scholarly journals External Quality Assessment (EQA) for Molecular Diagnostics of Zika Virus: Experiences from an International EQA Programme, 2016–2018

Viruses ◽  
2018 ◽  
Vol 10 (9) ◽  
pp. 491 ◽  
Author(s):  
Oliver Donoso Mantke ◽  
Elaine McCulloch ◽  
Paul Wallace ◽  
Constanze Yue ◽  
Sally Baylis ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Diagnostics ◽  
Zika Virus ◽  
External Quality Assessment ◽  
Test Methods ◽  
Analytical Sensitivity ◽  
External Quality ◽  
Diagnostic Assays ◽  
Continuous Quality ◽  
Continuous Quality Assurance

Quality Control for Molecular Diagnostics (QCMD), an international provider for External Quality Assessment (EQA) programmes, has introduced a programme for molecular diagnostics of Zika virus (ZIKV) in 2016, which has been continuously offered to interested laboratories since that time. The EQA schemes provided from 2016 to 2018 revealed that 86.7% (92/106), 82.4% (89/108), and 88.2% (90/102) of the participating laboratories reported correct results for all samples, respectively in 2016, 2017, and 2018. The review of results indicated a need for improvement concerning analytical sensitivity and specificity of the test methods. Comparison with the outcomes of other EQA initiatives briefly summarized here show that continuous quality assurance is important to improve laboratory performance and to increase preparedness with reliable diagnostic assays for effective patient management, infection and outbreak control.

scholarly journals Most but not all laboratories can detect the recently emerged Neisseria gonorrhoeae porA mutants – results from the QCMD 2013 N. gonorrhoeae external quality assessment programme

2014 ◽  
Vol 19 (8) ◽  
Author(s):  
D Luijt ◽  
C Di Lorenzo ◽  
A M van Loon ◽  
M Unemo
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
False Negative ◽  
Molecular Diagnostic ◽  
External Quality ◽  
Diagnostic Assays ◽  
Assessment Programme ◽  
Negative Results ◽  
False Negative Results

We describe the results of the Quality Control for Molecular Diagnostics 2013 Neisseria gonorrhoeae external quality assessment programme that included an N. gonorrhoeae strain harbouring an N. meningitidis porA gene which causes false-negative results in molecular diagnostic assays targeting the gonococcal porA pseudogene. Enhanced awareness of the international transmission of such gonococcal strains is needed to avoid false-negative results in both in-house and commercial molecular diagnostic assays used in laboratories worldwide, but particularly in Europe.

scholarly journals External Quality Assessment of MERS-CoV Molecular Diagnostics During the 2015 Korean Outbreak

2016 ◽  
Vol 36 (3) ◽  
pp. 230-234 ◽  
Author(s):  
Moon-Woo Seong ◽  
Seung Jun Lee ◽  
Sung Im Cho ◽  
Kyungphil Ko ◽  
Mi-Na Kim ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Diagnostics ◽  
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.

scholarly journals First international external quality assessment of molecular diagnostics for Mers-CoV

2015 ◽  
Vol 69 ◽  
pp. 81-85 ◽  
Author(s):  
Suzan D. Pas ◽  
Pranav Patel ◽  
Chantal Reusken ◽  
Cristina Domingo ◽  
Victor M. Corman ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Diagnostics ◽  
External Quality Assessment ◽  
External Quality

Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018

2019 ◽  
Vol 57 (6) ◽  
pp. 812-821 ◽  
Author(s):  
Min Duan ◽  
Fengfeng Kang ◽  
Haijian Zhao ◽  
Wei Wang ◽  
Yuxuan Du ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Quality Indicators ◽  
External Quality Assessment ◽  
External Quality ◽  
Factors Affecting ◽  
Laboratory Errors ◽  
Continuous Quality ◽  
Clinical Laboratories ◽  
Information Construction ◽  
Quality Specifications

Abstract Background This study aimed to comprehensively evaluate laboratory quality in China and explore factors affecting laboratory errors through analyzing the external quality assessment (EQA) results of quality indicators (QIs). Methods According to model 3 (interpretive) of the proficiency testing scheme, the National Center for Clinical Laboratories of China (CNCCL) developed a questionnaire for 15 QIs. Clinical laboratories from different provinces of China participated in the EQA program of QIs annually and submitted data via an online reporting system named Clinet-EQA. The results of QIs were expressed in percentage and sigma value or minute. Three levels of quality specifications (QSs) were defined based on percentile values. Furthermore, the QIs were analyzed by disciplines, hospital scales and information construction levels of participant laboratories. Results A total of 3450 laboratories nationwide continuously attended the EQA program and submitted complete data from 2015 to 2018. The performance of most QIs has improved year by year. QIs in post-analytical gained the best performance with sigma values that varied from 5.3σ to 6.0σ. The comparison of results among different disciplines showed significant differences for five QIs. More than half of QIs had statistical differences among different hospital scales measured by hospital grades and number of hospital beds. The performance of nine QIs were influenced by information construction levels of participant laboratories. Conclusions The overall laboratory quality in China has improved since the initiation of EQA program for QIs, but the performance of some QIs was still unsatisfactory. Therefore, laboratories should make efforts for continuous quality improvement based on information provided by QSs.

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