scholarly journals Toscana, West Nile, Usutu and tick-borne encephalitis viruses: external quality assessment for molecular detection of emerging neurotropic viruses in Europe, 2017

2019 ◽  
Vol 24 (50) ◽  
Author(s):  
Chantal Reusken ◽  
Cecile Baronti ◽  
Ramona Mögling ◽  
Anna Papa ◽  
Katrin Leitmeyer ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Detection ◽  
External Quality Assessment ◽  
Positive Sample ◽  
European Economic Area ◽  
Virus Species ◽  
West Nile ◽  
External Quality ◽  
Tick Borne Encephalitis ◽  
Diagnostic Capability

Background Neurotropic arboviruses are increasingly recognised as causative agents of neurological disease in Europe but underdiagnosis is still suspected. Capability for accurate diagnosis is a prerequisite for adequate clinical and public health response. Aim To improve diagnostic capability in EVD-LabNet laboratories, we organised an external quality assessment (EQA) focusing on molecular detection of Toscana (TOSV), Usutu (USUV), West Nile (WNV) and tick-borne encephalitis viruses (TBEV). Methods Sixty-nine laboratories were invited. The EQA panel included two WNV RNA-positive samples (lineages 1 and 2), two TOSV RNA-positive samples (lineages A and B), one TBEV RNA-positive sample (Western subtype), one USUV RNA-positive sample and four negative samples. The EQA focused on overall capability rather than sensitivity of the used techniques. Only detection of one, clinically relevant, concentration per virus species and lineage was assessed. Results The final EQA analysis included 51 laboratories from 35 countries; 44 of these laboratories were from 28 of 31 countries in the European Union/European Economic Area (EU/EEA). USUV diagnostic capability was lowest (28 laboratories in 18 countries), WNV detection capacity was highest (48 laboratories in 32 countries). Twenty-five laboratories were able to test the whole EQA panel, of which only 11 provided completely correct results. The highest scores were observed for WNV and TOSV (92%), followed by TBEV (86%) and USUV (75%). Conclusion We observed wide variety in extraction methods and RT-PCR tests, showing a profound absence of standardisation across European laboratories. Overall, the results were not satisfactory; capacity and capability need to be improved in 40 laboratories.

scholarly journals Need for additional capacity and improved capability for molecular detection of yellow fever virus in European Expert Laboratories: External Quality Assessment, March 2018

2018 ◽  
Vol 23 (28) ◽  
Author(s):  
Cristina Domingo ◽  
Heinz Ellerbrok ◽  
Marion Koopmans ◽  
Andreas Nitsche ◽  
Katrin Leitmeyer ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Yellow Fever ◽  
Molecular Detection ◽  
Yellow Fever Virus ◽  
External Quality Assessment ◽  
Fever Virus ◽  
European Economic Area ◽  
External Quality ◽  
Economic Area ◽  
Additional Capacity

An external quality assessment of yellow fever virus (YFV) molecular detection in European laboratories was organised in rapid response to an increase in human cases in Brazil in 2018 with risk of import to Europe. Detection of YFV was assessed among 32 laboratories in 23/31 European Union (EU) and European Economic Area (EEA) countries and two laboratories in one non-EU/EEA country. Adequate capabilities were lacking in 10/23 countries; five did not participate as they lacked implemented assays.

scholarly journals The versatility of external quality assessment for the surveillance of laboratory and in vitro diagnostic performance: SARS-CoV-2 viral genome detection in Austria

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Christoph Buchta ◽  
Jeremy V. Camp ◽  
Jovana Jovanovic ◽  
Peter Chiba ◽  
Elisabeth Puchhammer-Stöckl ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
False Negative ◽  
Positive Sample ◽  
Performance Criteria ◽  
External Quality ◽  
Assay Sensitivity ◽  
Dilution Series ◽  
Test Systems

Abstract Objectives External quality assessment (EQA) schemes provide information on individual and general analytical performance of participating laboratories and test systems. The aim of this study was to investigate the use and performance of SARS-CoV-2 virus genome detection systems in Austrian laboratories and their preparedness to face challenges associated with the pandemic. Methods Seven samples were selected to evaluate performance and estimate variability of reported results. Notably, a dilution series was included in the panel as a measure of reproducibility and sensitivity. Several performance criteria were evaluated for individual participants as well as in the cohort of all participants. Results A total of 109 laboratories participated and used 134 platforms, including 67 different combinations of extraction and PCR platforms and corresponding reagents. There were no false positives and 10 (1.2%) false negative results, including nine in the weakly positive sample (C t ∼35.9, ∼640 copies/mL). Twenty (22%) laboratories reported results of mutation detection. Twenty-five (19%) test systems included amplification of human RNA as evidence of proper sampling. The overall linearity of C t values from individual test systems for the dilution series was good, but inter-assay variability was high. Both operator-related and systematic failures appear to have caused incorrect results. Conclusions Beyond providing certification for participating laboratories, EQA provides the opportunity for participants to evaluate their performance against others so that they may improve operating procedures and test systems. Well-selected EQA samples offer additional inferences to be made about assay sensitivity and reproducibility, which have practical applications.

scholarly journals Correction: External Quality Assessment of Molecular Detection of Ebola Virus in China

PLoS ONE ◽  
2016 ◽  
Vol 11 (3) ◽  
pp. e0151695
Author(s):  
Guojing Wang ◽  
Yu Sun ◽  
Kuo Zhang ◽  
Tingting Jia ◽  
Mingju Hao ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Ebola Virus ◽  
Molecular Detection ◽  
External Quality Assessment ◽  
External Quality

scholarly journals External Quality Assessment for Molecular Detection of Bordetella pertussis in European Laboratories

2005 ◽  
Vol 43 (1) ◽  
pp. 30-35 ◽  
Author(s):  
G. Muyldermans ◽  
O. Soetens ◽  
M. Antoine ◽  
S. Bruisten ◽  
B. Vincart ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Bordetella Pertussis ◽  
Molecular Detection ◽  
External Quality Assessment ◽  
External Quality

scholarly journals External quality assessment for the molecular detection of MERS-CoV in China

2016 ◽  
Vol 75 ◽  
pp. 5-9 ◽  
Author(s):  
Lei Zhang ◽  
Mingju Hao ◽  
Kuo Zhang ◽  
Rui Zhang ◽  
Guigao Lin ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Detection ◽  
External Quality Assessment ◽  
External Quality

scholarly journals Variable Sensitivity in Molecular Detection of Zika Virus in European Expert Laboratories: External Quality Assessment, November 2016

2017 ◽  
Vol 55 (11) ◽  
pp. 3219-3226 ◽  
Author(s):  
Remi Charrel ◽  
Ramona Mögling ◽  
Suzan Pas ◽  
Anna Papa ◽  
Cecile Baronti ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Zika Virus ◽  
Molecular Detection ◽  
Yellow Fever Virus ◽  
External Quality Assessment ◽  
Health Concern ◽  
Molecular Testing ◽  
Acid Extraction ◽  
External Quality ◽  
Core Samples

ABSTRACTZika virus (ZIKV) infections are a significant public health concern. A strong capability for ZIKV detection is an absolute requirement for adequate preparedness and response strategies and individual patient care. The objective of this study was to assess and improve the capability of European expert laboratories for molecular testing for ZIKV through an external quality assessment (EQA) scheme. Laboratories were provided a panel of 12 samples which included negative samples, samples containing African- or Asian-lineage ZIKV at various concentrations (103to 109copies/ml), and samples containing dengue virus, yellow fever virus, or chikungunya virus. The results were analyzed on the basis of the outcomes of testing for the samples and the extraction and detection method used. Samples with a ZIKV RNA status scored correctly by >50% of the laboratories were designated the core sample. A total of 85 panel outcomes were submitted by 50 laboratories in 31 countries. The results designated all samples as core samples. Thirty-three percent (28/85) of the panel outcomes identified all samples. Analysis at the laboratory level showed that only 40% of the laboratories (20/50), representing 45% of the countries, scored sufficiently; i.e., they had at least one test operational that scored all core samples correctly. There is a need for improvement of the molecular detection of ZIKV in 60% of the participating laboratories. While the specificity of the tests was more robust, the results of the EQA showed large variation in test sensitivity. Improvements should focus on both nucleic acid extraction and ZIKV detection methods.

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