Pub Date : 2023-05-30DOI: 10.1515/labmed-2023-0011
Fabian Berns, Niclas Heilig, Florian Stumpe, Jan Kirchhoff
Abstract Despite substantial gains facilitated by Artificial Intelligence (AI) in recent years, it has to be applied very cautiously in sensitive domains like medicine due to the lack of explainability of many methods in this field. We aim to provide a system to overcome these issues of medical AI applications by means of our concept of medical operational AI detailed in this paper. We make use of various methods of AI and utilize knowledge graphs in particular. The latter is continuously updated by medical experts based on medical literature such as peer-reviewed papers and standard online sources such as UpToDate. We thoroughly derive a multi-level system tackling the corresponding challenges. In particular, its design encompasses (i) holistic diagnostic assistance on a macro level, (ii) predicitions and detailed suggestions for specific medical domains on a micro level, as well as (iii) AI-based optimizations of the overall system on a meta level. We detail practical merits of medical operational AI and discuss the state of the art beyond our solution.
{"title":"Medical operational AI: artificial intelligence in routine medical operations","authors":"Fabian Berns, Niclas Heilig, Florian Stumpe, Jan Kirchhoff","doi":"10.1515/labmed-2023-0011","DOIUrl":"https://doi.org/10.1515/labmed-2023-0011","url":null,"abstract":"Abstract Despite substantial gains facilitated by Artificial Intelligence (AI) in recent years, it has to be applied very cautiously in sensitive domains like medicine due to the lack of explainability of many methods in this field. We aim to provide a system to overcome these issues of medical AI applications by means of our concept of medical operational AI detailed in this paper. We make use of various methods of AI and utilize knowledge graphs in particular. The latter is continuously updated by medical experts based on medical literature such as peer-reviewed papers and standard online sources such as UpToDate. We thoroughly derive a multi-level system tackling the corresponding challenges. In particular, its design encompasses (i) holistic diagnostic assistance on a macro level, (ii) predicitions and detailed suggestions for specific medical domains on a micro level, as well as (iii) AI-based optimizations of the overall system on a meta level. We detail practical merits of medical operational AI and discuss the state of the art beyond our solution.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42882057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-05-23DOI: 10.1515/labmed-2022-0137
H. Baum, S. Chun, P. Findeisen, Hans Fleurkens, Hyunjung Gu, Jinyoung Hong, Franziska Prévôt, Dawid Radziszewski, M. Rossier, Nico Vogt, J. Furrer, K. Klopprogge, C. Schneider-Thauern
Abstract Objectives We evaluated analytical performance, functionality, reliability, and comparability of cobas® pure integrated solutions (Roche Diagnostics) under routine-like conditions. Methods The study was conducted in Europe and Asia (five sites). Seventy-six applications covering ion selective electrolytes (ISE), clinical chemistry (CC), and immunochemistry (IC) analytes were assessed using Elecsys® immunochemistry assays (Roche Diagnostics). Samples included control material and pseudonymized residual samples (plasma/serum/urine). Analytical performance, functionality, and system reliability were evaluated. An inter-laboratory survey, routine simulation imprecision (RSI) and method comparison experiments, and dedicated workflow runs were conducted. Results Most coefficients of variation (CVs) for repeatability were <1 % for ISE, ≤2 % for CC, and <2.5 % for IC assays; for intermediate precision were ≤2 % for ISE and CC, and <2.5 % for IC assays; and for reproducibility were ≤3 % for ISE and CC, and <2.5 % for IC assays. Most RSI reference (94 %) and random part (93 %) CVs were ≤2 %; 99 % of runs completed without system-related interruption. 218 method comparisons generated median Passing–Bablok slope of 1.00, median bias at the medical decision point of −0.1 %, and median Pearson’s r of 0.998. Conclusions cobas pure integrated solutions demonstrated precise and accurate results under routine-like conditions and comparable results vs. commercial analyzers, supporting implementation into routine practice.
{"title":"Performance evaluation of cobas pure integrated solutions at multiple sites in Europe and Asia","authors":"H. Baum, S. Chun, P. Findeisen, Hans Fleurkens, Hyunjung Gu, Jinyoung Hong, Franziska Prévôt, Dawid Radziszewski, M. Rossier, Nico Vogt, J. Furrer, K. Klopprogge, C. Schneider-Thauern","doi":"10.1515/labmed-2022-0137","DOIUrl":"https://doi.org/10.1515/labmed-2022-0137","url":null,"abstract":"Abstract Objectives We evaluated analytical performance, functionality, reliability, and comparability of cobas® pure integrated solutions (Roche Diagnostics) under routine-like conditions. Methods The study was conducted in Europe and Asia (five sites). Seventy-six applications covering ion selective electrolytes (ISE), clinical chemistry (CC), and immunochemistry (IC) analytes were assessed using Elecsys® immunochemistry assays (Roche Diagnostics). Samples included control material and pseudonymized residual samples (plasma/serum/urine). Analytical performance, functionality, and system reliability were evaluated. An inter-laboratory survey, routine simulation imprecision (RSI) and method comparison experiments, and dedicated workflow runs were conducted. Results Most coefficients of variation (CVs) for repeatability were <1 % for ISE, ≤2 % for CC, and <2.5 % for IC assays; for intermediate precision were ≤2 % for ISE and CC, and <2.5 % for IC assays; and for reproducibility were ≤3 % for ISE and CC, and <2.5 % for IC assays. Most RSI reference (94 %) and random part (93 %) CVs were ≤2 %; 99 % of runs completed without system-related interruption. 218 method comparisons generated median Passing–Bablok slope of 1.00, median bias at the medical decision point of −0.1 %, and median Pearson’s r of 0.998. Conclusions cobas pure integrated solutions demonstrated precise and accurate results under routine-like conditions and comparable results vs. commercial analyzers, supporting implementation into routine practice.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2023-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44202517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-05-19DOI: 10.1515/labmed-2023-0020
Julian E. Gebauer, Jakob Adler
Abstract In many areas of healthcare, digitization has progressed only slowly so far. The SARS-CoV-2 pandemic in particular has shown how valuable software solutions that are deployable at short notice, can be. In this review we present some selected possibilities of the easy-to-learn programming language R and demonstrate potential applications of the package Shiny in the fields of statistical analysis and laboratory medicine. In addition to a brief tabular overview of published applications, we present two examples of their use in routine laboratory workflows. The first example demonstrates how a Shiny app can be used to estimate the minimal difference (MD) of laboratory analytes, while the second example illustrates how pre- and post-analytical processing steps can be integrated into a fully automated workflow using R and the Shiny package.
{"title":"Using Shiny apps for statistical analyses and laboratory workflows","authors":"Julian E. Gebauer, Jakob Adler","doi":"10.1515/labmed-2023-0020","DOIUrl":"https://doi.org/10.1515/labmed-2023-0020","url":null,"abstract":"Abstract In many areas of healthcare, digitization has progressed only slowly so far. The SARS-CoV-2 pandemic in particular has shown how valuable software solutions that are deployable at short notice, can be. In this review we present some selected possibilities of the easy-to-learn programming language R and demonstrate potential applications of the package Shiny in the fields of statistical analysis and laboratory medicine. In addition to a brief tabular overview of published applications, we present two examples of their use in routine laboratory workflows. The first example demonstrates how a Shiny app can be used to estimate the minimal difference (MD) of laboratory analytes, while the second example illustrates how pre- and post-analytical processing steps can be integrated into a fully automated workflow using R and the Shiny package.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2023-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45033123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-05-18DOI: 10.1515/labmed-2023-0032
R. Markewitz, S. Sharifzadeh, R. Junker, K. Wandinger
Abstract Objectives To better characterize occurrence and extent of anticoagulant-associated pseudothrombocytopenia (PTCP) in the daily routine of a high-throughput clinical laboratory in order to draw conclusions on a more precise definition of this phenomenon. Methods Concomitant platelet counts in both EDTA and citrate whole blood (WB) performed in our laboratory over a period of four years and 9 months, were analyzed, calculating the correlation, as well as the absolute difference in the results obtained from both materials, cross-referencing these measures with automated flags for platelet aggregates and the results of the visual examination for platelet aggregates of peripheral blood smears. Results Platelet counts in both materials were strongly correlated (ρ=0.86; p<0.0001) but are on average significantly higher in EDTA WB than in citrate WB (median difference: 11 ± 14.8/nL, p<0.0001). This is in spite of numerous instances of EDTA-associated PTCP recorded in our data, where the opposite is the case. The automated flag for possible platelet aggregates was shown to be very unspecific, while a machine-learning algorithm suggested the difference in platelet counts between EDTA and citrate WB as a predictor of platelet aggregates. Conclusions EDTA-associated PTCP is a regular occurrence. Differences in platelet counts between EDTA and citrate WB appear to be a far better predictor of PTCP than automated flags. A clear and useful definition of PTCP is still missing, however, and cannot be derived from our data either, indicating the need for further research.
{"title":"EDTA-associated pseudothrombocytopenia: definition and real-world occurrence","authors":"R. Markewitz, S. Sharifzadeh, R. Junker, K. Wandinger","doi":"10.1515/labmed-2023-0032","DOIUrl":"https://doi.org/10.1515/labmed-2023-0032","url":null,"abstract":"Abstract Objectives To better characterize occurrence and extent of anticoagulant-associated pseudothrombocytopenia (PTCP) in the daily routine of a high-throughput clinical laboratory in order to draw conclusions on a more precise definition of this phenomenon. Methods Concomitant platelet counts in both EDTA and citrate whole blood (WB) performed in our laboratory over a period of four years and 9 months, were analyzed, calculating the correlation, as well as the absolute difference in the results obtained from both materials, cross-referencing these measures with automated flags for platelet aggregates and the results of the visual examination for platelet aggregates of peripheral blood smears. Results Platelet counts in both materials were strongly correlated (ρ=0.86; p<0.0001) but are on average significantly higher in EDTA WB than in citrate WB (median difference: 11 ± 14.8/nL, p<0.0001). This is in spite of numerous instances of EDTA-associated PTCP recorded in our data, where the opposite is the case. The automated flag for possible platelet aggregates was shown to be very unspecific, while a machine-learning algorithm suggested the difference in platelet counts between EDTA and citrate WB as a predictor of platelet aggregates. Conclusions EDTA-associated PTCP is a regular occurrence. Differences in platelet counts between EDTA and citrate WB appear to be a far better predictor of PTCP than automated flags. A clear and useful definition of PTCP is still missing, however, and cannot be derived from our data either, indicating the need for further research.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2023-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42721801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-05-10DOI: 10.1515/labmed-2022-0114
Chi Zhang, Feng-li Zheng, Xiaoyong Wu
Abstract Objectives To explore the predictive value of C-reactive protein (CRP)-to-albumin (ALB) ratio (CAR) for the risk of 28-day mortality in patients with severe pneumonia. Methods A total of 152 patients with severe pneumonia treated from January 2020 to January 2022 were enrolled and assigned into survival group (n=107) and death group (n=45) according to their survival status after treatment for 28 d. Their clinical data were compared, and the influencing factors for 28-day mortality were explored by multiple logistic regression analysis. The receiver operating characteristic (ROC) curve was plotted to assess the value of CAR for predicting 28-day mortality risk. A risk prediction model was constructed, and its prediction efficiency was evaluated. Results The death group had significantly older age, Acute Physiology and Chronic Health Evaluation (APACHE) II score, Murray Lung Injury Score, Sequential Organ Failure Assessment score, white blood cell count, neutrophil count, red cell volume distribution width, neutrophil-to-lymphocyte ratio (NLR), fibrinogen, procalcitonin, blood lactic acid (Lac), CRP and CAR and significantly lower oxygenation index and ALB than those of the survival group (p<0.05). APACHE II score, NLR, Lac and CAR were independent risk factors for 28-day mortality (p<0.05). AUC of the established prediction model was 0.826, with sensitivity of 88.45 % and specificity of 87.32 %, indicating high discrimination. The nomogram model had clinical value when the risk threshold probability was 11–93 %. Conclusions CAR is an independent risk factor that shows a high predictive value for the 28-day mortality risk in patients with severe pneumonia.
{"title":"Predictive value of C-reactive protein-to-albumin ratio for risk of 28-day mortality in patients with severe pneumonia","authors":"Chi Zhang, Feng-li Zheng, Xiaoyong Wu","doi":"10.1515/labmed-2022-0114","DOIUrl":"https://doi.org/10.1515/labmed-2022-0114","url":null,"abstract":"Abstract Objectives To explore the predictive value of C-reactive protein (CRP)-to-albumin (ALB) ratio (CAR) for the risk of 28-day mortality in patients with severe pneumonia. Methods A total of 152 patients with severe pneumonia treated from January 2020 to January 2022 were enrolled and assigned into survival group (n=107) and death group (n=45) according to their survival status after treatment for 28 d. Their clinical data were compared, and the influencing factors for 28-day mortality were explored by multiple logistic regression analysis. The receiver operating characteristic (ROC) curve was plotted to assess the value of CAR for predicting 28-day mortality risk. A risk prediction model was constructed, and its prediction efficiency was evaluated. Results The death group had significantly older age, Acute Physiology and Chronic Health Evaluation (APACHE) II score, Murray Lung Injury Score, Sequential Organ Failure Assessment score, white blood cell count, neutrophil count, red cell volume distribution width, neutrophil-to-lymphocyte ratio (NLR), fibrinogen, procalcitonin, blood lactic acid (Lac), CRP and CAR and significantly lower oxygenation index and ALB than those of the survival group (p<0.05). APACHE II score, NLR, Lac and CAR were independent risk factors for 28-day mortality (p<0.05). AUC of the established prediction model was 0.826, with sensitivity of 88.45 % and specificity of 87.32 %, indicating high discrimination. The nomogram model had clinical value when the risk threshold probability was 11–93 %. Conclusions CAR is an independent risk factor that shows a high predictive value for the 28-day mortality risk in patients with severe pneumonia.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2023-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46300230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-05-09DOI: 10.1515/labmed-2022-0149
Miao Liu, Di Huang, En-yu Liang, Bishun Deng, Hui Huang, Zi-lin Zhao, Lina Deng, Xiaowan Wang, Haibiao Lin, K. Bao, Peng Xu, Minhong He
Abstract Objectives Interleukin 21 (IL-21) is a receptor participating in innate immunity and correlates with the activation of innate immune cells. We sought to investigate the role of plasma IL-21 in patients with idiopathic membranous nephropathy (IMN). Methods This was a cross-sectional and case-control study. We analyzed plasma IL-21 in patients with IMN, with other kidney diseases as the diseased controls (DCs), and the healthy controls (HCs), regarding their associations with the risk of having IMN and IMN severity. Results We enrolled 132, 22, and 38 patients with IMN, DC, and HC, respectively. Plasma IL-21 was significantly higher in those with IMN [9.42 (6.93, 12.60)] and DC [7.84 (2.90, 7.95)] compared with HC [5.60 (2.90, 7.10)] (p<0.05). Plasma IL-21 was significantly higher in those with IMN stage III [10.36 (6.94, 20.88)] and II [9.75 (7.60, 14.27)] than those with IMN stage I [6.99 (3.91, 9.08)] (p<0.05). Plasma IL-21 was significantly higher in those with a positive anti-phospholipase A2 receptor antibody (PLA2R) [9.60 (8.27, 12.93)] than those with a negative anti-PLA2R antibody [4.84 (2.90, 11.28)] (p<0.05). Receiver operator characteristic curve analysis showed that a cutoff value of 7.665 pg/mL distinguished patients with IMN from HC and DC with a sensitivity and specificity of 68.94 and 89.47 %, respectively, and the area under the curve was 0.8184. A cutoff value of 7.830 pg/mL identified those with IMN stage II with a sensitivity and specificity of 74.03 and 89.47 %, respectively, with an area under the curve of 0.8718 (p<0.001). Multivariate regression showed that plasma IL-21 was positively correlated with anti-PLA2R and 24 h urine protein, and negatively correlated with total protein and serum albumin. Conclusions Plasma IL-21 levels increased significantly in patients with IMN. IL-21 may therefore serve as a biomarker for IMN.
{"title":"Elevated plasma interleukin 21 is associated with higher probability and severity of idiopathic membranous nephropathy","authors":"Miao Liu, Di Huang, En-yu Liang, Bishun Deng, Hui Huang, Zi-lin Zhao, Lina Deng, Xiaowan Wang, Haibiao Lin, K. Bao, Peng Xu, Minhong He","doi":"10.1515/labmed-2022-0149","DOIUrl":"https://doi.org/10.1515/labmed-2022-0149","url":null,"abstract":"Abstract Objectives Interleukin 21 (IL-21) is a receptor participating in innate immunity and correlates with the activation of innate immune cells. We sought to investigate the role of plasma IL-21 in patients with idiopathic membranous nephropathy (IMN). Methods This was a cross-sectional and case-control study. We analyzed plasma IL-21 in patients with IMN, with other kidney diseases as the diseased controls (DCs), and the healthy controls (HCs), regarding their associations with the risk of having IMN and IMN severity. Results We enrolled 132, 22, and 38 patients with IMN, DC, and HC, respectively. Plasma IL-21 was significantly higher in those with IMN [9.42 (6.93, 12.60)] and DC [7.84 (2.90, 7.95)] compared with HC [5.60 (2.90, 7.10)] (p<0.05). Plasma IL-21 was significantly higher in those with IMN stage III [10.36 (6.94, 20.88)] and II [9.75 (7.60, 14.27)] than those with IMN stage I [6.99 (3.91, 9.08)] (p<0.05). Plasma IL-21 was significantly higher in those with a positive anti-phospholipase A2 receptor antibody (PLA2R) [9.60 (8.27, 12.93)] than those with a negative anti-PLA2R antibody [4.84 (2.90, 11.28)] (p<0.05). Receiver operator characteristic curve analysis showed that a cutoff value of 7.665 pg/mL distinguished patients with IMN from HC and DC with a sensitivity and specificity of 68.94 and 89.47 %, respectively, and the area under the curve was 0.8184. A cutoff value of 7.830 pg/mL identified those with IMN stage II with a sensitivity and specificity of 74.03 and 89.47 %, respectively, with an area under the curve of 0.8718 (p<0.001). Multivariate regression showed that plasma IL-21 was positively correlated with anti-PLA2R and 24 h urine protein, and negatively correlated with total protein and serum albumin. Conclusions Plasma IL-21 levels increased significantly in patients with IMN. IL-21 may therefore serve as a biomarker for IMN.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2023-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48432509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-04-19DOI: 10.1515/labmed-2023-0013
Stefan Pleus, S. Schauer, A. Baumstark, Alexandra Beil, N. Jendrike, Manuela Link, Eva Zschornack, Anne Beltzer, C. Haug, G. Freckmann
Abstract Objectives Differences between capillary and venous glucose concentrations have been reported in the past. In continuous glucose monitoring (CGM) system performance studies, comparator measurements are often performed in venous samples, despite CGM systems typically aiming at providing capillary-like values. In this study, differences between venous, capillary and interstitial glucose concentrations, measured with a laboratory analyzer, a self-monitoring of blood glucose (SMBG) system and an intermittent-scanning CGM system were investigated in subjects without diabetes after glucose load. Methods During the study, an oral glucose tolerance test (oGTT) was performed with 41 participants who had no known history of diabetes (mean age 25.5 ± 9.7 years). Venous blood samples for measurement with a laboratory analyzer were collected before drinking the standardized 75 g glucose solution and after 60 and 120 min. In parallel, capillary blood was obtained for measurement with a laboratory analyzer and an SMBG system, and interstitial glucose values were measured with an intermittent-scanning CGM system. Results Glucose concentrations in the fasting state were slightly different for the three different compartments whereas considerable differences (some median differences exceeding 30 %) in glucose concentration were observed 60 and 120 min after the start of the oGTT. Conclusions Marked differences with a high inter-individual variability between venous, capillary, and interstitial fluid glucose concentrations were found especially after glucose load. These differences can affect perceived CGM accuracy in performance studies depending on the specific comparator method used, and they are potentially relevant in clinical practice, like diabetes diagnosis.
{"title":"Differences in venous, capillary and interstitial glucose concentrations in individuals without diabetes after glucose load","authors":"Stefan Pleus, S. Schauer, A. Baumstark, Alexandra Beil, N. Jendrike, Manuela Link, Eva Zschornack, Anne Beltzer, C. Haug, G. Freckmann","doi":"10.1515/labmed-2023-0013","DOIUrl":"https://doi.org/10.1515/labmed-2023-0013","url":null,"abstract":"Abstract Objectives Differences between capillary and venous glucose concentrations have been reported in the past. In continuous glucose monitoring (CGM) system performance studies, comparator measurements are often performed in venous samples, despite CGM systems typically aiming at providing capillary-like values. In this study, differences between venous, capillary and interstitial glucose concentrations, measured with a laboratory analyzer, a self-monitoring of blood glucose (SMBG) system and an intermittent-scanning CGM system were investigated in subjects without diabetes after glucose load. Methods During the study, an oral glucose tolerance test (oGTT) was performed with 41 participants who had no known history of diabetes (mean age 25.5 ± 9.7 years). Venous blood samples for measurement with a laboratory analyzer were collected before drinking the standardized 75 g glucose solution and after 60 and 120 min. In parallel, capillary blood was obtained for measurement with a laboratory analyzer and an SMBG system, and interstitial glucose values were measured with an intermittent-scanning CGM system. Results Glucose concentrations in the fasting state were slightly different for the three different compartments whereas considerable differences (some median differences exceeding 30 %) in glucose concentration were observed 60 and 120 min after the start of the oGTT. Conclusions Marked differences with a high inter-individual variability between venous, capillary, and interstitial fluid glucose concentrations were found especially after glucose load. These differences can affect perceived CGM accuracy in performance studies depending on the specific comparator method used, and they are potentially relevant in clinical practice, like diabetes diagnosis.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2023-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48386406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-04-01DOI: 10.1515/labmed-2023-frontmatter2
{"title":"Frontmatter","authors":"","doi":"10.1515/labmed-2023-frontmatter2","DOIUrl":"https://doi.org/10.1515/labmed-2023-frontmatter2","url":null,"abstract":"","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135373496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-03-24DOI: 10.1515/labmed-2022-0167
J. Weikert, Angelina Mehrländer, R. Baber
Abstract Objectives Biobanked samples are becoming increasingly important for research outcomes. Most of the biobanking processes (from preparation to storage) are affected by temperature in a time-dependent manner and have a high impact on sample quality. We aimed to validate time and temperature sensitive processes such as sample preparation, transport, sorting, and storage, which have a high impact on sample quality. Methods Temperature was measured using internal or external temperature data loggers. We analysed the temperature and present real data from our sample transport on dry ice and with the CryoPod, from our ultra-low temperature freezers (UTFs) of different manufacturers and cryostores. We also tested sample sorting on dry ice and in a cryogenic workbench. Results In the UTFs, we identified temperature zones with a temperature difference from 4.7 °C up to 20.8 °C across the whole UTF. For sample transport within approximately 30 min we observed temperatures of −80.2 °C ± 4.0 °C and −173.9 °C ± 16.9 °C for dry ice boxes and the CryoPod, respectively. Sorting on dry ice was best in a polystyrene box half-filled with dry ice pellets, although the temperature increased by 7.5 °C within the first 5 min, whereas the temperature in the cryogenic workbench remained stable below −100 °C for hours. Conclusions Time and temperature play a crucial role in the entire biobanking process, with sometimes immense temperature fluctuations in some equipment. We recommend the validation or verification of all equipment and processes used to avoid pre-analytical errors in accordance with DIN EN ISO 20387.
摘要目的生物样本对研究成果越来越重要。大多数生物库过程(从制备到储存)都受温度的影响，并且对样品质量有很大的影响。我们旨在验证时间和温度敏感的过程，如样品制备、运输、分拣和储存，这些过程对样品质量有很大影响。方法采用内、外温度记录仪测温。我们分析了样品在干冰和CryoPod上运输的温度和真实数据，这些数据来自不同制造商的超低温冷冻机(utf)和冷冻库。我们还在干冰和低温工作台上测试了样品分选。在UTF中，我们确定了整个UTF的温差从4.7°C到20.8°C的温度区域。对于大约30分钟的样品运输，我们观察到干冰盒和CryoPod的温度分别为- 80.2°C±4.0°C和- 173.9°C±16.9°C。在半填充干冰球的聚苯乙烯箱中，在干冰上分选效果最好，尽管在前5分钟内温度升高了7.5℃，而在低温工作台上的温度在- 100℃以下保持稳定数小时。结论时间和温度在整个生物库过程中起着至关重要的作用，有时某些设备的温度波动很大。我们建议根据DIN EN ISO 20387对所有设备和工艺进行确认或验证，以避免分析前误差。
{"title":"Keep cool! Observed temperature variations at different process stages of the biobanking workflow – examples from the Leipzig medical biobank","authors":"J. Weikert, Angelina Mehrländer, R. Baber","doi":"10.1515/labmed-2022-0167","DOIUrl":"https://doi.org/10.1515/labmed-2022-0167","url":null,"abstract":"Abstract Objectives Biobanked samples are becoming increasingly important for research outcomes. Most of the biobanking processes (from preparation to storage) are affected by temperature in a time-dependent manner and have a high impact on sample quality. We aimed to validate time and temperature sensitive processes such as sample preparation, transport, sorting, and storage, which have a high impact on sample quality. Methods Temperature was measured using internal or external temperature data loggers. We analysed the temperature and present real data from our sample transport on dry ice and with the CryoPod, from our ultra-low temperature freezers (UTFs) of different manufacturers and cryostores. We also tested sample sorting on dry ice and in a cryogenic workbench. Results In the UTFs, we identified temperature zones with a temperature difference from 4.7 °C up to 20.8 °C across the whole UTF. For sample transport within approximately 30 min we observed temperatures of −80.2 °C ± 4.0 °C and −173.9 °C ± 16.9 °C for dry ice boxes and the CryoPod, respectively. Sorting on dry ice was best in a polystyrene box half-filled with dry ice pellets, although the temperature increased by 7.5 °C within the first 5 min, whereas the temperature in the cryogenic workbench remained stable below −100 °C for hours. Conclusions Time and temperature play a crucial role in the entire biobanking process, with sometimes immense temperature fluctuations in some equipment. We recommend the validation or verification of all equipment and processes used to avoid pre-analytical errors in accordance with DIN EN ISO 20387.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2023-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44933070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-03-24DOI: 10.1515/labmed-2022-0155
Sixuan Wang, Xiaoxi Wang, Ling-bin Shu
Abstract Objectives Routine blood examination, one of the most commonly performed tests in clinical laboratories, directly reflects the overall state of the body such as inflammation, anemia, and thrombocytopenia. The accuracy of these indicators by tests may be perturbed by various factors including anticoagulants, antibodies, and temperatures. Pseudoleukopenia caused by leukoagglutination was rarely described in the literature. Case presentation We report a rare and unusual pseudo-leukopenia case of a 75-year-old female with a stroke. Blood samples from the patient were collected using different anticoagulants and determined the hematologic parameters and blood smears. We observed the extent of leukocyte aggregation at different anticoagulants or temperatures. The intensity of leukoagglutination was attenuated after incubating at 37 °C for 30 min. After anti-infection treatment and symptomatic treatment, the leukoagglutination of the patient gradually weakened. Conclusions We have found the reason for the pseudo-leukopenia and the leukocyte aggregation phenomenon may vary with disease progression.
{"title":"A case report of pseudoleukopenia: playing hide-and-seek","authors":"Sixuan Wang, Xiaoxi Wang, Ling-bin Shu","doi":"10.1515/labmed-2022-0155","DOIUrl":"https://doi.org/10.1515/labmed-2022-0155","url":null,"abstract":"Abstract Objectives Routine blood examination, one of the most commonly performed tests in clinical laboratories, directly reflects the overall state of the body such as inflammation, anemia, and thrombocytopenia. The accuracy of these indicators by tests may be perturbed by various factors including anticoagulants, antibodies, and temperatures. Pseudoleukopenia caused by leukoagglutination was rarely described in the literature. Case presentation We report a rare and unusual pseudo-leukopenia case of a 75-year-old female with a stroke. Blood samples from the patient were collected using different anticoagulants and determined the hematologic parameters and blood smears. We observed the extent of leukocyte aggregation at different anticoagulants or temperatures. The intensity of leukoagglutination was attenuated after incubating at 37 °C for 30 min. After anti-infection treatment and symptomatic treatment, the leukoagglutination of the patient gradually weakened. Conclusions We have found the reason for the pseudo-leukopenia and the leukocyte aggregation phenomenon may vary with disease progression.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2023-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44054719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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