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评估欧洲的流感病毒抗病毒药物敏感性检测:首次外部质量评估试验的结果。

Evaluation of influenza virus antiviral susceptibility testing in Europe: results from the first external quality assessment exercise.

机构信息

Health Protection Agency, London NW9 5EQ, UK.

出版信息

J Clin Virol. 2013 Mar;56(3):212-8. doi: 10.1016/j.jcv.2012.11.005. Epub 2012 Nov 30.

Abstract

BACKGROUND

The first antiviral susceptibility testing external quality assessment (EQA) was held for European influenza reference laboratories during winter 2010/11.

OBJECTIVES

To assess European network influenza antiviral susceptibility testing capability and provide participants with an independent performance evaluation.

STUDY DESIGN

The EQA panel contained ten coded specimens of inactivated human influenza A and B viruses with reduced susceptibility to neuraminidase inhibitors (NAI), or adamantanes. Twenty-four laboratories from 19 member states of the WHO European region analysed the panel using phenotypic (determination of 50% inhibitory concentration (IC(50)) values by neuraminidase (NA) enzyme inhibition assay) and/or genotypic methods.

RESULTS

All 24 laboratories returned genotypic data for A(H1N1)pdm09 influenza virus, 18 (75%) for former seasonal A(H1N1), 16 (67%) for A(H3N2) and 15 (63%) for influenza B virus, correctly identifying NAI or adamantane reduced susceptibility-associated substitutions in the NA (mean 84%; range 52-100%) or M2 (mean 85%; range 73-94%), respectively. Thirteen laboratories (54%) returned phenotypic NAI susceptibility data. Despite inter-laboratory and inter-assay IC(50) value variation, all 13 laboratories correctly identified oseltamivir reduced susceptibility/resistance in pure preparations of A(H1N1) oseltamivir-resistant viruses. However, only 11 (85%) identified oseltamivir reduced susceptibility/resistance in a mixture of A(H1N1)pdm09 oseltamivir-sensitive/-resistant viruses. Furthermore, 3 laboratories (23%) considered oseltamivir-sensitive influenza B virus reduced susceptible/resistant.

CONCLUSIONS

Detection of NA-H275Y in A(H1N1) viruses was achieved by most laboratories. IC(50) values and interpretation thereof varied for a sensitive/resistant virus mixture and for influenza B virus. The results of this exercise will assist harmonisation of antiviral susceptibility testing, interpretation and reporting within the European network through targeted training.

摘要

背景

2010/11 年冬季,首次针对欧洲流感参考实验室进行了抗病毒药敏检测外部质量评估(EQA)。

目的

评估欧洲网络流感抗病毒药敏检测能力,并为参与者提供独立的性能评估。

研究设计

EQA 检测板包含十种编码的已灭活的人源流感 A 型和 B 型病毒,这些病毒对神经氨酸酶抑制剂(NAI)或金刚烷胺具有耐药性。来自世界卫生组织欧洲区域的 19 个成员国的 24 个实验室使用表型(通过神经氨酸酶(NA)酶抑制试验测定 50%抑制浓度(IC50)值)和/或基因型方法分析了检测板。

结果

所有 24 个实验室均报告了 A(H1N1)pdm09 流感病毒的基因型数据,18 个实验室(75%)报告了前季节性 A(H1N1),16 个实验室(67%)报告了 A(H3N2),15 个实验室(63%)报告了 B 型流感病毒,正确识别了 NAI 或金刚烷胺耐药相关的 NA(平均 84%;范围 52-100%)或 M2(平均 85%;范围 73-94%)取代。13 个实验室(54%)报告了表型 NAI 药敏数据。尽管存在实验室间和试验间 IC50 值的差异,但所有 13 个实验室均正确鉴定了纯奥司他韦耐药病毒中奥司他韦的敏感性/耐药性。然而,只有 11 个实验室(85%)鉴定了 A(H1N1)pdm09 奥司他韦敏感/耐药病毒混合物中的奥司他韦敏感性/耐药性。此外,有 3 个实验室(23%)认为奥司他韦敏感的 B 型流感病毒具有耐药性。

结论

大多数实验室均能检测到 A(H1N1)病毒中的 NA-H275Y。对于敏感/耐药病毒混合物和 B 型流感病毒,IC50 值及其解释存在差异。该研究结果将通过有针对性的培训,协助欧洲网络内抗病毒药敏检测、解释和报告的协调统一。

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