Dataset Information

External Quality Assessment for Tuberculosis Diagnosis and Drug Resistance in the European Union: A Five Year Multicentre Implementation Study.

ABSTRACT:

Background

External quality assurance (EQA) systems are essential to ensure accurate diagnosis of TB and drug-resistant TB. The implementation of EQA through organising regular EQA rounds and identification of training needs is one of the key activities of the European TB reference laboratory network (ERLTB-Net). The aim of this study was to analyse the results of the EQA rounds in a systematic manner and to identify potential benefits as well as common problems encountered by the participants.

Methods

The ERLTB-Net developed seven EQA modules to test laboratories' proficiency for TB detection and drug susceptibility testing using both conventional and rapid molecular tools. All National TB Reference laboratories in the European Union and European Economic Area (EU/EEA) Member States were invited to participate in the EQA scheme.

Results

A total of 32 National TB Reference laboratories participated in six EQA rounds conducted in 2010-2014. The participation rate ranged from 52.9% - 94.1% over different modules and rounds. Overall, laboratories demonstrated very good proficiency proving their ability to diagnose TB and drug-resistant TB with high accuracy in a timely manner. A small number of laboratories encountered problems with identification of specific Non-tuberculous Mycobacteria (NTMs) (N = 5) and drug susceptibility testing to Pyrazinamide, Amikacin, Capreomycin, and Ethambutol (N = 4).

Conclusions

The European TB Reference laboratories showed a steady and high level of performance in the six EQA rounds. A network such as ERLTB-Net can be instrumental in developing and implementing EQA and in establishing collaboration between laboratories to improve the diagnosis of TB in the EU/EEA.

SUBMITTER: Nikolayevskyy V

PROVIDER: S-EPMC4824391 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Publications

External Quality Assessment for Tuberculosis Diagnosis and Drug Resistance in the European Union: A Five Year Multicentre Implementation Study.

Nikolayevskyy Vladyslav V Hillemann Doris D Richter Elvira E Ahmed Nada N van der Werf Marieke J MJ Kodmon Csaba C Drobniewski Francis F Ruesch-Gerdes Sabine S

PloS one 20160407 4

<h4>Background</h4>External quality assurance (EQA) systems are essential to ensure accurate diagnosis of TB and drug-resistant TB. The implementation of EQA through organising regular EQA rounds and identification of training needs is one of the key activities of the European TB reference laboratory network (ERLTB-Net). The aim of this study was to analyse the results of the EQA rounds in a systematic manner and to identify potential benefits as well as common problems encountered by the partic ...[more]

PMID: 27055064

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Project description:Here, we report the development and key features of the first external quality assessment (EQA) scheme for Mycobacterium tuberculosis whole-genome sequencing (WGS). The results of four rounds (2017 to 2020) of implementation within the European tuberculosis reference laboratories network (ERLTB-Net-2) are presented and discussed. EQA panels comprising 10 genomic DNAs were distributed to ERLTB-Net 2 laboratories volunteering to participate in this exercise. Since 2018, five FASTQ files were added to better assess the dry WGS processes, and in 2020, three of the five files were replaced by synthetic files (providing additional flexibility for the mutations included in the panels). Ten National tuberculosis reference laboratories participated in all four EQA rounds, and seven participated in at least one. High-confidence resistance mutations were correctly identified by all laboratories, but challenges remained with respect to the identification of mixed loci and interpretation of rare mutations. M. tuberculosis genotyping and clustering analysis was >90% accurate for pure samples with the main challenges being related to the analysis of mixed genotypes and DNA FASTQ files. The development and implementation of this WGS EQA scheme has contributed to the continuous improvement in performance of participating laboratories in M. tuberculosis WGS and data analysis. This scheme can serve as a model of comprehensive quality assessment for M. tuberculosis WGS that can be replicated in different settings worldwide. IMPORTANCE The wider availability of whole-genome sequencing (WGS) coupled to new developments in bioinformatic tools and databases to interpret Mycobacterium tuberculosis complex WGS data has accelerated the adoption of this method for the routine prediction of antimycobacterial drug resistance and genotyping, thus necessitating the establishment of a comprehensive external quality control system. Here, we report 4 years of development and results from such a panel.

Project description:BACKGROUND:Tuberculosis (TB) control programmes rely heavily on laboratories to support both clinical care and public health. Qualified personnel with adequate technical and managerial skills comprise an integral component of any quality assured laboratory. Training a new generation of TB laboratory specialists was identified as a critical priority in the European Union /European Economic Area (EU/EEA). A tailored training programme for TB reference laboratory professionals was developed and implemented within the European Reference Laboratory Network for Tuberculosis to increase the pool of technical experts available to step into leadership roles in the TB laboratory community. Three cohorts of selected laboratory specialists participated in a series of trainings from 2009 to 2016. METHODS:We conducted an evaluation of the training programme using a structured questionnaire administered via the EUSurvey website, with the aim of documenting the benefits and contribution as well as suggesting improvements and future direction of the programme. All graduated participants and all current ERLTB-Net members were invited to participate in the online survey and descriptive quantitative analysis was performed. RESULTS:The evaluation found significant benefits for both the participants and the participants' institutions, with improvements being reported in laboratory practices and management including implementation of new diagnostic techniques and career progression for participants. The training programme differed from other international and European initiatives in a number of important ways; the curriculum is unique in the scope and range of topics covered; the programme targets senior level professionals and future directors; cohorts were limited to 8-10 participants; and the programme involved a number of workshops (5-7) taking place over a two-year period. Relationships and collaborations established between individuals and institutions were valued as an important success of the initiative. Suggestions on how the impact of the programme could be enhanced included equipping participants to perform laboratory assessments in low-resource settings outside the EU, thus bolstering global TB control. CONCLUSION:Based on the findings presented the training programme has proved to be successful in developing leadership, expertise, partnerships and networks to support TB laboratories and has contributed significant benefits to strengthening European National Reference laboratories in the fight against TB.

Project description:BackgroundEstimates of the economic burden of work injuries and diseases can help policymakers prioritize occupational health and safety policies and interventions in order to best allocate scarce resources. Several attempts have been made to estimate these economic burdens at the national level, but most have not included a comprehensive list of cost components, and none have attempted to implement a standard approach across several countries. The aim of our study is to develop a framework for estimating the economic burden of work injuries and diseases and implement it for selected European Union countries.MethodsWe develop an incidence cost framework using a bottom-up approach to estimate the societal burden of work injuries and diseases and implement it for five European Union countries. Three broad categories of costs are considered-direct healthcare, indirect productivity and intangible health-related quality of life costs. We begin with data on newly diagnosed work injuries and diseases from calendar year 2015. We consider lifetime costs for cases across all categories and incurred by all stakeholders. Sensitivity analysis is undertaken for key parameters.ResultsIndirect costs are the largest part of the economic burden, then direct costs and intangible costs. As a percentage of GDP, the highest overall costs are for Poland (10.4%), then Italy (6.7%), The Netherlands (3.6%), Germany (3.3%) and Finland (2.7%). The Netherlands has the highest per case costs (€75,342), then Italy (€58,411), Germany (€44,919), Finland (€43,069) and Poland (€38,918). Costs per working-age population are highest for Italy (€4956), then The Netherlands (€2930), Poland (€2793), Germany (€2527) and Finland (€2331).ConclusionsOur framework serves as a template for estimating the economic burden of work injuries and diseases across countries in the European Union and elsewhere. Results can assist policymakers with identifying health and safety priority areas based on the magnitude of components, particularly when stratified by key characteristics such as industry, injury/disease, age and sex. Case costing can serve as an input into the economic evaluation of prevention initiatives. Comparisons across countries provide insights into the relevant performance of health and safety systems.

Dataset Information

External Quality Assessment for Tuberculosis Diagnosis and Drug Resistance in the European Union: A Five Year Multicentre Implementation Study.

Background

Methods

Results

Conclusions

Publications

External Quality Assessment for Tuberculosis Diagnosis and Drug Resistance in the European Union: A Five Year Multicentre Implementation Study.

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