Midwest Respiratory Virus Program, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Clin Microbiol Rev. 2012 Apr;25(2):344-61. doi: 10.1128/CMR.05016-11.
The menu of diagnostic tools that can be utilized to establish a diagnosis of influenza is extensive and includes classic virology techniques as well as new and emerging methods. This review of how the various existing diagnostic methods have been utilized, first in the context of a rapidly evolving outbreak of novel influenza virus and then during the different subsequent phases and waves of the pandemic, demonstrates the unique roles, advantages, and limitations of each of these methods. Rapid antigen tests were used extensively throughout the pandemic. Recognition of the low negative predictive values of these tests is important. Private laboratories with preexisting expertise, infrastructure, and resources for rapid development, validation, and implementation of laboratory-developed assays played an unprecedented role in helping to meet the diagnostic demands during the pandemic. FDA-cleared assays remain an important element of the diagnostic armamentarium during a pandemic, and a process must be developed with the FDA to allow manufacturers to modify these assays for detection of novel strains in a timely fashion. The need and role for subtyping of influenza viruses and antiviral susceptibility testing will likely depend on qualitative (circulating subtypes and their resistance patterns) and quantitative (relative prevalence) characterization of influenza viruses circulating during future epidemics and pandemics.
可用于确诊流感的诊断工具种类繁多，包括经典病毒学技术以及新兴方法。本文综述了在新型流感病毒迅速暴发期间以及随后的大流行不同阶段和波次中，各种现有诊断方法的应用情况，展示了这些方法各自的独特作用、优势和局限性。在整个大流行期间，快速抗原检测得到了广泛应用。认识到这些检测的阴性预测值较低非常重要。具有快速开发、验证和实施实验室开发检测经验、基础设施和资源的私营实验室，在满足大流行期间的诊断需求方面发挥了前所未有的作用。获得 FDA 批准的检测方法仍然是大流行期间诊断工具包的重要组成部分，必须与 FDA 共同制定一个流程，以便制造商能够及时修改这些检测方法以检测新型菌株。流感病毒的亚型分析和抗病毒药敏检测的需求和作用可能取决于未来流行和大流行期间循环流感病毒的定性（循环亚型及其耐药模式）和定量（相对流行率）特征。
