10174 ReSARS® CoV-2 (N) IgG ELISA Kit – IVD

Designation: Semi-quantitative detection of Human IgG antibodies specific for SARS-CoV-2 N protein
Applications: ELISA microplate
Storage: 2-8°C
Shipping: Refrigerated; blue ice packs
Availability and Regulatory Status: For In Vitro Diagnostic Use – This test has not been reviewed for the US FDA. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Results from antibody testing shoud not be used to diagnose or exclude acute SARS-CoV-2 infection. 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. Not to be used to test donated blood.

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This assay is a direct ELISA detecting Human IgG antibodies specific for SARS CoV-2 nucleoprotein (N Protein). Diluted samples, Reference, Positive and Negative Controls are incubated in microwells coated with a mixture of recombinant SARS CoV-2 N antigens. Incubation allows the anti-SARS CoV-2 antibody present in the samples to react with the immobilized antigen mixture. After the removal of unbound serum or plasma proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added forming complexes with the bound IgG anti-SARS CoV-2 antibody. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of TMB substrate. Color develops in the wells at an intensity proportional to the concentration of IgG anti-SARS CoV-2 antibody in the sample. Optical Density (O.D.) results are obtained by reading the absorbance (A450nm minus A620nm) using an ELISA plate reader. It is recommended that the user establish a cut-off for the study population using SARS CoV-2 sero-negative samples. It is also recommended that IgG positive convalescent SARS CoV-2 samples from the study population be included in each assay as an additional reference sample.

Package insert for 10174 ReSARS CoV-2 (N) IgG ELISA (IVD) pdf

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