Prof. Musabaev E.I. Quality Control Systems for Hepatitis B and C diagnostics in Uzbekistan.

1. Prof. Musabaev E.I. Quality Control Systems for Hepatitis B and C diagnostics in Uzbekistan.

2. Background Prevalence of HBV and HCV infections in Uzbekistan

3. Background Dates • February, 1998. The agreement amongst Government of Swiss Confederation, Division of Humanitarian Aid and Swiss Disaster Relief (SDR) and Republic of Uzbekistan "Aid in the fight against viral hepatitis in Uzbekistan" • March, 1999. Establishing of the Reference Laboratory • Autumn, 1999. Educational program for laboratory specialists of Uzbekistan was developed in common with Centers for Disease Control and Prevention (CDC, USA). • Autumn, 1999. First reference HBsAg panel was created with specialists of CDC and Swiss Quality Control center. • November, 1999. First Qulity Control Seminar for laboratory specialists of Uzbekistan organised by CDC. • October, 2000.Mandatory of participation in EQA

4. Aims & Tasks Improvement of Efficiency and Effectiveness of Diagnostic Laboratories • Creation of panels for EQA for the following markers (concerning the priorities): • HBsAg • anti-HCV • AIDS/anti-HIV-1 and anti-HIV-2 • Providing of Diagnostic laboratories of the Republic by the reference panels created in Reference laboratory. • External Quality Assessment of the Diagnostic laboratories of: • blood banks; • sanitary-epidemiological stations; • infectious diseases hospitals; • private diagnostic clinics;

5. Aims & Tasks Improvement of Diagnostic Kits Quality Used in Uzbekistan • Quality Control of imported and home-produced ELISA test-systems with a purpose of preparation/taking decision about possibility of their licensing and further using. • Conducting the trials of diagnostic kits with use of Reference panels and/or and 200-250 serum samples received from different regions of the Republic attested with Referent ELISA test-system (Ortho Diagnostic Systems); • Rendering methodical and technical aid to the home-producers of ELISA. • Trials of kits during its construction; • Interpretation of results;

6. Aims & Tasks Raising the Education Level of Medical Specialists Training specialists of diagnostic laboratories of Uzbekistan in essential theoretical and practical skills: • Development of the educational programs for the low- and middle-level specialists of diagnostic laboratories; • Organisation and conducting practical symposia for epidemiologists in the different regions of Uzbekistan • Organisation and conducting practical symposia for diagnostic laboratory specialists

7. Results HBsAg-panel for EQC №1 - 4000 ng - native highly reactive serum №2 - 4 ng - 1000-fold dilution of serum №1 №3 - 1 ng - 4000-fold dilution of serum №1 №4 - 0,5 ng - 8000-fold dilution of serum №1 №5 - 0,25 ng - 16000-fold dilution of serum №1 №6 - 0,125 ng - 32000-fold dilution of serum №1 №7 - Diluent pool №8 - Serum negative for HBsAg • HBsAg concentration is determined by calibration against ay-subtype of HBsAg standard presented by CDC (USA). • Calibration was carried out only for the samples №2-6 whose reactivity was directly proportional to the dilution degree (Lambert-Ber low). • Calibration was performed with “Ortho” (USA) and “Dia-Sorin” (Italy) ELISA

8. Results Anti-HCV panel for EQC

9. Results Questionnaire for External Quality Assessment

10. Results Results of External Quality Control of HCV diagnostic in some provinces of Uzbekistan

11. Results National Reference HBsAg panel for quality control of diagnostic kitsHBsAg positive samples (N=9) are diluted to the end point in the negative for all viral hepatitis markers human serum pool (N=2). HBsAg negative samples (N=36) are undiluted.Titration: 1:1; 1:10 000; 1:100 000; 1:200 000; 1:500 000;

12. Framework Field of Our Activity Regional Blood Transfusion Services 15 labs Private Diagnostic Laboratories Regional AIDS Centres 15 labs Manufactures of Diagnostic kits: Nihol, Uzbekistan; Posbon, Uzbekistan; Radiopreparat, Uzbekistan; Institute of Genetics, Uzbekistan; Vector Best, Russia Sanitary Epidemiological Control Services 14 labs

13. Framework The founders of the Reference laboratory SWISS AGENCY FOR DEVELOPMENT COOPERATION Federal Office for Foreign Economic Affairs MINISTRY OF PUBLIC HEALTH SERVICES OF UZBEKISTAN SWISS QUALITY CONTROL CENTER Geneva, Switzerland

14. Framework Collaboration • CDC, International and viral hepatitis Department, Atlanta, USA • Department of Virology, University of Helsinki, Finland • Tarasevich’s Institute of Standardisation and Quality Control, Moscow, Russia • Departament of blood tranfusion,University of Nogoi,Japan • National Reference Laboratory of Kirgiztan • National Reference Laboratory of Turkmenistan • National Reference Laboratory of Kazahstan

15. Acknowledgements This work was supported by Swiss Disaster Relief (SDR), Swiss Agency for Development and Cooperation and Centers for Disease Control and Prevention (CDC, USA) • Personal thanks to: • Dr. Favorov M.O. Regional Director of CDC’s programms in Central Asia • Dr. Deom A. Director of Swiss Quality Control Center • Dr. Kalashnikova T.V. CDC, consultant

16. Acknowledgements • Reference laboratory staff: • Ongarbaev A. • Mustafaeva E. • Albetkova A.