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与实时逆转录聚合酶链反应相比,甲型H1N1pdm09流感病毒感染儿童中快速流感诊断检测和免疫荧光检测的准确性

Accuracy of rapid influenza diagnostic test and immunofluorescence assay compared to real time RT-PCR in children with influenza A(H1N1)pdm09 infection.

作者信息

Nitsch-Osuch Aneta, Woźniak-Kosek Agnieszka, Brydak Lidia Bernadeta

机构信息

Department of Family Medicine, Warsaw Medical University, Banacha 1a, 02-097 Warsaw, Poland.

出版信息

Postepy Hig Med Dosw (Online). 2012 Oct 22;66:752-7. doi: 10.5604/17322693.1015040.

Abstract

INTRODUCTION

The influenza burden among children is underestimated. The aim of our study was to estimate the accuracy of the rapid influenza detection test (RIDT) BD Directigen™ EZ Flu A+B® and direct immunofluorescence assay (DFA) used among children with influenza-like illness (ILI) consulted in the ambulatory care clinic.

MATERIAL/METHODS: A total of 150 patients were enrolled in the study. Inclusion criteria were: age less than 59 months, presentation of ILI according to the CDC (Centers for Disease Control and Prevention) definition (fever >37.8°C, cough and/or sore throat in the absence of another known cause of illness), duration of symptoms shorter than 96 hours. Two nasal swabs and one pharyngeal swab were obtained from patients and tested by RIDT, DFA and real time RT-PCR as the reference method.

RESULTS

For influenza A (H1N1)pdm09 virus sensitivity of RIDT was 62.2% (95% CI 46.5-76.2%), specificity 97.1% (95% CI 91.8-99.4%), PPV 90.3% (95% CI 74.3-98%), NPV 85.7% (95% CI 78.1-91.5%), for DFA sensitivity was 60% (95% CI 51.9-63.2%), specificity 96% (95% CI 88.7-98.8%), PPV 93.1% (95% CI 80.5-98%), NPV 72.7% (95% CI 67.2-74.9%). Analysis of logistic regression revealed that the chance of receiving a true positive result of RIDT was twice as high when the test was conducted during the first 48 hours of symptoms (OR 0.40 vs OR 0.22).

CONCLUSIONS

The accuracy of RIDT is comparable with DFA and both methods are very specific but moderately sensitive in diagnosis of influenza in young children. Both methods may be recommended for screening for influenza among children.

摘要

引言

儿童流感负担被低估。我们研究的目的是评估快速流感检测试验(RIDT)BD Directigen™ EZ Flu A+B®以及直接免疫荧光法(DFA)在门诊就诊的流感样疾病(ILI)儿童中使用时的准确性。

材料/方法:共有150名患者纳入本研究。纳入标准为:年龄小于59个月,根据美国疾病控制与预防中心(CDC)定义出现ILI(发热>37.8°C,咳嗽和/或咽痛且无其他已知病因),症状持续时间短于96小时。从患者处采集两支鼻拭子和一支咽拭子,通过RIDT、DFA检测,并以实时逆转录聚合酶链反应(RT-PCR)作为参考方法进行检测。

结果

对于甲型(H1N1)pdm09流感病毒,RIDT的敏感性为62.2%(95%置信区间46.5 - 76.2%),特异性为97.1%(95%置信区间91.8 - 99.4%),阳性预测值为90.3%(95%置信区间74.3 - 98%),阴性预测值为85.7%(95%置信区间78.1 - 91.5%);DFA的敏感性为60%(95%置信区间51.9 - 63.2%),特异性为96%(95%置信区间88.7 - 98.8%),阳性预测值为93.1%(95%置信区间80.5 - 98%),阴性预测值为72.7%(95%置信区间67.2 - 74.9%)。逻辑回归分析显示,在症状出现的前48小时内进行检测时,获得RIDT真阳性结果的几率是其他时间的两倍(比值比0.40对0.22)。

结论

RIDT的准确性与DFA相当,两种方法在幼儿流感诊断中都具有很高的特异性,但敏感性中等。两种方法均可推荐用于儿童流感筛查。

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