labelled anti-SARS-CoV-2 N protein antibody and the sample in sequence. If the sample contains N protein, a solid-phase antibody-antigen-biotin-labelled antibody complex is formed. After washing the microplate, streptavidin labelled with HRP is added to further form an immune complex. The unbound substances are washed away, and a substrate solution containing TMB and urea hydrogen peroxide is added to the microplate. The wells are blue in color, and after being stopped by the stop solution, they can turn into yellow. The absorbance value was read using a microplate ELISA reader with a wavelength of 450 nm, using 620nm to 690nm as the reference wavelength. And the content of SARS-CoV-2 N protein in the sample was calculated according to the concentration of the SARS-CoV-2 calibrator.

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 TBD

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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