Virology, II Policlinico, Federico II University Hospital of Naples, Naples, Italy.
J Clin Virol. 2010 Oct;49(2):105-10. doi: 10.1016/j.jcv.2010.07.011. Epub 2010 Aug 21.
Screening and diagnosis of Rubella virus infection rely on testing for specific IgG and IgM. Immunoassays may yield different IgG results especially at low values, with difficulties in the evaluation of protective immunity. IgM levels decrease until negative a few weeks or months after acute infection, but individual and assay-related variability is common.
To evaluate the performance characteristics of the automated immunoassay for Rubella IgG and IgM on the Abbott ARCHITECT.
Twelve laboratories from 7 different Italian regions assayed 6268 routine specimens, comparing qualitative results for IgG and IgM and quantitative for IgG with other widespread immunoassays. Prevalence data for IgG were disaggregated by patients' group and by age in order to evaluate vaccination coverage.
Qualitative concordance for IgG was 97.3% vs. Abbott AxSYM, 95.0% vs. DiaSorin Liaison and 97.7% vs. Behring Enzygnost; ARCHITECT was more sensitive than Liaison and equivalent to the other assays, with a good correlation of IU/mL values with AxSYM (r = 0.89). IgG prevalence was 87.1% among pregnant women, indicating a sub-optimal vaccine coverage. IgM reactivity was 1%, except in one site due to an outbreak. IgM concordance was 97.5% vs. Abbott AxSYM, 97.9% vs. DiaSorin Liaison and 97.7% vs. Behring Enzygnost; ARCHITECT was more specific than AxSYM.
Our study confirms that in Italy Rubella vaccination coverage among pregnant women is insufficient. The new Rubella IgG and IgM assays on the ARCHITECT analyzer showed a good performance in comparison with other commercial methods. The results obtained and the good precision, indicate their suitability for routine testing.
风疹病毒感染的筛查和诊断依赖于对特异性 IgG 和 IgM 的检测。免疫测定法在低值时可能会产生不同的 IgG 结果，因此评估保护性免疫存在困难。IgM 水平在急性感染后几周或几个月内降至阴性，但个体和检测相关的变异性很常见。
评估 Abbott ARCHITECT 上用于风疹 IgG 和 IgM 的自动化免疫测定法的性能特征。
来自意大利 7 个不同地区的 12 个实验室检测了 6268 例常规标本，比较了 IgG 和 IgM 的定性结果以及 IgG 的定量结果与其他广泛使用的免疫测定法的结果。为了评估疫苗接种覆盖率，按患者群体和年龄对 IgG 的流行数据进行了细分。
与 Abbott AxSYM 相比，IgG 的定性一致性为 97.3%，与 DiaSorin Liaison 相比为 95.0%，与 Behring Enzygnost 相比为 97.7%；ARCHITECT 比 Liaison 更敏感，与其他检测方法等效，与 AxSYM 的 IU/mL 值相关性良好（r = 0.89）。孕妇中 IgG 的流行率为 87.1%，表明疫苗接种覆盖率不足。IgM 反应性为 1%，除了一个检测点因爆发而呈阳性。与 Abbott AxSYM 相比，IgM 的一致性为 97.5%，与 DiaSorin Liaison 相比为 97.9%，与 Behring Enzygnost 相比为 97.7%；ARCHITECT 比 AxSYM 更具特异性。
我们的研究证实，意大利孕妇风疹疫苗接种覆盖率不足。ARCHITECT 分析仪上的新风疹 IgG 和 IgM 检测方法与其他商业方法相比表现良好。获得的结果和良好的精密度表明它们适合常规检测。
