Analytical reactivity of 13 commercially available rapid influenza diagnostic tests with H3N2v and recently circulating influenza viruses
Analytical reactivity of 13 commercially available rapid influenza diagnostic tests with H3N2v and recently circulating influenza viruses
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DOI：
10.1111/irv.12246
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发表时间：
2014-07-01
影响因子：
4.4
通讯作者：
Henrickson, Kelly J.
中科院分区：
文献类型：
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作者：
Bose, Michael E.;Sasman, Amy;Henrickson, Kelly J.
目的临床上广泛使用的快速流感诊断试验(RIDT)使用简单，在15分钟内就能得到结果，但报道的性能参差不齐，当出现新的或变异病毒时，这引起了人们的关注。这项研究的目标是使用三种不同的病毒测量方法评估13种RIDT对最近流行的季节性和H3N2v流感病毒的分析反应性。设计的病毒库以感染剂量(ID50)和核蛋白(NP)浓度为特征，以半对数稀释，并用每次RIDT和实时RT-PCR进行检测。结果NP浓度与RIDT反应性有很强的相关性，而与ID50或Ct值的相关性较弱。在所有甲型流感病毒(IAV)中，只有4种RIDT以最低稀释度检测到病毒NP。多个RIDT未检测到的甲型流感病毒NP水平较低。在13个RIDT中，与NP水平相比，9个IAV的反应性没有显著差异。结论以前关于RIDT性能的报告通常比较基于ID50滴度的反应性，在本研究中，ID50滴度与制备的病毒样本中病毒NP的比例仅有微弱的相关性。在RIDT反应性与NP浓度强烈相关的背景下，H3N2v被发现与季节性循环IAV一样具有反应性。虽然这些发现可能不能反映这些RIDT的临床表现，但在未来，测量NP浓度可能有助于评估现有RIDT的可比反应性，或评估与新进化或新出现的病毒的反应性。
Objectives Rapid influenza diagnostic tests (RIDTs) used widely in clinical practice are simple to use and provide results within 15minutes; however, reported performance is variable, which causes concern when novel or variant viruses emerge. This study's goal was to assess the analytical reactivity of 13 RIDTs with recently circulating seasonal and H3N2v influenza viruses, using three different viral measures. Design Virus stocks were characterized by infectious dose (ID50) and nucleoprotein (NP) concentration, diluted at half-log dilutions, and tested with each RIDT and real-time RT-PCR. Results Strong correlation was observed between NP concentration and RIDT reactivity; however, only weak correlation was seen with ID50 or Ct values. Only four RIDTs detected viral NP at the lowest dilution for all influenza A viruses (IAV). Influenza A viruses not detected by more than one RIDT had lower NP levels. Of the 13 RIDTs, 9 had no significant differences in reactivity across IAV when compared to NP levels. Conclusions Previous reports of RIDT performance typically compare reactivity based on ID50 titers, which in this study correlated only weakly with proportional amounts of viral NP in prepared virus samples. In the context of the strong correlation of RIDT reactivity with NP concentration, H3N2v was found to be as reactive as seasonal circulating IAV. While these findings may not reflect clinical performance of these RIDTs, measuring NP concentration can be useful in the future to assess comparable reactivity of available RIDTs, or to assess reactivity with newly evolving or emerging viruses.