Drug Names

Generic Name：Human anti-SARS-CoV2(S-RBD) (Delta B.1.617.2) IgG ELISA Kit

Principle

This kit was based on indirect enzyme-linked immune-sorbent assay technology. Recombinant nucleocapsid protein was pre-coated onto 96-well plates. And the HRP conjugated antibody was used as detection antibodies. The standards, test samples and HRP conjugated detection antibody were added to the wells subsequently, and washed with wash buffer. TMB substrates were used to visualize HRP enzymatic reaction. TMB was catalyzed by HRP to produce a blue color product that changed into yellow after adding acidic stop solution. The density of yellow is proportional to the target amount of sample captured in plate. Read the O.D. absorbance at 450nm in a microplate reader, and then the concentration of target can be calculated.

Recovery

Matrices listed below were spiked with certain level of Anti-SARS-CoV2(S-RBD) (Delta B. 1 .617.2) IgG and the recovery rates were calculated by comparing the measured value to the expected amount of Anti-SARS-CoV2(S-RBD) (Delta B. 1 .617.2) IgG in samples.

Matrix	Recovery Range (%)	Average (%)
Serum(n=5)	80- 104	92
EDTA Plasma(n=5)	90-96	93
Heparin Plasma(n=5)	89- 105	96

Linearity

The linearity of the kit was assayed by testing samples spiked with appropriate concentration of Anti-SARS-CoV2(S-RBD) (Delta B. 1 .617.2) IgG and their serial dilutions. The results were demonstrated by percentage of calculated concentration to the expectation.

Sample	1:2	1:4	1:8
Serum(n=5)	84- 100%	82- 105%	80-99%
EDTA Plasma(n=5)	90- 101%	92- 101%	92-99%
Heparin Plasma(n=5)	94- 100%	91- 100%	92-99%

Precision

Intra-Assay: CV<8%

Inter-Assay: CV<10%

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