Laboratory diagnosis of TB in Bulgaria. Elizabeta Bachiyska, TB NRL, NCIPD

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1 Laboratory diagnosis of TB in Bulgaria Elizabeta Bachiyska, TB NRL, NCIPD

2 Country profile Location: South East Europe, Balkan peninsula Area: ,6 m 2 Population * : inhabitants Capital ** : Sofia, inhabitants Government type: Parliamentary Republic EU member, 2007 Administrative divisions: 28 regions (oblast) Source: *Eurostat, 2014; ** National Statistical Institute, 2011

3 Background information The population of with 49% male The ethnic background of the population: Bulgarian 76.9%; Turkish 8%;Roma 4.4%; other 0.7% (including Russian, Armenian), other (unknown) 10% In the last 25 years population decline, a low birth rate, a low fertility rate, a high mortality rate and an ageing population (an international migration and negative population growth) Life span 70.9 years for males and 77.9 for female The main causes of death diseases of the circulatory system (592 death/ ) and neoplasms (156 deaths/ ) Public health services (including TB treatment) are funded by the MoH Source: 1. European Commission. Eurostat Dimova A, Rohova M, Moutafova E, Atanasova E, Koeva S, Panteli D et al. Bulgaria: Health system review. Health Systems in Transition, 2012, 14(3):1 186.

4 National context and political commitment to National policies of tuberculosis control 1998 Implementation of DOTS in four pilot regions % DOTS coverage 2005 Establishment of TBNRL, NCIPD 2006 Country Coordinating Mechanism (CCM) to Fight AIDS and TB; Successfully applied in GFATM Round 6:To Improve the TB Control in Bulgaria 2007 NTP in Bulgaria, Successfully applied in GFATM Round 8: To Strengthen the NTP in Bulgaria 2009 Bulgaria was included in the list of 27 high burden MDR-TB countries 2012 NTP in Bulgaria, Successfully applied in GFATM: Improving the NTP 2016 NTP in Bulgaria,

5 TB country profile, 2014 Source: ECDC, Tuberculosis surveillance and monitoring in Europe, 2016

6 Some epidemiological data, Bulgaria, 2015 Total number of cases: 1660 Notification rate per : 23.0 MDR-TB: 3.6% (n=24) Cases with DST results: 86.2% (n=674) Mono RIF-R: 0.6% (n=4) Mono INH-R: 2.22% (n=15) Mono STR-R: 0.6% (n=4) Mono EMB-R: 0.74% (n=5) Refugees: persons screened for risk of TB Out of them: microbiologically tested Out of them: 6 positive (from Syria) Prisoners: 24 TB cases (14 New pulmonary cases) Culture positive: 12 cases - 1 MDR-TB The total number MDR-TB cases: 8 ( ) Source: NTP, 2016

7 New TB cases in Bulgaria, per population Source: National Center for Public Health and Analysis, NTP

8 TB cases, Notification rate, MDR-TB, Number of cases MDR-TB numbers Notification rate MDR-TB % Source: ECDC, Tuberculosis surveillance and monitoring in Europe, 2016

9 First DRS in Bulgaria, 2010 Distribution of the resistance among all patients Category New % PTC % Total % Susceptible % % % MDR-TB % % % Mono INH % % % Mono RMP % % % Total % % % Source: T.Varleva, E.Bachiyska, V. Milanov, M. Zamfirova, E. Borroni, D. Falzon, M. Dara, D. Cirillo, MDR-TB in Bulgaria: results of a nationwide survey, 2010, IJTLD, 44 World Conference on Lung Health of the IUATLD,.2013, Vol.17, Num 12, Suppl2,p S495

10 TB Laboratory network 33 TB labs, situated in different settings: Multi-profile Hospitals 14 Specialized Hospitals for Active Treatment of Lung Diseases 15 Specialized Hospitals for Prolonged Treatment of Lung Diseases 2 State Psychiatric Hospital with a ward for patients with active tuberculosis 1 NRL 1 Workload of the TB network, Year SM C DST

11 1 NRL TB SM, C, FLD, SLD, LPA, EQA Level 4 3 Regional SM, C, FLD, LPA Laboratories Level 3 26 Intermediate level SM, C Laboratories Level 2 3 Peripheral Level 1 SM Laboratories Organization of the TB laboratory network in Bulgaria

12 Procurement of equipment, consumables and reagents for TB diagnosis in Bulgaria NTP GF Staining solution for ZN Microscopy slides Solid media (LJ) Liquid media (MGIT for BACTEC) Kits for FLDs and SLDs (for BACTEC) Identification kits (MTC/NTM) LPA for resistance FLDs and SLDs Species identification of NTM Consumables for risks groups Spoligo and VNTR kits Up-to-date lab equipment Training courses of lab technicians EQA: on site evaluation

13 Structure of NCIPD Virology Dpt Epidemiology Dpt Microbiology Dpt NRL of Mycology NRL of Enteric Pathogens Immunology Dpt NCIPD NRL of Pathogenic cocci and Corynebacteria NRL of Biohazard Level 3 Infections Parasitological Dpt NRL for Leptospira, Borrelia, Listeria NRL for Tuberculosis Nosocomial Dpt NRL for Molecular Biology Respiratory infections and tuberculosis NRL for Control and Monitoring of Antimicrobial Resistance

14 Laboratory procedures in NRL Smear microscopy: Ziehl-Neelsen staining Cultures: NALC-NaOH decontamination LJ + BACTEC MGIT Identification: BD MGIT TBc Test -MPT64Ag Species Identification: GT Mycobacterium CM, AS, MTBC Phenotypic DST: FLD& SLD BACTEC MGIT 960 BD EpiCenter with the TB exist Molecular DST (LPA): GT MTBDRplus GT MTBDRsl

15 NTM in Bulgaria, Samples from 304 TB suspected patients Prevalence of the males: 60,20% (n=183) Over 65 year old patients: 33,2% (n=101) Prevalence of patients from the big cities: Sofia, Varna and Plovdiv M. smegmatis NTM M. szulgai M. scrofulaceum M. marinum M.genavense M. celatum M. shimoidei M. mucogenicum M. abscessus M. kansasii M. avium M. perigrinum M. chelonae M. intracellulare р. Mycobacterium M. lentiflavum M. fortuitum M. gordonae 0,33% 0,33% 0,33% 0,33% 0,33% 0,33% 0,66% 1,97% 2,63% 3,29% 4,93% 5,92% 6,25% 6,91% 14,14% 15,13% 15,79% 20,39% Number BAL 10% Urine 1% GL 11% Sputum 77% CSF 1% Samples, Source: Ю. Атанасова и сътр., Нетуберкулозни микобактерии в България-разпространение и диагноза, 14 конгрес на БАМ, София, 2016, П 30, Сборник научни трудове, стр. 63.

16 Biodiversity among MDR-TB strains in Bulgaria, (n = 253) SIT Lineage/Sublineage N % 41 TUR T T T T Beijing LAM3/S T H3-T SIT New H S T X Beijing SIT H SIT TUR Source: 1. С. Панайотов и съавт., Генетично биоразнообразие на чувствителни и MDR-TB щамове в България, Мед. преглед, 52, 2016, 3, S. Panaiotov, et al.,beijing Lineage of MDR-TB in Bulgaria, , Emer. Inf. Dis, Vol. 20, 2014,

17 Biodiversity among sensitive TB strains in Bulgaria, , n = 441 SIT Lineage/Sublineage N % SIT Lineage/Sublineage N % 125 T T S T H T T LAM3/S H TUR X T T LAM H T T T T H X T T T1-RUS BOV T T LAM T Ural T Beijing LAM3/S LAM T H LAM11-ZWE T T T T H3-T T H Source: 1. С. Панайотов и съавт., Генетично биоразнообразие на чувствителни и MDR-TB щамове в България, Мед. преглед, 52, 2016, 3, S. Panaiotov, et al.,beijing Lineage of MDR-TB in Bulgaria, , Emer. Inf. Dis, Vol. 20, 2014,

18 Biodiversity among XDR-TB strains in Bulgaria, (n = 18) SIT1 SIT41 SIT53 Source: 1. S. Yordanova et al., MDR-TB with additional fluoroquinolone resistance in Bulgaria, Probl. Inf. Paras. Dis., vol 43, 2/2015, С. Йорданова и съавт., Разнообразие на XDR-TB в България, 14 конгрес на БАМ, София, 2016, П 29, 62.

19 TB External Quality Assurance in Bulgaria 1. Manual for microbiological diagnosis and treatment of TB: 2009; Microbiological Standard (new issue 2010) # Management of quality: - Microbiological labs in Bulgaria have to participate in the EQA schemes of NCIPD, Microbiological dpt: 2 times/year: sub national level - NRLs have to participate in EQA schemes of external organization: supra national level - Accreditation of labs, according to Bulgarian legislation

20 External Quality Assurance supra- and sub national level in Bulgaria WHO SNL, Italy, INSTAND e.v., Germany TB NRL, NCIPD National network of TB laboratories

21 External Quality Assurance supra- and sub national level in Bulgaria

22 NRL TB, TB EQA schemes (supra national level) NRL TB has participated successfully in INSTAND s EQA TB scheme since 2006: 1. Microscopy 2. Culture 3. Identification 4. NAAT 5. DST, FLDs &SLDs Since 2007 NRL TB participated successfully in 3 rd, 4 th, 5 th, 6 th and 7 th rounds of proficiency testing for DST (FLDs & SLDs), WHO-SNL, Rome, Italy Accreditation ISO: (since 2008)

23 NRL TB EQA, sub national level GF NCIPD On Site Evaluation: annually; 33 TB labs; since 2009 Blinded Rechecking of microscopy results: annually; 33 TB labs; since 2009 Panel Testing of AFB smear microscopy: twice per year; since 2006 Panel Testing of cultures: twice per year; since 2010 Panel Testing of DST: twice per year; since 2010

24 Training courses in TBNRL, NCIPD

25 Renovation of the building of TB NRL, NCIPD, 2014

26 Some challenges in TB diagnosis in Bulgaria Finish of the GF donation for Bulgaria in 2018 Slow tender procedures for purchase of equipment, consumables and reagents for TB diagnosis Costly maintenance of lab equipment and systems The low payment for the TB lab staff Age structure of doctors, biologists and lab technicians Start functioning of nominated 3 Regional TB labs TB Information System is not web based yet Introduction of GX

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