Structure and duties of Blood service

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NATIONAL CENTER FOR TRANSFUSION MEDICINE Prevalence of infectious diseases among Mongolian blood donors Namjil Erdenebayar General director of The National Center for Transfusion Medicine, Mongolia NCTM, 210648 Sukhbaatar district, 14210 Peace Enkhtaivan(Peace) Avenue 13, Ulaanbaatar, Mongolia Ub-14210, post-48, box-22сүт, Tel/Fax: 976-11-312857, E-mail: nctmmgl@gmail.com Structure and duties of Blood service MOHS NCTM Blood Banks/26/ Ministry of Health is responsible for blood service: Encouraging the Blood Service in order to approve and implement the principles, guidelines related to the blood safety. Ensuring professional methods for activities of implementing the Mongolian Government policy. The National Center for Transfusion Medicine, which is a specialized professional service that deals with producing safe and sample blood supplies to local and private hospitals throughout Mongolia as well as continually managing, guiding and embracing all Hospital Blood banks. Blood Banks provide the hospitals in rural areas with necessary blood and blood products and specialized management and guidance for soum level. 1

Legal aspects Blood collection from non-remunerated blood donors was introduced in 1994 and legislated by the Ministry of Health in 2000. The Donor Law was approved in 2000 by the Great Khural (Parliament) of Mongolia and revised in 2012. The Government policy on Improving provision and supply with safe blood and blood products was approved in 2007 by the Great Khural. The Plan of Action for 2008-2015 to implement the Government policy for improvement of provision with safe blood and blood products was approved in 2008 by article 111 of Government Resolution. The NCTM have 26 blood banks in 21 province 2

Chronology of screening for TTI in Mongolia 1973- Implementation of hepatitis B surface antigen (HBsAg) in routine screening of blood donors 1991-Implementation of HIV antibody (Anti-HIV) in routine screening of blood donors 1997-Implementation of hepatitis C antibody (Anti-HCV ) in routine screening of blood donors 2010- implementation of ELISA method for syphilis. 2012-.PCR technology has been introduced in the NCTM to screen for HBV, HCV and HIV. WHO recommendation Screening of all blood donations should be mandotory HIV-I/II, HBV, HCV, Syphilis Depending on the geographic location, demographic dynamics, percentage of foreign citizens in the population Mongolia HIV-I/II, HBV, HCV, Syphilis Inaddition CMV, HTLV-I/II, EBV, HHV, Parvovirus-B19, West-Nile virus, Chikungunya virus 3

Infectious testing method in blood service At soum level At aimag level At NCTM 100% with RAPID TESTS ELISA/Chemiluminescence ELISA and PCR Order 02, 2016 of Health Minister for improving blood safety Algorithm for TTI screening tests in blood donor 2010-International algorithm has been introduced for TTI tests of blood donors approved by the WHO. 4

The prevalence Hepatitis B /2011-2015/ hepatitis B Hepatitis B viral infection among blood donors in Mongolia 6,0% 5,0% 4,0% 3,0% 2,0% 1,0% 2011 2012 2013 2014 2015 Blood Bank 4,8% 4,7% 4,0% 3,7% 2,4% NCTM 4,4% 4,1% 4,6% 3,7% 2,2% In 2015 the prevalence of hepatitis B viral infection among blood donors decreased 2 fold compared to 2011 The prevalence Hepatitis C /2011-2015/ Hepatitis C viral infection among blood donors in Mongolia prevalence 4,0% 3,5% 3,0% 2,5% 2,0% 1,5% 1,0% 0,5% 2011 2012 2013 2014 2015 Blood bank 3,4% 3,0% 2,7% 2,3% 2,3% NCTM 3,6% 2,6% 3,3% 2,6% 2,7% In 2015 the prevalence of hepatitis C viral infection among blood donors decreased about 1% compared to 2011 5

The prevalence Syphilis /2011-2015/ prevalence % 3,5% 3,0% 2,5% 2,0% 1,5% 1,0% 0,5% The prevalence of syphilis among blood donors 2011 2012 2013 2014 2015 Blood bank 1,5% 3,2% 3,0% 2,4% 2,3% NCTM 1,7% 2,8% 3,2% 3,2% 2,7% Since 2010 introduced the Syphilis Ab test is a solid phase ELISA for qualitative detection of antibodies Ig G and Ig M against Treponema Pallidum. Therefore, prevalence of syphilis among blood donors has increasing in past years. The prevalence HIV /2011-2015/ 2 2 prevalence 2 1 1 2 1 2011 2012 2013 2014 2015 Blood bank 0,007% 0,002% 0,01% 0,006% NCTM 0,003% 0,006% 0,01% The prevalence of HIV infection among blood donors only 0-2 cases reported in year. 6

Elimination by TTI 35000 30000 25000 20000 15000 10000 5000 35,0% 30,8% 29,3% 30396 3 25,1% 26097 2070020854 22639 25,0% 20,7% 1653718109 2 13752 152921550516379 18,4% 17,7% 15,0% 10,4% 9,6% 8,7% 8,1% 7,2% 1 5,0% 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Total tested blood donor Elimination by TTI /by percent/ Screening for PCR positive % 0,70% 0,60% 0,50% 0,40% 0,30% 0,20% 0,10% The results of PCR 0,00% 2012 2013 2014 2015 HBV DNA 0,58% 0,23% 0,23% 0,18% HCV RNA 0,07% 0,04% 0,01% 0,02% Nucleic acid amplification testing shortens WP, thereby offering blood centers a much higher sensitivity for detecting viral infections. We used to PCR for whom with absence serological markers of infection. Positive results of PCR are decreasing in last years. 7

Study of Screening for HTLV-I/II infection HTLV-I/II specific IgG antibodies not detected all 716 studied blood donors. HTLV-I/II specific IgG antibodies and nationality Хүснэгт 2. HTLV-I/II Ig G Mongolian Another country positive - - negative 100% (709) 100%(7) Total 100% (709) 100%(7) B.Tsogbadrakh, N.Erdenebayar 2014 The prevalence of CMV among blood donors CMV - specific IgG antibodies were detected in 99.2 % (710) of the studied subjects and, CMV - specific IgM antibodies in 0.1 % ( 1 ). Screening for CMV- IgG and CMV- IgM CMV IgG CMV IgM Positive Negative Positive 1 709 Negative 0 6 B.Tsogbadrakh, N.Erdenebayar 2014 Total 1 715 8

Quality assurance for TTI 2005-started participate to EQAS program for TTI organized by an Australian NRL 2013- started a national EQAS program for TTI test and involved laboratories of Ulaanbaatar and Rural areas /MEQAS/. Further To implement of PCR technology to donor screening for TTI of aimag s BB step by step. To implement accreditation ISO 9001 : 2015 9

THANKS FOR YOUR ATTENTION SAFE BLOOD SAVE А LIFE 10