Intended Use
The Human Anti-HCoV 229E IgM ELISA Kit is an immunoassay suitable for quantifying IgM antibody activity specific for S1 subunit of the spike protein of the HCoV 229E virus, etiologic agent for the COVID-19 respiratory disease, in serum or plasma of vaccinated, immunized and/or infected hosts.
This immunoassay is suitable for:
o Determining immune status relative to non-immune controls;
o Assessing efficacy of vaccines, including dosage, adjuvantcy, route of immunization, and timing;
o Qualifying and standardizing vaccine batches & protocols.
The assay is for research use only (RUO) and is not intended nor validated for diagnosing HCoV 229E virus disease. Reagents contain no virus or viral antigens.
Storage
The microtiter well plate and all other reagents, if unopened, are stable at 2-8 °C until the expiration date printed on the box label.
Sensitivity
The HCoV 229E S1-coated plate, anti-human IgM-HRP concentration, and Low NSB Sample Diluent are optimized to differentiate anti-HCoV 229E S1 IgM from background (nonantibody) signal with human serum/plasma samples diluted 1:500.
General Description
Coronaviruses are a group of highly diverse RNA virus in the Coronaviridae family that are divided in 4 genera: alpha, beta, gamma and delta that cause disease varying from mild to severe in human and animals. Coronaviruses endemic to humans include the alphacoronavirus 229E and NL63 and betacoronaviruses OC43 and HKU1 that can cause influenza-like illness or pneumonia in humans. The genome of the coronavirus encodes 23 putative proteins including 4 major structural proteins: nucleocapsid [N protein], spike [S protein], membrane [M] and small envelope proteins [E]. The S protein is a glycoprotein essential for viral attachment to the host cell surface receptors and translocation into the infected cells; trimers of the S protein make up the spikes of the virus. For cell entry, S1 binds to a host receptor for viral attachment, and S2 undergoes dramatic structural changes to fuse the viral and host membranes. The sequences, structures, and membranefusion mechanisms of the S2 subunits are conserved among different coronavirus genera. However, the S1 subunits from different coronavirus genera share little or no significant sequence similarity.