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WANTAI SARS-CoV-2 IgG ELISA (Quantitative
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The WANTAI SARS-CoV-2 IgG ELISA (Quantitative) is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for quantitative detection of IgG-class antibodies to SARS-CoV-2 virus in human serum or plasma. The WANTAI SARS-CoV-2 IgG ELISA (Quantitative) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, or as an aid in individual vaccination management decisions. The quantitative result obtained with this kit is as a reference for clinician only, cannot be used as the sole
basis for further individual vaccination and treatment.

Principle of the test
The WANTAI SARS-CoV-2 IgG ELISA (Quantitative) employs solid phase, indirect ELISA method for detection of
IgG-class antibodies to SARS-CoV-2 in two-step incubation procedure. Polystyrene microwell strips are pre-coated
with SARS-CoV-2 recombinant antigen. During the first incubation step, SARS-CoV-2 IgG antibodies, if present, will
be bound to the solid phase pre-coated antigens. The wells are washed to remove unbound serum proteins and then,
anti-human IgG antibodies (anti-IgG) conjugated to horseradish peroxidase (HRP-Conjugate) is added. During the
second incubation step, these HRP-conjugated antibodies will be bound to any antigen-antibody (IgG) complexes
previously formed and the unbound HRP-conjugate is then removed by washing. Chromogen solutions containing
Tetramethyl benzidine (TMB) and urea peroxide are added to the wells and in presence of the
antigen-antibody-anti-IgG (HRP) immunocomplex, the colorless chromogens are hydrolyzed by the bound HRP
conjugate to a blue colored product. The blue color turns yellow after stopping the reaction with sulfuric acid. The
absorbance value (A value) can be measured and is proportional to the titer of IgG antibody in the specimen. The IgG
antibody titer in the specimen can be calculated by double logarithmic curve fitted with the standard concentration and A value. Wells containing specimens negative for SARS-CoV-2 IgG remain colorless.

This kit contains reagents sufficient for testing of maximum of 91 specimens in a test run.

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