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Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara

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https://www.readbyqxmd.com/read/30022890/evaluating-analytical-quality-in-clinical-biochemistry-laboratory-using-six-sigma
#1
Xuehui Mao, Jing Shao, Bingchang Zhang, Yong Wang
Introduction: In recent years, Six Sigma metrics has became the hotspot in all trades and professions, which contributes a general procedure to explain the performance on sigma scale. Nowadays, many large companies, such as General Healthcare, Siemens, etc ., have applied Six Sigma to clinical medicine and achieved satisfactory results. In this paper, we aim to evaluate the process performance of our laboratory by using Sigma metrics, thereby choosing the correct analytical quality control approach for each parameter...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022889/using-sigma-metrics-to-establish-analytical-product-performance-requirements-and-optimize-analytical-performance-of-an-in-vitro-diagnostic-assay-using-a-theoretical-total-psa-assay-as-an-example
#2
Victoria Petrides, Sharon Schneider
Introduction: Establishing analytical performance requirements for in vitro diagnostic (IVD) assays is a challenging process. Manufacturers try to optimize analytical performance by choosing amongst many combinations of different product performance characteristics. Sigma metrics and method decision charts can be helpful aids in choosing appropriate analytical performance requirements. The objective of this research was to demonstrate the use of Sigma metrics and method decision charts to help establish analytical performance requirements and to optimize analytical performance at medical decision concentrations for an IVD assay...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022888/utilization-of-a-healthcare-failure-mode-and-effects-analysis-to-identify-error-sources-in-the-preanalytical-phase-in-two-tertiary-hospital-laboratories
#3
Adolfo Romero, Juan Gómez-Salgado, Adolfo Romero-Arana, Carlos Ruiz-Frutos
Introduction: The presence of errors in the preanalytical phase is a thoroughly studied problem. A strategy to increase their source detection might be the use of the Healthcare Failure Mode and Effects Analysis (HFMEA). The aim of this study is improving the capacity of identifying sources of error during the preanalytical period in samples provided by primary care clinics (PCC) with the use of the HFMEA as a tool in the laboratories of two tertiary hospitals. Materials and methods: A HFMEA was carried out in each laboratory, by means of the creation of groups of experts with similar characteristics (doctors and nurses from PCC and laboratory, support staff, and laboratory technicians)...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022887/evaluation-of-the-analytical-performances-of-cobas-6500-and-sysmex-un-series-automated-urinalysis-systems-with-manual-microscopic-particle-counting
#4
Ebubekir Bakan, Zafer Bayraktutan, Nurcan Kilic Baygutalp, Mehmet Ali Gul, Fatma Zuhal Umudum, Nuri Bakan
Introduction: Automated urinalysis systems are valuable tools in clinical laboratories, especially those with a high work load. The objective of this study was to compare the analytical performance of Sysmex UN series urine analyser, which may become a new one in our laboratory, with the Cobas 6500 automated urine analyser, which is used in our laboratory for a long time. For comparisons, manual microscopical examination was accepted as reference method. Materials and methods: A total of 470 urine samples were tested in the two automated urinalysis systems, and urine sediment testing with manual microscopy was applied to a 100 pathological samples of the total 470...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022886/comparison-between-sigma-metrics-in-four-accredited-egyptian-medical-laboratories-in-some-biochemical-tests-an-initiative-towards-sigma-calculation-harmonization
#5
Rania El Sharkawy, Sten Westgard, Ahmed M Awad, AbdelKarem Omneya I Ahmed, El Hadidi Iman, Ahmed Gaballah, Eman Shaheen
Introduction: Analytical quality is an essential requirement for best practice in any medical laboratory. Lack of a harmonized approach for sigma calculation is considered an obstacle in the objective comparability of analytical performance among laboratories adopting sigma metrics. It is urgently needed that all laboratory professionals interested in the analytical quality to work hard towards harmonization protocol for sigma calculation in order to properly select their analytical goals...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022885/comprehensive-evaluation-of-the-internal-and-external-quality-control-to-redefine-analytical-quality-goals
#6
Beatriz Varela, Gonzalo Pacheco
Introduction: The aim of this work is to design a selection algorithm for total allowable error (TEa) source using a graphic tool that, by integrating internal (IQC) and external (EQC) quality control performances, enables the laboratory to evaluate which TEa source better fits the test analytical performance. Materials and methods: Two analytical performance indicators (bias and Sigma metrics) were estimated for 23 biochemistry tests during 2016. Bias was estimated on the EQC, and Sigma metrics was calculated through the results obtained in the IQC...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022884/application-of-sigma-metrics-in-assessing-the-clinical-performance-of-verified-versus-non-verified-reagents-for-routine-biochemical-analytes
#7
Shuang Cao, Xiaosong Qin
Introduction: Sigma metrics analysis is considered an objective method to evaluate the performance of a new measurement system. This study was designed to assess the analytical performance of verified versus non-verified reagents for routine biochemical analytes in terms of Sigma metrics. Materials and methods: The coefficient of variation (CV) was calculated according to the mean and standard deviation (SD) derived from the internal quality control for 20 consecutive days...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022883/sigma-metrics-for-assessing-the-analytical-quality-of-clinical-chemistry-assays-a-comparison-of-two-approaches-electronic-supplementary-material-available-online-for-this-article
#8
Xiuzhi Guo, Tianjiao Zhang, Xuehui Gao, Pengchang Li, Tingting You, Qiong Wu, Jie Wu, Fang Zhao, Liangyu Xia, Ermu Xu, Ling Qiu, Xinqi Cheng
Introduction: Two approaches were compared for the calculation of coefficient of variation (CV) and bias, and their effect on sigma calculation, when different allowable total error (TEa) values were used to determine the optimal method for Six Sigma quality management in the clinical laboratory. Materials and methods: Sigma metrics for routine clinical chemistry tests using three systems (Beckman AU5800, Roche C8000, Siemens Dimension) were determined in June 2017 in the laboratory of Peking Union Medical College Hospital...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022882/risk-analysis-and-assessment-based-on-sigma-metrics-and-intended-use
#9
Yong Xia, Hao Xue, Cunliang Yan, Bowen Li, ShuQiong Zhang, Mingyang Li, Ling Ji
Introduction: In order to ensure the quality in clinical laboratories and meet the low risk requirements of patients and clinicians, a risk analysis and assessment model based on Sigma metrics and intended use was constructed, based on which differential sigma performance ( σ ) expectations of 42 analytes were developed. Materials and methods: Failure mode and effects analysis was applied to produce an analytic risk rating based on three factors, each test of which was graded as follows: 1) Sigma metrics; 2) the severity of harm; 3) intended use...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022881/corrigendum-to-the-potential-of-component-resolved-diagnosis-in-laboratory-diagnostics-of-allergy
#10
Slavica Dodig, Ivana Čepelak
[This corrects the article DOI: 10.11613/BM.2018.020501.].
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022880/sigma-metrics-in-laboratory-medicine-revisited-we-are-on-the-right-road-with-the-wrong-map
#11
REVIEW
Wytze P Oosterhuis, Abdurrahman Coskun
Reliable procedures are needed to quantify the performance of instruments and methods in order to increase the quality in clinical laboratories. The Sigma metrics serves that purpose, and in the present study, the current methods for the calculation of the Sigma metrics are critically evaluated. Although the conventional model based on permissible (or allowable) total error is widely used, it has been shown to be flawed. An alternative method is proposed based on the within-subject biological variation. This model is conceptually similar to the model used in industry to quantify measurement performance, based on the concept of the number of distinct categories and consistent with the Six Sigma methodology...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022879/analytical-sigma-metrics-a-review-of-six-sigma-implementation-tools-for-medical-laboratories
#12
REVIEW
Sten Westgard, Hassan Bayat, James O Westgard
Sigma metrics have become a useful tool for all parts of the quality control (QC) design process. Through the allowable total error model of laboratory testing, analytical assay performance can be judged on the Six Sigma scale. This not only allows benchmarking the performance of methods and instruments on a universal scale, it allows laboratories to easily visualize performance, optimize the QC rules and numbers of control measurements they implement, and now even schedule the frequency of running those controls...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022878/special-issue-on-six-sigma-metrics-experiences-and-recommendations
#13
EDITORIAL
Sten Westgard, Hassan Bayat, James O Westgard
No abstract text is available yet for this article.
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/30022877/expected-long-term-defect-rate-of-analytical-performance-in-the-medical-laboratory-assured-sigma-versus-observed-sigma
#14
REVIEW
Hassan Bayat
Reliability of laboratory results is determined by the ratio of incorrect results expected in long-term. Sigma is a measure of defect ratio, therefore long-term Sigma is a measure of the reliability of laboratory results. Commonly, long-term Sigma is estimated based on the short-term Sigma. The Six Sigma methodology assumes that in long-term performances will shift up to 1.5 Sigma, and therefore the long-term Sigma is considered 1.5 Sigma less than short-term Sigma. Analytical performance in the medical laboratory is prone to shifts larger than 1...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/29666561/comparison-of-barricor%C3%A2-vs-lithium-heparin-tubes-for-selected-routine-biochemical-analytes-and-evaluation-of-post-centrifugation-stability
#15
COMPARATIVE STUDY
Anne Marie Dupuy, Stéphanie Badiou, Delphine Daubin, Anne Sophie Bargnoux, Chloé Magnan, Kadda Klouche, Jean Paul Cristol
Introduction: Obtaining suitable results unaffected by pre- or postanalytical phases is pivotal for clinical chemistry service. We aimed comparison and stability of nine biochemical analytes after centrifugation using Barricor™ plasma tubes with mechanical separator vs standard Vacutainer® lithium heparin tubes. Materials and methods: We collected samples on six healthy volunteers and nine patients from intensive care units into 6 mL plastic Vacutainer® lithium heparin tubes and 5...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/29666560/storage-stability-of-commonly-used-haematological-parameters-at-33-%C3%A2-c-electronic-supplementary-material-available-online-for-this-article
#16
Ashish Jain, Sanchit Jain, Neha Singh, Priyanka Aswal, Shweta Pal, Sushant Kumar Meinia, Nilotpal Chowdhury
Introduction: This study aimed to investigate the analytical bias in haematological parameters induced by storage at 33 ºC. Materials and methods: Blood from the diversion pouch of 20 blood donors were collected in K 2 EDTA vials and stored at 33 ºC. Readings from each vial were taken at 0, 4, 6, 12, 24, 48 and 72 hours after collection on the Sysmex XP-100 analyser (Sysmex Corporation, Kobe, Japan). The percent difference from the baseline readings were calculated and subjected to a Wilcoxon signed rank test at a Holm corrected significance level of 0...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/29666559/assessing-performance-in-pre-season-wrestling-athletes-using-biomarkers
#17
Ionas Papassotiriou, Artemissia-Phoebe Nifli
Introduction: Although regular training introduces the desired changes in athletes' metabolism towards optimal final performance, literature is rarely focusing on the metabolic responses off-competition. Therefore, the aim of this study was to evaluate biochemical indices during typical preseason training in wrestling athletes. Materials and methods: Twenty male freestyle and Greco-roman wrestlers (14 to 31 years) followed a typical session of the preparatory phase...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/29666558/verification-of-a-novel-point-of-care-hba-1c-device-in-real-world-clinical-practice-by-comparison-to-three-high-performance-liquid-chromatography-instruments
#18
COMPARATIVE STUDY
Yufei Wang, Wei Peng, Junling Tang, Lu Dong, Chengchen Gu, Xin Zhang, Jian Zhou, Weiping Jia
Introduction: A real world clinical study was designed and conducted to evaluate the performance of a novel point-of-care device for determination of glycated haemoglobin A1c (HbA1c ), A1C EZ 2.0, in daily clinical practice. Materials and methods: Five hundred and fourteen subjects were included in this study, and divided into three groups. HbA1c was measured by A1C EZ 2.0 and three different high performance liquid chromatography (HPLC) devices: Bio-Rad Variant II Turbo, Tosoh HLC-723 G8 and Premier Hb9210 separately...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/29666557/the-impact-of-delayed-sample-handling-and-type-of-anticoagulant-on-the-interpretation-of-dysplastic-signs-detected-by-flow-cytometry
#19
Bettina Kárai, Zsófia Miltényi, Lajos Gergely, Marianna Száraz-Széles, János Kappelmayer, Zsuzsanna Hevessy
Introduction: A growing body of evidence supports the usefulness of dysplastic signs detected by flow cytometry in the diagnosis of myelodysplastic syndromes (MDS). Our aim was to assess the impact of pre-analytical variables (delayed sample handling, type of anticoagulant, and different clones of antibody) in the interpretation of flow cytometric results. Material and methods: Bone marrow samples were labelled and analysed immediately after aspiration and on two consecutive days...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/29666556/maturity-onset-diabetes-of-the-young-due-to-hnf1a-variants-in-croatia
#20
Tamara Pavić, Agata Juszczak, Edita Pape Medvidović, Carla Burrows, Mario Šekerija, Amanda J Bennett, Jadranka Ćuća Knežević, Anna L Gloyn, Gordan Lauc, Mark I McCarthy, Olga Gornik, Katharine R Owen
Introduction: Maturity onset diabetes of the young due to HNF1A mutations (HNF1A-MODY) is the most frequent form of monogenic diabetes in adults. It is often misdiagnosed as type 1 or type 2 diabetes, but establishing genetic diagnosis is important, as treatment differs from the common types of diabetes. HNF1A-MODY has not been investigated in Croatia before due to limited access to genetic testing. In this study we aimed to describe the characteristics of young adults diagnosed with diabetes before the age of 45 years, who have rare HNF1A allele variants, and estimate the prevalence of HNF1A-MODY in Croatia...
June 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
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