Pub Date : 2023-12-27DOI: 10.1515/labmed-2023-0139
Matthias Nauck
{"title":"Editorial to: German Society for Clinical Chemistry and Laboratory Medicine – areas of expertise – division reports from the German Congress of Laboratory Medicine 2022 in Mannheim, 13–14 October 2022","authors":"Matthias Nauck","doi":"10.1515/labmed-2023-0139","DOIUrl":"https://doi.org/10.1515/labmed-2023-0139","url":null,"abstract":"","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"2 5","pages":""},"PeriodicalIF":1.2,"publicationDate":"2023-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139153620","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 : 2023-12-20DOI: 10.1515/labmed-2023-0084
Lingli Wang, Xiaomei Zhang, Yi Qin, Feng Wang, Ming Cui, Yingjuan Shi, Yu Chen
Objectives To evaluate the extent of agreement between two blood collection methods for electrolytes, central venous blood sampling by the push-pull technique versus venipuncture, and to mitigate errors in blood sampling by a potassium-based quality control procedure. Methods A comparative within-subject study was carried out for adult patients in the intensive care unit. Intraclass correlation coefficients (ICCs) were used to estimate concordance, and Bland–Altman analysis and clinically acceptable limits were used to compare the equivalence of the two methods. An in-house checklist was designed to identify errors made by nurses throughout central venous blood sampling by the push-pull technique, the corrective training and quality control procedure were conducted, and the rate of errors, incidence of hemolysis and distribution of potassium concentrations were comparatively analyzed for the quality of central venous blood sampling before and after the quality control procedure. Results All the ICCs of 220 paired blood samples displayed excellent reliability, except for potassium. Most of the electrolyte variables were within the clinically acceptable limits, and the results showed that the potassium concentrations did not seem to sufficiently affect clinical decision-making. A total of 30 nurses accepted 90 observations before and after the quality control procedure, and the results showed that blood exposure and repeated disconnections of the line in the push-pull technique were always the main problems throughout the process of central venous blood sampling. In addition, after improvement, the number of patients with hypokalemia or hyperkalemia tended to decrease, but the difference was not statistically significant. For all of the blood samples, only three push-pull paired samples received hemolysis notice. Conclusions Central venous blood sampling by the push-pull technique could be an acceptable substitute for most electrolytes via venipuncture, but caution should be exercised for potassium-based quality control procedures.
{"title":"A quality control procedure for central venous blood sampling based on potassium concentrations","authors":"Lingli Wang, Xiaomei Zhang, Yi Qin, Feng Wang, Ming Cui, Yingjuan Shi, Yu Chen","doi":"10.1515/labmed-2023-0084","DOIUrl":"https://doi.org/10.1515/labmed-2023-0084","url":null,"abstract":"Objectives To evaluate the extent of agreement between two blood collection methods for electrolytes, central venous blood sampling by the push-pull technique versus venipuncture, and to mitigate errors in blood sampling by a potassium-based quality control procedure. Methods A comparative within-subject study was carried out for adult patients in the intensive care unit. Intraclass correlation coefficients (ICCs) were used to estimate concordance, and Bland–Altman analysis and clinically acceptable limits were used to compare the equivalence of the two methods. An in-house checklist was designed to identify errors made by nurses throughout central venous blood sampling by the push-pull technique, the corrective training and quality control procedure were conducted, and the rate of errors, incidence of hemolysis and distribution of potassium concentrations were comparatively analyzed for the quality of central venous blood sampling before and after the quality control procedure. Results All the ICCs of 220 paired blood samples displayed excellent reliability, except for potassium. Most of the electrolyte variables were within the clinically acceptable limits, and the results showed that the potassium concentrations did not seem to sufficiently affect clinical decision-making. A total of 30 nurses accepted 90 observations before and after the quality control procedure, and the results showed that blood exposure and repeated disconnections of the line in the push-pull technique were always the main problems throughout the process of central venous blood sampling. In addition, after improvement, the number of patients with hypokalemia or hyperkalemia tended to decrease, but the difference was not statistically significant. For all of the blood samples, only three push-pull paired samples received hemolysis notice. Conclusions Central venous blood sampling by the push-pull technique could be an acceptable substitute for most electrolytes via venipuncture, but caution should be exercised for potassium-based quality control procedures.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"1 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2023-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138824617","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 : 2023-11-13DOI: 10.1515/labmed-2023-0064
Christine Van Laer, Lieselot Dedeene, Lien Gruwier, Bram Vanmechelen, Talent Hwandih, Konstantinos Mintzas, Marion Münster, Nancy Boeckx
Abstract Objectives The cellular composition of body fluids (BF) provides insight into disease pathology and is an important diagnostic parameter. The well-established Sysmex XN haematology analyser (XN) offers automated BF analysis and is in routine use in many laboratories. In this study the performance of the new Sysmex XR analyser (XR) in testing BF is compared to the XN. Methods Cerebrospinal, pleural, peritoneal, and synovial fluids, as well as bronchoalveolar lavage (BAL) samples, were processed in BF mode on both analysers. Standard statistical methods were used to evaluate the performance of XR compared to the reference XN. Results Cell counts were generated from a total of 356 measurements from 307 patient BF samples. After application of exclusion criteria, 86 cerebrospinal, 77 peritoneal, 78 pleural, and 89 synovial fluid sample pairs were compared. An excellent correlation coefficient (r) between the two analysers was observed for all diagnostic parameters; WBC-BF: 0.996, RBC-BF: 0.974, TC-BF: 0.995, MN#: 0.994, MN%: 0.830, PMN#: 0.985 and PMN%: 0.835. The research parameters also performed equally well (r values of 0.900–0.994). The performance of diluted and undiluted samples was equally good. Similar results for diagnostic and research parameters were obtained from 62 BAL samples (r values of 0.899–0.992). Conclusions This study demonstrates that the automated BF counts on the new Sysmex XR analyser are equivalent to that of the XN for all BF types analysed.
{"title":"Performance evaluation of the automated body fluid analysis of the new Sysmex XR haematology analyser","authors":"Christine Van Laer, Lieselot Dedeene, Lien Gruwier, Bram Vanmechelen, Talent Hwandih, Konstantinos Mintzas, Marion Münster, Nancy Boeckx","doi":"10.1515/labmed-2023-0064","DOIUrl":"https://doi.org/10.1515/labmed-2023-0064","url":null,"abstract":"Abstract Objectives The cellular composition of body fluids (BF) provides insight into disease pathology and is an important diagnostic parameter. The well-established Sysmex XN haematology analyser (XN) offers automated BF analysis and is in routine use in many laboratories. In this study the performance of the new Sysmex XR analyser (XR) in testing BF is compared to the XN. Methods Cerebrospinal, pleural, peritoneal, and synovial fluids, as well as bronchoalveolar lavage (BAL) samples, were processed in BF mode on both analysers. Standard statistical methods were used to evaluate the performance of XR compared to the reference XN. Results Cell counts were generated from a total of 356 measurements from 307 patient BF samples. After application of exclusion criteria, 86 cerebrospinal, 77 peritoneal, 78 pleural, and 89 synovial fluid sample pairs were compared. An excellent correlation coefficient (r) between the two analysers was observed for all diagnostic parameters; WBC-BF: 0.996, RBC-BF: 0.974, TC-BF: 0.995, MN#: 0.994, MN%: 0.830, PMN#: 0.985 and PMN%: 0.835. The research parameters also performed equally well (r values of 0.900–0.994). The performance of diluted and undiluted samples was equally good. Similar results for diagnostic and research parameters were obtained from 62 BAL samples (r values of 0.899–0.992). Conclusions This study demonstrates that the automated BF counts on the new Sysmex XR analyser are equivalent to that of the XN for all BF types analysed.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"53 33","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134993796","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 : 2023-11-13DOI: 10.1515/labmed-2023-0099
Ming Wang, Chaowen Yu, Shi Tang, Zhihong Liao, Kexing Wan, Shan Liu
Abstract Objectives The aim is to evaluate the effect of viral inactivation methods on the quality and quantity of compounds in dried blood spots (DBS). Methods Three effective and common inactivation methods were selected via the literature search, including: heating at 56 °C for 30 min, irradiation with UVC for 30 min, and surface wetting with 70 % ethanol. The concentration and clinical predicting significance of hormones, amino acids, and acylcarnitines from DBS were assessed, and the quality and quantity of extracted deoxyribonucleic acid (DNA) from DBS were evaluated. Results Compared to control, we found that there was no significant difference on hormones concentration in the DBS treated by heating at 56 °C for 30 min (thyroid stimulating hormone p=0.36, 17-hydroxyprogesterone p=0.52). And heating at 56 °C for 30 min had a minimal changed coefficient of variation on the concentration of amino acids and acylcarnitines. All three inactivation methods slightly changed the yield of DNA extraction, but did not affect the quality of the DNA. Importantly, the three inactivation methods wouldn’t change the clinical predicting significance of above-compounds mostly, especially heating at 56 °C for 30 min. Conclusions Considering the minimal effect on the quality and quantity of various compounds, the contaminated DBS could be pretreated by the three inactivation methods, as temporary emergency inactivation methods, especially heating at 56 °C for 30 min.
{"title":"The quality and quantity of compounds affected by viral inactivation methods in dried blood spots","authors":"Ming Wang, Chaowen Yu, Shi Tang, Zhihong Liao, Kexing Wan, Shan Liu","doi":"10.1515/labmed-2023-0099","DOIUrl":"https://doi.org/10.1515/labmed-2023-0099","url":null,"abstract":"Abstract Objectives The aim is to evaluate the effect of viral inactivation methods on the quality and quantity of compounds in dried blood spots (DBS). Methods Three effective and common inactivation methods were selected via the literature search, including: heating at 56 °C for 30 min, irradiation with UVC for 30 min, and surface wetting with 70 % ethanol. The concentration and clinical predicting significance of hormones, amino acids, and acylcarnitines from DBS were assessed, and the quality and quantity of extracted deoxyribonucleic acid (DNA) from DBS were evaluated. Results Compared to control, we found that there was no significant difference on hormones concentration in the DBS treated by heating at 56 °C for 30 min (thyroid stimulating hormone p=0.36, 17-hydroxyprogesterone p=0.52). And heating at 56 °C for 30 min had a minimal changed coefficient of variation on the concentration of amino acids and acylcarnitines. All three inactivation methods slightly changed the yield of DNA extraction, but did not affect the quality of the DNA. Importantly, the three inactivation methods wouldn’t change the clinical predicting significance of above-compounds mostly, especially heating at 56 °C for 30 min. Conclusions Considering the minimal effect on the quality and quantity of various compounds, the contaminated DBS could be pretreated by the three inactivation methods, as temporary emergency inactivation methods, especially heating at 56 °C for 30 min.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"53 36","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134993793","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 : 2023-11-10DOI: 10.1515/labmed-2023-0082
Jana Wütherich, Stephanie Zylla, Emmanuel Bissé, Matthias Nauck, Astrid Petersmann
Abstract Objectives Even though reliable glucose concentration measurements are essential in diagnosis and monitoring of diabetes mellitus, external quality assurance based on mandatory reference method values can only be conducted to a limited extent for measurements in whole blood. The reason is the lack of stabilized whole blood materials suitable for the application in glucose measurement devices used in near-patient testing. Methods Two patented whole blood stabilizers were tested using four commercially available near-patient testing devices and one patient self-testing device for plasma-referenced glucose measurements. Furthermore, a laboratory method for plasma-glucose measurements was included. Venous whole blood samples from 30 apparently healthy volunteers were used. Two whole blood samples (stabilizer A and B) per subject were kept at room temperature over the study period of seven days and aliquots were taken each day from the original sample for measurement on all devices. After venous puncture, left over whole blood from the collection system was used for immediate glucose measurements without stabilizer on the near-patient testing devices. Results Each investigated device gave stable results at least for one of the two stabilizers for a period of four days. Imprecision based on quality controls ranged between 1.7 and 4.8 % coefficient of variation for near-patient testing devices, but did not reflect observed variability in measurement results from stabilized and unstabilized whole blood in one device. In addition, a considerable deviation of 0.8 mmol/L was observed among the near-patient testing devices underlining the need for reference method values in external quality control. Conclusions Our study provides proof of concept that for each investigated device at least one stabilizer of glucose in whole blood shows a good performance for at least four days. Therefore, these stabilizers appear to be suitable candidate materials for external quality assessment of near-patient testing devices.
{"title":"Proof of concept: stabilized whole blood material suitable for external quality assessment of near-patient testing devices","authors":"Jana Wütherich, Stephanie Zylla, Emmanuel Bissé, Matthias Nauck, Astrid Petersmann","doi":"10.1515/labmed-2023-0082","DOIUrl":"https://doi.org/10.1515/labmed-2023-0082","url":null,"abstract":"Abstract Objectives Even though reliable glucose concentration measurements are essential in diagnosis and monitoring of diabetes mellitus, external quality assurance based on mandatory reference method values can only be conducted to a limited extent for measurements in whole blood. The reason is the lack of stabilized whole blood materials suitable for the application in glucose measurement devices used in near-patient testing. Methods Two patented whole blood stabilizers were tested using four commercially available near-patient testing devices and one patient self-testing device for plasma-referenced glucose measurements. Furthermore, a laboratory method for plasma-glucose measurements was included. Venous whole blood samples from 30 apparently healthy volunteers were used. Two whole blood samples (stabilizer A and B) per subject were kept at room temperature over the study period of seven days and aliquots were taken each day from the original sample for measurement on all devices. After venous puncture, left over whole blood from the collection system was used for immediate glucose measurements without stabilizer on the near-patient testing devices. Results Each investigated device gave stable results at least for one of the two stabilizers for a period of four days. Imprecision based on quality controls ranged between 1.7 and 4.8 % coefficient of variation for near-patient testing devices, but did not reflect observed variability in measurement results from stabilized and unstabilized whole blood in one device. In addition, a considerable deviation of 0.8 mmol/L was observed among the near-patient testing devices underlining the need for reference method values in external quality control. Conclusions Our study provides proof of concept that for each investigated device at least one stabilizer of glucose in whole blood shows a good performance for at least four days. Therefore, these stabilizers appear to be suitable candidate materials for external quality assessment of near-patient testing devices.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"57 19","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135091948","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 : 2023-11-10DOI: 10.1515/labmed-2023-0077
Ci Li, Zhe Xu, Hongqi Sun, Liu Yang, Manjie Nie, Weihua Gong, Junmei Yang, Tiewei Li
Abstract Objectives IL-6 is an inflammatory marker and urea nitrogen (UREA) is a common indicator of glomerular filtration function. Their combined detection has predictive value for the severity of neonatal pneumonia. Methods We performed a cross-sectional analysis of the clinical and laboratory data, collected from 105 neonatal patients (including 76 mild to moderate pneumonia patients and 29 severe pneumonia patients). Results Mann–Whitney U-test showed serum IL-6 and UREA levels were significantly increased in severe pneumonia, compared with that in mild to moderate pneumonia (p<0.05). Correlation analysis showed the severity of neonatal pneumonia was positively correlated with serum IL-6 (r=0.284, p<0.05) and UREA (r=0.303, p<0.05) levels. Multivariate logistic regression analysis showed the increased levels of IL-6 (OR=1.002, 95 % CI 1.001–1.004) and UREA (OR=1.420, 95 % CI 1.046–1.926) were independent risk factors for the severity of neonatal pneumonia. ROC curve analysis showed that the predictive value of combined detection of serum IL-6 and UREA in the severity of neonatal pneumonia was better than that of either detection alone (area under curve [AUC] = 0.809, 95 % CI 0.711–0.894, p<0.001). Conclusions Combined detection of IL-6 and UREA had a good predictive value for evaluating the severity of neonatal pneumonia.
目的IL-6是炎症标志物，尿素氮(urea)是肾小球滤过功能的常用指标。它们的联合检测对新生儿肺炎的严重程度有预测价值。方法对105例新生儿患者(包括76例轻中度肺炎患者和29例重症肺炎患者)的临床和实验室资料进行横断面分析。结果Mann-Whitney u检验显示，重症肺炎患者血清IL-6和尿素水平明显高于轻、中度肺炎患者(p < 0.05)。相关性分析显示，新生儿肺炎严重程度与血清IL-6 (r=0.284, p < 0.05)、尿素(r=0.303, p < 0.05)水平呈正相关。多因素logistic回归分析显示，IL-6水平升高(OR=1.002, 95% CI 1.001 ~ 1.004)和尿素水平升高(OR=1.420, 95% CI 1.046 ~ 1.926)是新生儿肺炎严重程度的独立危险因素。ROC曲线分析显示，联合检测血清IL-6和尿素对新生儿肺炎严重程度的预测价值优于单独检测两者(曲线下面积[AUC] = 0.809, 95% CI = 0.711-0.894, p<0.001)。结论IL-6与尿素联合检测对评价新生儿肺炎严重程度有较好的预测价值。
{"title":"Predictive value of combined serum IL-6 with UREA on severity of neonatal pneumonia: an observational study","authors":"Ci Li, Zhe Xu, Hongqi Sun, Liu Yang, Manjie Nie, Weihua Gong, Junmei Yang, Tiewei Li","doi":"10.1515/labmed-2023-0077","DOIUrl":"https://doi.org/10.1515/labmed-2023-0077","url":null,"abstract":"Abstract Objectives IL-6 is an inflammatory marker and urea nitrogen (UREA) is a common indicator of glomerular filtration function. Their combined detection has predictive value for the severity of neonatal pneumonia. Methods We performed a cross-sectional analysis of the clinical and laboratory data, collected from 105 neonatal patients (including 76 mild to moderate pneumonia patients and 29 severe pneumonia patients). Results Mann–Whitney U-test showed serum IL-6 and UREA levels were significantly increased in severe pneumonia, compared with that in mild to moderate pneumonia (p<0.05). Correlation analysis showed the severity of neonatal pneumonia was positively correlated with serum IL-6 (r=0.284, p<0.05) and UREA (r=0.303, p<0.05) levels. Multivariate logistic regression analysis showed the increased levels of IL-6 (OR=1.002, 95 % CI 1.001–1.004) and UREA (OR=1.420, 95 % CI 1.046–1.926) were independent risk factors for the severity of neonatal pneumonia. ROC curve analysis showed that the predictive value of combined detection of serum IL-6 and UREA in the severity of neonatal pneumonia was better than that of either detection alone (area under curve [AUC] = 0.809, 95 % CI 0.711–0.894, p<0.001). Conclusions Combined detection of IL-6 and UREA had a good predictive value for evaluating the severity of neonatal pneumonia.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"57 11","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135091955","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 : 2023-11-07DOI: 10.1515/labmed-2023-0073
Cheri Mayes, Tracey Gwilliam, Etienne R. Mahe
Abstract Objectives Digital pathology is becoming standard in the delivery of timely, high-quality clinical services, inclusive of morphological assessment in laboratory hematology. While many digital hematology systems are designed with high-throughput in mind, CellaVision ® has recently developed a low-throughput instrument, the CellaVision ® DC-1. The utility of the CellaVision ® DC-1 was tested in a distributed laboratory system, with a focus on turn-around times (TATs). Methods We evaluated the TATs of a CellaVision ® DC-1 workflow, with specimens originating in a small spoke-laboratory referring materials to a central hub-laboratory. Our spoke-laboratories perform on-site complete blood counts (CBC’s) and manual peripheral blood smears (PBS’s), with complex cases referred for review to the hub-laboratory. Baseline TATs were collected, followed by prospective evaluation of 21 cases analyzed using the CellaVision ® DC-1, with digital review by spoke-laboratory staff in concert with remote review by hub-laboratory staff. The TATs for the same 21 cases by standard manual assessment were compared. Results Improvement in the distribution of TATs using the CellaVision ® DC-1 was noted relative to the retrospective spoke-laboratory data (Mann–Whitney U=26, p<0.0001) and the parallel manual PBS review (Wilcoxon W=190, p<0.0001). The CellaVision ® DC-1 permitted a significant reduction in case-assessment times (Wilcoxon W=105, p=0.0001). No significant diagnostic discrepancies were identified during the testing timeframe. Conclusions We describe a real-world assessment of the CellaVision ® DC-1 analyzer in a distributed (hub-and-spoke) laboratory network, linking low-volume laboratories to high-throughput sites. Our evaluation highlights significant improvements in case TATs with a CellaVision ® DC-1 assisted digital pathology workflow.
{"title":"Improving turn-around times in low-throughput distributed hematology laboratory settings with the CellaVision<sup>®</sup> DC-1 instrument","authors":"Cheri Mayes, Tracey Gwilliam, Etienne R. Mahe","doi":"10.1515/labmed-2023-0073","DOIUrl":"https://doi.org/10.1515/labmed-2023-0073","url":null,"abstract":"Abstract Objectives Digital pathology is becoming standard in the delivery of timely, high-quality clinical services, inclusive of morphological assessment in laboratory hematology. While many digital hematology systems are designed with high-throughput in mind, CellaVision ® has recently developed a low-throughput instrument, the CellaVision ® DC-1. The utility of the CellaVision ® DC-1 was tested in a distributed laboratory system, with a focus on turn-around times (TATs). Methods We evaluated the TATs of a CellaVision ® DC-1 workflow, with specimens originating in a small spoke-laboratory referring materials to a central hub-laboratory. Our spoke-laboratories perform on-site complete blood counts (CBC’s) and manual peripheral blood smears (PBS’s), with complex cases referred for review to the hub-laboratory. Baseline TATs were collected, followed by prospective evaluation of 21 cases analyzed using the CellaVision ® DC-1, with digital review by spoke-laboratory staff in concert with remote review by hub-laboratory staff. The TATs for the same 21 cases by standard manual assessment were compared. Results Improvement in the distribution of TATs using the CellaVision ® DC-1 was noted relative to the retrospective spoke-laboratory data (Mann–Whitney U=26, p<0.0001) and the parallel manual PBS review (Wilcoxon W=190, p<0.0001). The CellaVision ® DC-1 permitted a significant reduction in case-assessment times (Wilcoxon W=105, p=0.0001). No significant diagnostic discrepancies were identified during the testing timeframe. Conclusions We describe a real-world assessment of the CellaVision ® DC-1 analyzer in a distributed (hub-and-spoke) laboratory network, linking low-volume laboratories to high-throughput sites. Our evaluation highlights significant improvements in case TATs with a CellaVision ® DC-1 assisted digital pathology workflow.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"88 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135480407","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 : 2023-10-18DOI: 10.1515/labmed-2023-0078
Peter Mirtschink, Volker Neumeister, Mario Menschikowski, Rayan Suliman, Gunter Wolf, Jana Kade, Oliver Tiebel, David M. Poitz
Abstract Objectives The ‘Thomas plot’ is a very helpful diagnostic tool for evaluation, monitoring and therapy of the iron status and on the hemoglobinization of the reticulocytes of patients. In 2021 Roche Diagnostics launched a second generation assay for determination of the soluble transferrin receptor (sTfR). Here we compare the old and the new assay for sTfR and analyze the consequences for the ‘Thomas plot’. Methods Measurement of sTfR, ferritin and CRP were done using a Cobas8000 system. Hemoglobin content of reticulocytes (Ret-He) was determined using a Sysmex XN9000 system. Results The second generation of sTfR assay showed consistently lower sTfR values compared to the first generation, which would result in a left shift of the ‘Thomas plot’ and may lead to false diagnosis of patients using the original cut-offs. Fifteen thousand five hundred ninty two data sets for ‘Thomas plot’ from 2016 to 2021 were retrospectively analyzed to estimate how many patients in our hospital would be affected. In result around 5 % of all ‘Thomas plots’ would be affected by the lower sTfR values of the second generation assays. Conclusions Due to the lower sTfR values measured with the second generation assay new cut-offs for the Ferritin-Index (sTfR/lg Ferritin) should be used in order to correctly diagnose the iron status of patients.
{"title":"Second generation of soluble transferrin receptor assay – consequences for the interpretation of the ‘Thomas plot’","authors":"Peter Mirtschink, Volker Neumeister, Mario Menschikowski, Rayan Suliman, Gunter Wolf, Jana Kade, Oliver Tiebel, David M. Poitz","doi":"10.1515/labmed-2023-0078","DOIUrl":"https://doi.org/10.1515/labmed-2023-0078","url":null,"abstract":"Abstract Objectives The ‘Thomas plot’ is a very helpful diagnostic tool for evaluation, monitoring and therapy of the iron status and on the hemoglobinization of the reticulocytes of patients. In 2021 Roche Diagnostics launched a second generation assay for determination of the soluble transferrin receptor (sTfR). Here we compare the old and the new assay for sTfR and analyze the consequences for the ‘Thomas plot’. Methods Measurement of sTfR, ferritin and CRP were done using a Cobas8000 system. Hemoglobin content of reticulocytes (Ret-He) was determined using a Sysmex XN9000 system. Results The second generation of sTfR assay showed consistently lower sTfR values compared to the first generation, which would result in a left shift of the ‘Thomas plot’ and may lead to false diagnosis of patients using the original cut-offs. Fifteen thousand five hundred ninty two data sets for ‘Thomas plot’ from 2016 to 2021 were retrospectively analyzed to estimate how many patients in our hospital would be affected. In result around 5 % of all ‘Thomas plots’ would be affected by the lower sTfR values of the second generation assays. Conclusions Due to the lower sTfR values measured with the second generation assay new cut-offs for the Ferritin-Index (sTfR/lg Ferritin) should be used in order to correctly diagnose the iron status of patients.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135823731","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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