Performance of 14 rubella IgG immunoassays on samples with low positive or negative haemagglutination inhibition results
Performance of 14 rubella IgG immunoassays on samples with low positive or negative haemagglutination inhibition results
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DOI：
10.1016/j.jcv.2015.11.022
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发表时间：
2016-01-01
影响因子：
8.8
通讯作者：
Panning, Marcus
中科院分区：
文献类型：
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作者：
Huzly, Daniela;Hanselmann, Ingeborg;Panning, Marcus
背景：风疹 IgG 检测是产前护理和血清流行病学研究中的常规检查。最近有人担心血清阳性率正在下降，对疫苗接种政策提出质疑。风疹 IgG 检测的制造商和血清流行病学研究的作者使用不同的临界值来定义血清阳性。由于多年来风疹病毒循环减少，使用不适当的截止值可能会高估血清阴性率。 目标：使用不同的截止值定义，我们比较了 14 种当前的风疹 IgG 免疫测定法，以检测低阳性或阴性血凝抑制 (HI) 滴度样本中的灵敏度和定性结果一致性。 研究设计：本研究纳入了来自患者和医护人员的 150 个临床样本。所有样本均采用 14 种不同的风疹 IgG 免疫测定法进行测量。使用重组风疹 IgG 免疫印迹作为参考标准来定义血清阳性。结果：如果单独分析灰区结果，则使用制造商截止定义的定性结果的一致性为 56.4%，如果将灰区结果定义为阳性，则为 69.8%。使用 10 IU/ml 或 15 IU/ml 的通用截止值，一致性分别为 70% 和 61.4%。使用不同的临界值定义，124 个免疫印迹阳性样本中多达 71 个在免疫测定中呈阴性。阳性样本定量结果的平均变异系数 (CV) 为 51%（范围 19-113%）。结论：在当前检测疫苗接种覆盖率较高的人群中，通过测量风疹 IgG 来确定风疹免疫力会导致大量假阴性结果。应讨论疫苗接种覆盖率高的国家中常规风疹抗体检测的价值。 (C) 2015 Elsevier B.V. 保留所有权利。
Background: Rubella IgG testing is routinely done in prenatal care and seroepidemiological studies. Recently concern was raised that seropositivity rates were decreasing questioning vaccination policies. Manufacturers of rubella IgG assays and authors of seroepidemiological studies use different cut-offs for the definition of seropositivity. As rubella virus circulation is reduced since many years, seronegativity rates might be overestimated using an inappropriate cut-off.Objectives: Using different cut-off definitions we compared fourteen current rubella IgG immunoassays for sensitivity and qualitative result concordance in samples with low positive or negative haemagglutination inhibition (HI) titre.Study design: 150 clinical samples from patients and health care workers were included in the study. All samples were measured in 14 different rubella IgG immunoassays. Seropositivity was defined using recombinant rubella IgG immunoblot as reference standard.Results: The concordance of qualitative results using the manufacturers cut-off definitions was 56.4% if grey-zone results were analysed separately and 69.8% if grey-zone results were defined as positive. Using universal cut-offs of 10 IU/ml or 15 IU/ml the concordance was 70% and 61.4% respectively. Using the different cut-off definitions up to 71 out of the 124 immunoblot-positive samples tested negative in the immunoassays. The mean coefficient of variation (CV) of quantitative results in positive samples was 51% (range 19-113%).Conclusions: Determination of rubella immunity by measurement of rubella-IgG in a population with high vaccination coverage with current assays leads to a high number of false negative results. The value of routine rubella antibody testing in countries with high vaccination coverage should be discussed. (C) 2015 Elsevier B.V. All rights reserved.