Yonsei Med J.  2014 Mar;55(2):459-466.

Evaluation of a Commercial Glycoprotein Enzyme-Linked Immunosorbent Assay for Measuring Vaccine Immunity to Varicella

• Kim YH
• Hwang JY
• Shim HM
• Lee E
• Park S
• Park H

Abstract

PURPOSE
To evaluate a recently marketed commercial glycoprotein enzyme-linked immunosorbent assay (gpEIA) kit, the VaccZyme(TM) VZV gpEIA, for measuring the immunity of varicella-vaccinated children.
MATERIALS AND METHODS
We investigated the accuracy and reproducibility of the VaccZyme(TM) VZV gpEIA kit for the detection of antibodies to VZV. We also examined the sensitivity, specificity, and correlation between antibody titers calculated with gpEIA versus fluorescent antibody to membrane antigen (FAMA) by using sera of 349 children, ranging from 1 to 6 years old.
RESULTS
VaccZyme(TM) VZV gpEIA gave precise and reproducible intra- and inter-assay results. FAMA and gpEIA titers showed a linear correlation (Pearson correlation coefficient=0.987). The sensitivity and specificity of the VaccZyme(TM) gpEIA was 31.4% and 100%, respectively, when the guidelines of the gpEIA (<100 mIU/mL) and FAMA 1:4 were adopted as cutoff values. However, the maximum sensitivity and specificity were 88.9% and 95.1%, respectively, with the highest correlation (kappa=0.840), if the cutoff values were set with gpEIA at 49.7 mIU/mL and FAMA 1:16.
CONCLUSION
These results demonstrate that the VaccZyme(TM) VZV gpEIA kit gave precise and reproducible data for measuring antibody titer after varicella vaccination. The results also showed that the antibody titer calculated with the VaccZyme(TM) gpEIA kit strongly correlated with the FAMA titer. However, cutoff values should be re-optimized for the evaluation of vaccine immunity.

Keyword

Varicella; vaccine; immunogenicity; gpEIA; FAMA test

MeSH Terms

Antibodies
Chickenpox*
Child
Enzyme-Linked Immunosorbent Assay*
Glycoproteins*
Humans
Membranes
Methods
Sensitivity and Specificity
Vaccination
Antibodies
Glycoproteins

Figure

• 

  Fig. 1 Microphotograph images of VZV infected MGLu cell in FAMA test. The images were taken by Axioscope fluorescent microscope (A-F) and Leica SP2 confocal microscope (G and H). Reading criteria for FAMA using WHO standard VZV IgG was set as follows 1 IU/mL as "3+" (A); 500 mIU/mL as "3+" (B); 31.2 mIU/mL as "2+" (C); 7.8 mIU/mL as "1+" (D); 3.9 mIU/mL as "weak" (E); 0.98 mIU/mL as "negative" (F); single plane (G); z-stack (H). VZV, varicella-zoster virus; FAMA, fluorescent antibody to membrane antigen; MGLu, human embryonic lung fibroblast.

• 

  Fig. 2 Correlation between gpEIA and FAMA titers of 349 children without VZV histories (Pearson correlation coefficient=0.987). gpEIA, glycoprotein enzyme-linked immunosorbent assay; FAMA, fluorescent antibody to membrane antigen; VZV, varicella-zoster virus.

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