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Standardizing the Influenza Neuraminidase Inhibition Assay among United States Public Health Laboratories Conducting Virological Surveillance

tetano

Editor, Senior Moderator
Antiviral Res. 2016 Jan 22. pii: S0166-3542(16)30011-0. doi: 10.1016/j.antiviral.2016.01.009. [Epub ahead of print]
[h=1]Standardizing the Influenza Neuraminidase Inhibition Assay among United States Public Health Laboratories Conducting Virological Surveillance.[/h] Okomo-Adhiambo M[SUP]1[/SUP], Mishin VP[SUP]1[/SUP], Sleeman K[SUP]1[/SUP], Saguar E[SUP]2[/SUP], Guevara H[SUP]3[/SUP], Reisdorf E[SUP]3[/SUP], Griesser RH[SUP]3[/SUP], Spackman KJ[SUP]4[/SUP], Mendenhall M[SUP]4[/SUP], Carlos MP[SUP]5[/SUP], Healey B[SUP]5[/SUP], St George K[SUP]6[/SUP], Laplante J[SUP]6[/SUP], Aden T[SUP]7[/SUP], Chester S[SUP]7[/SUP], Xu X[SUP]1[/SUP], Gubareva LV[SUP]8[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Monitoring influenza virus susceptibility to neuraminidase (NA) inhibitors (NAIs) is vital for detecting drug-resistant variants, and is primarily assessed using NA inhibition (NI) assays, supplemented by NA sequence analysis. However, differences in NI testing methodologies between surveillance laboratories results in variability of 50% inhibitory concentration (IC[SUB]50[/SUB]) values, which impacts data sharing, reporting and interpretation. In 2011, the Centers for Disease Control and Prevention (CDC), in collaboration with the Association for Public Health Laboratories (APHL) spearheaded efforts to standardize fluorescence-based NI assay testing in the United States (U.S.), with the goal of achieving consistency of IC[SUB]50[/SUB] data.
[h=4]METHODS:[/h] For the standardization process, three participating state public health laboratories (PHLs), designated as National Surveillance Reference Centers for Influenza (NSRC-Is), assessed the NAI susceptibility of the 2011-12 CDC reference virus panel using stepwise procedures with support from the CDC reference laboratory. Next, the NSRC-Is assessed the NAI susceptibility of season 2011-12 U.S. influenza surveillance isolates (n=940), with a large subset (n=742) tested in parallel by CDC. Subsequently, U.S. influenza surveillance isolates (n=9629) circulating during the next three influenza seasons (2012-15), were independently tested by the three NSRC-Is (n=7331) and CDC (n=2298).
[h=4]RESULTS:[/h] The NI assay IC[SUB]50[/SUB]s generated by respective NSRC-Is using viruses and drugs prepared by CDC were similar to those obtained with viruses and drugs prepared in-house, and were uniform between laboratories. IC[SUB]50[/SUB]s for U.S. surveillance isolates tested during four consecutive influenza seasons (2011-15) were consistent from season to season, within and between laboratories.
[h=4]CONCLUSION:[/h] These results show that the NI assay is robust enough to be standardized, marking the first time IC[SUB]50[/SUB] data have been normalized across multiple laboratories, and used for U.S. national NAI susceptibility surveillance.
Copyright ? 2016. Published by Elsevier B.V.


[h=4]KEYWORDS:[/h] Assay standardization; neuraminidase inhibition; oseltamivir; peramivir; zanamivir

PMID: 26808479 [PubMed - as supplied by publisher]
 
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