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Xpert Flu PCR 检测与 OSOM 免疫层析快速检测法在急诊科成年患者中用于甲型和乙型流感病毒的诊断性能。

Diagnostic performances of the Xpert Flu PCR test and the OSOM immunochromatographic rapid test for influenza A and B virus among adult patients in the Emergency Department.

机构信息

Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Universitaire Paris Nord Val de Seine, Emergency Department, Paris, France; Université Paris Diderot, Sorbonne Paris Cité, EA 7334, Recherche clinique coordonnée ville-hôpital, Méthodologies et Société (REMES), Paris, France; Study Group for Efficiency and Quality of Emergency Departments and Non-Scheduled Activities Departments, Paris, France.

IAME (Infection, Antimicrobials, Modelling, Evolution), Université Paris Diderot, Sorbonne Paris Cité, UMR 1137, INSERM, Paris, France; Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Universitaire Paris Nord Val de Seine, Laboratoire de Virologie, Hôpital Bichat, AP-HP, Paris, France.

出版信息

J Clin Virol. 2018 Feb-Mar;99-100:5-9. doi: 10.1016/j.jcv.2017.12.005. Epub 2017 Dec 13.

Abstract

BACKGROUND

New rapid influenza diagnostic tests (RIDT) are available but their clinical utility in adults has not been validated.

OBJECTIVES

To evaluate the diagnostic performances of OSOM Ultra Flu A&B a RIDT on viral strains of influenza A/B from the last epidemic season, and its feasibility by Emergency Department (ED) physicians and nurses.

STUDY DESIGN

Of the 1099 patients admitted to the ED with suspected influenza, all having a nasopharyngeal swab tested by the Xpert Flu PCR and then stored at -20 °C; 500 were selected at random and their samples were tested using the RIDT. Two experts reviewed ED and hospital medical records and all virological data to define influenza cases. Intra- and inter-observer variability were calculated.

RESULTS

Of the 500 patients included 45% were ≥75 years, 122 (24.4%) presented with influenza based on clinical and virological criteria. PCR test performances (%) were Se 98.4 (95% CI 93.6-99.7), Spe 99.7 (98.3-100), PPV 99.2 (94.8-100) and NPV 99.5 (97.9-100); and RIDT performances were Se 95.1 (89.2-97.9), Spe 98.4 (96.4-99.4), PPV 95.1 (87.2-99.9) and NPV 98.4 (96.4-98). There was no difference in test performance between influenza A and B virus nor between the influenza A subtypes. Intra- and inter-observer variability of RIDT were 0.94 (0.89-0.99) and 0.96 (0.92-1).

CONCLUSION

Our results show that the Xpert Flu PCR and the OSOM Ultra Flu A&B Test perform very well in diagnosing strains of circulating virus in adults and elderly. Our results also confirm the feasibility of this RIDT at point-of-care by ED staff.

摘要

背景

新的快速流感诊断检测(RIDT)已经可用,但尚未在成人中验证其临床效用。

目的

评估 OSOM Ultra Flu A&B RIDT 在过去流行季节的流感 A/B 病毒株中的诊断性能,以及急诊医师和护士使用该 RIDT 的可行性。

研究设计

从急诊科收治的 1099 例疑似流感患者中,所有患者均进行鼻咽拭子 Xpert Flu PCR 检测,然后储存在-20°C;随机选择 500 例患者,对其样本进行 RIDT 检测。两位专家回顾了 ED 和医院的病历以及所有病毒学数据,以确定流感病例。计算了观察者内和观察者间的变异性。

结果

在 500 例纳入患者中,45%的患者年龄≥75 岁,122 例(24.4%)根据临床和病毒学标准诊断为流感。PCR 检测的性能(%)为 Se 98.4(95%CI 93.6-99.7)、Spe 99.7(98.3-100)、PPV 99.2(94.8-100)和 NPV 99.5(97.9-100);RIDT 的性能分别为 Se 95.1(89.2-97.9)、Spe 98.4(96.4-99.4)、PPV 95.1(87.2-99.9)和 NPV 98.4(96.4-98.4)。流感 A 型和 B 型病毒以及流感 A 亚型之间的检测性能无差异。RIDT 的观察者内和观察者间变异性分别为 0.94(0.89-0.99)和 0.96(0.92-1)。

结论

我们的结果表明,Xpert Flu PCR 和 OSOM Ultra Flu A&B 检测在诊断成人和老年人中流行病毒株方面表现非常出色。我们的结果还证实了 ED 工作人员在床边使用这种 RIDT 的可行性。

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