The added value of a European Union tuberculosis reference laboratory network – analysis of the national reference laboratory activities

F A Drobniewski,S Hoffner,O Pogoryelova,A J Ozin,V Nikolayevskyy,D Manissero

doi:10.2807/ese.13.12.08076-en

F A Drobniewski, S Hoffner + Show 4 more

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https://doi.org/10.2807/ese.13.12.08076-en

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Abstract

National reference laboratories (NRL) and other laboratories are the cornerstones of well-functioning tuberculosis programmes and surveillance activities. However, the scope and activity of NRL services for mycobacterial identification and drug susceptibility testing (DST) has not been examined in detail across the European Union (EU), nor has the added value of cooperation and networking at the European level been explored with regard to strengthening laboratory services. Therefore, the European Centre for Disease Prevention and Control (ECDC) has commissioned a survey to explore these issues and to identify areas of work that could bring added value by supporting networking activities of tuberculosis (TB) reference laboratories in the EU. Structured questionnaires were sent to TB reference laboratory experts in the EU and European Economic Area (EEA) countries, and in three additional countries selected on the basis of their networking activities with EU projects and other initiatives (Switzerland, Croatia and Israel). The compiled results describe the activities and structure of 32 NRLs (29 countries replied, a response rate of 91%). The analysis of the survey led to the following recommendations for strengthening TB laboratory services: (1) implementing of the published European standards for TB laboratory services with respect to infrastructure, national reference functions, biosafety, human resources, quality assurance, operational research (including evaluation of new medical diagnostics), accuracy and speed, appropriately trained staff; (2) ensuring that laboratories only perform activities for which they have demonstrated proficiency; (3) implement validated and standardised second-line drug susceptibility testing (DST), including drugs used to define extensively drug-resistant tuberculosis (XDR TB); (4) aiming to identify Mycobacterium tuberculosis complex (MTBC) and rifampicin (RIF) resistance in over 90% of cultures and cases from smear-positive sputum directly within one to two working days. To realise some of the above recommendations and to strengthen links of TB surveillance and microbiology activities in the EU, a list of suggested generic areas of activities for an EU network of reference laboratories is presented. Such a network would build on and link to existing networks and initiatives at the European and global level.

Highlights

Tuberculosis (TB) remains a major cause of morbidity and mortality in Europe
Materials and Methods A structured questionnaire was sent electronically to TB reference laboratory experts within the European Union (EU)/Economic Area (EEA) countries as well as to Switzerland, Croatia and Israel, countries that are involved in other EU-supported initiatives relevant to this survey. These experts were identified through the following sources or criteria: (1) They were included on lists of directors of national TB reference laboratory (NRL) held by EuroTB and World Health Organization (WHO) EURO; (2) They were the recipients of specimen panels which are sent to NRLs globally by the WHO Global Project on TB Drug Resistance
Responses were received from 32 TB reference laboratory experts, situated in laboratories in the cities indicated below, and representing 27 EU/EEA countries as well as two countries outside the EU (29 countries overall, a response rate of 91%): Figure 1 Rapid detection of Mycobacterium tuberculosis in direct clinical specimens

Summary

Introduction

In 2005, 51 of 53 countries in the World Health Organization (WHO) European region reported 426,717 cases (an overall notification rate of 48 TB cases per 100,000 population or 8% of the total number of cases reported globally) [1,2]. Even in low incidence countries [18] notification rates in vulnerable and highrisk populations can be as high as those reported in high burden countries globally [2]. High MDR TB rates are reported mainly in the Baltic States, but drug-resistant cases are found throughout the whole of the EU, with occasional outbreaks in countries with a low incidence of TB [2,3,4,5,6,7,8]

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