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Title: Successes and short comings in four years of an international external quality assurance program for animal Influenza surveillance

Author
item Spackman, Erica
item CARDONA, CAROL - University Of Minnesota
item MUNOZ-AGUAYO, JEANNETTE - University Of Minnesota
item FLEMING, SUSAN - University Of Minnesota

Submitted to: PLOS ONE
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 9/22/2016
Publication Date: 10/27/2016
Publication URL: https://handle.nal.usda.gov/10113/63289
Citation: Spackman, E., Cardona, C., Munoz-Aguayo, J., Fleming, S. 2016. Successes and short comings in four years of an international external quality assurance program for animal Influenza surveillance. PLoS One. 11(10):e0164261. doi:10.1371/journal.pone.0164261.

Interpretive Summary: Quality control and assurance (QA/QC) are crucial to ensure accurate results in disease monitoring and surveillance testing. Numerous laboratories around the world which conduct surveillance for influenza A in animals are affiliated with an NIH research consortium, the Centers of excellence for influenza research and surveillance (CEIRS). A QA/QC program was implemented to help laboratories in this program evaluate their testing procedures and personnel training. During the first three rounds of testing a total of 41 labs from 21 countries participated. It was shown that the vast majority of laboratories had adequate testing procedures in place, and were detecting the influenza virus as expected. A small number of labs were able to identify problems with their testing protocols and subsequently fix them as evidenced by improved scores.

Technical Abstract: The US National institutes of Health-Centers of Excellence for Influenza Research and Surveillance is a research consortium that funds numerous labs worldwide to conduct influenza A surveillance in diverse animal species. There is no harmonization of testing procedures among these labs; therefore an external quality assurance (EQA) program was implemented to evaluate testing accuracy among labs in the program in 2012. Accurate detection of novel influenza A variants is crucial because of the broad host range and potentially high virulence of the virus in diverse species. Two molecular detection sample sets and 2 serology sample sets (one with avian origin isolates, and one with mammalian origin isolates each) were made available at approximately six month intervals. Participating labs tested the material in accordance with their own protocols. During a five year period a total of 41 labs from 23 countries ordered a total of 132 avian molecular, 121 mammalian molecular and 90 serology sample sets. Testing was completed by 111 individuals. Detection of type A influenza by RT-PCR was reliable with a pass rate (80% or greater agreement with expected results) of 86.6% for avian and 86.2% for mammalian origin isolates. However, identification of subtype by RT-PCR was relatively poor with 54.1% and 75.9% accuracy for avian and mammalian influenza isolates respectively. Serological testing had an overall pass rate of 86.9% and 22/23 labs used commercial ELISA kits. Based on the results of this EQA program six labs modified their procedures to improve accuracy and one lab identified an unknown equipment problem. These data represent the successful implementation of an international EQA program for an infectious disease; insights into the logistics and test design are also discussed.