EU Laboratory Capability Monitoring System (EULabCap) : report on 2013 survey of EU/EEA country capabilities and capacities.
Date: 2016-04-08
Institutions: European Centre for Disease Prevention and Control
Subjects: biology, disease prevention, epidemiology, medical research, public health, report, research body

TECHNICAL REPORT  

EU Laboratory Capability 
 Monitoring System (EULabCap)

Report on 2013 survey of EU/EEA country  
capabilities and capacities 

www.ecdc.europa.eu

ECDC TECHNICAL REPORT 

EU Laboratory Capability Monitoring 
System (EULabCap) 

Report on 2013 survey of EU/EEA country capabilities and capacities 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This report of the European Centre for Disease Prevention and Control (ECDC) was coordinated by Katrin 
Leitmeyer, Laura Espinosa and Marc Struelens (ECDC Microbiology Coordination section). Amanda Ozin, ECDC 
Microbiology Coordination section, led on the development and piloting of the survey tool and contributed to the 
preliminary draft report.  

Contributing authors 
National Microbiology Focal Points (NMFP) contributing to the survey design, data collection/validation, results 
interpretation and advice on analysis design and reporting format were: Franz Allerberger (Austria NMFP member), 
Petra Apfalter (Austria NMFP alternate), Steven Van Gucht (Belgium NMFP member), Michael Kalaï (Belgium NMFP 
alternate), Iva Christova (Bulgaria NMFP member), Stefka Krumova (Bulgaria NMFP alternate), Vera Katalinić-
Janković (Croatia NMFP member), Blazenka Hunjak (Croatia NMFP alternate), Despo Bagatzouni (Cyprus NMFP 
member), Sophia Kyradji (Cyprus NMFP alternate), Pavla Křížová (Czech Republic NMFP member), Martina 
Havlíčková (Czech Republic NMFP alternate), Thea Kølsen Fischer (Denmark NMFP member), Kurt Fuursted 
(Denmark NMFP alternate), Rita Peetso (Estonia NMFP member), Külli Rae (Estonia NMFP alternate), Jaana 
Pirhonen (Finland NMFP member), Carita Savolainen-Kopra (Finland NMFP alternate), Bruno Coignard (France 
NMFP member), Sylvie Quelet (France NMFP alternate), Guido Werner (Germany NMFP member), Alkiviadis 
Vatopoulos (Greece NMFP member), Ildikó Visontai (Hungary NMFP member), Ágnes Dánielisz (Hungary NMFP 
alternate), Karl Kristinsson (Iceland NMFP member), Eoghan O'Neill (Ireland NMFP member), Robert Cunney 
(Ireland NMFP alternate), Giovanni Rezza (Italy NMFP member), Paola Stefanelli (Italy NMFP alternate), Nicole 
Werner-Keišs (Latvia NMFP member), Arta Olga Balode (Latvia NMFP alternate), Algirdas Griškevičius (Lithuania 
NMFP member), Tatjana Kazanova (Lithuania NMFP alternate), Joël Mossong (Luxembourg NMFP member), 
Matthias Opp (Luxembourg NMFP alternate), Christopher Barbara (Malta NMFP member), Paul Caruana (Malta 
NMFP alternate), Nico Meessen (Netherlands NMFP member), Ellen Stobberingh (Netherlands NMFP alternate), 
Ingeborg Sundvalen Aaberge (Norway NMFP member), Dominique Caugant (Norway NMFP alternate), Waleria 
Hryniewicz (Poland NMFP member), Rafał Gierczyński (Poland NMFP alternate), Jorge Machado (Portugal NMFP 
member), Maria Damian (Romania NMFP member), Luminita Smaranda Iancu (Romania NMFP alternate), Cyril 
Klement (Slovak Republic NMFP member), Lucia Madarova (Slovak Republic NMFP alternate), Metka Paragi 
(Slovenia NMFP member), Katarina Prosenc (Slovenia NMFP alternate), Julio Moreno Vazquez (Spain NMFP 
member), José Miguel Rubio Muñoz (Spain NMFP alternate), Karin Tegmark-Wisell (Sweden NMFP member), Hans 
Gaines (Sweden NMFP alternate), Maria Zambon (United Kingdom NMFP member) and Nandini Shetty (United 
Kingdom NMFP alternate). 

Advisory Forum (AF) members contributing to the survey design, results interpretation and reporting format were: 
Herman Van Oyen (Belgium), Mira Kojouharova (Bulgaria), Aleksandar Šimunović (Croatia), Niki Paphitou (Cyprus), 
Jan Kynčl (Czech Republic), Kåre Mølbak (Denmark), Kuulo Kutsar (Estonia), Frank Van Loock (European 
Commission, AF observer), Mika Salminen (Finland), Jean-Claude Descenclos (France), Andreas Gilsdorf (Germany 
AF alternate), Ágnes Csohán (Hungary), Haraldur Briem (Iceland), Darina O'Flanagan (Ireland), Silvia Declich 
(Italy), Robert Hemmer (Luxembourg), Hanne Nøkleby (Norway), Isabel Noguer (Spain, AF alternate), Birgitta 
Lesko (Sweden AF alternate) and Paul Cosford (United Kingdom). 

ECDC experts contributing to data collection/validation, analysis design and results interpretation, in alphabetical 
order, were: Cornelia Adlhoch, Sabrina Bacci, Laszlo Balkanyi, Julien Beauté, Eeva Broberg, Ida Czumbel, Helena de 
Carvalho Gomes, Birgitta de Jong, Assimoula Economopoulou, Celine Gossner, Jolanta Griskeviciene, Gaetan 
Guyodo, Hervé Zeller, Liselotte Högberg, Yvan Hutin, Csaba Ködmön, Saara Kotila, Piotr Kramarz, Laurence 
Marrama, Taina Niskanen, Daniel Palm, Anastasia Pharris, Gianfranco Spiteri, Carl Suetens, Johanna Takkinen, 
Svetla Tsolova, Ivo Van Walle and Robert Whittaker. 

Suggested citation: European Centre for Disease Prevention and Control. EU Laboratory Capability Monitoring 
System (EULabCap) – Report on 2013 survey of EU/EEA country capabilities and capacities. Stockholm: ECDC; 
2016. 

Stockholm, February 2016 

ISBN 978-92-9193-738-7 

doi 10.2900/63194 

Catalogue number TQ-02-16-067-EN-N 

© European Centre for Disease Prevention and Control, 2016 

Reproduction is authorised, provided the source is acknowledged 

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TECHNICAL REPORT 

EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Contents 

Abbreviations ............................................................................................................................................... iv 
Executive summary ........................................................................................................................................ 1 
Background .............................................................................................................................................. 1 
Methods ................................................................................................................................................... 1 
Results .................................................................................................................................................... 1 
Conclusion ............................................................................................................................................... 2 
Introduction .................................................................................................................................................. 3 
Materials and methods .............................................................................................................................. 3 
Data collection and validation process ......................................................................................................... 5 
Data analysis and interpretation ................................................................................................................. 5 
Data reporting .......................................................................................................................................... 5 
Individual country reports .......................................................................................................................... 5 
Results .......................................................................................................................................................... 6 
Response rate and data completeness ........................................................................................................ 6 
Laboratory capabilities and capacities at EU/EEA level .................................................................................. 6 
Laboratory capabilities and capacities at country level .................................................................................. 8 
Relation between capability index and health expenditure .......................................................................... 10 
Primary testing ....................................................................................................................................... 11 
National reference laboratory service ........................................................................................................ 13 
Laboratory-based surveillance and epidemic response support .................................................................... 15 
Discussion ................................................................................................................................................... 16 
Conclusions ................................................................................................................................................. 17 
References .................................................................................................................................................. 18 
Annexes ...................................................................................................................................................... 19 

Figures 

Figure 1. Structural overview of the EULabCap indicators, as grouped by dimension and target ............................ 4 
Figure 2. Indicator completeness and distribution of missing data by country ...................................................... 6 
Figure 3. Boxplot of the EULabCap index scores by dimension ........................................................................... 7 
Figure 4. Distribution of country EULabCap 2013 index scores by target .............................................................7 
Figure 5. Distribution of overall EULabCap index country scores 2013 .................................................................8 
Figure 6. Levels of public health microbiology system capabilities and capacities  ........................................................9 
Figure 7. Radar graphs of EULabCap target index scores for each country ........................................................ 10 
Figure 8. Scatter plot and correlation coefficient based on linear regression between the EULabCap country index 2013 
and total national health expenditure per capita in 2012 ...................................................................................... 11 
Figure 9. EU distribution of scoring results by country for 20 EULabCap indicators within primary diagnostic testing  .... 12 
Figure 10. EU distribution of scoring results by country for 20 EULabCap indicators within National Reference 
Laboratory services ...................................................................................................................................... 13 
Figure 11. EU distribution of scoring results by country for 20 EULabCap indicators within surveillance and epidemic 
response support services ............................................................................................................................. 15 

Tables 

Table 1. Distribution of EULabCap indicators by dimension, element and function measured ................................. 4 
Table 2. Interpretation of score levels for laboratory capability and capacity ........................................................ 5 
Table 3. Distribution of EU capability/capacity based on EU median index scores by target  .................................. 8 
Table 4. Number of EU/EEA countries reporting diagnostic confirmation and pathogen identification testing available within 
the country for the 53 diseases/health issues listed in Decision 2119 ........................................................................ 14 

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TECHNICAL REPORT 

Abbreviations 

AF 

AMR 

ARV 

CPE 

EARS-Net 

EQA 

EU/EEA 

EULabCap 

ERLTB-Net 

ESBL 

EUCAST 

FWD 

HIV 

IQR 

MDR TB 

MERS-CoV 

MLST 

NMFP 

NRL 

OECD 

PCR 

Q1 

Q3 

SMAP 

Advisory Forum 

antimicrobial resistance 

antiretroviral 

carbapenemase-producing Enterobacteriaceae 

European Antimicrobial Resistance Surveillance Network 

External Quality Assessment 

European Union/European Economic Area 

EU Laboratory Capability Monitoring System 

European Reference Laboratories Network for Tuberculosis 

extended spectrum beta-lactamase-producing Enterobacteriaceae 

European Committee on Antimicrobial Susceptibility Testing 

food and waterborne diseases 

human immunodeficiency virus  

inter-quartile range  

multidrug-resistant tuberculosis 

Middle East respiratory syndrome coronavirus (MERS-CoV) 

multi locus sequence typing 

National Microbiology Focal Points 

National Reference Laboratories 

The Organisation for Economic Cooperation and Development 
polymerase chain reaction  
first quartile 

third quartile  

Strategic Multi-Annual Plan 

VTEC/STEC 

verotoxin- or Shiga toxin-producing  

TESSy 

TB 

TB-DST 

VHF 

WGS 

WHO 

The European Surveillance System 

tuberculosis 

tuberculosis drug susceptibility testing 

viral haemorrhagic fever 

whole genome sequencing 

World Health Organization 

Glossary of terms 

Laboratory capability 

Laboratory capacity 

Consists of the ability to perform the following functions: manage laboratory 
activities; perform sample management; conduct testing and analysis for 
routine and surge capacity; support public health investigations and report 
results [1]. 
Consists of output services completed over a defined time period for each 
capability [2]. 

National Microbiology Focal Points  Nominated representatives for public health microbiology in the EU/EEA 

National Reference Laboratories  

Public health microbiology 

Member States as part of the Competent Body Structure [3]. 
Laboratories with national responsibility and appropriate tools and skills to be 
able to collaborate in national surveillance and capacity to deal with emergency 
situations [4,5]. 
A cross-cutting area of microbiology that spans the fields of human, animal, 
food, water, and environmental microbiology, with a focus on human health and 
disease. It covers the laboratory contribution to detection and diagnosis of 
infectious microorganisms, and the characterisation and surveillance of 
microorganisms with the potential to affect populations [4,5]. 

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TECHNICAL REPORT 

EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Executive summary 

Background 

The ECDC public health microbiology strategy (2012–2016) and laboratory support within ECDC strategic multi-
annual programme (2014–2020) aim to strengthen the capability and capacity of the EU public health microbiology 
system to provide the timely and reliable information that underpins infectious threat detection, assessment and 
surveillance at Member State and EU level for effective prevention and control of infectious diseases [4,6]. To 
ascertain how well this is delivered, ECDC, in close collaboration with the National Microbiology Focal Points (NMFP) 
and the Advisory Forum (AF), has developed and piloted a system (EULabCap) for monitoring key public health 
microbiology capabilities and capacity for EU surveillance and epidemic preparedness on an annual basis. This 
assessment aims to help policymakers identify possible areas for action and to evaluate the impact of capacity 
strengthening activities and health system reforms. This report presents the indicator results in 2013 for 30 EU and 
EEA (European Economic Area) countries.  

Methods 

The EULabCap monitoring tool combines 60 technical indicators to assess the capability and capacity of 
microbiology laboratories to provide essential public health functions, as defined in EU policies and action plans, 
international health regulations and technical standards. The indicators are grouped into 12 targets which are 
distributed across the following three public health microbiology system dimensions: primary diagnostic testing, 
national microbiology reference laboratory (NRL) services and laboratory-based surveillance and epidemic response 
support. Each indicator can be scored at three levels: low, intermediate and high capability or capacity. Aggregated 
indices have been calculated for each target and dimension as the average of component indicator scores, 
adjusting all index values on a scale of 0–10. 

The EULabCap indicators are of a composite nature in terms of which element (structure or process) of the public 
health microbiology system they measure and how they measure it (functional capability or capacity). They 
comprise 24 structure and 36 process indicators. They are divided into 38 indicators of laboratory capability and 22 
of service capacity. About 3/4 of the indicators are based on EU policy targets or international technical standards, 
while the remainder assess EU surveillance and alert system contributions. 

A mixed method was used for data collection and scoring. To minimise the data reporting burden for the Member 
States, information for 20 indicators was retrieved by ECDC from data sets accessible in The European Surveillance 
System (TESSy) and EU disease network reports. The NMFPs used a questionnaire to collect information from their 
country for the remaining 40 indicators. 

The first data call on 2013 outputs was launched in September 2014. Two rounds of validation were performed 
with the NMFPs to ensure data accuracy and preliminary reports were reviewed in joint consultation with the 
NMFPs and the AF in May 2015. The draft reports were critically reviewed and the findings broadly supported in 
terms of validity and public health relevance. The AF/NMFPs advised ECDC on the main conclusions to be drawn 
from the first survey, as well as the optimal reporting and publication format to enable benchmarking. 

Results 

The country response to the survey was 100% (30/30 EU/EEA countries). Data from 2013 were provided for 96% 
of the indicators (range per country, 70–100%). The average EULabCap aggregated index score was 6.8 on a scale 
of 1–10, suggesting that the EU as a whole has a strong public health microbiology system capability and 
substantial capacity to fulfil its surveillance and response requirements.  

Substantial inter-country variation was found across all system targets, with overall performance indices per 
country ranging from 4 to 9. There was also diversity of scores among targets, with common challenging areas for 
which many countries lacked critical capabilities and/or showed low capacity. The areas of best practice with 
consistently high scores, largely meeting policy targets and standards, included antimicrobial drug susceptibility 
testing and antimicrobial drug resistance characterisation and monitoring, capabilities of national reference 
laboratory services, and laboratory collaboration within national and EU surveillance networks. The main challenges 
were in the target areas for provision and regulation of clinical microbiology services; diagnostic testing utilisation; 
diagnostic testing guidelines and national reference laboratory services relating to molecular typing for surveillance 
and national outbreak response support.  

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TECHNICAL REPORT 

Conclusion 

The high response rate of the EU/EEA countries in the first EULabCap survey highlights the EU/EEA countries’ 
commitment to participating in this new health system monitoring and benchmarking process, thanks to the 
engagement of the NMFPs.  

The first results showed that in 2013 the EU had a strong overall public health microbiology system capability, as 
indicated by the average index score of 6.8 out of 10. However, there was substantial inter-country variation in the 
scores, especially in primary diagnostic services and in some of the functions and technical capabilities of reference 
laboratories. 

The results were perceived by the AF and NMFPs as offering significant added value for the comparison of best 
practices, as well as for considering specific areas of improvement. In addition, they encouraged the use of this 
information for benchmarking public health microbiology systems by country. The annual reporting of EULabCap 
information can be used to monitor strengths and vulnerabilities in the national and EU network systems. It is 
anticipated that it will be useful to inform public health policies and evaluate their impact.  

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EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Introduction 

The detection and characterisation of infectious agents causing human disease by diagnostic and reference 
microbiology laboratories provides pivotal information for clinical management, public health surveillance and 
outbreak alert and response. As the epidemic of Ebola virus disease in West Africa has dramatically shown, any gap 
in laboratory capacity at local and national levels may prove disastrous due to delayed outbreak recognition and 
response. Provision of sufficient national laboratory capacity for infectious health threat detection and control is 
required to fulfil the obligations set forth in EU [7] and international legislation [8]. This capacity hinges on close 
collaboration with the national surveillance institutes and adequate funding, infrastructure, and human resources 
within the national healthcare system. 

Public health microbiology systems comprise three intertwined components. First, clinical laboratories performing 
primary diagnostics, antimicrobial drug susceptibility testing and screening focused on patient management and 
preventive services. Second, public health laboratories serving reference functions on a national or subnational 
level such as specialist diagnostics and biological agent characterisation. Third, laboratory networks performing 
harmonisation of methods, quality assessment and contribution to public health surveillance and alert systems, 
nationally and internationally. 

National health systems in Europe are undergoing continuous administrative and organisational reforms to face up 
to the challenge of maintaining universal access to essential and high-quality care with reduced resources [3]. 
Following the financial crisis in 2008, health expenditure has either stopped growing or even decreased in various 
degrees across the EU Member States [3]. Public health budget cuts have affected resources available to and 
investment in laboratory operations. The Founding Regulation of ECDC (EC No. 851/2004) states that ‘by 
encouraging cooperation between expert and reference laboratories, the Centre shall foster the development of 
sufficient capacity within the Community for the diagnosis, detection, identification and characterization of 
infectious agents which may threaten public health’ [9]. In this dynamic context, monitoring the collective 
laboratory capabilities in the EU/EEA is important to identify best practices and address potential vulnerabilities. 

Europe benefits from a decade-long legacy of collaboration between infectious disease experts, microbiologists and 
epidemiologists in dedicated surveillance networks and other professional initiatives to harmonise laboratory 
methods, promote quality, and build capacity. Results from previous laboratory mapping exercises in the EU 
conducted by ECDC [9] and the European Commission [10], have revealed a wide diversity in services, 
infrastructure, technical capacity, public health activities and human resources. Specific areas identified as being of 
potential EU added-value included the training of laboratory staff, method harmonisation and the devolution of 
specialist technical capacity at supranational level [9,10]. 

The ECDC public health microbiology strategy (2012–2016) and laboratory support within its strategic multi-annual 
programme (2014–2020) aim to strengthen the capability and capacity of the EU public health microbiology system 
to provide the timely and reliable information that underpins infectious threat detection, assessment and 
surveillance at Member State and EU level, as needed for effective prevention and control of infectious diseases 
[4,6]. To ascertain how well this is delivered, ECDC, in close collaboration with the National Microbiology Focal 
Points (NMFP) and the Advisory Forum (AF), developed and piloted a system (EULabCap) for monitoring key public 
health microbiology capabilities and capacity for EU surveillance and epidemic preparedness on an annual basis. 
After piloting the data collection and indicator scoring instrument in 2012–14, the first data call was launched in 
2014 to collect the information on 2013 system outputs for 30 EU/EEA countries.  

The NMFP are the main contributors to the data collection and verification. They are responsible for disseminating 
the annual EULabCap country profile report within their Competent Bodies, in accordance with their terms of 
reference [6]. At the national level information can be used for informing decision makers on options to strengthen 
the system where relevant (e.g. by adopting good practice or initiating bilateral laboratory cooperation). ECDC will 
also use the annual results on EULabCap to plan its laboratory support work in the coming years.  

This report presents the EULabCap survey results as achieved in 2013 for 30 EU/EEA countries.  

Materials and methods 

Survey population 

The first data call was launched in September 2014 to collect the information on the 2013 capabilities and 
capacities of the 28 EU Member States and two EEA countries. Liechtenstein declined the offer to be included in 
the survey due to the outsourcing arrangements they have in place with laboratories in Switzerland to meet their 
public health microbiology needs. 

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EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey  

TECHNICAL REPORT 

Survey tool  

An Excel-based data collection tool was developed and pilot tested for feasibility and clarity in close collaboration 
with the NMFPs. The EULabCap monitoring tool is composed of 60 performance indicators grouped into 12 targets 
(Annex 1) which are equally distributed across the following three public health microbiology system dimensions: 
primary diagnostic testing, national microbiology reference laboratory (NRL) services and laboratory-based 
surveillance and epidemic response support (Figure 1). 

Figure 1. Structural overview of the EULabCap indicators as grouped by dimension and target 

The EULabCap indicators (Annex 1) are of a composite nature in terms of what element of the system they 
measure (structure or process) and how they measure it (functional capability or capacity). They comprise 24 
structure and 36 process indicators. They are divided into 38 indicators for laboratory capability and 22 for capacity 
(Table 1). The policy rationale for the design of indicators/targets and score levels was based on previously agreed 
EU policy targets or international technical standards for three-quarters of the indicators, while the remainder 
assess EU surveillance and alert system contributions (Annexes 2 and 3). 

Table 1. Distribution of EULabCap indicators by dimension, element and function measured 

Dimension 

Number of indicators  
 by element 

Number of indicators  
by function 

Structure 

Process  

Capability  

Capacity  

Primary diagnostic testing 
National microbiology 
reference laboratory 
services 
Laboratory-based 
surveillance and epidemic 
response support 
Total 

11 
5 

8 

24 

9 
15 

12 

36 

11 
14 

13 

38 

9 
6 

7 

22 

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TECHNICAL REPORT 

EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Scoring system 

Each indicator has three possible scores (0, 1, 2) and a ‘not available’ or ‘not applicable’ option. Each score was 
assigned to either a low, intermediate or high level of laboratory capability/capacity, based on the WHO laboratory 
assessment tool (Table 2) [11].  

Table 2. Interpretation of score levels for laboratory capability and capacity 

Source 

Interpretation 

Level 

0 

1 

2 

No or limited capability/capacity 

Low 

Partial capability/capacity (e.g. below 
the EU target, or partial compliance) 

Intermediate 

Complete capability/capacity (e.g. EU 
target reached, or high compliance) 

High 

NA* 

Capability/capacity not known 

* NA (not available or not applicable) was not included in the calculation of the specific target. 

Data collection and validation process 

A mixed method was used for data collection. To minimise the burden for the Member States, information for 20 
indicators was retrieved by ECDC from data sets accessible in The European Surveillance System (TESSy) and EU 
disease network reports. The NMFP collected information for the remaining 40 indicators by means of a 
questionnaire (Annex 3). Two rounds of validation were performed with the NMFP to ensure data accuracy and 
correct score calculation. 

Data analysis and interpretation 

Data completeness was calculated as a percentage for each indicator across the EU/EEA and overall for each 
country. Aggregated performance indices were calculated for each target and dimension as the average of 
component indicator scores per country, adjusting values on a scale of 0–10. Descriptive data analysis including 
measures of central tendency (mean and median) and dispersion (standard deviation and inter-quartile range) of 
indicator scores and aggregated indices across the EU/EEA were calculated using Excel 2010. Overall EULabCap 
index scores per country were graded qualitatively at three performance levels: low (0 to 5.9), intermediate (6.0 to 
7.9) and high (8.0 to 10). Statistical analysis of the correlation between EULabCap country score and national 
health expenditure per capita in 2012, as reported to OECD (The Organisation for Economic Cooperation and 
Development) [3], was performed using STATA 13. 

The draft preliminary EULabCap 2013 reports (individual country reports and EU/EEA report) were shared with 
NMFPs for review in April 2015. The EU report was critically reviewed and discussed at the joint NMFP-Advisory 
Forum meeting in May 2015. The draft reports were broadly supported in terms of validity and public health 
relevance of the findings, subject to minor modifications of the tool. One indicator was found not to be feasible and 
was replaced in the majority of countries. A further 10 indicators were edited to enhance clarity or precision in 
June 2015. A final round of 2013 data reporting/verification for these indicators was undertaken with all NMFPs 
between June and September 2015. 

Data reporting 

Aggregated report for the EU/EEA 

This technical report displays aggregated data on the EULabCap scores for all 30 participating EU/EEA countries, 
using histograms, radar and bar graphs, and maps to visualise the distribution of performance scores for the 
system overall, by target and dimension. A scatterplot diagram and linear regression analysis are presented to 
explore the relation between EULabCap index and national health expenditure in the previous year. 

Individual country reports 

For all the 30 participating EU/EEA countries an individual EULabCap country report was prepared, including 
detailed information on the country’s profile. This report was shared with the respective NMFP, intended for 
dissemination within and use by the Coordinating Competent Bodies of the country. 

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TECHNICAL REPORT 

Each country report displayed the country’s scores for all indicators compared with the mean EU/EEA scores for 
each target and indicator. In addition, a radar graph comparing the country score with the EU inter-quartile range 
(IQR) for the 12 targets enabled the identification of targets with deviations below or above the EU middle range. 
For individual country reports, the country EULabCap indices were grouped into four relative levels of public health 
microbiology system capabilities and capacities: imbalanced (first quartile score), fair (second quartile score), 
strong (third quartile score) and very strong (fourth quartile score). 

A customised executive summary addressing the question ‘How well was your country performing in 2013?’ 
highlighted country-specific areas of high performance and drew attention to areas of under-performance based on 
the reported indicators.  

Results 

Response rate and data completeness 

The country response to the survey was 100% (30/30 countries). The 2013 data for all 30 countries were provided 
for 95% of the indicators (1 717 out of 1 800 data points), ranging from 70–100% by country and from 64–100% 
by indicator (Figure 2).  

Six indicators had missing data from more than three countries (Figure 2). Those indicators were, in order of 
increasing completeness, 2.34, 3.13, 2.32, 1.33, 2.24 and 2.33. 

Figure 2. Indicator completeness and distribution of missing data by country (sorted by descending 
order of completeness 

NA (not applicable) answers correspond to blue cells 

Laboratory capabilities and capacities at EU/EEA level 

The average EULabCap aggregated index score was 6.8 on a scale of 1–10. 

The index scores showed different distributions across dimensions, with a median index of 6.4 (IQR 5.4–7.4) for 
primary diagnostic testing, 7.0 (IQR, 6.1–7.8) for NRL services and 7.3 (IQR, 5.9–8.7) for laboratory-based 
surveillance and epidemic response support (Figure 3).  

6 

1.111.121.131.141.151.211.221.231.241.251.311.321.331.341.351.411.421.431.441.452.112.122.132.142.152.212.222.232.242.252.312.322.332.342.352.412.422.432.442.453.113.123.133.143.153.213.223.233.243.253.313.323.333.343.353.413.423.433.443.45TOTALBelgium............................................................0Denmark............................................................0Finland............................................................0Luxemb.............................................................0Spain............................................................0Sweden............................................................0Austria...........................................................1Bulgaria...........................................................1Estonia...........................................................1France...........................................................1Ireland...........................................................1Norway...........................................................1Slovenia...........................................................1UK...........................................................1Cyprus......................................................6Czech R...........................................................2Greece..........................................................2Hungary..........................................................2Italy..........................................................2Netherl...........................................................2Romania..........................................................2Slovakia..........................................................2Croatia.........................................................3Germany.........................................................3Latvia........................................................4Lithuania........................................................4Portugal......................................................6Poland....................................................8Iceland...................................................9Malta..........................................18TOTAL200100011030600120201111000061151142122211042301010003320001183COUNTRYINDICATOR REFERENCE NUMBER 
 
 
 
 
 
 
 
 
 
 
 
TECHNICAL REPORT 

EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Figure 3. Boxplot of the EULabCap index scores by dimension (N=30 countries)  

The distribution of the EU median and interquartile range for EULabCap index scores by target and dimension of 
the public health microbiology system is shown in Figure 4. 

Figure 4. Distribution (median and inter-quartile range) of country EULabCap 2013 index scores by 
target (N=30 EU/EEA countries) 

Grouping these results according to the EU/EEA median score per target made it possible to identify three levels of 
target capability/capacity (high, intermediate and low comparative performance) (Table 3). 

7 

46810Distribution of country EULabCap indices by dimension, N=30 countries, 2013Primary diagnostic testingNRL servicesSurveillance/epidemic response supportBox-plot of quartiles and range of score for: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey  

TECHNICAL REPORT 

Table 3. Distribution of EU capability/capacity based on EU median index scores by target 

High performance targets  

(median ≥ 7.4) 

Intermediate performance 
targets 

(median 6.4-7.3) 

Low performance targets 

(median ≤ 6.3) 

1.4 Antimicrobial drug susceptibility 
testing 

2.4 Antimicrobial drug resistance 
characterisation and monitoring 

1.1 Provision and regulation of 
clinical microbiology services 

2.1 Provision/regulation of national 
reference microbiology services 

2.2 Reference diagnostic 
confirmation and pathogen 
identification 

3.2 Active participation in EU 
disease networks 

3.1 National surveillance networks 

1.2 Diagnostic testing guidelines 

3.3 National outbreak response 
support 

1.3 Primary diagnostic testing 
utilisation 

3.4 (Re-)emerging diseases 
laboratory preparedness and 
response support 

2.3 Molecular typing for surveillance 

Laboratory capabilities and capacities at country level 

The EULabCap index showed substantial inter-country variation with unimodal distribution of country scores 
ranging from 4.1 to 9.2 (Figure 5).  

Figure 5. Distribution of overall EULabCap index country scores 2013 (N=30 EU/EEA countries) 

The map in Figure 6 shows the geographical distribution of performance by country based on three levels (low, 
medium and high). In addition, Annex 4 includes maps showing the geographical distribution of each target 
performance level by country based on the same three categories as Figure 6. 

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Figure 6. Levels of public health microbiology system capabilities and capacities (N=30 EU/EEA countries) 

In addition to variation in the EULabCap overall country score, there was substantial variation within each country 
in the target index scores distribution. This is shown in the radar graphs (Figure 7), displaying the shape linking 
target index scores for each EU/EEA country. There is a noticeable imbalance in the performance scores achieved 
across targets in a number of countries. 

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Figure 7. Radar graphs of EULabCap target index scores for each country (red line), from top left to 
bottom right, in ascending order of total index country score, compared with the EU inter-quartile 
range (grey line), N=30 EU/EEA countries, 2013 

The graphs display the same variables and axis scales as shown in Figure 4. 

Relation between capability index and health expenditure  

The overall EULabCap capability index ranged from 4.1 to 9.2/10 by country. As data on direct monetary or other 
resource inputs into the national microbiology system are not available, an exploratory analysis was performed to 
examine the relation between country capability index and national health expenditure [3,12], used as crude proxy 
of financial input (Figure 8). A direct linear relationship was found between the country level of expenditure and 
the EULabCap index. However, only about 38 percent of the variance in the EULabCap index across countries was 
predicted by the level of health expenditure, indicating that other factors enabled low resource spending countries 
to achieve strong performance with their microbiology system. 

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EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Figure 8. Scatter plot and correlation coefficient based on linear regression between the EULabCap 
country index 2013 and total national health expenditure per capita in 2012 (N=30 EU/EEA countries) [3] 

R2 = 0.38 
p-value = <0.001 

Primary diagnostic testing 

A more detailed analysis of country scores per indicator in each system dimension revealed EU strengths and 
weaknesses in specific technical areas. Figure 9 displays the distribution of countries’ scores and the EU/EEA mean 
for the 20 primary diagnostic testing indicators.  

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Figure 9. EU distribution of scoring results by country for the 20 EULabCap indicators within the 
dimension of primary diagnostic testing  

Lower levels of capability/capacity were noted for a number of indicators within targets on the provision and 
regulation of clinical microbiology services, diagnostic testing guidance and primary diagnostic testing utilisation. In 
particular, substantial gaps were noted for medical laboratory licensing, accreditation and biosafety regulation and 
oversight (Target 1.1). Guidance on diagnostic testing was frequently lacking or not evaluated for antenatal 
infection and for Clostridium difficile infection (Target 1.2). With regard to capacity indicators for test service 
utilisation (Target 1.3), a majority of EU/EEA countries missed the TB and HIV testing targets from EU action plans 
for disease control and a majority did not measure Clostridium difficile testing rates in hospital care for 2013. 

In contrast, primary antimicrobial drug susceptibility testing (Target 1.4) showed high levels of capability/capacity, 
highlighted by wide implementation of EUCAST standards and high quality results in external quality assessment 
schemes in the majority of EU/EEA countries. 

From the perspective of accessibility of care, it is noticeable that clinical microbiology laboratory tests were publicly 
funded or reimbursed at least in part for in- and out-patient testing in 77% of EU/EEA countries and that testing 
for HIV infection and tuberculosis was available to undocumented migrants in 87% of countries. 

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EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

National reference laboratory service 

Figure 10 displays the distribution of countries’ scores and the EU/EEA mean for the 20 National Reference 
Laboratory services indicators.  

Figure 10. EU distribution of scoring results by country for the 20 EULabCap indicators within the 
dimension of National Reference Laboratory services 

Notes on Fig. 10: 

Indicator 2.24. STEC serogrouping coverage. Non-typeable and non-typed isolates were included in the percentage 
calculation of those with serogrouping. This calculation might have underestimated the countries’ real capabilities as non-typeable 
isolates may occur due to biological variation.  

Indicator 2.33. MDR-TB genotyping coverage. One third of the countries had a ‘non-applicable’ value because data were 
retrieved from TESSy and they did not participate in the ECDC molecular typing for surveillance pilot project activities for MDR-TB. 
The performance measured by this indicator depends on countries volunteering to participate in these EU activities.  

Indicator 2.34. N. meningitidis genotyping coverage. Performing MLST, fetA and porA sequencing for a full application of 
the EU-recommended Neisseria meningitidis fine typing scheme is resource-demanding. Partial application (i.e. reporting fetA and 
porA sequences) is not taken into account with the indicator as scored in 2013.  

Overall, the provision/regulation of national reference microbiology services including diagnostic confirmation, 
pathogen identification and antimicrobial drug resistance monitoring by NRL (Targets 2.1, 2.2 and 2.4) showed 
high score levels for most capability/capacity indicators. 

In particular, 90% of EU/EEA countries reported in-country capability for case confirmation and pathogen 
identification for more than 35 of the 53 EU-notifiable communicable diseases (Indicator 2.21) according to the 
laboratory criteria described in the EU case definitions [13]. Confirmation capability was reported by all EU/EEA 
countries for 10 listed diseases (Table 4). These include high-priority and/or epidemic-prone diseases (e.g. 

13 

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influenza, tuberculosis and listeriosis). For 47 listed diseases there was also widespread capability for detection and 
diagnosis in 25–30 countries. Fewer (15 to 24) countries could domestically confirm the remaining rare diseases or 
agents which require specialised testing facilities, materials, and know-how (e.g. viral haemorrhagic fever, smallpox 
or rabies). For all countries that do not have national capabilities, the NMFP mentioned that they have technical 
cooperation with other countries.  

Table 4. Number of EU/EEA countries reporting diagnostic confirmation and pathogen identification testing 
available within the country for the 53 diseases/health issues listed in Decision 2119, in accordance with the 
EU surveillance case definitions of the Community Network [13] 

Disease/health issue 

No. of 
countries 
(N=30) 

Disease/health issue 

Influenza 

Influenza A 

Listeriosis 

Measles 

Meningoccocal disease, invasive 

Pneumococcal disease, invasive 

Rubella 

No. of 
countries 
(N=30) 

30 

Gonorrhoea 

Legionnaires’ disease 

Poliomyelitis 

Q Fever 

West Nile Fever 

Echinococcosis 

SARS 

Salmonellosis (not S. Typhi, S. Paratyphi) 

Tick-borne encephalitis  

Trichinellosis 

Chlamydial infection, including LGV 

Leptospirosis 

Plague 

Tularaemia 

Viral haemorrhagic fevers  

29 

Tetanus 

Botulism 

Yellow fever 

Creutzfeldt-Jakob disease, variant 

Rabies 

Smallpox  

28 

Tuberculosis 

Avian influenza 

Cholera 

Diphtheria 

Haemophilus influenzae, invasive 

Hepatitis B 

Hepatitis C 

Malaria 

Mumps 

Rubella, congenital 

STEC/VTEC 

Toxoplasmosis 

Typhoid/paratyphoid fever 

AIDS and HIV 

Anthrax 

Brucellosis 

Campylobacteriosis 

Cryptosporidiosis 

Giardiasis 

Hepatitis A 

Pertussis 

Shigellosis 

Syphilis  

Syphilis, congenital and neonatal 

Yersiniosis 

27 

26 

25 

24 

23 

22 

21 

15 

In contrast, the use of molecular typing characterisation of pathogens for surveillance (Target 2.3) indicated a low level of 
capability/capacity in many EU/EEA countries, as measured by the indicators. However, many of these indicators were 
scored based on TESSy reported data and therefore did not measure the national typing capacity but the capacity shared 
at EU surveillance level, a process which in 2013 was at the early stage of development (based on volunteer country 
participation). As expected, in 2013 no country was routinely using whole genome sequencing-based typing of human 
pathogens for national surveillance, as no such protocol had yet been standardised. 

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Laboratory-based surveillance and epidemic response 
support 

Figure 11 indicates the distribution of countries’ scores and the EU/EEA mean score for the 20 laboratory-based 
surveillance and epidemic response support indicators. 

Figure 11. EU distribution of scoring results by country for the 20 EULabCap indicators within the 
dimension of surveillance and response support 

Overall, indicators of laboratory contribution to national surveillance networks, national outbreak response support, 
and preparedness and response for (re-)emerging diseases showed an intermediate level of capability/capacity 
performance. The target ‘Active participation in EU disease networks’ had the best performance overall with an 
EU/EEA mean score of 8.6, reaching near complete country participation for the tuberculosis and Legionella 
networks. 

Strong performance scores were also reported by a majority of countries for the operation of national sentinel 
surveillance networks. Remarkably, 83% of EU/EEA countries had collaboration in place between reference 
laboratories and national networks of clinical laboratories for more than five diseases under surveillance. 

However, many countries reported low or medium scores for automation of microbiology data reporting and 
capability of cluster detection especially based on molecular typing (e.g. for Listeria or hepatitis A). Laboratory 
expert participation in outbreak response also showed limited performance for many countries. Although 60% of 
EU/EEA countries had a 24/7 NRL response support duty in place in 2013, only 40% of the countries reported 
strong NRL contribution to outbreak investigations and testing of preparedness plans. 

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Discussion 

The EULabCap is the first initiative to measure the whole spectrum of microbiology laboratory capabilities and 
capacities required to underpin effective communicable disease surveillance and epidemic preparedness at the EU 
and country levels. The use of a new indicator framework applying a common terminology and taxonomy of 
services was pivotal to the success of this process. With an average EULabCap index score of 6.8 on a scale of 0–
10 in 2013, the EU as a whole showed evidence of a strong public health microbiology system, with substantial 
capacity to collectively fulfil its communicable disease surveillance and response requirements.  

The data collection method proved feasible in this first call for 2013 data. The remarkable 100% country response 
and 96% completeness of indicators showed the commitment of the NMFP to this project. However, the dataset 
had some limitations. For various reasons some countries were not able to provide data for all indicators. 
Explanations for the missing information included: a lack of formally designated NRL or outsourcing of reference 
services to other countries; low disease incidence or limited referral of samples to NRL from primary diagnostic 
laboratories; countries having a small population with centralised care and primary/specialist laboratory testing and 
time constraints for collecting the information from other stakeholders or databases. Indicators that measure 
information sharing within a national reference laboratory system are only applicable to countries with more than 
one clinical and reference laboratory. As ‘not available/not applicable’ values were not included in the performance 
score calculation by target, this ascertainment bias may have led to an under- or over-estimation of performance. 
The missing data or not applicable indicators were low frequency and therefore unlikely to affect the overall 
robustness of the indicators, except for a few countries. In addition, the four indicators on microbial typing 
performance, which were considered less robust due to difficulties in data collection and/or scoring criteria, will be 
improved in the next survey. 

Significantly, two-fold variation in EULabCap country indices was noted across the EU/EEA. A moderate linear 
correlation was observed between the country index and the total health expenditure. However, only about a third 
of the inter-country variance in the EULabCap index was predicted by the level of health expenditure. This 
observation suggests that there are more factors determining system strength than the overall health spending per 
capita. High capability indices were noted in some low spending countries and vice versa, suggesting either a 
different allocation of these expenditures to the laboratory services between countries, and/or differences in the 
cost-efficiency of services. 

The comparison of score distribution by dimension indicated the lowest EU median scores in the primary testing 
dimension, reflecting gaps in clinical laboratory service provision and regulation within national healthcare systems. 
The median score of EULabCap index for the NRL services dimension was high and showed limited inter-country 
variance. This observation may reflect convergence across the EU of national public health practices after several 
decades of sharing experience and collaboration. Nevertheless, five years after publication of the NMFP consensus 
guidance, NRLs were not officially nominated by health authorities in one third of the EU/EEA countries and only a 
minority of countries have reached agreement on accreditation and public funding of these services. Regarding 
NRL contribution to surveillance and response, strong overall EU indices were accompanied by wider inter-country 
variance. The high level of participation in ECDC disease-specific laboratory networks is a key finding that builds on 
a legacy of longstanding collaboration between laboratory scientists and public health specialists in Europe. 

The high level of capability/capacity noted in antimicrobial drug susceptibility testing highlights the successful 
implementation of the harmonised susceptibility breakpoints established by the European Committee on 
Antimicrobial Susceptibility Testing (EUCAST). This positive finding can be related to the number of EU initiatives 
and the fact that global policy is now focusing on the health threat of antimicrobial resistance. It is also a credit to 
professional leadership across Europe to see how antimicrobial testing practice has been harmonised to improve 
the quality of care and surveillance [14,15]. 

Regarding molecular typing, low scores were expected in 2013 for indicators on typing capacity as reported to 
TESSy since the integration of molecular typing into EU surveillance was only piloted by voluntary reporting on 
foodborne disease and MDR-TB. Moreover, as indicated in the footnote to Figure 13, based on feedback from 
participants a number of minor corrections will be introduced in the next survey to the classification criteria for 
measuring typing coverage. It will be interesting to follow the trends in future TESSy reporting of molecular typing 
information and to see how quickly the 19 countries planning to use whole genome sequencing for surveillance 
move to practical application. 

Strong scores were reported by a majority of countries for the operation of national sentinel surveillance networks. 
However, most countries reported low or medium scores for indicators of rapid microbiology data reporting and 
cluster detection capability. This finding indicates that there are opportunities for enhanced application of IT 
solutions to facilitate laboratory-based surveillance and alert systems within and across EU/EEA countries.  

Almost all countries declared having access to the range of specific agent diagnostic capabilities required to meet 
EU surveillance reporting obligations. There were only a handful of rare diseases or high-consequence pathogens 
requiring specialised containment facilities for which countries relied on third party arrangements. It would be 
useful to know in terms of preparedness whether these external service agreements were ad hoc or through pre-

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arranged contracts. The data reported here on diagnostic capability may overstate the true capability and not 
assess capacity in terms of volume or frequency of testing. It would be informative to cross-check these self-
reported domestic or cross-border technical capabilities with the results of recent External Quality Assessment 
(EQA) exercises for the detection of specific agents [16-19]. This is illustrated by the discrepancies recorded in the 
EQA exercise for diphtheria diagnostics held in 2013: only 9/30 participating EU/EEA countries correctly detected 
toxin production in Corynebacterium diphtheriae strains [17], whereas 29/30 countries reported diphtheria 
diagnostic confirmation capability in accordance with the EU case definition in EULabCap.  

A majority of EU/EEA countries had a strong capacity for diagnosis and further characterisation of emerging 
disease agents, such as avian influenza H7N9, MERS-CoV, Ebola virus and rare and/or imported viruses. This 
observation is consistent with the results of dedicated activities in the field of preparedness and response for these 
agents in Europe [19]. Since information on capability/capacity for diagnostics of other (re-)emerging infectious 
diseases (e.g. Lyme disease, new strains of multidrug-resistant bacteria) is not captured by the EULabCap, should 
an event occur caused by these or other unusual agents, ad hoc surveys within EU disease networks should be 
undertaken to rapidly appraise the detection capacity in Europe. 

Conclusions 

With an average EULabCap aggregated index score of 6.8 out of 10, the EU as a whole shows evidence of a strong 
overall public health microbiology system capability and substantial capacity to fulfil its surveillance and response 
requirements.  

However, substantial inter-country variation was found across all system targets, and the average EU/EEA scores 
were also divergent across targets, indicating that there were common challenge areas for which many countries 
showed more limited provision of critical capabilities and/or low capacity.  

The main challenges were found in:  

 
 

primary diagnostic service regulation, guidance and utilisation 
laboratory support to national outbreak response. 

The areas of best practice with consistently high levels of performance, largely meeting policy targets and 
standards, included: 

 
 
 

primary antimicrobial drug susceptibility testing and antimicrobial resistance monitoring, 
capability scope of the national reference laboratory services 
active laboratory collaboration within national and EU surveillance networks.  

The EULabCap annual monitoring aims to inform national competent bodies as well as policy makers at the 
national and EU level. This first survey on 2013 capacities sets out the baseline for monitoring country and EU 
public health microbiology performance. ECDC will prioritise its support activities to focus on challenging areas 
within its mandate, in collaboration with the EU/EEA countries, the European Commission and other European 
agencies and partners. Future surveys should provide information for evaluating the impact of national policies and 
EU support activities on system performance. 

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References 

Centers for Disease Control and Prevention. Public Health Preparedness Capabilities: National Standards for State and 
Local Planning. USA: CDC, 2011. Available from: http://www.cdc.gov/phpr/capabilities/DSLR_capabilities_July.pdf 

Witt-Kushner J, Astles JR, Ridderhof JC, Martin RA, Wilcke B, Downes FP, et al. Core Functions and Capabilities of State 
Public Health Laboratories: A Report of the Association of Public Health Laboratories. Morbidity and Mortality Weekly 
Report (MMWR). 2002 September 20;51(RR14):1-8. 

OECD. Health at a Glance: Europe 2014. OECD Publishing, 2014. 

European Centre for Disease Prevention and Control. Updated Public Health Microbiology Strategy and Work Plan 2012-
2016. Stockholm: ECDC, 2011. 

European Centre for Disease Prevention and Control. Core functions of microbiology reference laboratories for 
communicable diseases. Stockholm: ECDC; 2010. 

European Centre for Disease Prevention and Control. Coordination Competent Bodies: structures, interactions and terms 
of references. Stockholm ECDC, 2012. 

Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border 
threats to health and repealing Decision No 2119/98/EC Text with EEA relevance (2013). 

World Health Organisation. International Health Regulations. Second ed. Geneva: WHO; 2005. 

European Centre for Disease Prevention and Control. Fostering collaboration in public health microbiology in the European 
Union. Stockholm ECDC, 2010. 

European Commission. Call for tender no Chafea/2014/Health/06 concerning the study on cost-benefit analysis of 
reference laboratories for human pathogens Luxembourg: EC/CHAFEA; 2011. Available from: 
http://cordis.europa.eu/news/rcn/30157_en.html 

World Health Organisation. Laboratory Assessment Tool. Geneva: WHO/GCR; 2012. Available from: 
http://apps.who.int/iris/bitstream/10665/70874/3/WHO_HSE_GCR_LYO_2012.2_eng.pdf?ua=1&ua=1. 

European Commission. Eurostat database 2014.  

Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for 
the epidemiological surveillance and control of communicable diseases in the Community, (1998). 

Kahlmeter G. Defining antibiotic resistance - towards international harmonization. Uppsala Journal of Medical Sciences. 
2014 May;119(2):78-86. 

Brown D, Canton R, Dubreuil L, Gatermann S, Giske C, MacGowan A, et al. Widespread implementation of EUCAST 
breakpoints for antibacterial susceptibility testing in Europe. Euro Surveill. 2015;20(2). 

European Centre for Disease Prevention and Control. Forth External Quality Assessment Scheme for typing of verotoxin-
producing E. coli (VTEC) Stockholm ECDC, 2014. 

European Centre for Disease Prevention and Control. External quality assurance scheme for diphtheria diagnostics. 
Stockholm: ECDC, 2013. 

Pereyaslov D, Rosin P, Palm D, Zeller H, Gross D, Brown CS, et al. Laboratory capability and surveillance testing for Middle 
East respiratory syndrome coronavirus infection in the WHO European Region, June 2013. Euro Surveill. 
2014;19(40):20923. 

Both L, Neal S, De Zoysa A, Mann G, Czumbel I, Efstratiou A, et al. External quality assessments for microbiologic 
diagnosis of diphtheria in Europe. Journal of Clinical Microbiology. 2014 Dec;52(12):4381-4. 

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Annex 1. EULabCap survey list of targets, 
indicators and scoring options (with shorthand 
annotation for results presentation in red) 

Dimension 1. Primary Diagnostic Testing - Primary_diag 

Targets/Indicators 

Source (NMFP/ECDC) and scoring options 

Target 1.1. Regulation_clin_micro 
Provision and regulation of clinical microbiology services. 

Indicator 1.11. Test_reimbursement  
Clinical microbiology laboratory tests were funded/reimbursed in total, or in part, 
either by a national insurance scheme or by a governmental budget. 

Indicator 1.12. Lab_licencing  
Clinical microbiology laboratories obtained a licencing authorisation/registration from 
health authorities (or professional organisations) according to legal/regulatory 
requirements. 
Indicator 1.13. Lab_accreditation  
Clinical microbiology laboratories accredited (one or more) of their diagnostic tests 
according to ISO 17025, ISO 15189, or equivalent national standards.  
Please specify which standard(s) in the column ‘Additional information’.  
Indicator 1.14. Biosafety_general 
Clinical microbiology laboratories must receive a biosafety authorisation/permit for 
performing operations at Biosafety Level (BSL)2 and BSL3.  
Indicator 1.15. Biosafety_TB  
Culture-based tuberculosis diagnostic and drug susceptibility tests were restricted to 
laboratories compliant with performing BSL3 operations in line with the WHO 
Tuberculosis laboratory biosafety manual.  

NMFP  
NA = not available, 0 = no tests are reimbursed, 1 = for 
hospital in-patient testing, 2 = for in- and outpatient 
testing. 
NMFP  
NA = not available, 0 = not required by law/regulation, 1 
= required for some laboratories, 2 = required for all 
laboratories.  
NMFP  
NA = not available, 0 = no laboratories, 1 = some 
laboratories, 2 = all laboratories.  

NMFP  
NA = not available, 0 = not required by law/regulation, 1 
= for BSL3 facilities, 2 = for both BSL2 and BSL3 facilities. 
NMFP  
NA = not available, 0 = not required by law/regulation, 1 
= for DSTs, 2 = for all TB culture tests and TB DSTs. 

Target 1.2 Diag_guidance 
Diagnostic testing guidelines 

Indicator 1.21. Antenatal_screening  
National guidelines are available for antenatal screening of congenital infection and 
implementation is monitored within the country. 

Indicator 1.22. HIV_testing  
National guidelines are available for HIV testing. 

Indicator 1.23. Cdif_testing  
National guidelines are available for Clostridium difficile diagnostic testing in 
healthcare-associated diarrhoea.  

Indicator 1.24. CPE_screening  
National guidelines are available to screen hospitalised patients for carbapenem-non-
susceptible/carbapenemase-producing Enterobacteriaceae . 

Indicator 1.25. TB_diag_DST  
National guidelines are available for tuberculosis laboratory diagnostics and drug 
susceptibility testing. 

NMFP  
NA = not available, 0 = guidelines not available at the 
national level, 1 = guidelines are available without 
compliance monitoring, 2 = guidelines are implemented 
with compliance monitoring. 
NMFP  
NA = not available, 0 = guidelines not available at the 
national level, 1 = guidelines are available without 
compliance monitoring, 2 = guidelines are implemented 
with compliance monitoring. 
NMFP  
NA = not available, 0 = guidelines not available at the 
national level, 1 = guidelines are available without 
compliance monitoring, 2 = guidelines are implemented 
with compliance monitoring.  
NMFP  
NA = not available, 0 = guidelines not available at the 
national level, 1 = guidelines are available without 
compliance monitoring, 2 = guidelines are implemented 
with compliance monitoring.  
NMFP  
NA = not available, 0 = guidelines not available at the 
national level, 1 = guidelines are available without 
compliance monitoring, 2 = guidelines are implemented 
with compliance monitoring.  

Target 1.3 Diag_test_use 
Diagnostic testing utilisation 

Indicator 1.31. Diag_test_migrants 
Accessible diagnostic testing for HIV infection and/or tuberculosis was available to 
undocumented migrants in your country. 

Indicator 1.32. Blood_culture_test_rate 
Average number of blood culture sets tested/1000 hospital inpatient days reported by 
EARS-Net participating hospitals from your country. 
*The current report is based on 2012 data.  

NMFP 
NA = not applicable, 0 = testing is not available, 1 = 
testing available for HIV infection, 2 = testing available 
for HIV infection and tuberculosis. 
ECDC 
NA = not available/not applicable, 0 = information not 
reported to EARS-Net, 1 = low blood culture test 
utilisation rate/1000 patient days (first quartile), 2 = fair 
to high blood culture utilisation rate/1 000 patient days 
(upper three quartiles). 

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Targets/Indicators 

Source (NMFP/ECDC) and scoring options 

Indicator 1.33. Cdif_test_rate  
Total number of Clostridium difficile diagnostic tests** performed/1 000 hospital-in-
patient days, based on national estimate*. 

*Estimate can be determined by a (representative) sample via survey 
**A test = a stool sample tested for 1 or more diagnostic C. difficile assays including 
toxin immunoassay, toxin cytotoxic cell-culture assay, PCR, or culture. 

Indicator 1.34. TB_culture_DST  
Proportion of new pulmonary tuberculosis cases confirmed by culture and tested for 
susceptibility to first-line drugs. 

Indicator 1.35. HIV_late_diag  
Proportion of new HIV cases older than 14 years with initial CD4 counts (CD4<350 
cells/µl - late diagnosis) reported. 

NMFP  
NOTE: ECDC will use the numbers provided to 
calculate quartiles. 
NA = not available, 0 = not measured in the country, 1 = 
low diagnostic test utilisation rate/1000 patient days (first 
quartile); 2 = fair to high diagnostic test utilisation 
rate/1 000 patient days (upper three quartiles). 

ECDC 
NA = not available, 0 = <80% culture confirmed AND no 
DST, 1 = ≥80% culture confirmed BUT not 100% DST, 2 
= ≥80% culture confirmed AND 100% DST.  
ECDC 
NOTE: ECDC will use the numbers provided to 
calculate the country specific score according to 
the EU median (value). 
NA = not available/not applicable, 0 = CD4 cell count not 
reported to TESSy, 1 = >EU Median, 2 = ≤EU Median.  

Indicator 1.41. NAC  
A National Antimicrobial Susceptibility Committee (NAC) is established and its 
representative is a member of EUCAST General Committee.  
Indicator 1.42. EUCAST_bkpt_use  
Percentage of clinical laboratories that have used EUCAST 2013 clinical breakpoints for 
interpretive reporting of antibacterial drug susceptibility testing results to clinicians.  

Indicator 1.43. EUCAST_bkpt_use_EARSNet  
Percentage of clinical laboratories participating in EARS-Net that have used EUCAST 
2013 clinical breakpoints for interpretive reporting of antibacterial drug susceptibility 
testing results to clinicians. 
Indicator 1.44. ERLTB_0.8_DST  
Tuberculosis Reference Laboratories that participated in ECDC-funded ERLTB-Net 
external quality assessment scheme in 2013 achieved 80% performance level for 
culture and susceptibility testing for first- and second-line drugs.  
Indicator 1.45. Gono_0.1_AST  
National surveillance of gonococcal antimicrobial resistance is providing susceptibility 
data on 10% or more of notified gonorrhoea cases. 

Target 1.4 AST 
Antimicrobial drug susceptibility testing 
ECDC 
NA = not available/not applicable, 0 = not established, 1 
= NAC formation in process, 2 = NAC established.  
ECDC 
NA = not available/not applicable, 0 = <10% clinical 
laboratories, 1 = 10-50% clinical laboratories, 2 = >50% 
clinical laboratories. 
ECDC 
NA = not available/not applicable, 0 = <25% clinical 
laboratories, 1 = 25-75% clinical laboratories, 2 = >75% 
clinical laboratories. 
NMFP 
NA = not available/not applicable, 0 = no participation, 1 
= participation with performance <80%, 2 = participation 
with performance ≥80%. 
NMFP  
NA = not available/not applicable, 0 = no surveillance of 
AMR at national level, 1 = <10% of notified cases, 2 = 
≥10% of notified cases. 

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Dimension 2. National microbiology reference laboratory 
services – NRL 

Targets/Indicators 

Source (NMFP/ECDC) and scoring options 

Target 2.1 Regulation_NRL 
Provision and regulation of national reference microbiology services 

Indicator 2.11. NRL_funding  
National Reference Laboratory (NRL) for public health microbiology services 
were financially supported at least in part by health authorities or other 
competent bodies. 
Indicator 2.12. NRL_nomination  
NRLs were officially nominated by health authorities or other competent 
bodies. 
Indicator 2.13. NRL_core_functions 
2.13(a). The majority of NRLs delivered reference diagnostics. 
2.13(b). The majority of NRLs delivered reference material resources. 
2.13(c). The majority of NRLs delivered scientific advice and diagnostic 
guidance. 
2.13(d). The majority of NRLs delivered collaboration and research 
development. 
2.13(e). The majority of NRLs delivered monitoring, alert and response. 
Indicator 2.14. NRL_accreditation 
NRLs accredit at least some of their diagnostic tests according to ISO 17025, 
ISO 15189 or equivalent national standard.  
Indicator 2.15. NRL_BSL3 
NRLs have access to biocontainment facilities with biosafety authorisation for 
performing BSL 3 operations. 

NMFP  
NA = not available, 0 = no funding, 1 = funding to some NRLs, 2 
= funding to all NRLs. 

NMFP  
NA = not available/not applicable, 0 = no, 1 = some NRLs, 2 = 
all NRLs. 

NMFP  
NA = not available/not applicable, 0 = no, 1 = yes. 
NOTE: ECDC will use the scores provided for each 
function to calculate the overall score.  
NA = not available/not applicable, 0 = 1-2 functions, 1 = 3-4 
functions, 2 = all 5 functions. 

NMFP  
NA = not available/not applicable, 0 = no NRL accredited their 
tests, 1 = some NRLs, 2 = all NRLS. 
NMFP  
NA = not available/not applicable, 0 = no BSL3 facility available 
for NRLs, 1 = partial access for some BSL3 operations, 2 = full 
access for all BSL3 operations. 

Target 2.2 Ref_diag_id 
Reference diagnostic confirmation and pathogen identification 

Indicator 2.21. Diag_ident_53diseases 
Case confirmation* with pathogen identification for EU surveillance was 
available within your country by primary and/or reference laboratory for the 53 
communicable diseases and health issues. 

NMFP  
NA = not available/not applicable, 0 = <20 pathogens/issues, 1 
= 20-35 pathogens/issues, 2 = >35 pathogens/issues. 

* according to the laboratory criteria described in the case definitions of the 
Community Network (Decision 2119/98/EC).  
Indicator 2.22. Legionella_0.1_cult  
Culture confirmation of Legionnaires' disease was performed for notified cases 
in accordance with EU case definition/ELDS-Net guidance. 
Indicator 2.23. Pert_conf_0.1 
Laboratory confirmation of pertussis (by culture or PCR) was performed for 
notified cases in accordance with EU case definition/EUPertLabNet guidance.  
Indicator 2.24. Serogroup_STEC 
Serogrouping of Shiga toxin-producing/verotoxin-producing Escherichia coli 
(STEC/VTEC) isolates was performed in 2013 in accordance with EU case 
definition/ECDC FWD network guidance. 
Indicator 2.25. Test_SARI_viral  
National guidelines and reference virological diagnostic testing were available 
for investigation of Severe Acute Respiratory Infection clusters in accordance 
with WHO guidance. 

ECDC 
NA = not available/not applicable, 0 = not reported, 1 = <10%, 
2 = ≥10%. 
ECDC 
NA = not available/not applicable, 0 = no cases reported, 1 = 
<10%, 2 = ≥10%. 

ECDC 
NA = not available/not applicable, 0 = <80%, 1 = 80-99%, 2 = 
100%. 

NMFP  
NA = not available/not applicable, 0 = not available at the 
national level, 1 = implemented without monitoring, 2 = 
implemented with monitoring. 

Target 2.3 Molec_surveillance 
Molecular typing for surveillance 

Indicator 2.31. WGS_surveillance 
Whole genome sequencing (WGS) -based typing of human pathogens was 
used in national reference laboratories for routine surveillance. 

Indicator 2.32. Salm_0.2_typing 
Total number of Salmonella isolates genotyped by pulsed-field gel 
electrophoresis (PFGE) or Multilocus VNTR Analysis (MLVA) or WGS method 
reported to TESSy divided by the total number of Salmonellosis cases reported 
to TESSy. 
Indicator 2.33. MDR-TB_0.5_MIRU-VNTR  
Total number of multidrug-resistant (MDR)-Mycobacterium tuberculosis 
isolates genotyped by MIRU-VNTR method reported to TESSy divided by the 
total number cases reported to TESSy. 
Please comment if done at national level but not reported to TESSy. 
Indicator 2.34. N_meningitidis_0.2_mol.typing 
Total number of invasive Neisseria meningitidis isolates typed by serogroup: 
MLST:porA:fetA method reported to TESSy divided by the total number of 
invasive cases reported to TESSy. 
Please comment if done at national level but not reported to TESSy. 

NMFP  
NA = not available, 0 = no national plan in place, 1 = a plan in 
place/in progress for at least 1 human pathogen, 2 = WGS-based 
typing is used routinely for national surveillance - of at least 1 
human pathogen. 
ECDC 
NA = not available, 0 = not reported to TESSy, 1 = <20%, 2 = 
≥20%. 

ECDC 
NA = not available/not applicable, 0 = <20%, 1 = 20-50%, 2= > 
50%. 

ECDC 
NA = not available/not applicable, 0 = not reported to TESSy, 1 
= <20%, 2 = ≥20%. 

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Targets/Indicators 

Source (NMFP/ECDC) and scoring options 

Indicator 2.35. HIV_0.5_ARVseq 
Total number of HIV isolates genotyped by ARV target sequence analysis 
reported to TESSy divided by the total number of new HIV cases reported to 
TESSy. 
Please comment if done at national level but not reported to TESSy. 

NMFP 
NA = not available/not applicable, 0 = <20%, 1 = 20-50%, 2 = 
>50%. 

Target 2.4 AMR_monitoring 

Antimicrobial drug resistance characterisation and monitoring 

Indicator 2.41. MRSA_charact_surv 
Identification of antimicrobial resistance mechanisms and/or genotyping was 
performed for methicillin-resistant Staphylococcus aureus (MRSA) isolates in 
accordance with EUCAST/Staphylococcus aureus reference laboratory network 
guidance. 
Indicator 2.42. Carbapenemase_id_surv  
Identification of type of carbapenemase was performed for carbapenemase 
producing Gram-negative bacilli isolates in accordance with EUCAST 2013 
guidance. 

Indicator 2.43. ESBL_id_surv 
Identification of type of extended spectrum beta-lactamase was performed for 
ESBL-producing Gram negative bacilli isolates in accordance with EUCAST 2013 
guidance.  

Indicator 2.44. Influenza_NA-inhibitors_AST 
Human influenza virus susceptibility monitoring to neuraminidase inhibitors by 
phenotypic/genotypic methods was performed (by national services or a 
service agreement with another country) for human viral samples in 
accordance with ERLI-Net guidance.  
Indicator 2.45. AMR_animal_human_surv 
Cross-sector monitoring of antimicrobial resistance (AMR) in human and animal 
bacterial isolates of public health relevance was performed and reported 
annually based on antimicrobial susceptibility testing methodology calibrated to 
ISO and/or EUCAST methods.  

NMFP  
NA = not available/not applicable, 0 = not established/in process 
of establishment, 1 = performed upon request from diagnostic 
laboratory, 2 = performed as part of structured surveys for 
monitoring purposes. 
NMFP  
NA = not available/not applicable, 0 = not established/in process 
of establishment, 1 = performed upon request from diagnostic 
laboratory, 2 = performed as part of structured surveys for 
monitoring purposes. 
NMFP  
NA = not available/not applicable, 0 = not established/in process 
of establishment, 1 = performed upon request from diagnostic 
laboratory, 2 = performed as part of structured surveys for 
monitoring purposes. 
ECDC 
NA = not available/not applicable, 0 = method established but 
not used for weekly reporting, 1 = samples send for central 
testing to WHO CC, 2 = method established and weekly reporting 
to TESSy. 

NMFP  
NA = not available/not applicable, 0 = not established, 1 = 
occasional joint surveys, 2 = integrated annual reporting. 

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EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Dimension  3.  Laboratory-based  surveillance  and  epidemic 
response support - Surv_response_support 

Targets/Indicators 

Source (NMFP/ECDC) and scoring options 

Target 3.1 Surveillance 
National surveillance networks 

Indicator 3.11. Lab_surv_networks 
Reference laboratories and/or public health bodies were collaborating 
with national networks of clinical laboratories contributing data on 
surveillance of communicable diseases. 

NMFP 
NA = not available/not applicable, 0 = no national networks, 1 = 
networks for 1-5 diseases/AMR issues, 2 = networks for more than five 
diseases/AMR issues. 

Indicator 3.12. Lab_date_reporting 
Surveillance networks of clinical laboratories reported microbiological data 
to a central national public health surveillance database. 

*LIMS = laboratory information and management system. 

NMFP  
NA = not available/not applicable, 0 = no report OR only paper-based 
reporting, 1 = for at least one disease by online forms/email files, 2 = 
for at least one disease by machine to machine upload from a LIMS. 

Indicator 3.13. Outbreak_detection 
Microbiology data from laboratory-based national surveillance systems 
were centrally analysed and reported to stakeholders for incidence trends 
and early warning of excess rates/clusters of epidemic prone disease 
above baseline rates for diseases under EU surveillance. 

Indicator 3.14. Sentinel_net_ARI  
National sentinel network of virology laboratories was operating for 
surveillance of acute respiratory viral infections. 

Indicator 3.15. Chlamydia_surv 
National system for collecting and reporting surveillance data on 
Chlamydia trachomatis infection was in place AND reported laboratory-
based information in accordance with the guidance for Chlamydia control 
in Europe. 

NMFP 
NA = not available/not applicable, 0 = not performed at national level, 
1 = for at least one disease performed at least monthly, 2 = for at least 
one disease performed at least weekly. 

NMFP 
NA = not available/not applicable, 0 = no ARI OR ILI sentinel 
laboratory network operational, 1 = only influenza, 2 = influenza AND 
other respiratory viruses. 

NMFP  
NA = not available/not applicable, 0 = no reporting at national level, 1 
= partial system, 2 = full system. 

Target 3.2 EU_LabNet_participation 
Active participation in EU disease networks 

Indicator 3.21. ELDSNet_participation 
Country was an active participant in the European Legionnaires’ Disease 
Surveillance Network (ELDS-Net)  
- participated in external quality assessments (EQA) reported 
to/coordinated by ECDC  
- participated in annual meeting. 
Indicator 3.22. ENIVDNet_participation  
Country was an active participant in the European Network for 
diagnostics of imported viral diseases (ENIVD-Net)  
- participated in annual meeting 
- updating laboratory capacity information. 

Indicator 3.23. IBDLabNet_participation 
Country was actively participating in the European Invasive bacterial 
diseases Laboratory Network (IBD-LabNet)  
- participated in annual meeting  
- participated in workshops.  

Indicator 3.24. ERLTBNet_participation 
 Country was an active participant in European Reference Laboratory 
Network for TB (ERLTB-Net)  
- participated in annual meeting 
- completed list of capabilities in reference service table. 

Indicator 3.25. EuroGASP_participation 
Country was an active participant in the European Gonococcal 
Antimicrobial Surveillance Programme (Euro-GASP)  
- participated in EQA and/or laboratory training 
- participated in data collection for Neisseria gonorrhoea antimicrobial 
susceptibility testing. 

ECDC 
NA = not available/not applicable, 0 = no, 1 = EQA OR annual 
meeting, 2 = EQA AND annual meeting 

ECDC 
NA = not available/not applicable, 0 = no, 1 = annual meeting OR 
updated capabilities, 2 = annual meeting AND updated capabilities. 

ECDC 
NA = not available/not applicable, 0 = no, 1 = annual meeting OR 
workshops, 2 = annual meetings AND workshops. 

ECDC 
NA = not available/not applicable, 0 = no, 1 = annual meeting OR 
updated capabilities, 2 = annual meeting AND updated capabilities. 

ECDC 
NA = not available/not applicable, 0 = no, 1 = EQA OR laboratory 
training, 2 = susceptibility testing. 

Indicator 3.31. NRL_roles_preparedness 
NRLs had defined roles and responsibilities described in the national 
preparedness plan for response to epidemic prone/high consequence 
pathogens. 

NMFP 
NA = not available/not applicable, 0 = no, 1 = yes but without 
simulation exercises, 2 = yes with simulation exercises. 

Target 3.3 Outbreak_response 
National outbreak response support 

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TECHNICAL REPORT 

Indicator 3.32. NRL_role_outbreak 
Proportion of outbreaks investigated at the national level for which NRL 
personnel participated as a member of outbreak investigation team. 

NMFP 
NA = not available/not applicable, 0 = no, 1 = <25% of outbreaks, 2 = 
≥25% of outbreaks. 

Indicator 3.33. NRL_24/7_response  
NRLs for epidemic prone/high consequence pathogens have a mandate 
and trained personnel available for assistance in outbreak teams at 
national level.  

NMFP 
NA = not available/not applicable, 0 = no, 1 = working hours, 2 = 24/7 
duty roster. 

Indicator 3.34. Listeria_0.8_PFGEtyping  
Total number of Listeria isolates genotyped by pulsed-field gel 
electrophoresis (PFGE) out of total number of notified cases.  

NMFP 
NA = not available/not applicable, 0 = not done, 1 =<80%, 2 = 80-
100%. 

Indicator 3.35. HAV_0.2_genotyping 
Total number of hepatitis A virus clinical samples genotyped by sequence 
analysis out of all hepatitis A cases.  

NMFP  
NA = not available/not applicable, 0 = not done, 1 = <20%, 2 = 
≥20%. 

Target 3.4 Preparedness_response 
(Re)-emerging diseases laboratory preparedness and response support 

Indicator 3.41. Diag_cap_MERS-CoV 
Diagnostic capability for Middle East Respiratory Syndrome Coronavirus 
(MERS-CoV) infection in accordance with WHO surveillance guidance.  

NMFP 
NA = not available/not applicable, 0 = no, 1 = screening test only, 2 = 
screening AND confirmation/identification. 

Indicator 3.42. Diag_cap_H7N9 
Diagnostic capability for avian influenza A(H7N9) virus in accordance 
with ECDC/WHO surveillance guidance.  

NMFP 
NA = not available/not applicable, 0 = no, 1 = screening test only, 2 = 
screening AND confirmation/identification (H AND N antigens). 

Indicator 3.43. Diag_cap_Ebola 
Diagnostic capability (within country AND/OR through formal 
international agreement with other laboratories) for Ebola virus infection. 

NMFP 
NA = not available/not applicable, 0 = no national capacity but 
agreement, 1 = molecular detection at BSL3 level, 2 = further 
characterisation at BSL4 level. 

Indicator 3.44. Diag_cap_5rare 
One or more reference virology laboratories in your country have 
detection capability for the following five rare and/or imported viruses: 
Chikungunya/Dengue/Hantavirus/Tick borne encephalitis/West Nile 
fever. 

Indicator 3.45. Listeria_MT-OCP  
An operational contact point for molecular typing (MT-OCP) of Listeria 
monocytogenes is nominated for supporting molecular surveillance 
development and collaboration through the Epidemic Intelligence System 
– Food and Waterborne Diseases (EPIS-FWD) platform and has 
participated in Urgent Inquiries (UI) and/or Molecular Typing Cluster 
Investigations (MTCI).  

ECDC 
NA = not available/not applicable, 0 = none, 1 = for at least 2 out of 5, 
2 = for all five. 

ECDC 
NA = not available/not applicable, 0 = no MT-OCP for Listeria 
monocytogenes nominated, 1 = MT-OCP for Listeria monocytogenes 
nominated, 2 = MT-OCP for Listeria monocytogenes participates in UIs 
and/or MTCIs. 

24 

 
 
 
 
 
 
 
 
 
 
 
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EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Annex 2. Policy rationale for the EULabCap 
targets of key capabilities/capacities 

Target  

Rationale for key capability/capacity 

1.1. Provision and regulation of clinical microbiology 
services.  

1.2 Diagnostic testing guidelines  

1.3 Diagnostic testing utilisation 

1.4 Antimicrobial drug susceptibility testing 

2.1 Provision and regulation of national reference 
microbiology services  

2.2 Reference diagnostic confirmation and pathogen 
identification  

2.3 Molecular typing for surveillance  

2.4 Antimicrobial drug resistance characterisation and 
monitoring  

3.1 National surveillance networks  

Provision of reliable, quality-assured, safe and fully 
accessible clinical diagnostic microbiology services is a 
prerequisite for adequate case ascertainment and 
surveillance/threat notification systems.  

Availability of national primary diagnostic and 
screening testing guidelines (e.g. who to test, how to 
test, and when to test) is a prerequisite to guarantee 
sufficient sensitivity for case ascertainment and 
surveillance/threat notification systems.  

Awareness of national testing practices provides a 
basis for monitoring sensitivity of case ascertainment 
and surveillance/notification systems.  

Implementation and monitoring of compliance with 
EU standards for antimicrobial drug susceptibility 
testing is a prerequisite for accurate and comparable 
EU surveillance of antimicrobial resistance, in 
accordance with EU strategy on AMR. 

Organisation, regulation, and funding of national 
reference laboratory infrastructure and core public 
health functions are key elements for informing 
surveillance and epidemic preparedness at national 
and EU levels, in accordance with NMFP consensus. 

Availability of national reference laboratory testing 
capability and capacity and a robust sample referral 
and reporting system to the national authorities is a 
prerequisite for effective surveillance and epidemic 
preparedness at national and EU levels in accordance 
with NMFP consensus. 

Development and implementation of harmonised 
methodologies to integrate molecular typing data into 
surveillance for priority diseases form a prerequisite 
for informing public health action based on EU-wide 
risk assessment of disease transmission. 

Accurate characterisation and monitoring of 
antimicrobial resistance determinants across human 
and animal populations for national/EU-wide 
surveillance informs public health action to contain 
cross-border and cross-species transmission of 
multidrug-resistant pathogens. 

National surveillance networks connecting 
clinical/public health laboratories for reporting 
diagnostic information to surveillance databases and 
linking microbiological and epidemiological 
information are essential for efficient communicable 
disease and drug resistance surveillance and early 
infectious threat detection. 

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TECHNICAL REPORT 

Target  

Rationale for key capability/capacity 

3.2 Active participation in EU disease networks  

3.3 National outbreak response support  

3.4 (Re)-emerging diseases laboratory preparedness 
and response support  

Active participation and collaboration between experts 
in EU disease networks promotes exchange of best 
practice and capacity building which foster sufficient 
collective capacity in the EU for threat detection, 
investigation, disease surveillance and epidemic 
preparedness. 

Preparation and involvement of the national reference 
laboratory capacities and staff in outbreak monitoring 
and response activities in collaboration with clinicians, 
epidemiologists, and microbiologists ensure the 
effective contribution of laboratory testing to support 
epidemic detection and control. 

Up-to-date diagnostic capability for rare and (re)-
emerging diseases and effective channels for 
collaboration are critical for laboratory preparedness 
and the deployment of timely and reliable emergency 
response to national and cross-border events.  

26 

 
 
 
 
 
 
 
 
 
 
 
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EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Annex 3. References to EU/WHO policy 
documents or international standards applied 
for the design and performance scoring of 
EULabCap indicators 

Indicator  
reference 
number  
1.15 

1.22 

1.24 

1.25 

1.31 

1.32 

1.33 

1.34 

1.35  

1.41 

1.42 

1.43 

1.44 

1.45 

Reference document(s) 

Hyperlink  

WHO Tuberculosis laboratory biosafety 
manual  
European Union Standards for 
Tuberculosis Care 
Framework Action Plan to fight 
tuberculosis in the European Union  
United Nations General Assembly Special 
Sessions on HIV/AIDS - Guidelines on 
construction of core indicators 
HIV testing: increasing uptake and 
effectiveness in the European Union  
Dublin declaration on Partnership to 
fight HIV/AIDS in Europe and Central 
Asia 
Risk assessment on the spread of 
carbapenemase-producing 
Enterobacteriaceae (CPE) 
Framework Action Plan to fight 
tuberculosis in the European Union  
Migrant health: Access to HIV 
prevention, treatment and care for 
migrant populations in EU/EEA countries 
Antimicrobial resistance surveillance in 
Europe  
Underdiagnosis of Clostridium difficile 
across Europe: the European, 
multicentre, prospective, biannual, 
point-prevalence study of Clostridium 
difficile infection in hospitalised patients 
with diarrhoea (EUCLID) 
Clostridium difficile: Guidance on 
infection prevention and control 

Framework Action Plan to fight 
tuberculosis in the European Union  
Global update on HIV treatment 2013: 
Results, impact and opportunities; WHO 
in partnership with UNICEF and UNAIDS 
Dublin declaration on Partnership to 
fight HIV/AIDS in Europe and Central 
Asia 
EUCAST - Interaction of EUCAST 
Steering Committee with the network of 
national antimicrobial susceptibility 
testing committees 
EUCAST - Breakpoint tables for 
interpretation of MICs and zone 
diameters 
EUCAST - Breakpoint tables for 
interpretation of MICs and zone 
diameters 
Framework Action Plan to fight 
tuberculosis in the European Union  
Strengthening antimicrobial surveillance 
- Expanding Euro-GASP 

http://www.who.int/tb/publications/2012/tb_biosafety/en/ 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3393116/pdf/erj-39-04-
807.pdf 
http://ecdc.europa.eu/en/publications/publications/0803_spr_tb_action_pl
an.pdf 

http://www.unaids.org/en/media/unaids/contentassets/dataimport/pub/m
anual/2009/jc1676_core_indicators_2009_en.pdf 

http://ecdc.europa.eu/en/publications/Publications/101129_GUI_HIV_testi
ng.pdf 

http://www.unicef.org/ceecis/The_Dublin_Declaration.pdf 

http://staging.ecdcdmz.europa.eu/en/publications/Publications/110913_Ris
k_assessment_resistant_CPE.pdf 

http://ecdc.europa.eu/en/publications/publications/0803_spr_tb_action_pl
an.pdf 

http://ecdc.europa.eu/en/publications/publications/0907_ter_migrant_heal
th_hiv_access_to_treatment.pdf  

http://ecdc.europa.eu/en/publications/Publications/antimicrobial-
resistance-surveillance-europe-2012.pdf 

http://www.thelancet.com/journals/laninf/article/PIIS1473-
3099(14)70991-0/abstract  

http://ecdc.europa.eu/en/healthtopics/Healthcare-
associated_infections/guidance-infection-prevention-
control/Pages/guidance-prevention-control-infections-CDI.aspx  
http://ecdc.europa.eu/en/publications/publications/0803_spr_tb_action_pl
an.pdf 

http://www.unaids.org/en/media/unaids/contentassets/documents/unaids
publication/2013/20130630_treatment_report_en.pdf 

http://www.unicef.org/ceecis/The_Dublin_Declaration.pdf 

http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/EUCAST_S
OPs/EUCAST_SOP_5_0_Interaction_with_NACs_20130104.pdf 

http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Breakpoint
_tables/Breakpoint_table_v_3.1.pdf 

http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Breakpoint
_tables/Breakpoint_table_v_3.1.pdf 

http://ecdc.europa.eu/en/publications/publications/0803_spr_tb_action_pl
an.pdf 
http://www.ecdc.europa.eu/en/healthtopics/gonorrhoea/response-
plan/Pages/strengthening-antimicrobial-surveillance.aspx 

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TECHNICAL REPORT 

Indicator  
reference 
number  

Reference document(s) 

Hyperlink  

Response plan to control and manage 
the threat of multidrug-resistant 
gonorrhoea in Europe 
Gonococcal antimicrobial susceptibility 
surveillance in Europe, 2011  
Core functions of microbiology reference 
laboratories for communicable diseases 
Core functions of microbiology reference 
laboratories for communicable diseases 
Core functions of microbiology reference 
laboratories for communicable diseases 
Core functions of microbiology reference 
laboratories for communicable diseases 
WHO laboratory biosafety manual 

Case definitions for reporting 
communicable disease to the 
Community Network  
European Legionnaires’ Disease 
Surveillance Network (ELDSNet) 
External quality assurance scheme on 
PCR for Bordetella pertussis, 2012 
Diagnostic work-up of suspected STEC 
enteritis and HUS cases related to the 
ongoing outbreak of STEC O104:H4 
WHO SARS International Reference and 
Verification Laboratory Network: Policy 
and Procedures in the Inter-Epidemic 
Period 
Molecular surveillance pilot - Evaluation 
report, 2014, Meeting minutes 38th 
Advisory Forum  
Resolution of a Meningococcal Disease 
Outbreak from Whole-Genome 
Sequence Data with Rapid Web-Based 
Analysis Methods 
WHO HIV Drug Resistance Surveillance 
Network 
EUCAST guidelines for detection of 
resistance mechanisms and specific 
resistances of clinical and/or 
epidemiological importance 
EUCAST guidelines for detection of 
resistance mechanisms and specific 
resistances of clinical and/or 
epidemiological importance 
EUCAST guidelines for detection of 
resistance mechanisms and specific 
resistances of clinical and/or 
epidemiological importance 
ERLI-Net: Key tasks of the network  

EUCAST - Breakpoint tables for 
interpretation of MICs and zone 
diameters 
Core functions of microbiology reference 
laboratories for communicable diseases 
Case definitions for reporting 
communicable disease to the 
Community Network  
Chlamydia control in Europe 

ELDSNet 
ENIVD-CLRN 

IBDLab-Net 

http://www.ecdc.europa.eu/en/publications/Publications/1206-ECDC-MDR-
gonorrhoea-response-plan.pdf 

http://www.ecdc.europa.eu/en/publications/publications/gonococcal-
antimicrobial-susceptibility-surveillance-27-mar-2013.pdf 
http://www.ecdc.europa.eu/en/publications/Publications/1006_TER_Core_
functions_of_reference_labs.pdf 
http://www.ecdc.europa.eu/en/publications/Publications/1006_TER_Core_
functions_of_reference_labs.pdf 
http://www.ecdc.europa.eu/en/publications/Publications/1006_TER_Core_
functions_of_reference_labs.pdf 
http://www.ecdc.europa.eu/en/publications/Publications/1006_TER_Core_
functions_of_reference_labs.pdf 
http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua
=1 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:262:0001:0057:EN
:PDF 
http://ecdc.europa.eu/en/publications/publications/1202-ted-eldsnet-
operating-procedures.pdf 
http://www.ecdc.europa.eu/en/publications/Publications/20120906-TER-
EQA-pertusis.pdf 
http://ecdc.europa.eu/en/healthtopics/escherichia_coli/outbreaks/laborator
y_resources/Pages/diagnostic_guidance.aspx 

http://www.who.int/csr/resources/publications/en/SARSReferenceLab.pdf?
ua=1 

http://www.ecdc.europa.eu/en/aboutus/organisation/af/Pages/Meeting_mi
nutes.aspx 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3421817/pdf/zjm3046.pdf 

http://www.who.int/drugresistance/hivaids/en/HIVdrugnetwork.pdf  

http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Resistance
_mechanisms/EUCAST_detection_of_resistance_mechanisms_v1.0_20131
211.pdf  

http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Resistance
_mechanisms/EUCAST_detection_of_resistance_mechanisms_v1.0_20131
211.pdf  

http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Resistance
_mechanisms/EUCAST_detection_of_resistance_mechanisms_v1.0_20131
211.pdf  

http://ecdc.europa.eu/en/activities/surveillance/eisn/laboratory_network/p
ages/key_tasks.aspx  

http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Breakpoint
_tables/Breakpoint_table_v_3.1.pdf 

http://www.ecdc.europa.eu/en/publications/Publications/1006_TER_Core_
functions_of_reference_labs.pdf 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:262:0001:0057:EN
:PDF 
http://www.ecdc.europa.eu/en/publications/publications/0906_gui_chlamy
dia_control_in_europe.pdf 
http://ecdc.europa.eu/en/activities/surveillance/eldsnet/pages/index.aspx 
http://www.ecdc.europa.eu/en/activities/diseaseprogrammes/emerging_a
nd_vector_borne_diseases/pages/enivd.aspx  
http://www.ecdc.europa.eu/en/activities/surveillance/EU_IBD/Pages/index.
aspx  

2.11 

2.12 

2.13 

2.14 

2.15 

2.21 

2.22 

2.23 

2.24 

2.25 

2.32 

2.34 

2.35 

2.41 

2.42 

2.43 

2.44 

2.45 

3.11 

3.13 

3.15 

3.21 
3.22 

3.23 

28 

 
 
 
 
 
 
 
 
 
TECHNICAL REPORT 

EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

Indicator  
reference 
number  
3.24 

3.25 
3.31 

3.32 

3.33 

3.41 

3.42 

3.43 

3.45 

Reference document(s) 

Hyperlink  

ERLTB-Net 

Euro-GASP 
Core functions of microbiology reference 
laboratories for communicable diseases 
Core functions of microbiology reference 
laboratories for communicable diseases 
Core functions of microbiology reference 
laboratories for communicable diseases 
WHO guidelines for investigation of 
cases of human infection with Middle 
East Respiratory Syndrome Coronavirus 
(MERS-CoV), July 2013 
Severe respiratory disease associated 
with Middle East respiratory syndrome 
coronavirus (MERS-CoV) 
Laboratory preparedness in EU/EEA 
countries for detection of novel avian 
Influenza A (H7N9) virus, May 2013 
Algorithm for laboratory diagnosis of 
Ebola virus disease 
EPIS 

http://www.ecdc.europa.eu/en/press/news/Documents/100125_ERLN_TB
_information_flyer.pdf  
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19995  
http://www.ecdc.europa.eu/en/publications/Publications/1006_TER_Core_
functions_of_reference_labs.pdf 
http://www.ecdc.europa.eu/en/publications/Publications/1006_TER_Core_
functions_of_reference_labs.pdf 
http://www.ecdc.europa.eu/en/publications/Publications/1006_TER_Core_
functions_of_reference_labs.pdf 
http://www.who.int/csr/disease/coronavirus_infections/MERS_CoV_investi
gation_guideline_Jul13.pdf?ua=1 

http://www.ecdc.europa.eu/en/publications/Publications/Middle-East-
respiratory-syndrome-coronavirus-Saudi%20Arabia-Qatar-Jordan-
Germany-United-Kingdom.pdf 
http://www.eurosurveillance.org/images/dynamic/EE/V19N04/art20682.pd
f 

http://ecdc.europa.eu/en/healthtopics/ebola_marburg_fevers/algorithm-
evd-diagnosis/Pages/default.aspx 
http://www.ecdc.europa.eu/en/activities/epidemicintelligence/pages/epide
micintelligence_tools.aspx  

29 

 
 
 
 
 
 
 
 
 
 
 
 
EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey  

TECHNICAL REPORT 

Annex 4. Maps showing geographical distribution 
of each target performance level by country 
based on three levels (low, medium and high) 

30 

 
 
 
 
 
 
 
 
 
 
 
 
TECHNICAL REPORT 

EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey 

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
EU Laboratory Capability monitoring system (EULabCap) report on 2013 survey  

TECHNICAL REPORT 

32 

 
 
 
 
 
 
 
 
 
 
 
 
 
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