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Appendix M
Test Systems and Other Products Being Developed in Russian Laboratories1

The following new test systems have been proposed:

  • Biosensor biochips for diagnosis of hepatitis B and C (by the Institute of Biomedical Chemistry);

  • A test system for quantitative assessment of hepatitis B virus DNA using the competitive polymerase chain reaction (PCR) method;

  • A test system for quantitative assessment of the content of hepatitis C virus RNA in blood serum using the reverse transcription polymerase chain reaction (RT PCR) method in conjunction with an internal standard (by the Scientific Center of Hematology);

  • A diagnostic test usable not only for identification of hepatitis C virus, but also for the study of the seroconversion process during acute and chronic periods of the disease;

  • Test systems for detection of antibodies of classes M and G to hepatitis C virus based on immunoenzyme analysis;

  • A peptide-based diagnostic test usable for identification of hepatitis C virus (by the Ivanovsky Institute of Virology);

  • A test system for determination of the reproduction level of Aleutian mink disease using the dot blot hybridization method;

  • A PCR analysis-based test system for study of mixtures (pools) of blood to detect HIV genetic material (by the Andzhaparidze Institute for Viral Drug Research);

1  

Translated from the Russian by Supernova Translations.com.



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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Appendix M Test Systems and Other Products Being Developed in Russian Laboratories1 The following new test systems have been proposed: Biosensor biochips for diagnosis of hepatitis B and C (by the Institute of Biomedical Chemistry); A test system for quantitative assessment of hepatitis B virus DNA using the competitive polymerase chain reaction (PCR) method; A test system for quantitative assessment of the content of hepatitis C virus RNA in blood serum using the reverse transcription polymerase chain reaction (RT PCR) method in conjunction with an internal standard (by the Scientific Center of Hematology); A diagnostic test usable not only for identification of hepatitis C virus, but also for the study of the seroconversion process during acute and chronic periods of the disease; Test systems for detection of antibodies of classes M and G to hepatitis C virus based on immunoenzyme analysis; A peptide-based diagnostic test usable for identification of hepatitis C virus (by the Ivanovsky Institute of Virology); A test system for determination of the reproduction level of Aleutian mink disease using the dot blot hybridization method; A PCR analysis-based test system for study of mixtures (pools) of blood to detect HIV genetic material (by the Andzhaparidze Institute for Viral Drug Research); 1   Translated from the Russian by Supernova Translations.com.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security An immunoenzyme analysis-based test system for detection of HIV-1 sub-types, O type, and HIV-2, all of which are of special relevance for Russia; An immunoenzyme analysis-based test system for detection of the Crimean Fever virus antigen; An immunoenzyme analysis-based test system for detection of class G antibodies to the Congo-Crimean Hemorrhagic Fever virus; An immunoenzyme analysis-based test system for detection of arboviral infections, West Nile virus (by the Ivanovsky Institute of Virology); Diagnostic test systems for indication of antibodies to Respiratory Syncytial Virus (RSV), including immunoenzyme-based test systems, for identification of antibodies of different IgG subclasses (by the Institute for Influenza Research of the Northeastern Branch of the Russian Academy of Medical Sciences); A high-sensitivity express PCR method of tuberculosis mycobacteria detection (by the Central Institute for Tuberculosis Research); An immunoenzyme analysis-based test system for detection of antichlamydial antibodies in human blood sera using monoclonal genus-specific antichlamydial antibodies (by the Andzhaparidze Institute for Viral Drug Research); A test system for detection of Ureaplasma in biosamples through immunofluorescence reaction; A set of salmonellosis serological reagents B, C, D, and E for coagglutination reactions as a method of express diagnostics of intestinal infections; A test system for identification of cytokine-associated proteins from Helicobacter pylori in biological samples from infected persons through coagglutination reactions (by the Gamaleya Institute of Epidemiology and Microbiology); An immunoenzyme analysis-based test system for detection of antibodies to conditionally pathogenic bacteria (humoral immunity assessment); A selective growth medium for salmonellosis diagnostics (by the Mechnikov Institute for Vaccine and Serum Research); An immunoenzyme test system for laboratory-based diagnostics of early stages of Lyme borreliosis (by the Institute of Biochemistry of the Siberian Branch of the Russian Academy of Medical Sciences); Immunoenzyme reagents for detection of antibodies specific to testicular antigens that can be used for oncological diagnostics and assessment of effectiveness of tumor treatment (by the Institute of Clinical Immunology of the Siberian Branch of the Russian Academy of Medical Sciences); The STG-IFA immunoenzyme kit for detection of somatotropic hormone; The TTG-IFA immunoenzyme kit for detection of thyrotropic hormone; The AFP-IFA immunoenzyme kit for detection of alpha-fetoprotein; The HCG-IFA immunoenzyme kit for detection of human chorionic gonadotropin (by the Institute for Human Morphology Research); An immunoenzyme set for detection of prostatic specific antigen in blood serum (by the Russian Scientific Center of Oncology);

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security An immunochemical test system for diagnostics of perinatal damage to the nervous system (by the Scientific Center of Mental Welfare); A set of chemicals for quantitative assessment based on immunoenzyme analysis of total IgE in blood serum for allergy diagnostics (by the Mechnikov Institute for Vaccine and Serum Research); An immunoenzyme system for testing the effectiveness of the monoclonal drug Anti-CD20 Mabter by detection of antibodies in peripheral blood and spinal fluid; A test system for determination of von Willebrant Factor level in blood plasma; The Genamplanstin test system for determination of prothrombin time (by the Scientific Center of Hematology); A study of the anti-aggregate effect of drugs by determining the degree of thrombocyte aggregation for diagnostics and treatment of diseases of the circulatory system (by the Institute of Narcology). MEDICINAL PRODUCTS AND IMMUNOBIOLOGICAL DRUGS Clinical trials of drugs developed at the Institute of Pharmacology of the Russian Academy of Medical Sciences, such as Afobazol, Selank (anxiolytics), Noopept (a neurotropic drug), and Tropoxin (an anti-migraine drug), have completely confirmed the experimentally established range of their pharmacological effectiveness (by the Institute of Pharmacology). The neurotropic drug Semax was found to boost resistance to emotional stress, and this is of great importance from the standpoint of preventing stress conditions among persons whose professional activities involve elevated levels of risk (by the Anokhin Institute of Normal Physiology). Industrial trial procedures have been drafted for production of the drug Agemfil. The Russian Ministry of Health has developed and approved new regulatory and technical documentation including state standards governing the quality of such medicinal products as Adenin, plasma for fractioning, 5, 10, and 20 percent Albumin solution, Polyamine (by the Scientific Center of Hematology). More than 770 new derivatives of glycopeptide antibiotics have been synthesized. A new class of synthetic equivalents of anthracycline antibiotics (the naphtoindolochtnons, which are active against anthracycline-resistant tumors) has been discovered (by the Institute for Research and Discovery of New Antibiotics). A new drug, Affinoleikin, has been developed to treat psoriasis and atopic dermatitis. A model has been designed for aluminum-hydroxide-adsorbed diphtheria anatoxin vaccine enriched with corynebacterial affinitins (derivatives of fibronectin and plasminogen) and possessing a higher specific immunogenicity

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security compared to the commercially available drug (by the Mechnikov Institute for Vaccine and Serum Research). A vaccine-usable strain (ERA-CB 20M) of fixed rabies has been obtained (by the Ivanovsky Institute of Virology in collaboration with the Narvak Stock Company). The following vaccines have been created: HIV/AIDS vaccine based on the genetically-engineered drug Vichrepol (by the Ivanovsky Institute of Virology in collaboration with the Institute of Immunology of the Russian Ministry of Health) combined mumps-measles vaccine (by the Andzhaparidze Institute for Viral Drug Research) multi-component vaccine from conditionally pathogenic bacteria for prophylaxis of acute respiratory infections of non-influenza nature (by the Mechnikov Institute for Vaccine and Serum Research) A highly-specific serum for diagnostics of staphylococcus has been obtained. SOURCE: Ministry of Health (2003).