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The influenza A virus is known to cause influenza in birds and some mammals, like humans. Several subtypes of the influenza A virus have been isolated from wild birds. Occasionally, viruses can be transmitted from wild birds to domestic animals, like chickens or pigs. This may give rise to human influenza.<ref name="Arti2">Transmission of Avian Influenza A Viruses Between Animals and People, CDC, 2015, https://www.cdc.gov/flu/avianflu/virus-transmission.htm</ref>
Influenza A viruses are negative-sense, single-stranded RNA viruses. Subtypes of influenza A are characterized by proteins on the outermost membrane of the virus, called hemagglutinin (H or HA) and neuraminidase (N or NA). H and N are the antigens of the virus, and play an important role in the interaction between the host’s immunological response and the virus. Recently, researchers have reported the discovery of an antibody that is generally effective against all subtypes of the influenza A virus.<ref name="Arti3">Super antibody' fights off flu, BBC, 2011, James Gallagher, https://www.bbc.com/news/health-14324901</ref> Hemagglutinin will serve as this year's biomarker. In infected patients, bound hemagglutinin indicates the presence of the influenza virus. In the Testing Event, unbound hemagglutinin proteins will be used to mimic the immunologic response of the virus.
The subtype which will be used in SensUs 2021 is H1N1. Historically, H1N1 has been responsible for most deaths due to influenza. It is a popular influenza strain for research purposes.<ref name="Arti4">Prevalent Eurasian avian-like H1N1 swine influenza virus with 2009 pandemic viral genes facilitating human infection, Research Gate, 2020, Sun, Honglei & Xiao, Yihong & Liu, Jiyu & Wang, Dayan & Li, Fangtao & Wang, Chenxi & Li, Chong & Zhu, Junda & Song, Jingwei & Sun, Haoran & Zhimin, Jiang & Liu, Litao & Zhang, Xin & Wei, Kai & Dongjun, Hou & Pu, Juan & Sun, Yipeng & Tong, Qi & Bi, Yuhai & Liu, Jinhua https://www.researchgate.net/publication/342555087_Prevalent_Eurasian_avian-like_H1N1_swine_influenza_virus_with_2009_pandemic_viral_genes_facilitating_human_infection</ref><ref name="Arti5">Comparison of Hospitalized Patients With ARDS Caused by COVID-19 and H1N1, CHEST, Xiao Tang, Rong-Hui Du, Rui Wang, Tan-Ze Cao, Lu-Lu Guan, Cheng-Qing Yang, Qi Zhu, Ming Hu, Xu-Yan Li, Ying Li, Li-Rong Liang, Zhao-Hui Tong, Bing Sun, Peng Peng, Huan-Zhong Shi, 2020, https://www.sciencedirect.com/science/article/pii/S0012369220305584</ref><ref name="Arti6">Landscape of coordinated immune responses to H1N1 challenge in humans, Journal of Clinical Investigation, 2020, Zainab Rahil, Rebecca Leylek, Christian M. Schürch, Han Chen, Zach Bjornson-Hooper, Shannon R. Christensen, Pier Federico Gherardini, Salil S. Bhate, Matthew H. Spitzer, Gabriela K. Fragiadakis, Nilanjan Mukherjee, Nelson Kim, Sizun Jiang, Jennifer Yo, Brice Gaudilliere, Melton Affrime, Bonnie Bock, Scott E. Hensley, Juliana Idoyaga, Nima Aghaeepour, Kenneth Kim, Garry P. Nolan, David R. McIlwain https://www.sciencedirect.com/science/article/pii/S0012369220305584</ref> Due to its popularity among researchers, antigens and antibodies are commercially available, making H1N1 suitable as a target for the SensUs Competition.
For disease control, it is crucial to know the infection rate in a specific region. The results may influence critical decisions such as whether to perform other diagnostic testing or to implement infection prevention and control measures for influenza. Furthermore, manpower can be in short supply during a pandemic and the speed at which someone can be tested and receive the result is of vital importance.
Biosensors that will be developed in SensUs 2021 are envisioned to be used outside the hospital in a point-of-care (POC) setting. Inside the hospital there is not a big advantage, as there are already very specific and accurate tests available for that setting.<ref name="Arti28">Diagnosing Flu, CDC, 2020, https://www.cdc.gov/flu/symptoms/testing.htm</ref><ref name="Arti29">Information on Rapid Molecular Assays, RT-PCR, and other Molecular Assays for Diagnosis of Influenza Virus Infection, CDC, 2020, https://www.cdc.gov/flu/professionals/diagnosis/molecular-assays.htm</ref> Important applications are fast testing at the general practioner and at home. Therefore the test should be easy to use. The biosensors will be designed to enable a fast yes/no answer, based on measuring the concentration of viral hemagglutinin particles in the sample. The biosensors will not distinguish between different virus subtypes, as the subtype causing the pandemic is assumed to be known.
==State of the Art==
==Safety==
When working with the influenza virus, influenza infection in humans can occur following a laboratory accident. For safety reasons, inactivated virus unbound hemagglutinin particles will be used in SensUs 2021, as a substitute for infectious influenza virus particles.
===Lab protocols===