Hepatitis B virus (HBV), Hepatitis C virus (HCV) and Human immunodeficiency virus (HIV) are the main human pathogens that can transmitted through blood. Despite all health precautions transmission of these microorganisms during blood transfusion is the most important health problem. HBV is transmitted mainly by parenteral route. Acute viral hepatitis is developed in 10% of the people who are in contact with the HBV and fulminant hepatitis occurs in 0.1% of them. Among hepatitis viruses HCV is the most common cause of hepatitis and it is mostly transmitted through transfusion. 80% HCV infections are long-term chronic infections if patients left untreated. HIV is well known viruses that are transmitted by blood transfusion and sexually which, has a prevalence of 1.1% in adults all over the world. Transmission and infections caused by these pathogens can be managed by rapid diagnosis, effective treatment and screening. Transmission of viruses can be observed even serological indicators are negative. Also after transmission long term clinical signs that can result in death. For safe blood transfusion donors are questioned and their bloods are analyzed by screening tests.

 

Various clinical tests have developed for blood screening in the last 30 years but problem is that those tests are not suitable for each situation, also have some limitations. Nowadays viral screening is performed mainly by antigen detection and molecular methods. Molecular methods, which started as pool tests and used only in plasma products, have become mandatory in many countries. The main problem of molecular methods is excess cost. In some countries such as Austria, Lithuania, Poland, Spain, Portugal and Greece molecular methods to detect HBV DNA are optional while those tests are mandatory in Germany, Italy and Japan. Tests for presence of anti-HCV and anti-HIV positivity before blood transfusion indicate the importance of viral screening. In addition, window period of infections, the pre-seroconversion period and the sensitivity of the methods used to detect viruses demonstrate the necessity of molecular methods. Clinically, it is not possible to screen all of the viral agents transmitted by transfusion. Type of infection and pathogens, treatment and cost-effectiveness are important in determining the routine tests. HBV HCV HIV cause serious diseases that affect public health directly. Because of these factors these viruses must be included in screening test. Presence of HBV HCV and HIV viral screening tests are approved by Ministry of Health in Turkey.

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The Global Health Sector Strategy which is established by WHO anticipates that reducing risk of new hepatitis infection and mortality rate of hepatitis will remove viral hepatitis from being a risk to public health by 2030. On the other hand, 90-90-90 global HIV targets sets determined by the UNAIDS organization for ending the AIDS epidemic that has killed approximately 40 million people for years so this organization is aimed to diagnose 90% of HIV-infected people by 2020. For these reasons, fast, sensitive, reliable and economical new methods are needed for the laboratory diagnosis of those viral agents .

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The aim of the project is that development of cost-effective, susceptible and sensitive diagnostic kits which can be placed at bedside or in the field. Kits are aimed to be easy to use and interpret without necessity of expert and also are durable to various environmental conditions. Those kits can be used in case of emergency such as natural disasters, large-scale fires, and for medical and surgical intervention during war, for safety of hemodialysis patients and healthcare personnel against blood-borne diseases before or after medical intervention and for detection of blood-borne infectious agents in the military fields and blood banks.

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For this purpose, Compact Disc (CD) system (Labonadisk) will be produced. It will be integrated into microfluidic platform, which will work with centrifuge principle. It will perform all operations including the DNA / RNA isolation step in a closed way and keep reaction chemicals ready in lyophilized form.