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Diagnostics Improvements for HIV and Accompanying Infections

#2497


Improvement of Methods of Diagnostics of HIV-Infection and Accompanying Infections

Tech Area / Field

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

Status
3 Approved without Funding

Registration date
17.04.2002

Leading Institute
Research Center of Molecular Diagnostics and Theraphy, Russia, Moscow

Supporting institutes

  • L.A. Tarasevich State Institute of Standardization and Control of Biomedical Preparations, Russia, Moscow

Collaborators

  • Centers for Disease Control and Prevention (CDC) / National Center for Infectious Diseases / DASTLR, USA, GA, Atlanta

Project summary

Problem.

Infection by the Human Immunodeficiency Virus (HIV) leads to the disease Acquired Immunodeficiency Syndrome (AIDS). With its' spread, this infection does irreparable damage to humanity. As a result of HIV pandemia, more than ten million lives have been lost. Over the past several years, the territory of the Russian Federation Republic has observed the mass spread of HIV. More then 10,400 HIV-infected Russians were registered by the end of 1998. It is believed that the actual number of HIV-infected persons is around 25,000–30,000 people. Given these projections, the number of HIV infected people in Russia can be expected to exceed 800,000 by the end of the year 2000. In addition to the human suffering caused by HIV/AIDS, the spread of this disease brings enormous economic damage to Russia. Its' prevention exceeds the limits of a medical problem and becomes a national crisis.

Illnesses such as cytomegalovirus-infection (CMV) and herpes simplex virus-infection (HSV) are the most opportunistic ones burdening the course of AIDS. They are the major contributing cause of death in HIV-positive patients. Modern diagnostics and treatment can prolong the lives of HIV-infected patients.

Chlamydiosis is also cause for alarm. Each year, millions of Russians are infected by different strains of Chlamydia. In addition to the severe side effects caused by the Chlamydia infection itself, Chlamydiosis can confound the diagnosis of HIV/AIDS infected patients, causing misdiagnosis and inadequate treatment of patients.

Urogenitalis chlamydiosis can considerably augment the risk of HIV-infection. At this time, there are no national standards for quality for PCR test-systems and test-systems for antibodies to Chlamydia in Russia. At this time, no high quality test systems exist for revealing the antibodies of different classes of Chlamydia.

It is critical that standardized, high-quality test systems for the diagnosis of HIV-infection, CMV-infection, HSV-infection and Chlamydia infection be developed. Research directed towards creating new diagnostic systems and developing modern national standards for quality commercial test systems will greatly improve early diagnosis of those diseases.

Goals:

The aim of this project is improving the diagnostic systems associated with HIV, CMV, HSV and Chlamydia infections and to achieve modern national standards for quality EIA and PCR test systems for those illnesses. Achieving this aim would:

– elaborate demands to HIV sensitive cell lines, used for obtaining the products of the cell destruction caused by HIV;


– select the most productive strains of HIV;
– elaborate demands to peptides, synthetic and recombinant HIV and Chlamydia antigens, used for the creation of diagnostic test-systems;
– clone, express and produce highly purified recombinant antigens of HIV and Chlamydia suitable for the creation of new diagnostic test-systems;
– creation of new diagnostic test-systems, based on these HIV and Chlamydia antigens;
– elaborate demands to the selection of samples of serum from patients for the creation of standard panels of serums and the attestation of this panel;
– elaborate a stable DNA-panel for the estimation of the level of quality of PCR test-systems for CMV, HSV, HIV and Chlamydia infections;
– elaborate technology for the creation of standard stable panels for a production of EIA and PCR test-systems for HIV, CMV, HSV and Chlamydia infections;
– carry out a comparative analysis of Russian and foreign EIA test systems, revealing the antibodies of different classes of HIV, CMV, HSV and Chlamydia infections by using both home-produced standard panels and foreign ones;
– carry out a comparative analysis of the Russian and foreign PCR test-systems for the diagnostics of HIV, CMV, HSV and Chlamydia infections.

Current Scientific and technical knowledge:

Over the past year several years, organizations participating in this project investigated existing standards and searched for ways to perfect the preparations used for diagnosing HIV, CMV, HSV and Chlamydia infections. They worked also in the field of the obtaining of highly purified recombinant antigens.

The demonstration of the uniqueness of the approaches to the solution of scientific and technical problems.

Proposed technical and scientific solution to the scientific and technical problems is based upon own elaborations of participants of project and it is able to bring in considerable contribution towards perfecting the technology of producing diagnostic preparations.

Proposed Results:

We propose that investigation into the development of new diagnostic systems and national standards will yield the following results:

– systems and methods for standardization and attestation of viral and cell strains, suitable for the production of viral lizates, will be offered;


– a list of necessary properties of recombinant proteins and synthetic peptides used for making of the diagnostic preparations for HIV-infection and Chlamydia infection will be made;
– highly-purified recombinant antigens, suitable for getting diagnostic preparations for HIV and Chlamydia infections, will be cloned and received;
– PCR test-systems for the diagnostic of HIV, CMV, HSV and Chlamydia infection will be elaborated;
– the standards (panels of serums, DNA-standards) for HIV, CMV, HSV and Chlamydia infections will be elaborated and described;
– a comparative analysis of Russian and foreign test-systems and standard panels for HIV, SMV, HSV and Chlamydia infections will be made.

Possible continued collaboration after completion of the project:

a possibility for continued collaboration after the project is completed consists of elaboration and substantiation of the technical solution in the field of creation of commercial versions of standards (panels of serums, DNA-standards).


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