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Monitoring of Viral Hepatitis

#1519


Improvements of the Methods for Detecting Contamination of Donor Blood with Viruses of Hepatitis B, C, G and Monitoring Viral Hepatitis in the Donor Contingent at Defence Enterprises

Tech Area / Field

  • MED-DID/Diagnostics & Devices/Medicine
  • BIO-CGM/Cytology, Genetics and Molecular Biology/Biotechnology

Status
8 Project completed

Registration date
18.05.1999

Completion date
24.03.2006

Senior Project Manager
Gremyakova T A

Leading Institute
Research Center of Toxicology and Hygienic Regulation of Biopreparations, Russia, Moscow reg., Serpukhov

Supporting institutes

  • Ministry of Health / Blood Center, Russia, Moscow

Collaborators

  • Center for Biologics Evaluation and Research/US Food and Drug Administration, USA, MD, Rockville

Project summary

The project is devoted to the problem of increasing safety of transfusions, that is the urgent task of the up-to-date medicine. Among infections transferred through transfusions, viral hepatitis deserve special attention, in WHO materials the control of viral hepatitis is considered as one of the main problem of the public health services.

It is known that viral hepatitis B, C, D and G or HBV, HCV, HDV and HGV can be transferred with blood. As a virus of hepatitis D can persist in a host organism only with the presence of hepatitis B, the transfusion transmission of HDV may be prevented by the reliable diagnosis of HBV. Well known hepatitis B and C as well as newly discovered viral hepatitis G will be the objects of investigation under the given project.

The first goal of the project is devoted to comparative study of sensitivity and specificity of different methods for detecting markers of viral hepatitis in blood of donors worked at defence enterprises to improve the methods for increasing transfusion safety.

The second goal of the given project is monitoring the occurrence of hepatitis among population of Moscow and Moscow region.

Over many years the enterprises of defence complex had medical service system including donor services. In the framework of the state program at the defence enterprises, regular medical examinations and professional health-improvement measures took place, that is why the obtained data on blood contamination with parenteral hepatitis may be analysed in the dynamics for some years.

Under implementation of the research work on the proposed project the following methods will be used: molecular biology, immunological, and biochemical. Under implementation of the project, a wide examination of donor blood directed to revealing serological markers of HCV and HBV by enzymimmunoassay will be carried out.

Specific feature of hepatitis C is a very low concentration of agents in blood serum of a patient or carrier. Revealing and rejection of blood obtained from persons with anti-HCV allow to reduce a number of posttransfusion hepatitis C cases, because availability of antibodies may testify to circulation of virus. A blood of the same donors will be examined to detect DNA-HBV and RNA-HCV by the method of polymerase chain reaction. PCR allows to diagnose hepatitis B and C in HBs Ag and anti-HCV negative persons with chronic hepatitis B and C, to reveal HCV viremia in blood of donors with normal level of aminotransferase. Often RNA-HCV is a single marker of contamination with hepatitis C, because it is detected in of anti-HCV negative carriers.

At the present, to detect virus of hepatitis C, the method of PCR-diagnostics has been developed. During the first year of the project implementation the sensitive methods of serodiagnostics and/or PCR-diagnostics of HGV will be chosen and used for examination of donor blood.

Special attention will be given to the PCR performance using material of clinical samples as a matrix without the stage of isolation and purification of nucleic acids. It is a way used by some researchers. It reduces time necessary for PCR-diagnostics and simplifies it.

As the result of the work implementation, the statistics will be obtained and analysed concerning to:


– spreading markers of viral hepatitis B and C among donor contingent;
– cases of revealing markers of viral hepatitis G in donor blood, at the present its clinical role is under consideration;
– influence of social factors and unhealthy work conditions on spreading viral hepatitis B and C;
– advantages and disadvantages of the modern methods used for revealing contamination of donor blood with viruses of hepatitis B, C and G.

On the basis of the obtained data, the methodological recommendations to improve examination of donor blood may be proposed. Monitoring the occurrence of markers of viral hepatitis B, C and may be G among the donor contingent at enterprises of defence complex of Moscow and Moscow region will be carried out. If the interrelation between unhealthy work conditions and the frequency of viral contamination of donor blood will be revealed, practical recommendations for selection of the donor contingent to increase safety of transfusions will be done.

Foreign collaborators would take part in the project under the following directions:


1) patent information support of the project;
2) preparing and reviewing scientific publications;
3) scientific seminars on discussion the key points of the project implementation.


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