Seasonal and pandemic influenza pose ongoing risks to global human public health. The emergence of the novel influenza A(H1N1) 2009 virus in the human population has led to a global influenza pandemic. Influenza diagnostic tests which aid in case management and outbreak control and permit monitoring of disease spread and viral evolution are critical to patient care and public health efforts. As a result, laboratory testing strategies must be developed and optimized in each country. While sophisticated influenza tests are available in specialized laboratories their capacity may be overwhelmed during a pandemic. Despite the growing significance of diagnostics in modern medicine and increasing diagnostic capabilities, the need for cheap and easy-in-use test to detect influenza virus, allowing the diagnosing within few minutes, with the sensitivity allowing to detect viral infection at all stages of infection, was not still satisfied. There should be available technology that can be used in remote settings and in physician’s offices or clinics without laboratory services.
Influenza is one of the most common viral infectious diseases and a significant cause of morbidity and mortality in many regions of the world, also in Poland. Influenza virus – thanks to its adaptability – is one of the most dangerous pathogens in the world. According to estimates by the World Health Organization, every year 330 million to 1.575 billion people suffer from influenza and influenza-like viruses, 3 to 5 million people suffer from its acute symptoms, 250 to 500 thousand people die in a result of its complications. Particularly young children, the elderly and immunosuppressed patients are vulnerable to the disease.
The strategic objective of the Project is to develop a ready to use and commercialization prototype of an innovative test FLUSENSOR. It will be miniaturized, fast, ultra sensitive and inexpensive detection of all serotypes of influenza virus. This test will be produced in two versions:
A. FLUSENSOR for use in doctors’ offices, hospitals, clinics, laboratories, pharmacies (the s-called PoCs – Points of Care) will consist of two components: a disposable microsensor, replaced during the diagnostics of individual patients, and a reader – an electronic device for reading test results from the microsensor.
A. FLUSENSOR for use by individual patients will consist of a microsensor with integrated measuring systems, and the reading of the result will be possible on the screen of mobile devices or computers (after installing a free application/software).
FLUESENSOR will be characterized by the following functionalities:
A. Ultra-sensitivity of the microsensor for the detection of influenza.
A very high sensitivity of detection of influenza virus, already at as low level as of 5-10 virions of influenza virus in throat swab. The test will allow detection of the virus at all stages of infection, both in the initial stage of the disease, as well as in the case of movement of the virus into the lower respiratory tract, without the necessity to provide its high concentration or the test, which usually occurs within 48 hours after infection; rapid detection of the virus will shorten the recovery time of patients, as well as the spread of the virus, which will significantly reduce the level of morbidity during periods of greatest incidence. The possibility of detection of influenza virus at the level of 5-10 virions of influenza virus in the sample; this sensitivity is about 1000 times greater than in RIDT tests currently available on the market and similar to the sensitivity of molecular methods, which in relative terms gives analytical sensitivity of 99.9%.
B. Rapidity of obtaining a result.
The test will allow the diagnosis of disease entity in just 5 minutes after sampling of the test material. This is particularly important during the period of high number of influenza cases, when a large number of patients reports influenza-like symptoms. The use of internal control in the form of detection of proteins found in the saliva (mucin) will allow eliminating false negatives. Reading of the result will be ready within max. 3 minutes, while reading of the analysis in competitive products is from 10 to 60 minutes.
C. Low cost of materials and production of microsensors.
Due to the low cost of materials and production, as well as the miniaturization of the electrodes, the test will be one of the cheapest solutions among those available on the market, despite the higher sensitivity. At the same time in mass production that cost can be further reduced.
Analyses indicate that FLUESENSOR will be a very competitive product on the market of in vitro tests for immediate use. Its ease of use, sensitivity and price will increase the availability of proper diagnosis of influenza which will translate into its proper treatment. Furthermore, additional information obtained by performed tests will give more complete and dynamically changing picture of the flu season which will facilitate the national / world policy against flu. The previous analysis also indicates that the product can be introduced on Polish market, the EU and the US, which are characterized by a growing demand for products such as RIDT.
The main advantages of the use of FLUSENSOR:
• improving the quality of health care and increase public awareness in the context of viral and bacterial infections also for low-income patients due to low cost of devices.
• the reduction of the prescription of antibiotics by family practitioners;
• the reduction of preventive administration of antibiotics to patients;
• the usefulness of isolating patients who are carriers of pathogens;
• the prevention of infections following abdominal operations;
• the prevention of infections of elder and disabled patients avoiding logistics to family practitioners or physicians;
• implementation of new products will be the development of the biotechnology industry.
Currently, carried out studies and research indicate that the technology upon which FLUSENSOR has been created can be used for the development of a wide variety of diagnostic products, not yet available, viruses and bacteria, cancer, neurological dysfunction, veterinary use. Commercialization of first sensors is only the beginning of the development of Eton Group, which shall allow for the stable development of the Company.
