Human cytomegalovirus (HCMV), also called human betaherpesvirus type 5, is a common infection and a serious disease. CMV is an important pathogen in immunocompromised patients, including patients with solid organ and hematopoietic cell transplants, HIV-infected patients, and patients receiving immunomodulatory drugs.
CMV is a double-stranded DNA virus. And HCMV is a member of the Herpesviridae family and belongs to the Betaherpesvirinae subgroup.
Application of Cytomegalovirus (CMV) Antigen
Serologic Testing for CMV Infection
Infection with CMV results in the formation of antibodies against the virus, which remain in the body for a whole life. Enzyme-linked immunosorbent assay (ELISA) provides a common serologic test to determine the level of CMV antibodies. The results can be used to determine whether a child is acutely infected, has a history of infection, or is passively infected through maternal antibodies.
Diagnosis of CMV infection often begins with testing for anti-CMV IgG and IgM antibodies. IgG seroconversion indicates a recent infection; and the measurement of CMV IgG antibodies presents a previous infection. In IgM-positive patients, CMV IgG positive testing can be used to assess the duration of infection.
As an in vitro qualitative test, the Elecsys CMV IgG Assay is used to detect IgG antibodies to CMV in human serum, lithium heparin plasma, K2-EDTA plasma, and K3-EDTA plasma.
The kit uses a two-step sandwich immunoassay involving streptavidin microparticles, biotinylated recombinant CMV-specific antigen (produced in Escherichia coli) that is marked by ruthenium complex, and an electrochemiluminescence assay.
Roche Diagnostics developed Elecsys both CMV IgM and Elecsys CMV IgG.
Vaccines to Prevent or Treat CMV infection
Currently, there are no licensed vaccines against CMV infection. Several CMV vaccine platforms, including viral vectors, recombinant subunits, live attenuated vaccines, and mRNAs, are in Phase II and Phase III trials.
Currently, two vaccines, mRNA-1647 (mRNA vaccine) and ASP01131 (DNA vaccine), are in Phase III clinical trials.
The mRNA-1647 consists of six mRNAs. Among them, five of them encode five different proteins (UL128, UL130, UL131, gL, and gH), which together form a pentameric protein, and the sixth one encodes CMV glycoprotein B (gB) protein. mRNA-1647 was developed as a lipid nanoparticle (ASP01131) and is now in Phase III clinical trials.
ASP0113 is a therapeutic DNA vaccine including two plasmids, VCL-6365 and VCL-6368, and encoding human CMV gB and phosphoprotein 65 (pp65), respectively.
Yaohai Bio-Pharma Offers One-Stop CDMO Solution for CMV Antigen
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