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用于检测儿童中流行的甲型流感(H1N1)病毒的快速免疫层析检测法的性能特征。

Performance characteristics of a rapid immunochromatographic assay for detection of pandemic influenza A (H1N1) virus in children.

机构信息

University Children's Hospital Geneva, Geneva, Switzerland.

出版信息

Eur J Pediatr. 2011 Apr;170(4):511-7. doi: 10.1007/s00431-010-1326-0. Epub 2010 Oct 12.

Abstract

UNLABELLED

Rapid tests for diagnosis of influenza are valuable assets in the management of influenza in pediatric patients. However, test performance fluctuates with virus subtypes. We assessed the test characteristics of Influenzatop®, a rapid immunochromatographic influenza A and B test, in detecting pandemic 2009 influenza A (H1N1) in children up to 18 years of age, using reverse transcriptase polymerase chain reaction (RT-PCR) as the gold standard. Three hundred and one pediatric outpatients with influenza-like illness were included into the study. Overall sensitivity of Influenzatop® was 64% (95% confidence interval (CI) 56-71%) but increased to 92% (95% CI, 80-97%) when performed between 24 and 48 h after onset of symptoms. Positive Influenzatop® results among RT-PCR-positive patients were associated with higher viral load. No significant variation in test performance could be detected when analyzed by age and high versus low prevalence period. Overall test specificity was 99% (95% CI, 95-100%); positive and negative predictive values were 98% (95% CI, 93-99%) and 70% (95% CI, 63-76%), respectively.

CONCLUSION

Influenzatop® rapid influenza test is a sound tool in the diagnosis of H1N1 in pediatric patients when employed 24-48 h after onset of symptoms.

摘要

目的

评估 InfluenzaTop®,一种快速免疫层析流感 A 和 B 检测试剂盒,在检测儿童中流行的 2009 年甲型流感(H1N1)方面的性能,以逆转录聚合酶链反应(RT-PCR)为金标准。

方法

共纳入 310 例有流感样症状的儿科门诊患者。InfluenzaTop®的总灵敏度为 64%(95%CI,56-71%),但在症状出现后 24-48 小时内进行时,灵敏度增加到 92%(95%CI,80-97%)。在 RT-PCR 阳性患者中,InfluenzaTop®阳性结果与较高的病毒载量相关。未发现按年龄和高发期与低发期分析时,检测性能有明显差异。总的检测特异性为 99%(95%CI,95-100%);阳性和阴性预测值分别为 98%(95%CI,93-99%)和 70%(95%CI,63-76%)。

结论

InfluenzaTop®快速流感检测试剂盒在症状出现后 24-48 小时内使用时,是诊断儿童 H1N1 的可靠工具。

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