Evaluation of a commercial glycoprotein enzyme-linked immunosorbent assay for measuring vaccine immunity to varicella.
Evaluation of a commercial glycoprotein enzyme-linked immunosorbent assay for measuring vaccine immunity to varicella.
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DOI：
10.3349/ymj.2014.55.2.459
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发表时间：
2014-03
影响因子：
2.4
通讯作者：
Park H
中科院分区：
文献类型：
--
作者：
Kim YH;Hwang JY;Shim HM;Lee E;Park S;Park H
目的评价新近上市的检测水痘疫苗接种儿童免疫力的商品化糖蛋白酶联免疫吸附试验试剂盒VaccZyme™VZVgpEIA。我们考察了VaccZyme™VZVgpEIA试剂盒检测水痘病毒抗体的准确性和重复性。我们还用349名1-6岁儿童的血清检测了gpEIA计算的抗体效价与膜抗原荧光抗体(FAMA)之间的敏感性、特异性和相关性。VaccZyme™VZVgpEIA提供了准确和重复性好的批内和批间结果。FAMA和gpEIA滴度呈线性相关(皮尔逊相关系数=0.987)。以VaccZyme™gpEIA(100mIU/mLgpEIA)和FAMA1：4为临界值，其敏感性和特异性分别为31.4%和100%。以gpEIA为49.7mIU/m L，FAMA为1：16时，灵敏度和特异度分别为88.9%和95.1%，相关系数最高(κ=0.840)。结果表明，VaccZyme™VZVgpEIA试剂盒为水痘疫苗免疫后抗体滴度的检测提供了准确、可靠的数据。结果还表明，用VaccZyme™gpEIA试剂盒计算的抗体效价与FAMA效价具有很强的相关性。然而，对于疫苗免疫效果的评估，应重新优化分界值。
To evaluate a recently marketed commercial glycoprotein enzyme-linked immunosorbent assay (gpEIA) kit, the VaccZyme™ VZV gpEIA, for measuring the immunity of varicella-vaccinated children. We investigated the accuracy and reproducibility of the VaccZyme™ 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. VaccZyme™ 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™ 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 (κ=0.840), if the cutoff values were set with gpEIA at 49.7 mIU/mL and FAMA 1:16. These results demonstrate that the VaccZyme™ 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™ gpEIA kit strongly correlated with the FAMA titer. However, cutoff values should be re-optimized for the evaluation of vaccine immunity.