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快速诊断检测试剂盒与疾病预防控制中心流感 rRT-PCR 面板全球参考实验室在检测甲型和乙型流感方面的性能比较。

Comparison of performance between Fast Track Diagnostics Respiratory Kit and the CDC global reference laboratory for influenza rRT-PCR panel for detection of influenza A and influenza B.

机构信息

Laboratoire National de Référence-Grippes (LNR-G), Institut de Recherche en Sciences de la Santé (IRSS), Bobo Dioulasso, Burkina Faso.

Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Atlanta, GA, USA.

出版信息

Influenza Other Respir Viruses. 2021 May;15(3):381-388. doi: 10.1111/irv.12830. Epub 2021 Feb 26.

Abstract

BACKGROUND

Reliable diagnostics are a key to identifying influenza infections.

OBJECTIVES

Our objectives were to describe the detection of influenza among severe acute respiratory infection (SARI) cases, to compare test results from the Fast Track Diagnostics (FTD) Kit for influenza detection to the Centers for Disease Control (CDC) human influenza virus detection and characterization panel, and to assess seasonality of influenza in Burkina Faso.

METHODS

Nasopharyngeal and oropharyngeal specimens from SARI cases (hospitalized patients with fever, cough, and onset in the previous 10 days) were tested using the FTD-33 Kit and the CDC rRT-PCR influenza assays. We assessed sensitivity and specificity of the FTD-33 Kit for detecting influenza A, influenza B, and the influenza A(H1N1)pdm09 strain using the CDC human influenza rRT-PCR panel as the gold standard.

RESULTS

From December 2016 to February 2019, 1706 SARI cases were identified, 1511 specimens were tested, and 211 were positive for influenza A (14.0%) and 100 for influenza B (6.6%) by either assay. Higher influenza circulation occurred between November and April with varying peaks of influenza A and influenza B. Sensitivity of the FTD-33 assay was 91.9% for influenza A, 95.7% for influenza B, and 93.8% for A(H1N1)pdm09 subtype. Specificity was over 99% for all three tests.

CONCLUSIONS

Our study indicates that Burkina Faso has one peak of influenza each year which is similar to the Northern Hemisphere and differs from other countries in West Africa. We found high concordance of influenza results between the two assays indicating FTD-33 can be used to reliably detect influenza among SARI cases.

摘要

背景

可靠的诊断是识别流感感染的关键。

目的

我们的目的是描述严重急性呼吸道感染(SARI)病例中流感的检测情况,比较快速诊断检测试剂盒(FTD)对流感的检测结果与疾病控制中心(CDC)人类流感病毒检测和特征面板的结果,并评估布基纳法索流感的季节性。

方法

使用 FTD-33 试剂盒和 CDC rRT-PCR 流感检测方法检测 SARI 病例(发热、咳嗽、发病前 10 天内住院的患者)的鼻咽和口咽标本。我们使用 CDC 人类流感 rRT-PCR 面板评估 FTD-33 试剂盒检测流感 A、流感 B 和流感 A(H1N1)pdm09 株的敏感性和特异性,该面板作为金标准。

结果

2016 年 12 月至 2019 年 2 月,共发现 1706 例 SARI 病例,检测了 1511 份标本,两种检测方法均检测到 211 例流感 A(14.0%)阳性和 100 例流感 B(6.6%)阳性。11 月至 4 月流感循环较高,流感 A 和流感 B 的峰值不同。FTD-33 检测法对流感 A 的敏感性为 91.9%,对流感 B 的敏感性为 95.7%,对 A(H1N1)pdm09 亚型的敏感性为 93.8%。所有三种检测的特异性均超过 99%。

结论

我们的研究表明,布基纳法索每年有一个流感高峰,与北半球相似,与西非其他国家不同。我们发现两种检测方法的流感结果高度一致,表明 FTD-33 可用于可靠地检测 SARI 病例中的流感。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d14c/8051705/db37b8acc6fb/IRV-15-381-g001.jpg

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