115 results on '"External quality assessment (EQA)"'
Search Results
2. Importance of EQA/PT for the detection of genetic variants in comprehensive cancer genome testing.
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Matsushita, Kazuyuki, Ishige, Takayuki, Watanabe, Kousuke, Akahane, Toshiaki, Tanimoto, Akihide, Yoshimoto, Michiko, Yamakuchi, Munekazu, Hashiguchi, Teruto, Okugawa, Yoshinaga, Ikejiri, Makoto, Yamaguchi, Toshikazu, Yamasaki, Tadashi, Takeda, Mayu, Hibi, Masaaki, Akiyama, Naoki, Shimizu, Kaho, Hashimoto, Naonori, Sato, Hiroko, Tanaka, Yoshinori, and Amari, Fumie
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GENETIC variation , *NUCLEIC acids , *BRAF genes , *PATHOLOGICAL laboratories , *GENE frequency - Abstract
Comprehensive genomic profiling (CGP) is increasingly used as a clinical laboratory test and being applied to cancer treatment; however, standardization and external quality assessments (EQA) have not been fully developed. This study performed cost-effective EQA and proficiency tests (PT) for CGP testing among multiple institutions those belong to the EQA working group of Japan Association for Clinical Laboratory Science (JACLS). This study revealed that preanalytical processes, such as derived nucleic acids (NA) extraction from formalin fixed paraffine embedded (FFPE) samples, are critical. First, EQA with extracted DNA from cell lines showed a detection rate of 100% (9 out of 9) in KRAS (c.38G > A; p.G13D), PIK3CA (p.H1047R), and B-Raf proto-oncogene, serine/threonine kinase (BRAF) (c.1799 T > A; p.V600E) in cases of > 10% variant allele frequency (VAF). However, BRAF (c.1799 T > A; p.V600E) detection decreased to 67% (6 out of 9) for a VAF of 4.9%. Second, when DNA was extracted from FFPE samples, pathogenic variants and variants with companion diagnostic indications were detected in all 10 participating laboratories. Each variant had < 20% VAFs on average (8.1–19.1%) and wide variability among laboratories was observed (relative standard deviation, 13–60%). Nonetheless, BRAF (c.1798_1799delinsAA; p.V600K) of 8.1% VAF, EGFR (c.2235_2249del; p.E746_A750del) of 9.7% VAF, and EGFR (c.2254_2277del; p.S752_I759del) of 9.8% VAF were detected with 70% (7/10), 70% (7/10), and 60% (6/10) frequency, respectively. Therefore, 10% VAF in pre-analytic processing for DNA extraction from FFPE was critical for variant detection in CGP analysis. Further, incorrect results were reported in case independent variant calling of BRAF; c.1798_1799delinsAA (p.V600K) was mistakenly interpreted as c.1798G > A, and c.1799 T > A was on the other strand. In conclusion, the EQA/PT among 10 institutes with common samples revealed the importance of VAF in pre-analysis and helped us understand the significance of the pipeline and common pitfalls usually ignored by the internal quality control in a single institute. [ABSTRACT FROM AUTHOR]
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- 2025
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3. Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA)
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Buchta, Christoph, Marrington, Rachel, De la Salle, Barbara, Albarède, Stéphanie, Badrick, Tony, Berghäll, Heidi, Bullock, David, Coucke, Wim, Delatour, Vincent, Geilenkeuser, Wolf-Jochen, Griesmacher, Andrea, Henriksen, Gitte M., Huggett, Jim F., Luppa, Peter B., Pelanti, Jonna, Pezzati, Paola, Sandberg, Sverre, Spannagl, Michael, Thelen, Marc, and Restelli, Veronica
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PARTICIPATION , *LABORATORIES - Abstract
External quality assessment (EQA) cycles are the smallest complete units within EQA programs that laboratories can use to obtain external assessments of their performance. In each cycle, several samples are distributed to the laboratories registered for participation, and ideally, EQA programs not only cover the examination procedures but also the pre- and post-examination procedures. The properties and concentration range of measurands in individual samples are selected with regard to the intended challenge for the participants so that each sample fulfils its purpose. This aims to ensure the most significant possible information gain in every cycle using the lowest possible number of EQA samples and thus, under economically optimal conditions. Participants examine samples and the results are reported to the EQA provider, who compares them with the target values for individual measurands in every sample. The EQA provider assesses the laboratory performance, and finally communicates the assessment results to the participant. The participants evaluate the outcomes of the assessment of their examination results and can draw conclusions in the case of both failing and passing and, if necessary, define improvement measures. After completion, each cycle is evaluated by the provider so that limitations and weaknesses of the EQA program can be identified and appropriate measures taken, or to confirm its continued suitability and appropriateness. [ABSTRACT FROM AUTHOR]
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- 2025
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- View/download PDF
4. Importance of EQA/PT for the detection of genetic variants in comprehensive cancer genome testing
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Kazuyuki Matsushita, Takayuki Ishige, Kousuke Watanabe, Toshiaki Akahane, Akihide Tanimoto, Michiko Yoshimoto, Munekazu Yamakuchi, Teruto Hashiguchi, Yoshinaga Okugawa, Makoto Ikejiri, Toshikazu Yamaguchi, Tadashi Yamasaki, Mayu Takeda, Masaaki Hibi, Naoki Akiyama, Kaho Shimizu, Naonori Hashimoto, Hiroko Sato, Yoshinori Tanaka, Fumie Amari, and the EQA working group of Japan Association for Clinical Laboratory Science(JACLS)
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External quality assessment (EQA) ,Proficiency testing (PT) ,Genetic variants ,Comprehensive cancer genome testing ,NGS ,Medicine ,Science - Abstract
Abstract Comprehensive genomic profiling (CGP) is increasingly used as a clinical laboratory test and being applied to cancer treatment; however, standardization and external quality assessments (EQA) have not been fully developed. This study performed cost-effective EQA and proficiency tests (PT) for CGP testing among multiple institutions those belong to the EQA working group of Japan Association for Clinical Laboratory Science (JACLS). This study revealed that preanalytical processes, such as derived nucleic acids (NA) extraction from formalin fixed paraffine embedded (FFPE) samples, are critical. First, EQA with extracted DNA from cell lines showed a detection rate of 100% (9 out of 9) in KRAS (c.38G > A; p.G13D), PIK3CA (p.H1047R), and B-Raf proto-oncogene, serine/threonine kinase (BRAF) (c.1799 T > A; p.V600E) in cases of > 10% variant allele frequency (VAF). However, BRAF (c.1799 T > A; p.V600E) detection decreased to 67% (6 out of 9) for a VAF of 4.9%. Second, when DNA was extracted from FFPE samples, pathogenic variants and variants with companion diagnostic indications were detected in all 10 participating laboratories. Each variant had A, and c.1799 T > A was on the other strand. In conclusion, the EQA/PT among 10 institutes with common samples revealed the importance of VAF in pre-analysis and helped us understand the significance of the pipeline and common pitfalls usually ignored by the internal quality control in a single institute.
- Published
- 2025
- Full Text
- View/download PDF
5. Are the benefits of External Quality Assessment (EQA) recognized beyond the echo chamber?
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MacKenzie, Finlay
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LANGUAGE models , *CHEMICAL laboratories , *TECHNOLOGICAL innovations , *CLINICAL chemistry , *PATHOLOGICAL laboratories - Abstract
The article discusses the importance of External Quality Assessment (EQA) in Laboratory Medicine, highlighting its benefits and challenges. It emphasizes the need for wider recognition and understanding of EQA beyond experts in the field. The authors call for collaboration between EQA providers and users to improve patient care and standards in laboratory practices. The future of EQA involves adapting to new technologies and evolving healthcare practices, with a focus on enhancing patient pathways and diagnostic accuracy. [Extracted from the article]
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- 2025
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6. Editorial: Lessons from external quality control in laboratory medicine: important implications for public health!
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Nathalie Weiss, Ingo Schellenberg, and Klaus-Peter Hunfeld
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proficiency testing (PT) ,external quality assessment (EQA) ,public health ,laboratory medicine ,longitudinal analysis ,Biology (General) ,QH301-705.5 - Published
- 2024
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7. Experiences and challenges for EQA providers in assessing the commutability of control materials in accuracy-based EQA programs
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Laura Vierbaum, Patricia Kaiser, Michael Spannagl, Folker Wenzel, Mario Thevis, and Ingo Schellenberg
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external quality assessment (EQA) ,proficiency testing (PT) ,commutability ,reference measurement procedures ,trueness control ,traceability ,Medicine (General) ,R5-920 - Published
- 2024
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8. Longitudinal analysis of external quality assessment of immunoassay-based steroid hormone measurement indicates potential for improvement in standardization
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Laura Vierbaum, Nathalie Weiss, Patricia Kaiser, Marcel Kremser, Folker Wenzel, Mario Thevis, Ingo Schellenberg, and Peter B. Luppa
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external quality assessment (EQA) ,proficiency testing (PT) ,steroid hormones ,immunoassays ,accuracy ,standardization ,Biology (General) ,QH301-705.5 - Abstract
As hormonal disorders are linked to several diseases, the accurate quantitation of steroid hormone levels in serum is crucial in order to provide patients with a reliable diagnosis. Mass spectrometry-based methods are regarded as having the highest level of specificity and sensitivity. However, immunoassays are more commonly used in routine diagnostics to measure steroid levels as they are more cost effective and straightforward to conduct. This study analyzes the external quality assessment results for the measurement of testosterone, progesterone and 17β-estradiol in serum using immunoassays between early 2020 and May 2022. As reference measurement procedures are available for the three steroid hormones, the manufacturer-specific biases were normalized to the reference measurement values. The manufacturer-specific coefficients of variation were predominantly inconspicuous, below 20% for the three hormones when outliers are disregarded, however there were large differences between the various manufacturer collectives. For some collectives, the median bias to the respective reference measurement value was repeatedly greater than ±35%, which is the acceptance limit defined by the German Medical Association. In the case of testosterone and progesterone determination, some collectives tended to consistently over- or underestimate analyte concentrations compared to the reference measurement value, however, for 17β-estradiol determination, both positive and negative biases were observed. This insufficient level of accuracy suggests that cross-reactivity continues to be a fundamental challenge when antibody detection is used to quantify steroids with a high structural similarity. Distinct improvements in standardization are required to provide accurate analysis and thus, reliable clinical interpretations. The increased accuracy of the AX immunoassay for testosterone measurement, as observed in the INSTAND EQAs between 2020 and 2022, could be the result of a recalibration of the assay and raises hope for further improvement of standardization of immunoassay-based steroid hormone analyses in the coming years.
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- 2024
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9. An external quality assessment feasibility study; cross laboratory comparison of haemagglutination inhibition assay and microneutralization assay performance for seasonal influenza serology testing: A FLUCOP study.
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Waldock, Joanna, Weiss, Carol D., Wei Wang, Levine, Min Z., Jefferson, Stacie N., Ho, Sammy, Hoschler, Katja, Londt, Brandon Z., Masat, Elisa, Carolan, Louise, Sánchez-Ovando, Stephany, Fox, Annette, Shinji Watanabe, Miki Akimoto, Aya Sato, Noriko Kishida, Buys, Amelia, Maake, Lorens, Fourie, Cardia, and Caillet, Catherine
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SEASONAL influenza ,CONTRACT research organizations ,HEALTH facilities ,SEROLOGY ,FEASIBILITY studies - Abstract
Introduction: External Quality Assessment (EQA) schemes are designed to provide a snapshot of laboratory proficiency, identifying issues and providing feedback to improve laboratory performance and inter-laboratory agreement in testing. Currently there are no international EQA schemes for seasonal influenza serology testing. Here we present a feasibility study for conducting an EQA scheme for influenza serology methods. Methods: We invited participant laboratories from industry, contract research organizations (CROs), academia and public health institutions who regularly conduct hemagglutination inhibition (HAI) and microneutralization (MN) assays and have an interest in serology standardization. In total 16 laboratories returned data including 19 data sets for HAI assays and 9 data sets for MN assays. Results: Within run analysis demonstrated good laboratory performance for HAI, with intrinsically higher levels of intra-assay variation for MN assays. Between run analysis showed laboratory and strain specific issues, particularly with B strains for HAI, whilst MN testing was consistently good across labs and strains. Inter laboratory variability was higher for MN assays than HAI, however both assays showed a significant reduction in inter-laboratory variation when a human sera pool is used as a standard for normalization. Discussion: This study has received positive feedback from participants, highlighting the benefit such an EQA scheme would have on improving laboratory performance, reducing inter laboratory variation and raising awareness of both harmonized protocol use and the benefit of biological standards for seasonal influenza serology testing. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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10. International external quality assessment study for detection of monkeypox virus by PCR supporting laboratory preparedness during the 2022–2023 mpox outbreak and beyond.
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Ehmann, Rosina, Donoso Mantke, Oliver, McCulloch, Elaine, Yousef, Amani, Ricketts, Alastair, Staines, Harry, Bugert, Joachim J., Wölfel, Roman, and Niesters, Hubert G.M.
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MONKEYPOX , *VACCINIA , *DRILL core analysis , *ORTHOPOXVIRUSES , *AUTUMN - Abstract
• Mpox has triggered a demand for quality-assured MPXV PCR-diagnostic capabilities. • External Quality Assessment (EQA) is key to establish new diagnostic portfolios. • Performance levels in OPXV diagnostics increased compared to data from the 2000s. • One-third-of datasets were generated by OPXV-generic assays only. • Broader EQA participation is desirable for capacity build in developing countries. Diagnostic capabilities and correspondent External Quality Assessments (EQA) are key for outbreak preparedness. To support diagnostic facilities with a quality assessment of newly established monkeypox virus (MPXV) molecular diagnostic workflows, Quality Control for Molecular Diagnostics (QCMD) and the Bundeswehr Institute of Microbiology (IMB) piloted an international EQA study conducting four challenges from autumn 2022 to summer 2023 during the global mpox outbreak. To assess the performance (sensitivity/specificity) of molecular assays used by diagnostic laboratories. Inactivated EQA panels were prepared and distributed containing seven samples of clade Ia and clade IIb MPXV strains at different viral concentrations, two specificity controls with other zoonotic orthopoxviruses (vaccinia and cowpox virus) and a negative control. Assessment was based on reported qualitative testing results. In this outbreak-related EQA study, a total of 192 laboratories from 37 countries reported 346 qualitative datasets. Overall, core samples were correctly detected by approximately 92 % of participants in all four challenges. While sensitivity performance was acceptable in at least 90 % of datasets correctly reported even for educational MPXV-positive samples with low viral concentration [102 genome equivalents (GE)/mL], several laboratories reported the educational specificity controls as false positives or were unable to differentiate MPXV from related orthopoxviruses. Mpox is now a globally occurring infection with a demand for quality-assured diagnostic capabilities. The newly established EQA scheme presented here, offers a multi-purpose panel for orthopoxviruses with a focus on MPXV which will continue to ensure diagnostic quality in clinical settings with up-to-date sample panels. [ABSTRACT FROM AUTHOR]
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- 2024
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11. Evaluation of the diagnostic capacities for emerging arboviral diseases in the international network MediLabSecure from 2014 to 2018 - Importance of external quality assessments
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Guillain Mikaty, Séverine Matheus, Oliver Donoso Mantke, Elaine McCulloch, Heinz Zeichhardt, and Jean-Claude Manuguerra
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MediLabSecure ,Arboviruses ,External quality assessment (EQA) ,Molecular diagnostic ,Surveillance ,Infectious and parasitic diseases ,RC109-216 ,Public aspects of medicine ,RA1-1270 - Abstract
Background: Emerging infectious diseases pose an increasing threat to all nations around the world, including to developed countries. By definition, because they are rare or unknown, public health systems are not well prepared against these emerging diseases. To be fully prepared, countries must have implemented surveillance systems to monitor rare or unusual sanitary events. Methods: The capacity of diagnostic laboratories is a key component of surveillance systems since they are in charge of identifying the pathogens responsible for outbreaks in a timely manner. The MediLabSecure project aims at implementing a comprehensive surveillance system for vector-borne diseases around the Mediterranean and Black Sea regions. From 2014 to 2018, the human-virology group of MediLabSecure notably supported the implementation of molecular diagnostic capacities for eight arboviruses and one coronavirus in 19 laboratories of its network through sharing of protocols and reagents, and technical training of the scientific staff of beneficiary laboratories. Results: We report the results of External Quality Assessments for four of these viruses to assess the efficiency of the diagnostic for these threats emerging in the geographic area. The results for these EQA demonstrate the success of the project in the implementation of diagnostic technics for the identification of Dengue, Chikungunya, Zika, and West Niles viruses in laboratories that did not have the capacity before. However, results also show that some work is still to be done to strengthen the newly acquired capacity. Conclusion: The MediLabSecure project deployed an effort to build an efficient capacity in identifying and survey the emergence of arboviruses in the Mediterranean area. Diagnostic technics were successfully implemented in many of the laboratories of the network, but the effort must be maintained over time to strengthen these capacities.
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- 2022
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12. Detection ability of nucleic acid screen laboratory in blood bank based on NCCL external quality assessment data
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Yuena XIE, Tong PAN, Miao LIU, Fengyuan LI, and Jun LIU
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external quality assessment (eqa) ,blood banks ,nucleic acid test(nat) ,Diseases of the blood and blood-forming organs ,RC633-647.5 ,Medicine - Abstract
Objective To evaluate the laboratory's NAT ability by analyzing the feedback reports of nucleic acid test (NAT) results of external quality assessment (EQA) of National Center for Clinic Laboratories (NCCL), so as to improve the laboratory management details and ensure blood safety. Methods The data of NCCL NAT EQA of blood screening laboratory of Tianjin Blood Center (a total of five occasions from Jan 2019 to Jun 2021) were statistically analyzed. Results From Jan 2019 to Jun 2021, the laboratory participated in EQA for five times and all the results were qualified. The test results of NAT EQA HIV RNA/HCV RNA/HBV DNA detected by R1, R2 and R4 were consistent with the reference results. R3 showed false positive results (CT value 40.46) in the single donation detection of sample No.1925 in HCV RNA. Unreported data of the laboratory was that in the first EQA in 2021, the R4 showed false positive results (CT value 35.8) in in the single donation detection of sample No.2113 in HIV RNA. Conclusion The performance of each NAT screening system in our laboratory is relatively stable except occasional false positive results influenced by every factor. Potential problems can be found and continuously improved by assaying EQA reports and the extended experimental results of EQA samples to further improve the detection ability.
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- 2022
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13. An external quality assessment feasibility study; cross laboratory comparison of haemagglutination inhibition assay and microneutralization assay performance for seasonal influenza serology testing: A FLUCOP study
- Author
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Joanna Waldock, Carol D. Weiss, Wei Wang, Min Z. Levine, Stacie N. Jefferson, Sammy Ho, Katja Hoschler, Brandon Z. Londt, Elisa Masat, Louise Carolan, Stephany Sánchez-Ovando, Annette Fox, Shinji Watanabe, Miki Akimoto, Aya Sato, Noriko Kishida, Amelia Buys, Lorens Maake, Cardia Fourie, Catherine Caillet, Sandrine Raynaud, Richard J. Webby, Jennifer DeBeauchamp, Rebecca J. Cox, Sarah L. Lartey, Claudia M. Trombetta, Serena Marchi, Emanuele Montomoli, Iván Sanz-Muñoz, José María Eiros, Javier Sánchez-Martínez, Danny Duijsings, and Othmar G. Engelhardt
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influenza viruses ,external quality assessment (EQA) ,haemagglutination inhibition (HAI) ,microneutralization (MN) ,serology ,standardization ,Immunologic diseases. Allergy ,RC581-607 - Abstract
IntroductionExternal Quality Assessment (EQA) schemes are designed to provide a snapshot of laboratory proficiency, identifying issues and providing feedback to improve laboratory performance and inter-laboratory agreement in testing. Currently there are no international EQA schemes for seasonal influenza serology testing. Here we present a feasibility study for conducting an EQA scheme for influenza serology methods.MethodsWe invited participant laboratories from industry, contract research organizations (CROs), academia and public health institutions who regularly conduct hemagglutination inhibition (HAI) and microneutralization (MN) assays and have an interest in serology standardization. In total 16 laboratories returned data including 19 data sets for HAI assays and 9 data sets for MN assays.ResultsWithin run analysis demonstrated good laboratory performance for HAI, with intrinsically higher levels of intra-assay variation for MN assays. Between run analysis showed laboratory and strain specific issues, particularly with B strains for HAI, whilst MN testing was consistently good across labs and strains. Inter-laboratory variability was higher for MN assays than HAI, however both assays showed a significant reduction in inter-laboratory variation when a human sera pool is used as a standard for normalization.DiscussionThis study has received positive feedback from participants, highlighting the benefit such an EQA scheme would have on improving laboratory performance, reducing inter laboratory variation and raising awareness of both harmonized protocol use and the benefit of biological standards for seasonal influenza serology testing.
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- 2023
- Full Text
- View/download PDF
14. Selection and evaluation of suitable quality control strains for meropenem antimicrobial susceptibility testing through preliminary external quality assessment.
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Hirayama J, Aoki K, Komori K, Sugawara Y, Arai C, Ishii Y, Sugai M, and Tateda K
- Abstract
Background: Quality control (QC) of carbapenem susceptibility testing for Gram-negative bacteria faces challenges due to limited measuring ranges and the lack of suitable QC strains. This study aimed to select and evaluate QC strains for meropenem antimicrobial susceptibility testing (AST) through a pilot external quality assessment (EQA)., Methods: Candidate QC strains for meropenem AST were selected based on primary AST data and genomic information from the Japan Antimicrobial Resistant Bacterial Bank. Phenotype stability was verified through serial passaging and MIC comparison with original strains. The validated broth microdilution method was used to determine the target MIC value in a pilot EQA involving 47 clinical laboratories in Japan using ten different AST methods., Results: Two strains, Citrobacter freundii JBBDAJB-19-0032 (Strain-A) and Enterobacter hormaechei subsp. steigerwaltii JBEBAAB-19-0102 (Strain-B), both carrying bla
IMP-1 , were selected as candidate QC strains. The meropenem MICs for Strain-A and Strain-B were 4 mg/L and 2 mg/L, respectively. In the pilot EQA, 43 laboratories reported appropriate results for Strain-A and 40 laboratories reported appropriate results for Strain-B. The MIC range was 2-8 mg/L for Strain-A and 1-4 mg/L for Strain-B. However, 19 and 12 laboratories, respectively, reported out-of-range MICs using AST plates on the MicroScan WalkAway. Inappropriate results were reported by four and seven laboratories, respectively, using common methods for Strain-A and Strain-B, respectively., Conclusions: The candidate QC strains selected for this study are suitable for meropenem AST EQA, except when the measuring range of certain methods does not match their QC range., Competing Interests: Declaration of competing interest JH is an employee of bioMérieux Japan Ltd. All other authors have no conflicts of interest to declare., (Copyright © 2024 Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Infection Prevention and Control. Published by Elsevier Ltd. All rights reserved.)- Published
- 2024
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15. First Results of an External Quality Assessment (EQA) Scheme for Molecular, Serological and Antigenic Diagnostic Test for SARS-CoV-2 Detection in Lombardy Region (Northern Italy), 2020–2022.
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Pasotti, Fabio, Pellegrinelli, Laura, Liga, Giuseppa, Rizzetto, Manuela, Azzarà, Giovanna, Da Molin, Simona, Lungu, Oana Livia, Greco, Silvia, Galli, Cristina, Bubba, Laura, Pariani, Elena, Corradin, Matteo, Cereda, Danilo, and Buoro, Sabrina
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DIAGNOSIS methods , *NUCLEIC acids , *SARS-CoV-2 , *TEST methods , *QUALITY assurance - Abstract
For diagnosing SARS-CoV-2 infection and for monitoring its spread, the implementation of external quality assessment (EQA) schemes is mandatory to assess and ensure a standard quality according to national and international guidelines. Here, we present the results of the 2020, 2021, 2022 EQA schemes in Lombardy region for assessing the quality of the diagnostic laboratories involved in SARS-CoV-2 diagnosis. In the framework of the Quality Assurance Programs (QAPs), the routinely EQA schemes are managed by the regional reference centre for diagnostic laboratories quality (RRC-EQA) of the Lombardy region and are carried out by all the diagnostic laboratories. Three EQA programs were organized: (1) EQA of SARS-CoV-2 nucleic acid detection; (2) EQA of anti-SARS-CoV-2-antibody testing; (3) EQA of SARS-CoV-2 direct antigens detection. The percentage of concordance of 1938 molecular tests carried out within the SARS-CoV-2 nucleic acid detection EQA was 97.7%. The overall concordance of 1875 tests carried out within the anti-SARS-CoV-2 antibody EQA was 93.9% (79.6% for IgM). The overall concordance of 1495 tests carried out within the SARS-CoV-2 direct antigens detection EQA was 85% and it was negatively impacted by the results obtained by the analysis of weak positive samples. In conclusion, the EQA schemes for assessing the accuracy of SARS-CoV-2 diagnosis in the Lombardy region highlighted a suitable reproducibility and reliability of diagnostic assays, despite the heterogeneous landscape of SARS-CoV-2 tests and methods. Laboratory testing based on the detection of viral RNA in respiratory samples can be considered the gold standard for SARS-CoV-2 diagnosis. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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16. External quality assessment (EQA) combined with on-site technical evaluation for capacity building in clinical microbiology laboratories in Pakistan.
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Saeed, Noureen, Zeeshan, Muhammad, Saeed, Dania Khalid, Farooqi, Joveria, Shakoor, Sadia, Ahmed, Imran, Jabeen, Kausar, Rao, Jason, and Hasan, Rumina
- Abstract
Objectives: Implementation of standard laboratory practices towards accurate antimicrobial susceptibility testing (AST) is challenging in resource-constrained settings. Efforts to improve AST are required to address knowledge and practice gaps in such settings. In this study, we aimed to address these gaps through external quality assurance surveys and mentoring of laboratories in Pakistan. Methods: This prospective study (May 2017–September 2019) included 10 consenting laboratories. External quality assessment (EQA) was conducted quarterly and performance scored. Each EQA cycle was followed by an on-site technical visit during which AST methodology, quality procedures and laboratory safety were evaluated using a questionnaire developed for this study. Cumulative scores of performance in the EQA and in the technical evaluation were designated "Composite Laboratory Performance Score; CLPS". During on-site visits, feedback provided was to each participating laboratory towards addressing gaps identified. Results: Over the course of the study, our data show significant improvement in CLPS amongst the laboratories included. While improvement in the CLPS scores varied between laboratories, a linear regression model showed improvement within the cohort from 21.37 (May 2017) to 91.5 (September 2019); a significant overall increase of 70.13 points (p = 0.001). Conclusion: Interventions to improve AMR surveillance include quality assured reporting of antimicrobial resistance. Our data show that in resource-limited settings EQA surveys and on-site evaluations followed by guidance contribute towards such improvement. We propose that this model would be a useful tool for laboratory strengthening in such settings. [ABSTRACT FROM AUTHOR]
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- 2022
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17. External quality assessment providers' services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions.
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Buchta, Christoph, Coucke, Wim, Huf, Wolfgang, Griesmacher, Andrea, Müller, Mathias M., Mayr, Wolfgang R., Flesland, Øystein, Politis, Constantina, Wiersum-Osselton, Johanna, Aburto, Andrés, Badrick, Tony, Bouacida, Lobna, Budina, Marek, Duenas, Joseph A., Geilenkeuser, Wolf-Jochen, Guimarães, André V.P., Hecimovic, Ana, Jutzi, Markus, Lee, Chang-Keun, and Lim, Young Ae
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GOVERNMENT laboratories , *ABO blood group system , *BLOOD group incompatibility , *HEALTH & economic status - Abstract
Keywords: economic conditions; external quality assessment (EQA); laboratory performance; legal background EN economic conditions external quality assessment (EQA) laboratory performance legal background 361 369 9 02/07/22 20220201 NES 220201 Introduction The performance of medical laboratories is closely linked with patient safety [[1]]. Financial consequences of incorrect results When the data from all eligible countries are considered, there were more ABO (2.34% vs. 0.36%, p<0.0001) and RhD phenotyping (0.63% vs. 0.42%, p=0.0219) mistakes observed in the countries with financial consequences of incorrect results in EQA. Data from different EQA providers were combined according to country, parameter and year of reported EQA result. In addition to national legal and economic influencing factors, the effect of support from EQA providers for laboratories that reported incorrect results (6) and the effect of EQA sample frequency (7) were examined. [Extracted from the article]
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- 2022
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18. Evaluation of the diagnostic capacities for emerging arboviral diseases in the international network MediLabSecure from 2014 to 2018 - Importance of external quality assessments.
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Mikaty, Guillain, Matheus, Séverine, Donoso Mantke, Oliver, McCulloch, Elaine, Zeichhardt, Heinz, and Manuguerra, Jean-Claude
- Abstract
Emerging infectious diseases pose an increasing threat to all nations around the world, including to developed countries. By definition, because they are rare or unknown, public health systems are not well prepared against these emerging diseases. To be fully prepared, countries must have implemented surveillance systems to monitor rare or unusual sanitary events. The capacity of diagnostic laboratories is a key component of surveillance systems since they are in charge of identifying the pathogens responsible for outbreaks in a timely manner. The MediLabSecure project aims at implementing a comprehensive surveillance system for vector-borne diseases around the Mediterranean and Black Sea regions. From 2014 to 2018, the human-virology group of MediLabSecure notably supported the implementation of molecular diagnostic capacities for eight arboviruses and one coronavirus in 19 laboratories of its network through sharing of protocols and reagents, and technical training of the scientific staff of beneficiary laboratories. We report the results of External Quality Assessments for four of these viruses to assess the efficiency of the diagnostic for these threats emerging in the geographic area. The results for these EQA demonstrate the success of the project in the implementation of diagnostic technics for the identification of Dengue, Chikungunya, Zika, and West Niles viruses in laboratories that did not have the capacity before. However, results also show that some work is still to be done to strengthen the newly acquired capacity. The MediLabSecure project deployed an effort to build an efficient capacity in identifying and survey the emergence of arboviruses in the Mediterranean area. Diagnostic technics were successfully implemented in many of the laboratories of the network, but the effort must be maintained over time to strengthen these capacities. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
19. Editorial: Lessons from external quality control in laboratory medicine: important implications for public health!
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Weiss N, Schellenberg I, and Hunfeld KP
- Abstract
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were editorial board members of Frontiers, at the time of submission. This had no impact on the peer review process and the final decisions.
- Published
- 2024
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20. Experiences and challenges for EQA providers in assessing the commutability of control materials in accuracy-based EQA programs.
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Vierbaum L, Kaiser P, Spannagl M, Wenzel F, Thevis M, and Schellenberg I
- Abstract
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.
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- 2024
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21. External quality assessment of serum indices: Spanish SEQC-ML program.
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Gómez Rioja, Rubén, Ventura, Monserrat, Llopis, María Antonia, Bauça, Josep Miquel, Caballero Garralda, Andrea, Ibarz, Mercedes, Martinez, Debora, Gómez, Carolina, Salas Gómez-Pablos, Paloma, García del Pino, Isabel, Delgado, Jose, Puente, Juan Jose, and Marzana, Iciar
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CLINICAL chemistry , *QUALITY control , *RELIABILITY in engineering , *TEST reliability , *CLINICAL pathology - Abstract
Serum indices included in clinical chemistry instruments are widely used by laboratories to assess the quality of samples. Instruments that report quantitative results allow an evaluation of their diagnostic performance in a similar way to other biochemical tests. The Spanish Society of Laboratory Medicine (SEQC-ML) launched a monthly External Quality program of serum indices in 2018 using three lyophilized materials of simultaneous annual distribution. We present the results of the first three years of the program. The use of four different quality control materials with different concentrations in three alternate months allows an annual evaluation of the participant's accuracy. Assigned values are established by consensus among homogeneous groups, considering necessary at least 10 participants for a comparison at instrument level. The average percentage difference results per instrument allow the assessment of bias among groups. The imprecision of the three indices ranges between 3 and 9%, with no major differences among instruments. Significant differences were observed in all indices among instruments with more than 10 participants (Roche Cobas, Abbott Architect, Abbott Alinity and Siemens Advia). The 90th percentile of the distribution of percentage differences was used as the analytical performance specification (APS). An improvement in performance was observed in the first three years of the program, probably due to the learning curve effect. In 2020, APS of 7.8, 12.2 and 9.7% were proposed for hemolytic, icteric and lipemic indices, respectively. Serum indices have a great impact on the quality and the reliability of laboratory test results. Participation in proficiency testing programs for serum indices is helpful to encourage harmonization among providers and laboratories. [ABSTRACT FROM AUTHOR]
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- 2022
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22. Assessment of expertise in morphological identification of mosquito species (Diptera, Culicidae) using photomicrographs.
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Rahola, Nil, Günay, Filiz, Öztürk, Murat, Alten, Bulent, Aqeehal, Hanan A., Saadawi, Walid K., Shaibi, Taher, Kavran, Mihaela, Petrić, Dušan, Mitrović, Jelena, Pajovic, Igor, Velo, Enkelejda, Kadriaj, Përparim, Rogozi, Elton, Jani, Viola, Manucharyan, Arsen, Paronyan, Lusine, Sawalha, Samer, M'ghirbi, Youmna, and Bouattour, Ali
- Abstract
Copyright of Parasite (1252607X) is the property of EDP Sciences and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2022
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23. Assessment of droplet digital polymerase chain reaction for measuring BCR‐ABL1 in chronic myeloid leukaemia in an international interlaboratory study.
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Scott, Stuart, Cartwright, Ashley, Francis, Sebastian, Whitby, Liam, Sanzone, A. Pia, Mulder, André, Galimberti, Sara, Dulucq, Stephanie, Mauté, Carole, Lauricella, Calogero, Salmon, Matthew, Rose, Susan, Willoughby, Josh, Boeckx, Nancy, Pallisgaard, Niels, Maier, Jacqueline, Leibundgut, Elisabeth O., Zizkova, Hana, Ling Goh, Liuh, and Duong, Chinh
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CHRONIC myeloid leukemia , *POLYMERASE chain reaction , *REVERSE transcriptase polymerase chain reaction , *CHRONIC leukemia , *REVERSE transcriptase , *PROTEIN-tyrosine kinases - Abstract
Summary: Measurement of BCR activator of RhoGEF and GTPase ‐ABL proto‐oncogene 1, non‐receptor tyrosine kinase (BCR‐ABL1) mRNA levels by reverse transcription quantitative polymerase chain reaction (RTqPCR) has been critical to treatment protocols and clinical trials in chronic myeloid leukaemia; however, interlaboratory variation remains a significant issue. Reverse transcriptase droplet digital PCR (RTddPCR) has shown potential to improve testing but a large‐scale interlaboratory study is required to definitively establish this. In the present study, 10 BCR‐ABL1‐positive samples with levels ranging from molecular response (MR)1·0–MR5·0 were tested by 23 laboratories using RTddPCR with the QXDX BCR‐ABL %IS kit. A subset of participants tested the samples using RTqPCR. All 23 participants using RTddPCR detected BCR‐ABL1 in all samples to MR4·0. Detection rates for deep‐response samples were 95·7% at MR4·5, 78·3% at MR4·7 and 87·0% at MR5·0. Interlaboratory coefficient of variation was indirectly proportional to BCR‐ABL1 level ranging from 29·3% to 69·0%. Linearity ranged from 0·9330 to 1·000 (average 0·9936). When results were compared for the 11 participants who performed both RTddPCR and RTqPCR, RTddPCR showed a similar limit of detection to RTqPCR with reduced interlaboratory variation and better assay linearity. The ability to detect deep responses with RTddPCR, matched with an improved linearity and reduced interlaboratory variation will allow improved patient management, and is of particular importance for future clinical trials focussed on achieving and maintaining treatment‐free remission. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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24. 2020 年陕西省二级公立医院临床实验室室间质量评价 参加率和合格率调查分析.
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谢小娟, 孙晶晶, 樊港港, 魏力强, and 苏 欣
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PUBLIC hospitals ,CHINESE medicine ,TOTAL quality management ,MANN Whitney U Test ,LABORATORY management ,KRUSKAL-Wallis Test - Abstract
Copyright of Journal of Modern Laboratory Medicine is the property of Journal of Modern Laboratory Medicine Editorial Department and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2021
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25. First Results of an External Quality Assessment (EQA) Scheme for Molecular, Serological and Antigenic Diagnostic Test for SARS-CoV-2 Detection in Lombardy Region (Northern Italy), 2020–2022
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Fabio Pasotti, Laura Pellegrinelli, Giuseppa Liga, Manuela Rizzetto, Giovanna Azzarà, Simona Da Molin, Oana Livia Lungu, Silvia Greco, Cristina Galli, Laura Bubba, Elena Pariani, Matteo Corradin, Danilo Cereda, and Sabrina Buoro
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SARS-CoV-2 ,external quality assessment (EQA) ,SARS-CoV-2 nucleic acid detection ,anti-SARS-CoV-2 antibody test ,SARS-CoV-2 direct antigens detection ,Medicine (General) ,R5-920 - Abstract
For diagnosing SARS-CoV-2 infection and for monitoring its spread, the implementation of external quality assessment (EQA) schemes is mandatory to assess and ensure a standard quality according to national and international guidelines. Here, we present the results of the 2020, 2021, 2022 EQA schemes in Lombardy region for assessing the quality of the diagnostic laboratories involved in SARS-CoV-2 diagnosis. In the framework of the Quality Assurance Programs (QAPs), the routinely EQA schemes are managed by the regional reference centre for diagnostic laboratories quality (RRC-EQA) of the Lombardy region and are carried out by all the diagnostic laboratories. Three EQA programs were organized: (1) EQA of SARS-CoV-2 nucleic acid detection; (2) EQA of anti-SARS-CoV-2-antibody testing; (3) EQA of SARS-CoV-2 direct antigens detection. The percentage of concordance of 1938 molecular tests carried out within the SARS-CoV-2 nucleic acid detection EQA was 97.7%. The overall concordance of 1875 tests carried out within the anti-SARS-CoV-2 antibody EQA was 93.9% (79.6% for IgM). The overall concordance of 1495 tests carried out within the SARS-CoV-2 direct antigens detection EQA was 85% and it was negatively impacted by the results obtained by the analysis of weak positive samples. In conclusion, the EQA schemes for assessing the accuracy of SARS-CoV-2 diagnosis in the Lombardy region highlighted a suitable reproducibility and reliability of diagnostic assays, despite the heterogeneous landscape of SARS-CoV-2 tests and methods. Laboratory testing based on the detection of viral RNA in respiratory samples can be considered the gold standard for SARS-CoV-2 diagnosis.
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- 2022
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26. An evaluation of ten external quality assurance scheme (EQAS) materials for the faecal immunochemical test (FIT) for haemoglobin.
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O'Driscoll, Shane, Piggott, Carolyn, Bruce, Helen, and Benton, Sally C.
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FECES , *QUALITY assurance , *EARLY detection of cancer - Abstract
Objectives: External quality assessment schemes (EQAS) are being established worldwide to support the faecal immunochemical test (FIT) for haemoglobin (Hb). FIT is widely used as a screening test for colorectal cancer and increasingly in assessment of patients presenting with symptoms. EQA for FIT is provided in several matrices, each unique to the individual scheme. These include Hb suspended in a faecal-like matrix, lyophilised samples and liquid samples. The aim of this study was to evaluate commercially available EQAS and assess their suitability for use. Methods: Ten EQAS provided material for the study. EQA samples were analysed on four quantitative FIT systems. 15 faecal-like matrix samples were loaded per concentration per FIT system. Reconstituted lyophilised samples were examined five times on three separate occasions and liquid samples were examined 10 times per concentration per FIT system. The coefficient of variation (CV) was calculated per concentration of EQA for each FIT system. Results: Results from faecal-like matrix schemes had a higher median CV (12.4–19.0%) when compared to those from schemes providing liquid matrices (0.8–2.3%). The spread of CV values was also higher for results from faecal-like matrix schemes with an interquartile range (IQR) 4.4–24.0% vs. liquid IQR range of 0.3–2.5%. Conclusions: Hb results from faecal-like matrices, whilst more aligned to a patient or participant sample, are prone to pre-examination variation so do not assess the analytical accuracy of a FIT system. Liquid matrices are not prone to pre-examination variation and are better able to assess the accuracy of a FIT system. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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27. A pilot plasma-ctDNA ring trial for the Cobas® EGFR Mutation Test in clinical diagnostic laboratories.
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Ntzifa, Aliki, Kroupis, Christos, Haliassos, Alexander, and Lianidou, Evi
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- *
CIRCULATING tumor DNA , *LUNG cancer - Published
- 2019
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28. National External Quality Assessment follow-up: 2010–2017 Turkish experience.
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Mercan, Ferzane, Serdar, Muhittin A., Senes, Mehmet, Konukoglu, Dildar, İnal, Tamer Cevat, Alatas, Özkan, Pinar, Asli, Savci, Özlem, Güven, Muhammet, Gündüz, Mehmet, Eğin, Ertuğrul, Tipioğlu, Yasal Önder, Tekin, Ahmet, and Yucel, Doğan
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- *
MEDICAL laboratories , *STANDARD deviations , *SELF-discrepancy , *AWARENESS , *DATA entry - Abstract
Objective: Medical laboratories encounter critical obstacles in External Quality Assessment (EQA) practices that are key to assessment of the analytical period. Present study aims to unveil the challenges in nationwide inter-laboratory harmonization and suggest practical solutions. Materials and methods: EQA results of 1941 laboratories participating in 18 different EQA-programs between 2010 and 2017 were examined. Standard Deviation Index (SDI) of each program calculated using 801,028 sample data from 24 different clinical chemical tests were used to conduct a process assessment. Results: There is a significant discrepancy in unsatisfactory performance ratio among different EAQ-programs with an average of 3.4% (27,074 cases) between 2010 and 2017 and a decreasing trend (~40–50%) in 7-years. Programs with higher SDI display lower discrepancy rates. Reasons for unaccepted results appear to be data entry errors (8.27–22.2%), material dilution errors (5–11.4%), technical problems (3.76–7.9%); while random or unidentified causes account for a major of 44.9–59.5%. In 7-years, 15.7% reduction was observed in average SDI of all tests. Conclusion: With the launch of national EQA follow-up program, increased awareness of the analytical processes led to a decrease in unaccepted results and variances in the analytical period. Staff training is suggested as a significant measure. In addition, simultaneous assessment of SDI and allowable total error rates would reduce the variation between programs. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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29. Evaluation of West Nile Virus Diagnostic Capacities in Veterinary Laboratories of the Mediterranean and Black Sea Regions
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Elisa Pérez-Ramírez, Cristina Cano-Gómez, Francisco Llorente, Ani Vodica, Ljubiša Veljović, Natela Toklikishvilli, Kurtesh Sherifi, Soufien Sghaier, Amel Omani, Aida Kustura, Kiril Krstevski, Ilke Karayel-Hacioglu, Naglaa Mohamed Hagag, Jeanne El Hage, Hasmik Davdyan, Mohd Saddam Bintarif, Bojan Adzic, Nabil Abouchoaib, Miguel Ángel Jiménez-Clavero, and Jovita Fernández-Pinero
- Subjects
West Nile virus (WNV) ,Usutu virus (USUV) ,flavivirus ,external quality assessment (EQA) ,MediLabSecure ,diagnostics ,Medicine - Abstract
The increasing incidence of West Nile virus (WNV) in the Euro-Mediterranean area warrants the implementation of effective surveillance programs in animals. A crucial step in the fight against the disease is the evaluation of the capacity of the veterinary labs to accurately detect the infection in animal populations. In this context, the animal virology network of the MediLabSecure project organized an external quality assessment (EQA) to evaluate the WNV molecular and serological diagnostic capacities of beneficiary veterinary labs. Laboratories from 17 Mediterranean and Black Sea countries participated. The results of the triplex real time RT-PCR for simultaneous detection and differentiation of WNV lineage 1 (L1), lineage 2 (L2) and Usutu virus (USUV) were highly satisfactory, especially for L1 and L2, with detection rates of 97.9% and 100%, respectively. For USUV, 75% of the labs reported correct results. More limitations were observed for the generic detection of flaviviruses using conventional reverse-transcription polymerase chain reaction (RT-PCR), since only 46.1% reported correct results in the whole panel. As regards the serological panel, the results were excellent for the generic detection of WNV antibodies. More variability was observed for the specific detection of IgM antibodies with a higher percentage of incorrect results mainly in samples with low titers. This EQA provides a good overview of the WNV (and USUV) diagnostic performance of the involved veterinary labs and demonstrates that the implemented training program was successful in upgrading their diagnostic capacities.
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- 2020
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30. Longitudinal analysis of external quality assessment of immunoassay-based steroid hormone measurement indicates potential for improvement in standardization.
- Author
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Vierbaum L, Weiss N, Kaiser P, Kremser M, Wenzel F, Thevis M, Schellenberg I, and Luppa PB
- Abstract
As hormonal disorders are linked to several diseases, the accurate quantitation of steroid hormone levels in serum is crucial in order to provide patients with a reliable diagnosis. Mass spectrometry-based methods are regarded as having the highest level of specificity and sensitivity. However, immunoassays are more commonly used in routine diagnostics to measure steroid levels as they are more cost effective and straightforward to conduct. This study analyzes the external quality assessment results for the measurement of testosterone, progesterone and 17β-estradiol in serum using immunoassays between early 2020 and May 2022. As reference measurement procedures are available for the three steroid hormones, the manufacturer-specific biases were normalized to the reference measurement values. The manufacturer-specific coefficients of variation were predominantly inconspicuous, below 20% for the three hormones when outliers are disregarded, however there were large differences between the various manufacturer collectives. For some collectives, the median bias to the respective reference measurement value was repeatedly greater than ±35%, which is the acceptance limit defined by the German Medical Association. In the case of testosterone and progesterone determination, some collectives tended to consistently over- or underestimate analyte concentrations compared to the reference measurement value, however, for 17β-estradiol determination, both positive and negative biases were observed. This insufficient level of accuracy suggests that cross-reactivity continues to be a fundamental challenge when antibody detection is used to quantify steroids with a high structural similarity. Distinct improvements in standardization are required to provide accurate analysis and thus, reliable clinical interpretations. The increased accuracy of the AX immunoassay for testosterone measurement, as observed in the INSTAND EQAs between 2020 and 2022, could be the result of a recalibration of the assay and raises hope for further improvement of standardization of immunoassay-based steroid hormone analyses in the coming years., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Vierbaum, Weiss, Kaiser, Kremser, Wenzel, Thevis, Schellenberg and Luppa.)
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- 2024
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31. Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of immunohaematology external quality assessment results during 19 years in Austria.
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Buchta, Christoph, Coucke, Wim, Mayr, Wolfgang R., Müller, Mathias M., Oeser, Reinhard, Schweiger, Christian R., and Körmöczi, Günther F.
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- *
IMMUNOHEMATOLOGY , *MEDICAL laboratories , *ERROR rates , *QUALITY assurance , *CLINICAL pathology - Abstract
Background: ISO 9001 and ISO 15189 have been established as continuative models for quality systems beyond national laws, mandatory standards and guidelines of expert associations regarding analytical and organisational performance of medical laboratories and transfusion services. Although widely used, their impact on laboratory performance has not been investigated. Methods: We retrospectively analysed the results of 167 laboratories in 59 distributions of the Austrian red cell immunohaematology external quality assessment (EQA) scheme in the years 1999–2017. The performance for each parameter and trends of individual participants were compared with respect to certification or accreditation status of participants' quality systems and to laboratory type. Results: Considering more than 52,000 EQA results, the absence or presence of a laboratory quality management system showed different error rates. Laboratories with ISO 9001 or ISO 15189 certification/accreditation had 0.7% incorrect results, while this rate was doubled without such quality systems (1.4%, p=0.0002). Statistically significant error reductions were seen upon ISO 9001/ISO 15189 implementation (1.3% before vs. 0.7% after; p=0.0468). Transfusion services had fewer errors (0.9%) compared to hospital and independent laboratories (both 1.2%). Conclusions: Implementation and maintenance of quality systems according to ISO 9001 or ISO 15189 as well as laboratory specialisation result in better analytical performance as can be seen in immunohaematology EQA results. The conclusion is that these results apply to other laboratory tests and perhaps to other areas of health care. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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32. Quality Assurance in the Clinical Virology Laboratory
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Wallace, Paul and McCulloch, Elaine
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Quality control (QC) ,Serology ,Linearity ,External quality assessment (EQA) ,Validation ,Molecular diagnostics ,Verification ,Digital PCR ,Proficiency testing (PT) ,Quality assurance (QA) ,Article - Abstract
Quality assurance measures ensure competence and reliability in the laboratories procedures from patient specimen receipt (pre-analytical phase), specimen handling and testing (analytical phase), to the analysis and reporting of patient results (post-analytical phase). However, when faced with new challenges such as Coronavirus pandemic, the virology laboratory has to dynamic and responsive as well as able to adapt existing protocols, implement new technologies in response to the risks posed by the most recent threats to public health, while ensuring that the quality of the testing services provided, demonstrates clinical utility and meets appropriate regulatory requirements
- Published
- 2021
33. Assessment of expertise in morphological identification of mosquito species (Diptera, Culicidae) using photomicrographs
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Nil Rahola, Filiz Günay, Murat Öztürk, Bulent Alten, Hanan A. Aqeehal, Walid K. Saadawi, Taher Shaibi, Mihaela Kavran, Dušan Petrić, Jelena Mitrović, Igor Pajovic, Enkelejda Velo, Përparim Kadriaj, Elton Rogozi, Viola Jani, Arsen Manucharyan, Lusine Paronyan, Samer Sawalha, Youmna M’ghirbi, Ali Bouattour, Adel Rhim, Ahmed Ouni, Abdallah M. Samy, Shaimaa Abozeid, M’hammed Sarih, Najlaa Assaid, Soukaina Arich, Nikolina Sokolovska, Elizabeta Janceska, Kamal Eddine Benallal, Nabil Haddad, Renée Zakhia, Nesade Muja-Bajraktari, Kurtesh Sherifi, Majeda Arbaji, Jelena Marić, Violeta Santrac, Nato Dolidze, Philippe Boussès, Isra Deblauwe, Francis Schaffner, Vincent Robert, Maladies infectieuses et vecteurs : écologie, génétique, évolution et contrôle (MIVEGEC), and Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD [France-Sud])-Université de Montpellier (UM)
- Subjects
Identification ,Veterinary (miscellaneous) ,[SDV]Life Sciences [q-bio] ,Mosquito Vectors ,Gamification ,Disease Outbreaks ,Europe ,Infectious Diseases ,Key ,Culicidae ,Africa, Northern ,External Quality Assessment (EQA) ,Insect Science ,Larva ,Animals ,Humans ,Animal Science and Zoology ,Parasitology ,Female ,Vector - Abstract
Accurate identification of insect species is an indispensable and challenging requirement for every entomologist, particularly if the species is involved in disease outbreaks. The European MediLabSecure project designed an identification (ID) exercise available to any willing participant with the aim of assessing and improving knowledge in mosquito taxonomy. The exercise was based on high-definition photomicrographs of mosquitoes (26 adult females and 12 larvae) collected from the western Palaearctic. Sixty-five responses from Europe, North Africa and the Middle East were usable. The study demonstrated that the responders were better at identifying females (82% correct responses) than larvae (63%). When the responders reported that they were sure of the accuracy of their ID, the success rate of ID increased (92% for females and 88% for larvae). The top three tools used for ID were MosKeyTool (72% of responders), the ID key following Becker et al. [2010. Mosquitoes and their control, 2nd edn. Berlin: Springer] (38%), and the CD-ROM of Schaffner et al. [2001. Les moustiques d'Europe: logiciel d'identification et d'enseignement - The mosquitoes of Europe: an identification and training programme. Montpellier: IRD; EID] (32%), while other tools were used by less than 10% of responders. Responders reporting the identification of mosquitoes using the MosKeyTool were significantly better (80% correct responses) than non-MosKeyTool users (69%). Most responders (63%) used more than one ID tool. The feedback from responders in this study was positive, with the exercise being perceived as halfway between educational training and a fun quiz. It raised the importance of further expanding training in mosquito ID for better preparedness of mosquito surveillance and control programmes.Évaluation de l’expertise en identification morphologique des espèces de moustiques (Diptera, Culicidae) à l’aide de photomicrographies.L’identification précise des espèces d’insectes est une exigence indispensable et difficile pour tout entomologiste, en particulier si l’espèce est impliquée dans des épidémies. Le projet européen MediLabSecure a conçu un exercice d’identification (ID) accessible à tout participant volontaire dans le but d’évaluer et d’améliorer les connaissances en taxonomie des moustiques. L’exercice était basé sur des photomicrographies haute définition de moustiques (26 femelles adultes et 12 larves) prélevées dans le Paléarctique occidental. Soixante-cinq réponses d’Europe, d’Afrique du Nord et du Moyen-Orient ont été utilisables. L’étude a démontré que les répondants étaient meilleurs pour identifier les femelles (82 % de réponses correctes) que les larves (63 %). Lorsque les répondants ont déclaré être sûrs de l’exactitude de leur ID, le taux de réussite de l’identification était meilleur (92 % pour les femelles et 88 % pour les larves). Les trois principaux outils utilisés pour les ID étaient MosKeyTool (72 % des répondants), la clé d’identification du livre de Becker et al. (38%) et le CD-ROM de Schaffner et al. (32 %), tandis que d’autres outils étaient utilisés par moins de 10 % des répondants. Les répondants déclarant identifier des moustiques à l’aide de MosKeyTool étaient significativement meilleurs (80 % de réponses correctes) que les non-utilisateurs de MosKeyTool (69 %). La plupart des répondants (63 %) ont utilisé plus d’un outil d’identification. Les commentaires des répondants de cette étude ont été positifs, l’exercice étant perçu comme à mi-chemin entre une formation pédagogique et un quiz amusant. Il a souligné l’importance d’étendre la formation complémentaire à l’identification des moustiques pour une meilleure préparation des programmes de surveillance et de contrôle des moustiques.
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- 2022
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34. A new approach to define acceptance limits for hematology in external quality assessment schemes.
- Author
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Soumali, Mohamed Rida, Van Blerk, Marjan, Akharif, Abdelhadi, Albarède, Stéphanie, Kesseler, Dagmar, Gutierrez, Gabriela, de la Salle, Barbara, Plum, Inger, Guyard, Anne, Favia, Ana Paula, and Coucke, Wim
- Subjects
- *
HEMOGLOBINS , *LEUCOCYTES , *ERYTHROCYTES , *HEMATOCRIT , *BLOOD platelets , *RETICULOCYTES , *HEMATOLOGY - Abstract
Background: A study performed in 2007 comparing the evaluation procedures used in European external quality assessment schemes (EQAS) for hemoglobin and leukocyte concentrations showed that acceptance criteria vary widely. For this reason, the Hematology working group from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM) decided to perform a statistical study with the aim of establishing appropriate acceptance limits (AL) allowing harmonization between the evaluation procedures of European EQAS organizers. Methods: Eight EQAS organizers from seven European countries provided their hematology survey results from 2010 to 2012 for red blood cells (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), white blood cells (WBC), platelets and reticulocytes. More than 440,000 data were collected. The relation between the absolute value of the relative differences between reported EQA results and their corresponding assigned value (U-scores) was modeled by means of an adaptation of Thompson's "characteristic function". Quantile regression was used to investigate the percentiles of the U-scores for each target concentration range. For deriving AL, focus was mainly on the upper percentiles (90th, 95th and 99th). Results: For RBC, hemoglobin, hematocrit and MCV, no relation was found between the U-scores and the target concentrations for any of the percentiles. For WBC, platelets and reticulocytes, a relation with the target concentrations was found and concentration-dependent ALs were determined. Conclusions: The approach enabled to determine state of the art-based ALs, that were concentration-dependent when necessary and usable by various EQA providers. It could also easily be applied to other domains. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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35. International external quality assessment for SARS-CoV-2 molecular detection and survey on clinical laboratory preparedness during the COVID-19 pandemic, April/May 2020
- Author
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Daniela Niemeyer, Victor M. Corman, Christine Lammens, Elaine McCulloch, Herman Goossens, Oliver Donoso Mantke, Hubert G. M. Niesters, Paul E. Klapper, P. Wallace, Christian Drosten, Margareta Ieven, Veerle Matheeussen, RECOVER Project Collaborating Net, and Microbes in Health and Disease (MHD)
- Subjects
Epidemiology ,viruses ,Computer-assisted web interviewing ,medicine.disease_cause ,Disease Outbreaks ,outbreak control ,COVID-19 Testing ,Surveys and Questionnaires ,Pandemic ,media_common ,Coronavirus ,0303 health sciences ,Reverse Transcriptase Polymerase Chain Reaction ,virus diseases ,Clinical Laboratory Services ,3. Good health ,external quality assessment (EQA) ,Europe ,molecular detection ,Molecular Diagnostic Techniques ,Preparedness ,Coronavirus Infections ,Rapid Communication ,medicine.medical_specialty ,COVID-19 Vaccines ,Coronavirus disease 2019 (COVID-19) ,Pneumonia, Viral ,novel coronavirus ,Real-Time Polymerase Chain Reaction ,Sensitivity and Specificity ,03 medical and health sciences ,Betacoronavirus ,Virology ,External quality assessment ,medicine ,media_common.cataloged_instance ,laboratory preparedness ,Humans ,European union ,Pandemics ,030304 developmental biology ,030306 microbiology ,business.industry ,SARS-CoV-2 ,Clinical Laboratory Techniques ,Public Health, Environmental and Occupational Health ,Outbreak ,COVID-19 ,laboratory testing ,Emergency medicine ,Human medicine ,business - Abstract
Laboratory preparedness with quality-assured diagnostic assays is essential for controlling the current coronavirus disease (COVID-19) outbreak. We conducted an external quality assessment study with inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) samples to support clinical laboratories with a proficiency testing option for molecular assays. To analyse SARS-CoV-2 testing performance, we used an online questionnaire developed for the European Union project RECOVER to assess molecular testing capacities in clinical diagnostic laboratories.
- Published
- 2020
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36. External quality assessment of serum indices: Spanish SEQC-ML program
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Gómez Rioja R, Ventura M, Llopis MA, Bauça JM, Caballero Garralda A, Ibarz M, Martinez D, Gómez C, Salas Gómez-Pablos P, García Del Pino I, Delgado J, Puente JJ, and Marzana I
- Subjects
external quality assessment (EQA) ,serum indices ,proficiency testing scheme ,icterus ,hemolysis ,lipemia - Abstract
OBJECTIVES: Serum indices included in clinical chemistry instruments are widely used by laboratories to assess the quality of samples. Instruments that report quantitative results allow an evaluation of their diagnostic performance in a similar way to other biochemical tests. The Spanish Society of Laboratory Medicine (SEQC-ML) launched a monthly External Quality program of serum indices in 2018 using three lyophilized materials of simultaneous annual distribution. We present the results of the first three years of the program. METHODS: The use of four different quality control materials with different concentrations in three alternate months allows an annual evaluation of the participant's accuracy. Assigned values are established by consensus among homogeneous groups, considering necessary at least 10 participants for a comparison at instrument level. The average percentage difference results per instrument allow the assessment of bias among groups. RESULTS: The imprecision of the three indices ranges between 3 and 9%, with no major differences among instruments. Significant differences were observed in all indices among instruments with more than 10 participants (Roche Cobas, Abbott Architect, Abbott Alinity and Siemens Advia). The 90th percentile of the distribution of percentage differences was used as the analytical performance specification (APS). An improvement in performance was observed in the first three years of the program, probably due to the learning curve effect. In 2020, APS of 7.8, 12.2 and 9.7% were proposed for hemolytic, icteric and lipemic indices, respectively. CONCLUSIONS: Serum indices have a great impact on the quality and the reliability of laboratory test results. Participation in proficiency testing programs for serum indices is helpful to encourage harmonization among providers and laboratories.
- Published
- 2022
37. Complement analysis 2016: Clinical indications, laboratory diagnostics and quality control.
- Author
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Prohászka, Zoltán, Nilsson, Bo, Frazer-Abel, Ashley, and Kirschfink, Michael
- Subjects
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COMPLEMENT (Immunology) , *CLINICAL pathology , *BODY fluid analysis , *TARGETED drug delivery , *KIDNEY diseases , *ANGIONEUROTIC edema - Abstract
In recent years, complement analysis of body fluids and biopsies, going far beyond C3 and C4, has significantly enhanced our understanding of the disease process. Such expanded complement analysis allows for a more precise differential diagnosis and for critical monitoring of complement-targeted therapy. These changes are a result of the growing understanding of the involvement of complement in a diverse set of disorders. To appreciate the importance of proper complement analysis, it is important to understand the role it plays in disease. Historically, it was the absence of complement as manifested in severe infection that was noted. Since then complement has been connected to a variety of inflammatory disorders, such as autoimmune diseases and hereditary angioedema. While the role of complement in the rejection of renal grafts has been known longer, the significant impact of complement. In certain nephropathies has now led to the reclassification of some rare kidney diseases and an increased role for complement analysis in diagnosis. Even more unexpected is that complement has also been implicated in neural, ophtalmological and dermatological disorders. With this level of involvement in some varied and impactful health issues proper complement testing is clearly important; however, analysis of the complement system varies widely among laboratories. Except for a few proteins, such as C3 and C4, there are neither well-characterized standard preparations nor calibrated assays available. This is especially true for the inter-laboratory variation of tests which assess classical, alternative, or lectin pathway function. In addition, there is a need for the standardization of the measurement of complement activation products that are so critical in determining whether clinically relevant complement activation has occurred in vivo . Finally, autoantibodies to complement proteins (e.g. anti-C1q), C3 and C4 convertases (C3 and C4 nephritic factor) or to regulatory proteins (e.g. anti-C1inhibitor, anti-factor H) are important in defining autoimmune processes and diseases based on complement dysregulation. To improve the quality of complement laboratory analysis a standardization commmittee of the International Complement Society (ICS) and the International Union of Immunological Societies (IUIS) was formed to provide guidelines for modern complement analysis and standards for the development of international testing programs. [ABSTRACT FROM AUTHOR]
- Published
- 2016
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38. Assessment of droplet digital polymerase chain reaction for measuring BCR-ABL1 in chronic myeloid leukaemia in an international interlaboratory study
- Author
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Liam Whitby, Prasanthi Bhagavatula, Susan Rose, Andre B. Mulder, Elisabeth Oppliger Leibundgut, Edmond S. K. Ma, Sebastian Francis, Jacqueline Maier, Yogesh Shivakumar, Sara Galimberti, Lan Beppu, Josh Willoughby, Wing F Tang, Stéphanie Dulucq, Matthew Salmon, A. Pia Sanzone, Stuart Scott, Calogero Lauricella, Ashley Cartwright, Andrew D Chantry, Niels Pallisgaard, Hana Zizkova, Liuh Ling Goh, Carole Mauté, Nancy Boeckx, Chinh Duong, and Stem Cell Aging Leukemia and Lymphoma (SALL)
- Subjects
Oncology ,Laboratory Proficiency Testing ,NILOTINIB ,bcr-abl ,Fusion Proteins, bcr-abl ,RELAPSE ,RTddPCR ,Bcr abl1 ,0302 clinical medicine ,hemic and lymphatic diseases ,Digital polymerase chain reaction ,Chronic ,610 Medicine & health ,CML ,Tumor ,Leukemia ,Reverse Transcriptase Polymerase Chain Reaction ,breakpoint cluster region ,Hematology ,BCR-ABL1 ,Quality ,external quality assessment (EQA) ,Asia ,Biomarkers, Tumor ,Europe ,HL-60 Cells ,Humans ,K562 Cells ,Laboratories, Clinical ,Leukemia, Myelogenous, Chronic, BCR-ABL Positive ,Linear Models ,North America ,Reagent Kits, Diagnostic ,Reproducibility of Results ,Real-time polymerase chain reaction ,030220 oncology & carcinogenesis ,Reagent Kits ,Life Sciences & Biomedicine ,medicine.medical_specialty ,Coefficient of variation ,Chronic myeloid leukaemia ,IMATINIB ,03 medical and health sciences ,Clinical ,Internal medicine ,TRANSCRIPTS ,medicine ,Diagnostic ,Detection limit ,Science & Technology ,business.industry ,Fusion Proteins ,QUANTIFICATION ,Reverse transcriptase ,BCR-ABL Positive ,business ,Laboratories ,Biomarkers ,030215 immunology ,Myelogenous - Abstract
Measurement of BCR activator of RhoGEF and GTPase -ABL proto-oncogene 1, non-receptor tyrosine kinase (BCR-ABL1) mRNA levels by reverse transcription quantitative polymerase chain reaction (RTqPCR) has been critical to treatment protocols and clinical trials in chronic myeloid leukaemia; however, interlaboratory variation remains a significant issue. Reverse transcriptase droplet digital PCR (RTddPCR) has shown potential to improve testing but a large-scale interlaboratory study is required to definitively establish this. In the present study, 10 BCR-ABL1-positive samples with levels ranging from molecular response (MR)(1 center dot 0)-MR5 center dot 0 were tested by 23 laboratories using RTddPCR with the QXDX BCR-ABL %IS kit. A subset of participants tested the samples using RTqPCR. All 23 participants using RTddPCR detected BCR-ABL1 in all samples to MR4 center dot 0. Detection rates for deep-response samples were 95 center dot 7% at MR4 center dot 5, 78 center dot 3% at MR4 center dot 7 and 87 center dot 0% at MR5 center dot 0. Interlaboratory coefficient of variation was indirectly proportional to BCR-ABL1 level ranging from 29 center dot 3% to 69 center dot 0%. Linearity ranged from 0 center dot 9330 to 1 center dot 000 (average 0 center dot 9936). When results were compared for the 11 participants who performed both RTddPCR and RTqPCR, RTddPCR showed a similar limit of detection to RTqPCR with reduced interlaboratory variation and better assay linearity. The ability to detect deep responses with RTddPCR, matched with an improved linearity and reduced interlaboratory variation will allow improved patient management, and is of particular importance for future clinical trials focussed on achieving and maintaining treatment-free remission.
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- 2021
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39. Immunological characterization of the allergic contact mucositis related to the ingestion of nickel-rich foods.
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Di Tola, Marco, Marino, Mariacatia, Amodeo, Rachele, Tabacco, Fabio, Casale, Rossella, Portaro, Luciano, Borghini, Raffaele, Cristaudo, Antonio, Manna, Fedele, Rossi, Alfredo, De Pità, Ornella, Cardelli, Patrizia, and Picarelli, Antonio
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- *
MUCOUS membrane diseases , *ALLERGIES , *MINERAL content of food , *CYTOKINES , *IMMUNOHISTOCHEMISTRY , *LYMPHOCYTES ,PHYSIOLOGICAL effects of nickel - Abstract
Abstract: Background: The ingestion of nickel (Ni)-rich foods may result in allergic contact mucositis (ACM), a not yet well defined condition identifiable by oral mucosa patch test (omPT). Our aim was to characterize immunologically the ACM taking advantage from the allergen exposure that occurs during the omPT for Ni. Methods: Thirty-seven symptomatic patients underwent to omPT for Ni. Before and after omPT, serum and urine Ni concentrations were determined by mass spectrometry, the white blood cells were counted by hemochromocytometric assay, the peripheral lymphocyte typing was carried out by flow cytometry, total IgE and cytokine serum concentrations were measured by immunoenzymatic assays. The local lymphocyte typing was performed by immunohistochemistry only after omPT. Results: According to the omPT outcomes, 25 patients were defined as Ni-sensitive and the remaining 12 as controls. After omPT, serum and urine Ni concentrations increased significantly in all patients, while a significant increment of circulating lymphocytes and neutrophils was highlighted, respectively, in Ni-sensitive and control patients. Consistently, the Th and Tc circulating lymphocytes, as well as the Th/Tc ratio increased significantly in Ni-sensitive patients after omPT. No noteworthy increment in serum concentrations of total IgE and selected cytokines was observed in any patient after omPT. The presence of CD3+, CD4+, and CD8+ cells was highlighted on the oral mucosa biopsy samples taken from Ni-sensitive patients after omPT. Conclusions: In patients with ACM, a local adaptive response with increased lymphocyte trafficking appears to be the most likely mechanism of reaction to Ni administered with the omPT. [Copyright &y& Elsevier]
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- 2014
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40. A category 1 EQA scheme for comparison of laboratory performance and method performance: An international pilot study in the framework of the Calibration 2000 project.
- Author
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Jansen, Rob, Jassam, Nuthar, Thomas, Annette, Perich, Carmen, Fernandez-Calle, Pilar, Faria, Ana Paula, Correia, Helena, Barth, Julian H., Weykamp, Cas, Cobbaert, Christa, Thelen, Marc, and Ricós, Carmen
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- *
COMPARATIVE studies , *LABORATORY techniques , *PILOT projects , *CALIBRATION , *ERROR analysis in mathematics , *MAGNESIUM , *CALCIUM - Abstract
Abstract: Introduction: In the modern healthcare service, patients receive care in multiple hospitals and healthcare settings. Therefore, harmonization of results from different methods and instruments, both between and within laboratories, is of the utmost importance. The present pilot study aims to test the use of a Category 1 EQA scheme across four European countries by assessing the current level of equivalence of test results. Method: This work was led by the Dutch External Quality Assurance Scheme SKML and involved 28 laboratories from three regions in the UK, Spain and Portugal, and 120 laboratories from The Netherlands. A set of six commutable samples, targeted with reference methods, were circulated and 18 biochemistry analytes were tested. Results and conclusions: The Total Error (TE) score, defined as the probability (%) that results are within the Total Error Acceptable (TEA) limits, for the eighteen analytes was calculated. Our data show that there is a need for further harmonization of laboratory data, in particular for electrolytes (calcium, chloride, magnesium, sodium), enzymes (ALT, amylase, AST, LDH), lipids (HDL-cholesterol), and for substrates (creatinine, total protein). Lack of performance consistency between instruments was seen for most analytes. The lack of harmonization is still present despite manufacturer claims of established traceability. [Copyright &y& Elsevier]
- Published
- 2014
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41. Harmonization of growth hormone measurement results: The empirical approach.
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Ross, H.A., Lentjes, E.W.G.M., Menheere, P.M.M., and Sweep, C.G.J.
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- *
SOMATOTROPIN , *EMPIRICAL research , *FLORISTIC quality assessment , *BIOAVAILABILITY , *IMMUNOASSAY , *LABORATORY techniques - Abstract
Abstract: Growth hormone (hGH) is a measurand belonging to ISO category 4, indicating intrinsic unavailability of a reference measurement procedure and primary standard material. Large between-method differences have been raising confusion, especially in the interpretation of results of stimulation tests for exclusion of juvenile growth hormone deficiency. Within the framework of the external quality assessment scheme (EQAS) of the SKML (Dutch Foundation for Quality Assessment in Clinical Laboratories), attempts to reduce between-method variation of hGH measurements have been made, starting in 1994 with an inter-laboratory comparison of 9 different immunoassays by using a panel of sera and standard materials available at that time. Methods appeared to differ from each other largely in a systematic, sample-independent manner. These systematic differences are reflected in the hGH measurement results obtained in commutable sera. A commutable serum pool was introduced as a consensus reference material, permitting correction of each method's results to a common scale. Pair wise comparisons (“twin studies”) were carried out to investigate and corroborate the effectiveness of this material for harmonization. A significant reduction of the between-laboratory coefficient (CV) of variation from 22 to 9.0% was attained. [Copyright &y& Elsevier]
- Published
- 2014
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42. Evaluation of west nile virus diagnostic capacities in veterinary laboratories of the mediterranean and black sea regions
- Author
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Pérez-Ramírez, Elisa, Cano-Gómez, Cristina, Llorente, Francisco, Vodica, Ani, Veljović, Ljubiša, Toklikishvilli, Natela, Sherifi, Kurtesh, Sghaier, Soufien, Omani, Amel, Kustura, Aida, Krstevski, Kiril, Karayel-Hacioglu, Ilke, Hagag, Naglaa Mohamed, Hage, Jeanne El, Davdyan, Hasmik, Bintarif, Mohd Saddam, Adžić, Bojan, Abouchoaib, Nabil, Jiménez-Clavero, Miguel Ángel, Fernández-Pinero, Jovita, Pérez-Ramírez, Elisa, Cano-Gómez, Cristina, Llorente, Francisco, Vodica, Ani, Veljović, Ljubiša, Toklikishvilli, Natela, Sherifi, Kurtesh, Sghaier, Soufien, Omani, Amel, Kustura, Aida, Krstevski, Kiril, Karayel-Hacioglu, Ilke, Hagag, Naglaa Mohamed, Hage, Jeanne El, Davdyan, Hasmik, Bintarif, Mohd Saddam, Adžić, Bojan, Abouchoaib, Nabil, Jiménez-Clavero, Miguel Ángel, and Fernández-Pinero, Jovita
- Abstract
The increasing incidence of West Nile virus (WNV) in the Euro-Mediterranean area warrants the implementation of effective surveillance programs in animals. A crucial step in the fight against the disease is the evaluation of the capacity of the veterinary labs to accurately detect the infection in animal populations. In this context, the animal virology network of the MediLabSecure project organized an external quality assessment (EQA) to evaluate the WNV molecular and serological diagnostic capacities of beneficiary veterinary labs. Laboratories from 17 Mediterranean and Black Sea countries participated. The results of the triplex real time RT-PCR for simultaneous detection and differentiation of WNV lineage 1 (L1), lineage 2 (L2) and Usutu virus (USUV) were highly satisfactory, especially for L1 and L2, with detection rates of 97.9% and 100%, respectively. For USUV, 75% of the labs reported correct results. More limitations were observed for the generic detection of flaviviruses using conventional reverse-transcription polymerase chain reaction (RT-PCR), since only 46.1% reported correct results in the whole panel. As regards the serological panel, the results were excellent for the generic detection of WNV antibodies. More variability was observed for the specific detection of IgM antibodies with a higher percentage of incorrect results mainly in samples with low titers. This EQA provides a good overview of the WNV (and USUV) diagnostic performance of the involved veterinary labs and demonstrates that the implemented training program was successful in upgrading their diagnostic capacities.
- Published
- 2020
43. Evaluation of West Nile Virus Diagnostic Capacities in Veterinary Laboratories of the Mediterranean and Black Sea Regions
- Author
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European Commission, Pérez-Ramírez, E. [0000-0001-7701-9816], Cano-Gómez, Cristina [0000-0003-4979-983X], Llorente, Francisco [0000-0003-1566-0266], Vodica, Ani [0000-0003-4782-9708], Veljovic, Ljubisa [0000-0002-1482-3046], Sherifi, Kurtesh [0000-0002-3399-6428], Sghaier, Soufien [0000-0003-3608-9919], Kustura, Aida [0000-0003-0261-8771], Krstevski, Kiril [0000-0001-5453-3329], Karayel-Hacioglu, Ilke [0000-0003-1566-630X], El Hage, Jeanne [0000-0001-7910-8345], Adzic, Bojan [0000-0002-8903-1166], Jiménez-Clavero, Miguel Ángel [0000-0003-2125-9743], Fernández-Pinero, Jovita [0000-0001-9919-0112], Pérez-Ramírez, E., Cano-Gómez, Cristina, Llorente, Francisco, Vodica, Ani, Veljovic, Ljubisa, Toklikishvilli, Natela, Sherifi, Kurtesh, Sghaier, Soufien, Omani, Amel, Kustura, Aida, Krstevski, Kiril, Karayel-Hacioglu, Ilke, Hagag, Naglaa Mohamed, El Hage, Jeanne, Davdyan, Hasmik, Bintarif, Mohd Saddam, Adzic, Bojan, Abouchoaib, N., Jiménez-Clavero, Miguel Ángel, Fernández-Pinero, Jovita, European Commission, Pérez-Ramírez, E. [0000-0001-7701-9816], Cano-Gómez, Cristina [0000-0003-4979-983X], Llorente, Francisco [0000-0003-1566-0266], Vodica, Ani [0000-0003-4782-9708], Veljovic, Ljubisa [0000-0002-1482-3046], Sherifi, Kurtesh [0000-0002-3399-6428], Sghaier, Soufien [0000-0003-3608-9919], Kustura, Aida [0000-0003-0261-8771], Krstevski, Kiril [0000-0001-5453-3329], Karayel-Hacioglu, Ilke [0000-0003-1566-630X], El Hage, Jeanne [0000-0001-7910-8345], Adzic, Bojan [0000-0002-8903-1166], Jiménez-Clavero, Miguel Ángel [0000-0003-2125-9743], Fernández-Pinero, Jovita [0000-0001-9919-0112], Pérez-Ramírez, E., Cano-Gómez, Cristina, Llorente, Francisco, Vodica, Ani, Veljovic, Ljubisa, Toklikishvilli, Natela, Sherifi, Kurtesh, Sghaier, Soufien, Omani, Amel, Kustura, Aida, Krstevski, Kiril, Karayel-Hacioglu, Ilke, Hagag, Naglaa Mohamed, El Hage, Jeanne, Davdyan, Hasmik, Bintarif, Mohd Saddam, Adzic, Bojan, Abouchoaib, N., Jiménez-Clavero, Miguel Ángel, and Fernández-Pinero, Jovita
- Abstract
The increasing incidence of West Nile virus (WNV) in the Euro-Mediterranean area warrants the implementation of effective surveillance programs in animals. A crucial step in the fight against the disease is the evaluation of the capacity of the veterinary labs to accurately detect the infection in animal populations. In this context, the animal virology network of the MediLabSecure project organized an external quality assessment (EQA) to evaluate the WNV molecular and serological diagnostic capacities of beneficiary veterinary labs. Laboratories from 17 Mediterranean and Black Sea countries participated. The results of the triplex real time RT-PCR for simultaneous detection and differentiation of WNV lineage 1 (L1), lineage 2 (L2) and Usutu virus (USUV) were highly satisfactory, especially for L1 and L2, with detection rates of 97.9% and 100%, respectively. For USUV, 75% of the labs reported correct results. More limitations were observed for the generic detection of flaviviruses using conventional reverse-transcription polymerase chain reaction (RT-PCR), since only 46.1% reported correct results in the whole panel. As regards the serological panel, the results were excellent for the generic detection of WNV antibodies. More variability was observed for the specific detection of IgM antibodies with a higher percentage of incorrect results mainly in samples with low titers. This EQA provides a good overview of the WNV (and USUV) diagnostic performance of the involved veterinary labs and demonstrates that the implemented training program was successful in upgrading their diagnostic capacities.
- Published
- 2020
44. An improved reference measurement procedure for triglycerides and total glycerides in human serum by isotope dilution gas chromatography–mass spectrometry.
- Author
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Chen, Yizhao, Liu, Qinde, Yong, Sharon, Teo, Hui Ling, and Lee, Tong Kooi
- Subjects
- *
TRIGLYCERIDES , *GAS chromatography/Mass spectrometry (GC-MS) , *ISOTOPE dilution analysis , *MONOGLYCERIDES , *GLYCERIDES , *CHEMICAL sample preparation - Abstract
Abstract: Background: Triglycerides are widely tested in clinical laboratories using enzymatic methods for lipid profiling. As enzymatic methods can be affected by interferences from biological samples, this together with the non-specific nature of triglycerides measurement makes it necessary to verify the accuracy of the test results with a reference measurement procedure. Several such measurement procedures had been published. These procedures generally involved lengthy and laborious sample preparation steps. In this paper, an improved reference measurement procedure for triglycerides and total glycerides was reported which simplifies the sample preparation steps and greatly shortens the time taken. Methods: The procedure was based on isotope dilution gas chromatography–mass spectrometry (ID GC–MS) with tripalmitin as the calibration standard. Serum samples were first spiked with isotope-labeled tripalmitin. For the measurement of triglycerides, the serum samples were subjected to lipid extraction followed by separation of triglycerides from diglycerides and monoglycerides. Triglycerides were then hydrolyzed to glycerol, derivatized and injected into the GC–MS for quantification. For the measurement of total glycerides, the serum samples were hydrolyzed directly and derivatized before injection into the GC–MS for quantification. Results: All measurement results showed good precision with CV <1%. A certified reference material (CRM) of lipids in frozen human serum was used to verify the accuracy of the measurement. The obtained values for both triglycerides and total glycerides were well within the certified ranges of the CRM, with deviation <0.4% from the certified values. The relative expanded uncertainties were also comparable with the uncertainties associated with the certified values of the CRM. The validated procedure was used in an External Quality Assessment (EQA) Program organized by our laboratory to establish the assigned values for triglycerides and total glycerides. [Copyright &y& Elsevier]
- Published
- 2014
- Full Text
- View/download PDF
45. A 10-year human hepatitis B virus nucleic test external quality assessment in China: continual improvement.
- Author
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Wang, Lunan, Pan, Yang, Zhang, Kuo, Zhang, Rui, Sun, Yu, Xie, Jiehong, and Li, Jinming
- Subjects
- *
HEPATITIS B virus , *POLYMERASE chain reaction , *MEDICAL quality control , *BIOLOGICAL assay - Abstract
Abstract: Background: Remarkable progress has been made in the quality assurance of Hepatitis B virus (HBV) DNA nucleic amplification techniques (NAT) during the past decade. And this report presents a 10-year external quality assessment (EQA) program performed by National Center for Clinical Laboratories in China since 2003. Method: EQA panels were produced using freeze-dried HBV plasma or negative controls and then calibrated against the first International Standard for HBV DNA. Results: By 2012, total 35,570 qualitative EQA reports and 56,826 quantitative reports have been collected. The overall correct recognition rate in qualitative test increased from 95.15% in 2003 to 97.99% in 2012. The proportion of participants with acceptable quantitative results also rose to 87.99% in 2012 compared with that of 27.53% in 2003. Besides, we observed a satisfactory reproducibility of <5% in all parallel samples. However, some laboratories still had difficulties in exact quantification of some low viral loads, which near to the limits of the dynamic range of the assays. Conclusion: Taking together, current EQA program showed an encouraging improvement of HBV DNA NAT in China. Distributing more challenging samples and increasing the subtypes are still needed in the future. [Copyright &y& Elsevier]
- Published
- 2013
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46. National survey on critical values notification of 599 institutions in China.
- Author
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Zeng, Rong, Wang, Wei, and Wang, Zhiguo
- Subjects
- *
CLINICAL biochemistry , *PATHOLOGICAL laboratories , *PATHOLOGICAL physiology , *HEMOGLOBINS , *PROTHROMBIN - Abstract
Background: A national cross-sectional survey on the reporting of critical values was conducted to provide suggestions on monitoring of the quality indicator and obtain the goal of quality improvement. Methods: All clinical laboratories participating in the external quality assessment (EQA) programs of chemistry, blood gas, and hematology tests organized by the National Center for Clinical Laboratories (NCCL) were enrolled in our study. General information on the policy of critical values reporting and the particular problems about critical limits and practice of critical values reporting in the last 2 months were asked in the questionnaire. All collected data were analyzed by the special statistical software designed by the NCCL. Results: The return rate of surveys for critical values on clinical biochemistry, blood gas, and hematology testing were 46.11%, 41.14%, and 39.42%, respectively. Most laboratories in the surveys suggested they set different critical limits for children and adults. The analytes of critical values chosen most frequently were potassium, glucose, sodium, calcium, pH, pCO2, pO2, white blood cell (WBC) count, hemoglobin (Hb), prothrombin time (PT), activated partial thromboplastin time, and fibrinogen. The analytes with most critical values were potassium, blood gas, and creatinine for clinical biochemistry, pCO2 for blood gas, and WBC, Hb, and PT for hematology testing. The medians of critical limits for potassium, sodium, calcium, and glucose were not significantly different from the results of the national survey conducted by Kost in 1990. Conclusions: Remarkable inter-laboratory difference in the development and implementation of critical values reporting procedure were found. Laboratories should communicate with clinicians to obtain consensus on the analytes and limits of critical values. [ABSTRACT FROM AUTHOR]
- Published
- 2013
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47. Evaluation of the automatic editing tool RECall for HIV-1 pol and V3 loop sequences.
- Author
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Vinken, Lore, Megens, Sarah, Schrooten, Yoeri, Vandamme, Anne-Mieke, and Van Laethem, Kristel
- Subjects
- *
HIV infections , *THERAPEUTICS , *DRUG resistance , *AUTOMATIC control systems , *REVERSE transcriptase , *ANTIRETROVIRAL agents , *CLINICAL drug trials - Abstract
Highlights: [•] Genotypic drug resistance testing is routine practice in HIV-1 clinical care. [•] Analysing electropherograms is labour-intensive and can give inconsistent results. [•] Automatic editing tools could lead to standardization of the process. [•] Automatic editing tools could reduce the turn-around-time of the process. [Copyright &y& Elsevier]
- Published
- 2013
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48. Role of a quality management system in improving patient safety — Laboratory aspects.
- Author
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Allen, Lynn C.
- Subjects
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PATIENT safety , *PATHOLOGICAL laboratories , *HOSPITAL accreditation , *MEDICAL care , *MEDICAL literature , *CANADIANS - Abstract
Abstract: Objectives: The aim of this study is to describe how implementation of a quality management system (QMS) based on ISO 15189 enhances patient safety. Design and methods: A literature review showed that several European hospitals implemented a QMS based on ISO 9001 and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada. The requirements of a QMS based on ISO 15189 are outlined, and the impact of the implementation of each requirement on patient safety is summarized. The Quality Management Program – Laboratory Services in Ontario is briefly described, and the experience of Ontario laboratories with Ontario Laboratory Accreditation, based on ISO 15189, is outlined. Results: Several hospitals that implemented ISO 9001 reported either a positive impact or no impact on patient safety. Patient safety problems in Canadian laboratories are described. Implementation of each requirement of the QMS can be seen to have a positive effect on patient safety. Average laboratory conformance on Ontario Laboratory Accreditation is very high, and laboratories must address and resolve any nonconformities. Other standards, practices, and quality requirements may also contribute to patient safety. Conclusion: Implementation of a QMS based on ISO 15189 provides a solid foundation for quality in the laboratory and enhances patient safety. It helps to prevent patient safety issues; when such issues do occur, effective processes are in place for investigation and resolution. Patient safety problems in Canadian laboratories might have been prevented had effective QMSs been in place. Ontario Laboratory Accreditation has had a positive impact on quality in Ontario laboratories. [Copyright &y& Elsevier]
- Published
- 2013
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49. CLSI-based transference of the CALIPER database of pediatric reference intervals from Abbott to Beckman, Ortho, Roche and Siemens Clinical Chemistry Assays: Direct validation using reference samples from the CALIPER cohort.
- Author
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Estey, Mathew P., Cohen, Ashley H., Colantonio, David A., Chan, Man Khun, Marvasti, Tina Binesh, Randell, Edward, Delvin, Edgard, Cousineau, Jocelyne, Grey, Vijaylaxmi, Greenway, Donald, Meng, Qing H., Jung, Benjamin, Bhuiyan, Jalaluddin, Seccombe, David, and Adeli, Khosrow
- Subjects
- *
CLINICAL chemistry , *BIOLOGICAL assay , *COHORT analysis , *MEDICAL databases , *BIOMARKERS , *PEDIATRICS - Abstract
Abstract: Objectives: The CALIPER program recently established a comprehensive database of age- and sex-stratified pediatric reference intervals for 40 biochemical markers. However, this database was only directly applicable for Abbott ARCHITECT assays. We therefore sought to expand the scope of this database to biochemical assays from other major manufacturers, allowing for a much wider application of the CALIPER database. Design and methods: Based on CLSI C28-A3 and EP9-A2 guidelines, CALIPER reference intervals were transferred (using specific statistical criteria) to assays performed on four other commonly used clinical chemistry platforms including Beckman Coulter DxC800, Ortho Vitros 5600, Roche Cobas 6000, and Siemens Vista 1500. The resulting reference intervals were subjected to a thorough validation using 100 reference specimens (healthy community children and adolescents) from the CALIPER bio-bank, and all testing centers participated in an external quality assessment (EQA) evaluation. Results: In general, the transferred pediatric reference intervals were similar to those established in our previous study. However, assay-specific differences in reference limits were observed for many analytes, and in some instances were considerable. The results of the EQA evaluation generally mimicked the similarities and differences in reference limits among the five manufacturers' assays. In addition, the majority of transferred reference intervals were validated through the analysis of CALIPER reference samples. Conclusions: This study greatly extends the utility of the CALIPER reference interval database which is now directly applicable for assays performed on five major analytical platforms in clinical use, and should permit the worldwide application of CALIPER pediatric reference intervals. [Copyright &y& Elsevier]
- Published
- 2013
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50. External quality assessment of tumour marker analysis: state of the art and consequences for estimating diagnostic sensitivity and specificity
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Wood, William Graham and Reinauer, Hans
- Subjects
external quality assessment (EQA) ,tumour markers ,precision ,accuracy ,standardisation ,method comparison ,diagnostic specificity ,diagnostic sensitivity ,immunoassay ,Medicine - Abstract
This review shows the current analytical quality for the following analytes used as tumour markers in the external quality assessment (EQA)-programmes of Instand e.V., a national EQA-organiser in Germany: Corticotropin (ACTH), growth hormone (GH, hGH), prolactin (PRL), chorionic gonadotropin (CG, hCG), calcitonin (CT, hCT), thyroglobulin (Tg), carcinoembryonic antigen (CEA), CA-Antigens 125, 72-4, 15-3 and 19-9, alpha foetoprotein (AFP) and prostate-specific antigen (PSA). The results from the participants show a large variation in the precision of the methods used as well as in the comparability of results between methods for the same analyte. In general, the hormones used as tumour markers show better performance than the "CA-markers", which are often inadequately standardised and defined. In the case of one CA-marker (CA 72-4/TAG 72-4), the differences between the lowest kit median concentration and highest kit median concentration for one sample pair were 440% and 580%. The corresponding figures for ACTH were 123% and 156% and for CEA 180% and 184%. The classical tumour markers such as carcinoembryonic antigen (CEA) and alpha foetoprotein (AFP) performed markedly better than the CA-markers and PSA with regards to both inter- and intra-method comparability. The inter-laboratory precision for a given kit and marker was acceptable in many cases. The results show that only results from the same kit/method for each tumour marker can be used for cumulative or time-dependent comparison of results - for example pre-operative and post-operative follow up. In the case of prostate specific antigen (PSA), the kits used for free and total PSA must come from the same producer, if the generally accepted ratios are to have any diagnostic value. The need for kit- and laboratory-specific reference ranges and cut-off values for setting diagnostic specificity and sensitivity is highlighted from the EQA-results. The situation for inter-method comparability for the CA-Markers has not improved over the past decade. With the exception of calcitonin for detecting medullary thyroid carcinoma, chorionic gonadotropin in germ-cell tumours in men and thyroglobulin after total thyroidectomy, none of the remaining analytes appear to be suitable for screening purposes.
- Published
- 2005
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