Update on Influenza Diagnostics: Lessons from the Novel H1N1 Influenza A Pandemic

Abstract

SUMMARY 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.

Emerging Viral Diseases

“…44 Treatment Specific anti-viral treatment is available for swine flu. During the 2009 to 2010 H1N1 influenza A pandemic, the United States Centers for Disease Control and Prevention (CDC) released guidelines for the use of antivirals for patients with confirmed or suspected influenza virus infection, which include a neuraminidase inhibitor (orally inhaled or intravenous zanamivir, oral oseltamivir or newly developed intravenous peramivir).…”

Diagnostic Methods of Influenza a From Clinical Specimens: A Critical Review of Literature

“…In culture, the viruses cause different cytophatic effects, according to the main cell lines used for influenza isolation, such as: monkey kidney cells, Madin Darby canine kidney (MDCK) cells and A549 cells (Li et al 2009). This classic laboratory diagnostic method is recognized as an important gold-standard technique to be available in reference laboratories worldwide (Kumar & Henrickson 2012).…”

“…Influenza viruses are remarkably known for their features of continuous antigenic change through antigenic drift and shift (Webster et al 1992). This highlights the importance of rapid and reliable diagnostic methods to prevent shortcomings that would underscore the importance and impact on public health policy, decreasing and/or delaying detection of novel strains, prior to its widespread dissemination (Kumar & Henrickson 2012).…”

“…Taking into account the existing diagnostic systems, they can present a wide variation in diagnostic capabilities with regard to the cost, sensitivity, specificity, and other important performance characteristics, such as turnaround time, throughput, and complexity of use (Kumar & Henrickson 2012).…”

Evaluation of the Alere i Influenza A&B assay for rapid identification of influenza A and influenza B viruses

“…Molecular tests have become the gold standard to detect influenza viruses in clinical laboratories due to their high level of sensitivity and specificity (Kumar & Henrickson, 2012). One of the biggest limitations of these tests is that they are technically demanding, laborious, and usually have a slow turnaround time to results (Ginocchio et al, 2009).…”