INTRODUCTION:
Coronavirus disease 2019 (COVID-19) is
caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). When
humans are exposed to the virus, they can acquire immunity by forming IgG
antibodies against the spike protein on the viral envelope. It is vital to know
which individuals are already exposed to the virus by testing for the human IgGs
that are present in the serum against the viral spike protein. This reagent kit
is developed to help develop other diagnostic tests and assays to detect the human
IgGs against SARS-CoV-2 in the serum. The kit contains the key reagents
necessary (spike protein, antibodies, and binding standard), and these reagents can be used with
any ELISA-compatible microplates, and other generic buffers and reagents for HRP
detection.
DESCRIPTION:
Assay Principle:
This assay employs the quantitative
sandwich enzyme immunoassay technique. The user-provided 96-well plates are
coated with the capturing spike protein provided, The samples and standards are
applied to the wells. The detecting antibody is used to detect the signal from
the human IgG Fc in the samples. More details are provided in the protocol
booklet.
Key components included in the kit:
1. Capturing protein – SARS-CoV-2 spike
protein
2. Detecting antibody – HuFc Detection Antibody
3. Binding standard and positive control.
The following reagents
are NOT included in the kit and must be provided by the end users:
1. 96-well or 384-well ELISA
plates
2. Assay Diluent (PBS + 1% BSA)
3. Wash buffer (PBS + 0.01% Tween-20)
4. HRP substrate (TMB)
5. Stop solution (0.5N HCl)
6. Absorbance microplate reader (we recommend BMG LABTECH microplate readers)
ELISA assay reactivity is sensitive to
variations in operator, pipetting and washing techniques, incubation time,
temperature, composition of reagents, and other experimental variables. Assay
optimization may be required to generate the standard curve and fit the samples
in the specified detection range.
**Application for Emergence Use Authorization by FDA for diagnostic purposes is in process.
