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BD veritor™系统在基层医疗环境中快速检测甲型和乙型流感病毒的分析性能。

Analytical performance of the BD veritor™ system for rapid detection of influenza virus A and B in a primary healthcare setting.

作者信息

Mese Sevim, Akan Hulya, Badur Selim, Uyanik Aysun

机构信息

Department of Microbiology and Clinical Microbiology, Virology and Fundamental Immunology Unit, National Influenza Reference Laboratory, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.

Department of Family Medicine, Faculty of Medicine, Yeditepe University, Istanbul, Turkey.

出版信息

BMC Infect Dis. 2016 Sep 9;16(1):481. doi: 10.1186/s12879-016-1811-9.

Abstract

BACKGROUND

Infections with influenza A virus cannot be clinically differentiated from infections caused by influenza B virus or other respiratory viruses. Additionally, although antiviral treatment is available for influenza A virus, it is not effective for the other viruses and must be initiated early in the course of disease for it to be effective. For these reasons, there is a need for a rapid, accurate diagnostic test for use in physicians' offices at the time patients are seen. We report the first field performance of BD Veritor™ System for Rapid Detection of Flu A + B test compared to real time PCR. The performance of this test was compared to real time PCR performed in the Istanbul University Influenza Reference Laboratory.

METHOD

A single-blinded cross sectional study was conducted in nine different family medicine centers in Istanbul, Turkey between 01 November 2014 and 01 May 2015. For every patient, two specimens were collected, one for real time PCR and one for the Veritor test. Specimens for the Veritor test were immediately tested at the participating clinic according to the manufacturer's instructions. The specimens for real time PCR were transferred to the reference laboratory.

RESULTS

A total of 238 persons were included in the study: 72 (30 %) of the patients included in the study were below 19 years old and accepted as childhood group. Mean age of adults was 42.4 and children 10.2 years. A total of 122 patients out of 238 were positive for influenza. The clinical sensitivity and specificity of the Veritor test in all age groups was determined to be 80 and 94 %, respectively. Positive predictive value was 93 % and the negative one was 81 %.

CONCLUSION

Field performance of the rapid influenza test was high and found to be useful with respect to rational antiviral use, avoiding unnecessary antibiotic usage and the management of cases by the family physicians.

摘要

背景

甲型流感病毒感染在临床上无法与乙型流感病毒或其他呼吸道病毒引起的感染相区分。此外,虽然有针对甲型流感病毒的抗病毒治疗方法,但对其他病毒无效,且必须在病程早期开始使用才有效。基于这些原因,需要一种快速、准确的诊断测试,以便在患者就诊时能在医生办公室使用。我们报告了BD Veritor™系统快速检测甲型和乙型流感测试与实时聚合酶链反应(real time PCR)相比的首次现场性能。将该测试的性能与在伊斯坦布尔大学流感参考实验室进行的实时聚合酶链反应进行了比较。

方法

2014年11月1日至2015年5月1日期间,在土耳其伊斯坦布尔的九个不同家庭医学中心进行了一项单盲横断面研究。为每位患者采集两份样本,一份用于实时聚合酶链反应,一份用于Veritor测试。Veritor测试的样本在参与诊所按照制造商的说明立即进行检测。实时聚合酶链反应的样本被送往参考实验室。

结果

共有238人纳入研究:纳入研究的患者中有72人(30%)年龄在19岁以下,被视为儿童组。成人的平均年龄为42.4岁,儿童为10.2岁。238名患者中共有122人流感检测呈阳性。Veritor测试在所有年龄组中的临床敏感性和特异性分别确定为80%和94%。阳性预测值为93%,阴性预测值为81%。

结论

快速流感测试的现场性能很高,对于合理使用抗病毒药物、避免不必要的抗生素使用以及家庭医生对病例的管理很有用。

相似文献

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Clinical performance evaluation of the BD Veritor System Flu A+B assay.BD Veritor系统甲型/乙型流感检测的临床性能评估
J Virol Methods. 2014 Aug;204:86-90. doi: 10.1016/j.jviromet.2014.04.009. Epub 2014 Apr 18.

本文引用的文献

10
Molecular diagnosis of respiratory virus infections.呼吸道病毒感染的分子诊断。
Crit Rev Clin Lab Sci. 2011 Sep-Dec;48(5-6):217-49. doi: 10.3109/10408363.2011.640976.

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