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

Prevalence of HBV and HCV infections in Uzbekistan Background

zFebruary, 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" zMarch, 1999.Establishing of the Reference Laboratory zAutumn, Educational program for laboratory specialists of Uzbekistan was developed in common with Centers for Disease Control and Prevention (CDC, USA). z Autumn, First reference HBsAg panel was created with specialists of CDC and Swiss Quality Control center. zNovember, First Qulity Control Seminar for laboratory specialists of Uzbekistan organised by CDC.  October, 2000.Mandatory of participation in EQA Dates

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

zQuality 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 serum samples received from different regions of the Republic attested with Referent ELISA test-system (Ortho Diagnostic Systems); zRendering methodical and technical aid to the home-producers of ELISA. Trials of kits during its construction; Interpretation of results; Improvement of Diagnostic Kits Quality Used in Uzbekistan Aims & Tasks

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 Raising the Education Level of Medical Specialists Aims & Tasks

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

Anti-HCV panel for EQC Results

Questionnaire for External Quality Assessment Results

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

National Reference HBsAg panel for quality control of diagnostic kits HBsAg 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: ; 1: ; 1: ; Results

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

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 Framework

zCDC, International and viral hepatitis Department, Atlanta, USA zDepartment of Virology, University of Helsinki, Finland zTarasevich’s Institute of Standardisation and Quality Control, Moscow, Russia zDepartament of blood tranfusion,University of Nogoi,Japan zNational Reference Laboratory of Kirgiztan zNational Reference Laboratory of Turkmenistan zNational Reference Laboratory of Kazahstan Collaboration Framework

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) zPersonal thanks to: zDr. Favorov M.O. Regional Director of CDC’s programms in Central Asia zDr. Deom A.Director of Swiss Quality Control Center zDr. Kalashnikova T.V. CDC, consultant

zReference laboratory staff: zOngarbaev A. zMustafaeva E.  Albetkova A. Acknowledgements