Clinical Chemistry and Laboratory Medicine (CCLM)最新文献_第10页

Evaluation of a faecal calprotectin method using the OC-SENSOR PLEDIA 利用OC-SENSOR PLEDIA对粪钙保护蛋白方法的评价

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-14 DOI: 10.1515/cclm-2022-0126

S. O’Driscoll, C. Piggott, S. Benton

{"title":"Evaluation of a faecal calprotectin method using the OC-SENSOR PLEDIA","authors":"S. O’Driscoll, C. Piggott, S. Benton","doi":"10.1515/cclm-2022-0126","DOIUrl":"https://doi.org/10.1515/cclm-2022-0126","url":null,"abstract":"Abstract Objectives The National Institute for Health and Care Excellence recommends faecal calprotectin (f-cal) to help differentiate inflammatory bowel diseases from irritable bowel syndrome. Faecal samples for calprotectin have historically been collected at home by patients into screw-top pots and sent to laboratories where calprotectin is extracted and analysed. Faecal haemoglobin (f-Hb) samples are collected at home into specific collection devices containing stabilising buffer. We evaluated the OC-FCa method for f-cal, developed by Eiken Chemical Co., Ltd. (Japan) that uses the same collection device and analyser as f-Hb. Methods OC-FCa was assessed for limit of blank (LOB), limit of detection (LOD), limit of quantification (LOQ), within and between-run imprecision, linearity, prozone, recovery and carryover. A method comparison against the BÜHLMANN fCAL® turbo (BÜHLMANN Laboratories AG, Switzerland) was performed using patient samples and EQA. Results The LOB was 3 µg calprotectin/g faeces (µg/g), LOD 8 μg/g and LOQ 20 μg/g. Within and between-run imprecision was <5%; linearity was good (R2 > 0.99); prozone was appropriately detected; recovery was 99.6%; no observed carryover. OC-FCa showed a strong positive bias compared with BÜHLMANN fCAL® turbo (Z=−5.3587, p < 0.001). When categorised using our local pathway, which interprets calprotectin concentrations and need for further investigation, Cohen’s Kappa demonstrates substantial agreement at <50 μg/g (κ=0.80) and >150 μg/g (κ=0.63) and fair agreement (κ=0.22) in the borderline category 50–150 μg/g. Conclusions The OC-FCa method performed well in the evaluation. With the lack of standardisation for f-cal a clinical study is required to evaluate the positive bias and establish suitable cut-off levels.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87936766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

Life-threatening autoimmune hemolytic anemia following mRNA COVID-19 vaccination: don’t be too prudent with the red gold mRNA - COVID-19疫苗接种后危及生命的自身免疫性溶血性贫血:不要过于谨慎地使用红金

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-11 DOI: 10.1515/cclm-2022-0118

S. De Bruyne, Stijn Van Landeghem, A. Schauwvlieghe, L. Noens

引用次数: 8

Biological variation and reference change value as decision criteria in clinical use of tumor biomarkers. Are they really useful? 生物变异和参考变化值作为肿瘤生物标志物临床应用的判定标准。它们真的有用吗?

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-10 DOI: 10.1515/cclm-2022-0047

R. Dittadi, A. Fabricio, M. Gion

引用次数: 2

Reply to: Spurious results for total and free prostate-specific antigen (PSA); sometimes really "a riddle wrapped in a mystery inside an enigma". 答复前列腺特异性抗原 (PSA) 总含量和游离含量的错误结果；有时真是 "谜中谜"。

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-08 Print Date: 2022-04-26 DOI: 10.1515/cclm-2022-0088

Simona Ferraro, Elia Mario Biganzoli, Mario Plebani

引用次数: 0

Automated prediction of low ferritin concentrations using a machine learning algorithm 使用机器学习算法自动预测低铁蛋白浓度

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-08 DOI: 10.1515/cclm-2021-1194

S. Kurstjens, Thomas de Bel, A. van der Horst, R. Kusters, J. Krabbe, J. V. van Balveren

{"title":"Automated prediction of low ferritin concentrations using a machine learning algorithm","authors":"S. Kurstjens, Thomas de Bel, A. van der Horst, R. Kusters, J. Krabbe, J. V. van Balveren","doi":"10.1515/cclm-2021-1194","DOIUrl":"https://doi.org/10.1515/cclm-2021-1194","url":null,"abstract":"Abstract Objectives Computational algorithms for the interpretation of laboratory test results can support physicians and specialists in laboratory medicine. The aim of this study was to develop, implement and evaluate a machine learning algorithm that automatically assesses the risk of low body iron storage, reflected by low ferritin plasma levels, in anemic primary care patients using a minimal set of basic laboratory tests, namely complete blood count and C-reactive protein (CRP). Methods Laboratory measurements of anemic primary care patients were used to develop and validate a machine learning algorithm. The performance of the algorithm was compared to twelve specialists in laboratory medicine from three large teaching hospitals, who predicted if patients with anemia have low ferritin levels based on laboratory test reports (complete blood count and CRP). In a second round of assessments the algorithm outcome was provided to the specialists in laboratory medicine as a decision support tool. Results Two separate algorithms to predict low ferritin concentrations were developed based on two different chemistry analyzers, with an area under the curve of the ROC of 0.92 (Siemens) and 0.90 (Roche). The specialists in laboratory medicine were less accurate in predicting low ferritin concentrations compared to the algorithms, even when knowing the output of the algorithms as support tool. Implementation of the algorithm in the laboratory system resulted in one new iron deficiency diagnosis on average per day. Conclusions Low ferritin levels in anemic patients can be accurately predicted using a machine learning algorithm based on routine laboratory test results. Moreover, implementation of the algorithm in the laboratory system reduces the number of otherwise unrecognized iron deficiencies.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73710770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 10

Preanalytical quality improvement - an interdisciplinary journey, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE). 分析前质量改进--跨学科之旅，代表欧洲临床化学和实验室医学联合会（EFLM）分析前阶段工作组（WG-PRE）。

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-07 DOI: 10.1515/cclm-2022-0117

Janne Cadamuro, Geoffrey Baird, Gabriele Baumann, Karin Bolenius, Michael Cornes, Mercedes Ibarz, Tom Lewis, Gabriel Lima Oliveira, Giuseppe Lippi, Mario Plebani, Ana-Maria Simundic, Alexander von Meyer

{"title":"Preanalytical quality improvement - an interdisciplinary journey, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE).","authors":"Janne Cadamuro, Geoffrey Baird, Gabriele Baumann, Karin Bolenius, Michael Cornes, Mercedes Ibarz, Tom Lewis, Gabriel Lima Oliveira, Giuseppe Lippi, Mario Plebani, Ana-Maria Simundic, Alexander von Meyer","doi":"10.1515/cclm-2022-0117","DOIUrl":"10.1515/cclm-2022-0117","url":null,"abstract":"Since the beginning of laboratory medicine, the main focus was to provide high quality analytics. Over time the importance of the extra-analytical phases and their contribution to the overall quality became evident. However, as the initial preanalytical processes take place outside of the laboratory and mostly without its supervision, all professions participating in these process steps, from test selection to sample collection and transport, need to engage accordingly. Focusing solely on intra-laboratory processes will not be sufficient to achieve the best possible preanalytical quality. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has provided several recommendations, opinion papers and scientific evidence over the past years, aiming to standardize the preanalytical phase across Europe. One of its strategies to reach this goal are educational efforts. As such, the WG-PRE has organized five conferences in the past decade with the sole focus on preanalytical quality. This year's conference mainly aims to depict the views of different professions on preanalytical processes in order to acquire common ground as basis for further improvements. This article summarizes the content of this 6th preanalytical conference.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87468263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Identification of contagious SARS-CoV-2 infected individuals by Roche's Rapid Antigen Test. 用罗氏快速抗原检测法识别传染性 SARS-CoV-2 感染者。

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-07 Print Date: 2022-04-26 DOI: 10.1515/cclm-2021-1276

Harald H Kessler, Florian Prüller, Melina Hardt, Evelyn Stelzl, Esther Föderl-Höbenreich, Sabine Pailer, Andreas Lueger, Philipp Kreuzer, Kurt Zatloukal, Markus Herrmann

{"title":"Identification of contagious SARS-CoV-2 infected individuals by Roche's Rapid Antigen Test.","authors":"Harald H Kessler, Florian Prüller, Melina Hardt, Evelyn Stelzl, Esther Föderl-Höbenreich, Sabine Pailer, Andreas Lueger, Philipp Kreuzer, Kurt Zatloukal, Markus Herrmann","doi":"10.1515/cclm-2021-1276","DOIUrl":"10.1515/cclm-2021-1276","url":null,"abstract":"Objectives: Rapid antigen tests (RAT) can provide valuable information on the presence or absence SARS-CoV-2 within 15 min without the need of a laboratory. The analytical and diagnostic characteristics of available RATs has led to the question whether they can safely distinguish between infectious and non-infectious patients in an acute care setting.Methods: Three nasopharyngeal swabs for the analysis by RAT, reverse transcriptase real time polymerase chain reaction (RT-qPCR), and a cell culture based infection assay were collected from 67 patients that presented to the emergency department of the University Hospital of Graz (Austria). The first swab was used for on-site RAT testing in the emergency department using the Roche SARS-CoV-2 RAT. The second swab was sent to the central laboratory of the hospital for RT-qPCR with two independent methods (Cepheid Xpert® Xpress SARS-CoV-2 assay and Roche Cobas SARS-CoV-2 Test) and repeat RAT testing using the same commercial test. With the third swab a cell culture-based infection assay was performed.Results: The RATs performed from independent samples showed substantial agreement (Cohen's-kappa: 0.73, p<0.001). All patients with a positive RAT had positive RT-qPCR with cycle threshold (ct) values <25. Fifteen out of 55 RAT-negative samples were RT-qPCR positive with ct values between 25 and 40. The inoculation of cell cultures with RT-qPCR negative swabs and RT-qPCR positive swabs with ct values >25 did not induce cytopathic effects that were related to SARS-CoV-2. The infection assays from four RAT-negative patients showed cytopathic effects that were induced by other pathogens.Conclusions: The SARS-CoV-2 RAT from Roche Diagnostics is a valuable tool for managing symptomatic patients. RAT-negative patients may be regarded as non-contagious.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81726531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 7

Spurious results for total and free prostate-specific antigen (PSA); sometimes really "a riddle wrapped in a mystery inside an enigma". 前列腺特异性抗原（PSA）的总含量和游离含量结果有误；有时真是 "谜中谜，谜中谜"。

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-03 Print Date: 2022-04-26 DOI: 10.1515/cclm-2022-0036

Romolo Marco Dorizzi, Paolo Maltoni, Claudio Sgarzani, Monica Torello, Francesco Montanari

引用次数: 2

Health Technology Assessment to assess value of biomarkers in the decision-making process. 健康技术评估，评估生物标志物在决策过程中的价值。

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-03 Print Date: 2022-04-26 DOI: 10.1515/cclm-2021-1291

Simona Ferraro, Elia Mario Biganzoli, Silvana Castaldi, Mario Plebani

{"title":"Health Technology Assessment to assess value of biomarkers in the decision-making process.","authors":"Simona Ferraro, Elia Mario Biganzoli, Silvana Castaldi, Mario Plebani","doi":"10.1515/cclm-2021-1291","DOIUrl":"10.1515/cclm-2021-1291","url":null,"abstract":"Clinical practice guidelines (CPGs) on screening, surveillance, and treatment of several diseases recommend the selective use of biomarkers with central role in clinical decision-making and move towards including patients in this process. To this aim we will clarify the multidisciplinary interactions required to properly measure the cost-effectiveness of biomarkers with regard to the risk-benefit of the patients and how Health Technology Assessment (HTA) approach may assess value of biomarkers integrated within the decision-making process. HTA through the interaction of different skills provides high-quality research information on the effectiveness, costs, and impact of health technologies, including biomarkers. The biostatistical methodology is relevant to HTA but only meta-analysis is covered in depth, whereas proper approaches are needed to estimate the benefit-risk balance ratio. Several biomarkers underwent HTA evaluation and the final reports have pragmatically addressed: 1) a redesign of the screening based on biomarker; 2) a de-implementation/replacement of the test in clinical practice; 3) a selection of biomarkers with potential predictive ability and prognostic value; and 4) a stronger monitoring of the appropriateness of test request. The COVID-19 pandemic has disclosed the need to create a robust and sustainable system to urgently deal with global health concerns and the HTA methodology enables rapid cost-effective implementation of diagnostic tests allowing healthcare providers to make critical patient-management decisions.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75852846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 12

Trimester-specific reference values for the anticardiolipin antibody by chemiluminescence immunoassay in healthy pregnancy 用化学发光免疫分析法测定健康妊娠期抗心磷脂抗体特异性参考值

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-03-02 DOI: 10.1515/cclm-2022-0044

Rui Gao, Xin-ai Yue, Wanrong Huang, F. Yu, Lang Qin

引用次数: 0