Combination of native and recombinant cytomegalovirus antigens in a new ELISA for detection of CMV-specific antibodies.
BACKGROUND
Serological detection of cytomegalovirus (CMV)-specific antibodies varies greatly due to antigen composition and the lack of antigen standardization.


OBJECTIVE
To develop and evaluate a new ELISA with native and/or recombinant cytomegalovirus antigens for the detection of anti-CMV IgG and IgM antibodies.


RESULTS
The diagnostic performance of three anti-CMV ELISAs coated with different CMV antigen preparations, (i) native CMV antigen, (ii) a mixture of recombinant CMV peptides pp150, pp28, gB2 and pp52 and (iii) a combination of native CMV antigens and recombinant CMV IE1 antigen applied in the new Genzyme Virotech CMV ELISA, were compared. All tested sera were derived from patients or healthy blood donors and were predefined with the Dade Behring Enzygnost CMV ELISA as well as by CMV PCR analysis. Additionally, official well-characterized serum panels were also tested. The new Genzyme Virotech CMV ELISA IgG/IgM test applying a combination of native antigens and recombinant IE1 antigen was evaluated and the performance was compared to the Dade Behring Enzygnost CMV ELISA. The sensitivities were 98.9% (IgG) and 98.2% (IgM), the specificities were 98.8% (IgG) and 98.9% (IgM) for the Genzyme Virotech CMV ELISA. Furthermore all sera of the BBI mixed titer performance panel as well as the BBI seroconversion panel were identified 100% correctly with the new Genzyme Virotech ELISA.


CONCLUSIONS
These data suggest that the new Genzyme Virotech CMV ELISA has higher sensitivity and specificity than ELISAs based on native antigens or recombinant peptides only. Specific combinations of native and recombinant antigens increase the serological detection of CMV infections and may add to further standardization of CMV serology.
Busse
Clemens
C
Applied Tumor Virology, German Cancer Research Center, University of Heidelberg, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany.
Strubel
Andreas
A
Schnitzler
Paul
P
D000914:Antibodies, Viral / Q000097:blood*; D000918:Antibody Specificity; D000956:Antigens, Viral / Q000235:genetics / Q000276:immunology*; D003587:Cytomegalovirus / Q000276:immunology; D003586:Cytomegalovirus Infections / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D017874:Immediate-Early Proteins / Q000276:immunology*; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D011994:Recombinant Proteins / Q000235:genetics / Q000276:immunology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000914:Antibodies, Viral; D000956:Antigens, Viral; C088645:IE1 protein, cytomegalovirus; D017874:Immediate-Early Proteins; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D011994:Recombinant Proteins