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Review of current incidents and risk calculations used in the Royal College of Australasian Pathologists Key Incident Management and Monitoring Systems - a system that could be used by all Australasian medical laboratories, and easily adapted to worldwide use. 回顾澳大拉西亚皇家学院病理学家关键事件管理和监测系统中使用的当前事件和风险计算-该系统可用于所有澳大拉西亚医学实验室,并易于适应全球使用。
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 Epub Date: 2021-12-15 DOI: 10.11613/BM.2022.010702
Stephanie Gay, Belinda Pope, Tony Badrick, Michael Whiley
{"title":"Review of current incidents and risk calculations used in the Royal College of Australasian Pathologists Key Incident Management and Monitoring Systems - a system that could be used by all Australasian medical laboratories, and easily adapted to worldwide use.","authors":"Stephanie Gay,&nbsp;Belinda Pope,&nbsp;Tony Badrick,&nbsp;Michael Whiley","doi":"10.11613/BM.2022.010702","DOIUrl":"https://doi.org/10.11613/BM.2022.010702","url":null,"abstract":"<p><strong>Introduction: </strong>The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) Key Incident Monitoring and Management Systems (KIMMS) program has found that some existing Quality Indicators are too broad or not well defined. The risk matrix in use does not allow changes in incident Detection or Probability. In 2020, a review was performed: what issues should KIMMS include as Key Incidents and how could risk measurement be improved?</p><p><strong>Materials and methods: </strong>Twenty-seven networked and stand-alone laboratories enrolled in KIMMS during 2020 were surveyed on 45 current and new indicators of risk in the total testing process. They were asked which indicators they considered were significant in causing patient harm. Existing risk matrices in use by members of the KIMMS Advisory Committee laboratories were reviewed regarding their size or structure (3x3 or 5x5) and the descriptions of consequences and probability.</p><p><strong>Results: </strong>Thirteen participants indicated 21 indicators should be monitored, and the KIMMS Advisory committee added a further 13 (11 from the remaining 24 and 2 new). Of the five risk matrices reviewed, all consistently used a 5x5 matrix to estimate Consequences <i>vs</i> Probability of harm. The KIMMS advisory committee added a third parameter to the calculation of Risk, Detectability.</p><p><strong>Conclusion: </strong>All 34 pre- and post- indicators should be monitored, covering all aspects of the total testing cycle other than analytical. The risk measurement can be improved by introducing a 5x5 risk matrix to evaluate harm (consequences x probability) and then evaluating risk by adding detectability; risk equals harm x detectability.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8672387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39763730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
National Guidelines for the Performance of the Sweat Test in Diagnosis of Cystic Fibrosis on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine and the Cystic Fibrosis Centre - Paediatrics and adults, University Hospital Centre Zagreb. 代表克罗地亚医学生物化学和实验室医学学会以及萨格勒布大学医院中心的儿科和成人的囊性纤维化中心制定的诊断囊性纤维化的汗液试验国家准则。
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 DOI: 10.11613/BM.2022.010501
Jasna Leniček Krleža, Merica Aralica, Duška Tješić-Drinković, Karolina Crneković, Jelena Culej, Gordana Fressl Juroš, Verica Horvat, Dara Metzner, Dijana Pamuković Jaram, Alma Pipić Kitter, Fran Smaić, Sanela Šimić Vojak, Livija Šimičević, Valentina Verić
{"title":"National Guidelines for the Performance of the Sweat Test in Diagnosis of Cystic Fibrosis on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine and the Cystic Fibrosis Centre - Paediatrics and adults, University Hospital Centre Zagreb.","authors":"Jasna Leniček Krleža,&nbsp;Merica Aralica,&nbsp;Duška Tješić-Drinković,&nbsp;Karolina Crneković,&nbsp;Jelena Culej,&nbsp;Gordana Fressl Juroš,&nbsp;Verica Horvat,&nbsp;Dara Metzner,&nbsp;Dijana Pamuković Jaram,&nbsp;Alma Pipić Kitter,&nbsp;Fran Smaić,&nbsp;Sanela Šimić Vojak,&nbsp;Livija Šimičević,&nbsp;Valentina Verić","doi":"10.11613/BM.2022.010501","DOIUrl":"https://doi.org/10.11613/BM.2022.010501","url":null,"abstract":"<p><p>The sweat test (ST) is a cornerstone in the diagnosis of cystic fibrosis (CF), together with newborn screening and genetic testing. However, the performance of the ST can depend on the operator's skill, so several international guidelines have been published to standardise the ST, but inconsistencies remain. The joint Working Group for ST Standardisation (WG STS) of the Croatian Society of Medical Biochemistry and Laboratory Medicine, in association with cistic fybrosis health professional and the Cistic Fibrosis Centre for Paediatrics and Adults, have issued National Guidelines for the Performance of the Sweat Test in order to ensure consistency in ST performance and accuracy of reported results. Many of the standards were taken from the 2nd Edition of the UK Guidelines for Performance of the ST for the Diagnosis of CF, while others were taken from independent consensus statements from the WG STS based on local ST equipment and practices. The standards cover every step of the ST, from the indications for testing to reporting of results and their interpretation, including the analytical phase and quality control. In addition, National Guidelines include appendices with practical examples in order to aid implementation of the recommendations in routine practice.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8833251/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39834170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation and management of leukolysis-mediated pseudohyperkalemia in paediatric leukemic samples. 评估和处理白血病患儿白血病溶解介导的假性高钾血症。
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 DOI: 10.11613/BM.2022.010904
Lourens Jan Peter Nonkes, Valérie de Haas, Hans Kemperman, Albert Huisman, Ruben Eduardus Antonius Musson, Wouter Marcel Tiel Groenestege
{"title":"Evaluation and management of leukolysis-mediated pseudohyperkalemia in paediatric leukemic samples.","authors":"Lourens Jan Peter Nonkes,&nbsp;Valérie de Haas,&nbsp;Hans Kemperman,&nbsp;Albert Huisman,&nbsp;Ruben Eduardus Antonius Musson,&nbsp;Wouter Marcel Tiel Groenestege","doi":"10.11613/BM.2022.010904","DOIUrl":"https://doi.org/10.11613/BM.2022.010904","url":null,"abstract":"<p><strong>Introduction: </strong>Leukolysis-related pseudohyperkalemia due to preanalytical procedures may lead to erroneous (or absence of) treatment based on an invalid lab test result. We aimed to obtain a leukocyte threshold above which leukolysis-related pseudohyperkalemia becomes clinical relevant. Secondly, temporal dynamics of treatment-induced leukocyte decrease were studied to allow tailored implementation of laboratory information system (LIS) decision rules based on the leukocyte threshold to avoid leukolysis-related pseudohyperkalemia.</p><p><strong>Materials and methods: </strong>Potassium results of AU5811 routine chemistry (Beckman Coulter, Brea, California, USA) and iStat point of care (POC) (Abbott Diagnostics, Chicago, Illinois, USA) analysers were compared, the latter method being insensitive to leukolysis caused by pre-analytical procedures. Potassium results were combined with leukocyte counts obtained using a Cell-Dyn Sapphire haematology analyser (Abbott Diagnostics, Santa Clara, California, USA), resulting in 132 unique data triplets. Regression analysis was performed to establish a leukocyte threshold. The Reference Change Value (√2 x Z x √(CV<sub>a</sub> <sup>2</sup> + CV<sub>i</sub> <sup>2</sup>)) was used to calculate maximum allowable difference between routine analyser and POC potassium results (delta<sub>max</sub> + 0.58 mmol/L). Temporal analysis on the treatment-induced leukocyte decrease was performed by plotting leukocyte counts in time for all patients above the threshold leukocyte count (N = 41).</p><p><strong>Results: </strong>Established leukocyte threshold was 63 x10<sup>9</sup>/L. Temporal analysis showed leukocyte counts below the threshold within 8 days of treatment for all patients.</p><p><strong>Conclusions: </strong>Based on performed analyses we were able to implement LIS decision rules to reduce pseudohyperkalemia due to preanalytical procedures. This implementation can contribute to a reduction in erroneous (or absence of) treatments in the clinic.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8833246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39834174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Interpretative comments - need for harmonization? Results of the Croatian survey by the Working Group for Post-analytics. 解释性评论——需要统一吗?后分析工作小组克罗地亚调查的结果。
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 Epub Date: 2021-12-15 DOI: 10.11613/BM.2022.010901
Vladimira Rimac, Sonja Podolar, Anja Jokic, Jelena Vlasic Tanaskovic, Lorena Honovic, Jasna Lenicek Krleza
{"title":"Interpretative comments - need for harmonization? Results of the Croatian survey by the Working Group for Post-analytics.","authors":"Vladimira Rimac,&nbsp;Sonja Podolar,&nbsp;Anja Jokic,&nbsp;Jelena Vlasic Tanaskovic,&nbsp;Lorena Honovic,&nbsp;Jasna Lenicek Krleza","doi":"10.11613/BM.2022.010901","DOIUrl":"https://doi.org/10.11613/BM.2022.010901","url":null,"abstract":"<p><strong>Introduction: </strong>Interpretation of laboratory test results is a complex post-analytical activity that requires not only understanding of the clinical significance of laboratory results but also the analytical phase of laboratory work. The aims of this study were to determine: 1) the general opinion of Croatian medical biochemistry laboratories (MBLs) about the importance of interpretative comments on laboratory test reports, and 2) to find out whether harmonization of interpretative comments is needed.</p><p><strong>Materials and methods: </strong>This retrospective study was designed as a survey by the Working Group for Post-analytics as part of national External Quality Assessment (EQA) program. All 195 MBLs participating in the national EQA scheme, were invited to participate in the survey. Results are reported as percentages of the total number of survey participants.</p><p><strong>Results: </strong>Out of 195 MBLs, 162 participated in the survey (83%). Among them 59% MBLs implemented test result comments in routine according to national recommendations. The majority of laboratories (92%) state that interpretative comments added value to the laboratory reports, and a substantial part (72%) does not have feedback from physicians on their significance. Although physicians and patients ask for expert opinion, participants stated that the lack of interest of physicians (64%) as well as the inability to access patient's medical record (62%) affects the quality of expert opinion.</p><p><strong>Conclusion: </strong>Although most participants state that they use interpretative comments and provide expert opinions regarding test results, results of the present study indicate that harmonization for interpretative comments is needed.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8672392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39851748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reevaluation of von Willebrand disease diagnosis in a Croatian paediatric cohort combining bleeding scores, phenotypic laboratory assays and next generation sequencing: a pilot study. 结合出血评分、表型实验室分析和下一代测序对克罗地亚儿科队列血管性血友病诊断的重新评估:一项试点研究
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 DOI: 10.11613/BM.2022.010707
Ivana Lapić, Margareta Radić Antolic, Sara Dejanović Bekić, Désirée Coen-Herak, Ernest Bilić, Dunja Rogić, Renata Zadro
{"title":"Reevaluation of von Willebrand disease diagnosis in a Croatian paediatric cohort combining bleeding scores, phenotypic laboratory assays and next generation sequencing: a pilot study.","authors":"Ivana Lapić,&nbsp;Margareta Radić Antolic,&nbsp;Sara Dejanović Bekić,&nbsp;Désirée Coen-Herak,&nbsp;Ernest Bilić,&nbsp;Dunja Rogić,&nbsp;Renata Zadro","doi":"10.11613/BM.2022.010707","DOIUrl":"https://doi.org/10.11613/BM.2022.010707","url":null,"abstract":"<p><strong>Introduction: </strong>This study reevaluated von Willebrand disease (vWD) diagnosis in a Croatian paediatric cohort by combining bleeding scores (BS), phenotypic laboratory testing, and next-generation sequencing (NGS).</p><p><strong>Materials and methods: </strong>A total of 25 children (11 males and 14 females, median age 10 years, from 2 to 17) previously diagnosed with vWD were included. BS were calculated using an online bleeding assessment tool. Phenotypic laboratory analyses included platelet count, platelet function analyser closure times, prothrombin time, activated partial thromboplastin time, von Willebrand factor antigen (vWF:Ag), vWF gain-of-function mutant glycoprotein Ib binding activity (vWF:GPIbM), vWF collagen binding activity (vWF:CBA), factor VIII activity (FVIII:C) and multimeric analysis. Next-generation sequencing covered regions of both vWF and FVIII genes and was performed on MiSeq (Illumina, San Diego, USA).</p><p><strong>Results: </strong>Disease-associated variants identified in 15 patients comprised 11 distinct heterozygous vWF gene variants in 13 patients and one novel FVIII gene variant (p.Glu2085Lys) in two male siblings. Four vWF variants were novel (p.Gln499Pro, p.Asp1277Tyr, p.Asp1277His, p.Lys1491Glu). Three patients without distinctive variants had vWF:GPIbM between 30 and 50%. Patients with identified vWF gene variants had statistically significant lower values of vWF:GPIbM (P = 0.002), vWF:Ag (P = 0.007), vWF:CBA (P < 0.001) and FVIII:C (P = 0.002), compared to those without. Correlations between BS and phenotypic laboratory test results were not statistically significant for either of the tests.</p><p><strong>Conclusion: </strong>The applied diagnostic approach confirmed the diagnosis of vWD in 13 patients and mild haemophilia A in two. Limited utility of BS in the paediatric population was evidenced.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8833252/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39834172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Evaluation of the clinical chemistry tests analytical performance with Sigma Metric by using different quality specifications - Comparison of analyser actual performance with manufacturer data. 使用不同的质量规格,用西格玛标准评估临床化学检验的分析性能 - 比较分析仪的实际性能与制造商的数据。
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 Epub Date: 2021-12-15 DOI: 10.11613/BM.2022.010703
Murat Keleş
{"title":"Evaluation of the clinical chemistry tests analytical performance with Sigma Metric by using different quality specifications - Comparison of analyser actual performance with manufacturer data.","authors":"Murat Keleş","doi":"10.11613/BM.2022.010703","DOIUrl":"10.11613/BM.2022.010703","url":null,"abstract":"<p><strong>Introduction: </strong>The interest in quality management tools/methodologies is gradually increasing to ensure quality and accurate results in line with international standards in clinical laboratories. Six Sigma stands apart from other methodologies with its total quality management system approach. However, the lack of standardization in tolerance limits restricts the advantages for the process. Our study aimed both to evaluate the applicability of analytical quality goals with Roche Cobas c 702 analyser and to determine achievable goals specific to the analyser used.</p><p><strong>Materials and methods: </strong>The study examined under two main headings as Sigma<sub>laboratory</sub> and Sigma<sub>analyser</sub>. Sigma<sub>laboratory</sub> was calculated using internal and external quality control data by using Roche Cobas c 702 analyser for 21 routine biochemistry parameters and, Sigma<sub>analyser</sub> calculation was based on the manufacturer data presented in the package inserts of the reagents used in our laboratory during the study. Sigma values were calculated with the six sigma formula.</p><p><strong>Results: </strong>Considering the total number of targets achieved, Sigma<sub>analyser</sub> performed best by meeting all CLIA goals, while Sigma<sub>laboratory</sub> showed the lowest performance relative to biological variation (BV) desirable goals.</p><p><strong>Conclusions: </strong>The balance between the applicability and analytical assurance of \"goal-setting models\" should be well established. Even if the package insert data provided by the manufacturer were used in our study, it was observed that almost a quarter of the evaluated analytes failed to achieve even \"acceptable\" level performance according to BV-based goals. Therefore, \"state-of-the-art\" goals for the Six Sigma methodology are considered to be more reasonable, achievable, and compatible with today's technologies.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8672391/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39763731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The importance of regulation (EU) 2017/746 for quality control in medical laboratories. 法规(EU) 2017/746对医学实验室质量控制的重要性
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 Epub Date: 2021-12-15 DOI: 10.11613/BM.2022.010301
Cristiano Ialongo, Maria Sapio, Leda Elisabetta Antetomaso, Antonio Angeloni
{"title":"The importance of regulation (EU) 2017/746 for quality control in medical laboratories.","authors":"Cristiano Ialongo,&nbsp;Maria Sapio,&nbsp;Leda Elisabetta Antetomaso,&nbsp;Antonio Angeloni","doi":"10.11613/BM.2022.010301","DOIUrl":"https://doi.org/10.11613/BM.2022.010301","url":null,"abstract":"The guideline C24 (now in its 4th edition) issued by the Clinical and Laboratory Standards Institute (CLSI) recommends that for purchased quality control (QC), the laboratory should never use the manufacturer’s declared target (T) value but that identified by testing the product at least ten times with each new batch (1). Of course, verifying T is quite different from estimating the variability of the analytical process, albeit both are used for the statistical process control (SPC) since T should be the production target of the QC material on which the manufacturer has complete control.","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8672393/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39763728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Verification of Atellica 1500 and comparison with Iris urine analyser and urine culture. Atellica 1500的验证及与Iris尿液分析仪和尿液培养的比较。
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 Epub Date: 2021-12-15 DOI: 10.11613/BM.2022.010701
Ana Nikler, Helena Čičak, Danijela Bejuk, Vanja Radišić Biljak, Ana-Maria Šimundić
{"title":"Verification of Atellica 1500 and comparison with Iris urine analyser and urine culture.","authors":"Ana Nikler,&nbsp;Helena Čičak,&nbsp;Danijela Bejuk,&nbsp;Vanja Radišić Biljak,&nbsp;Ana-Maria Šimundić","doi":"10.11613/BM.2022.010701","DOIUrl":"https://doi.org/10.11613/BM.2022.010701","url":null,"abstract":"<p><strong>Introduction: </strong>The aims of study were to assess: 1) performance specifications of Atellica 1500, 2) comparability of Atellica 1500 and Iris, 3) the accuracy of both analysers in their ability to detect bacteria.</p><p><strong>Materials and methods: </strong>Carryover, linearity, precision, reproducibility, and limit of blank (LoB) verification were evaluated for erythrocyte and leukocyte counts. ICSH 2014 protocol was used for estimation of carryover, CLSI EP15-A3 for precision, and CLSI EP17 for LoB verification. Comparison for quantitative parameters was evaluated by Bland-Altman plot and Passing-Bablok regression. Qualitative parameters were evaluated by Weighted kappa analysis. Sixty-five urine samples were randomly selected and sent for urine culture which was used as reference method to determine the accuracy of bacteria detection by analysers.</p><p><strong>Results: </strong>Analytical specifications of Atellica 1500 were successfully verified. Total of 393 samples were used for qualitative comparison, while 269 for sediment urinalysis. Bland-Altman analysis showed statistically significant proportional bias for erythrocytes and leukocytes. Passing-Bablok analysis for leukocytes pointed to significant constant and minor proportional difference, while it was not performed for erythrocytes due to significant data deviation from linearity. Kappa analysis resulted in the strongest agreements for pH, ketones, glucose concentrations and leukocytes, while the poorest agreement for bacteria. The sensitivity and specificity of bacteria detection were: 91 (59-100)% and 76 (66-87)% for Atellica 1500 and 46 (17-77)% and 96 (87-100)% for Iris.</p><p><strong>Conclusion: </strong>There are large differences between Atellica 1500 and Iris analysers, due to which they are not comparable and can not be used interchangeably. While there was no difference in specificity of bacteria detection, Iris analyser had greater sensitivity.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8672386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39763729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Deviating glucose results in an international dual-center study. A root cause investigation. 一项国际双中心研究结果显示葡萄糖偏离。根本原因调查。
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 Epub Date: 2021-12-15 DOI: 10.11613/BM.2022.011001
Janne Cadamuro, Peter Bergsten, Katharina Mörwald, Anders Forslund, Marie Dahlbom, Jonas Bergquist, Iris Ciba, Susanne M Brunner, Jeanne Jabbour, Daniel Weghuber
{"title":"Deviating glucose results in an international dual-center study. A root cause investigation.","authors":"Janne Cadamuro,&nbsp;Peter Bergsten,&nbsp;Katharina Mörwald,&nbsp;Anders Forslund,&nbsp;Marie Dahlbom,&nbsp;Jonas Bergquist,&nbsp;Iris Ciba,&nbsp;Susanne M Brunner,&nbsp;Jeanne Jabbour,&nbsp;Daniel Weghuber","doi":"10.11613/BM.2022.011001","DOIUrl":"https://doi.org/10.11613/BM.2022.011001","url":null,"abstract":"<p><p>During a dual-center study on obese and normal weight children and adolescents, focusing on glucose metabolism, we observed a marked difference in glucose results (N = 16,840) between the two sites, Salzburg, Austria and Uppsala, Sweden (P < 0.001). After excluding differences in patient characteristics between the two populations as cause of this finding, we investigated other preanalytic influences. Finally, only the tubes used for blood collection at the two sites were left to evaluate. While the Vacuette FC-Mix tube (Greiner Bio-One, Kremsmünster, Austria) was used in Uppsala, in Salzburg blood collections were performed with a lithium heparin tube (LH-Monovette, Sarstedt, Germany). To prove our hypothesis, we collected two blood samples in either of these tubes from 51 children (Salzburg N = 27, Uppsala N = 24) and compared the measured glucose results. Indeed, we found the suspected bias and calculated a correction formula, which significantly diminished the differences of glucose results between the two sites (<i>P</i> = 0.023). Our finding is in line with those of other studies and although this issue should be widely known, we feel that it is widely neglected, especially when comparing glucose concentrations across Europe, using large databases without any information on preanalytic sample handling.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8672384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39851751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A sudden creatinine increase: A case report. 肌酸酐突然升高1例。
IF 3.3 3区 医学
Biochemia Medica Pub Date : 2022-02-15 DOI: 10.11613/BM.2022.011002
Bernhard Strasser, Sebastian Strasser, Josef Tomasits
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