Scandinavian Journal of Clinical & Laboratory Investigation最新文献

{"title":"Patient medians for NT-proBNP from six Swedish counties 2011-2021.","authors":"Morgan Lundgren, Peter Ridefelt, Maria K Eriksson, Thomas Cars, Anders Larsson","doi":"10.1080/00365513.2025.2528220","DOIUrl":"10.1080/00365513.2025.2528220","url":null,"abstract":"<p><p>NT-proBNP is crucial in diagnosing and monitoring heart failure. Data from external quality assessment (EQA) schemes reveal existing method differences among manufacturers. Median values of patient results can serve as a quality indicator. The aim was to study if differences between manufacturers seen in EQA data also are evident in patient medians. Over one million NT-proBNP results from adults during 2011-2021 were extracted from six Swedish counties. Results were grouped by method, county, and according to eGFR and diabetes diagnosis. Medians and consensus values were calculated. From 2011 to 2017, Roche accounted for 76% of NT-proBNP results. After 2017, other manufacturers entered and then methods yielded more diverse results. Findings for Roche and Siemens align with a previous EQA study, while Abbott's results differed. Between 2019 and 2021 Roche results were 2% above consensus, Siemens 16% above, Ortho 8% below, and Abbott 11% below. As the number of NT-proBNP requests increased, medians decreased, possibly due to updated guidelines and more widespread testing. Additionally, patients with eGFR < 60 mL/min/1.73m² BSA or diabetes had medians that were 2-3 times higher compared to the overall results. This study largely confirms varying levels noted in an EQA scheme between manufacturers of NT-proBNP methods, with a notable exception for unknown reasons for Abbott. The expected higher results for patients with eGFR < 60 mL/min/1.73m² BSA or diabetes reinforced the validity of calculated overall medians. Therefore, patient medians are a clinically relevant quality indicator, and a robust approach to monitor methods as a supplement to internal and external controls.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"368-378"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144560971","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}

{"title":"Cold activation in PT-INR samples - Myth or reality in the modern laboratory?","authors":"Annika Petersson, Karin Strandberg, Magnus Magnusson, Jenny Lerman, Kim Ekblom","doi":"10.1080/00365513.2025.2487972","DOIUrl":"10.1080/00365513.2025.2487972","url":null,"abstract":"<p><p>Guidelines on storage for samples intended for Prothrombin Time - International Normalized Ratio (PT-INR) analysis have changed over time, sometimes advising against cold storage due to presumed cold activation of the coagulation cascade. Previous studies on PT-INR storage have mainly been underpowered, performed in glass tubes, and not in a modern laboratory setting. In this study, we re-analyzed 1149 PT-INR samples, divided into low-level samples (PT-INR <1.3), and high-level samples (PT-INR 1.8-3.5) after 3 h of cold storage. We found no statistical difference for high-level samples but statistically higher PT-INR values in low-level samples. The differences were minor and not considered clinically relevant. No cold activation could be detected, as cold activation would have diminished PT-INR. These findings open the possibility of transporting and storing centrifuged PT-INR samples refrigerated. The higher PT-INR values in low-level samples after cold storage impede a mechanistic principle that needs to be further investigated.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"175-179"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143781020","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}

{"title":"Comparison of total calprotectin levels with S100A8 and S100A9 subunit levels in critically ill patients.","authors":"Kristina Sejersen, Aleksandra Mandic Havelka, Miklos Lipcsey, Anders Larsson","doi":"10.1080/00365513.2025.2512997","DOIUrl":"10.1080/00365513.2025.2512997","url":null,"abstract":"<p><p>Calprotectin is a 24 kD heterodimer of calcium-binding proteins S100A8 and S100A9. At present, there is a lack of knowledge about the specificity of various methods for calprotectin detection, whether they measure only dimers between S100A8 and S100A9, S100A8-S100A8 dimers, S100A9/S100A9 dimers, or free subunits. This study aimed to compare total calprotectin levels with those of its subunits, S100A8 and S100A9, in ICU patients. This prospective observational study includes 271 sepsis and non-sepsis patients. Inclusion criteria were admission to intensive care and the presence or need for an arterial catheter. Plasma total calprotectin was measured at ICU admission and the following two days by particle-enhanced turbidimetric (PETIA) calprotectin reagents from Gentian AS and a Mindray BS380 chemistry analyzer. S100A8 and S100A9 were analyzed by commercial sandwich ELISA DY4570-05, and DY5578, R&D Systems, respectively. Sepsis was defined according to Sepsis-3 as suspected infection and a Sequential organ failure assessment (SOFA) >2 on admission. Receiver operating characteristic (ROC) analysis showed that total calprotectin had a larger area under the curve (AUC) for distinguishing sepsis from non-sepsis patients (0.67) compared to S100A8 (0.59) and S100A9 (0.52). For predicting 30-day mortality, S100A9 had a higher AUC value (0.64) than S100A8 (0.59). However, weak correlations between total calprotectin and its subunits suggest no significant predictive relationship for 30-day mortality, while also highlighting potential assay harmonization challenges across manufacturers.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"299-304"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209410","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}

{"title":"Hb Tacoma is difficult to detect and may cause false results with different HbA1c methods.","authors":"Britta Landin, Soheir Beshara, Johan Eskils, Maria Nilsson, Sara Karlsson, Niklas Bark, Per Bjellerup","doi":"10.1080/00365513.2025.2547317","DOIUrl":"10.1080/00365513.2025.2547317","url":null,"abstract":"<p><p>The haemoglobin variant Hb Tacoma [HBB:c.93G > T;CD30(Arg > Ser) was detected in approximately 1 in 1000 patients tested for HbA1c at Karolinska University Hospital, Stockholm. Incidentally, five homozygous individuals were found, none of them presenting with severe haematological abnormalities. When the cation exchange chromatographic method Bio-Rad Variant II was used, chromatograms representing Hb Tacoma heterozygotes were easily misinterpreted as normal, although the HbA1c results were about 40% lower than those obtained by immunoassays. This is explained by the fact that the glycated form of Hb Tacoma coelutes with the LA1c fraction, while the main fraction of Hb Tacoma is not separated from normal HbA. Automatic calculation of the ratio LA1c/HbA1c was soon introduced and samples, where this ratio exceeded certain limits, were further investigated. In case of Hb Tacoma, HbA1c results were obtained from immunoassays. Several other HbA1c methods were evaluated using samples from Hb Tacoma heterozygotes. Unlike the Variant II method, the HbA1c results from the Bio-Rad D-100 method did not significantly differ from immunoassay. However, the results for Hb Tacoma samples deviated in an unpredictable way. The cation exchange chromatographic method Tosoh G11 constantly showed a positive bias. Hb Tacoma did not significantly affect the HbA1c results using immunoassays like Tina-quant Gen. 3 (Roche) and DCA Vantage (Siemens), an affinity method (Afinion 2, Abbott) or an enzymatic method (Alinity c, Abbott). Although the capillary electrophoresis HbA1c method (Sebia Capillarys 3 Tera) did not demonstrate any significant bias, the imprecision for this method was unacceptably high for samples with Hb Tacoma.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"420-429"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144967135","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}

{"title":"Revelations from charge-balance modeling.","authors":"Troels Ring, Stephen Edward Rees, Sebastian Frische","doi":"10.1080/00365513.2025.2559345","DOIUrl":"10.1080/00365513.2025.2559345","url":null,"abstract":"<p><p>In biological fluids the charge is dominated by strong ions with pH-independent complete dissociation. The requirement of electroneutrality in combination with the principle of mass conservation and rules of dissociation as understood from physical chemistry including auto-dissociation of water allows definite specification of charge in any water-based fluid with known composition. Herein, two important publications are revisited using charge-balance modeling. In the first case it is shown that knowing a fixed pH difference between two types of fibroblasts and knowing also the pH-dependent buffer-capacities in the two cells allows quantitative assessment of buffer concentrations and strong ion differences. In the second example it is shown that the difficult problem of finding by calculation or titration the titratable acidity in urine modeled as a phosphate solution with high ionic strength can be solved with just measuring urine SID and total phosphate concentration without knowing either the correct dissociation constant or pH in urine. It is suggested that charge-balance modeling based on basic physical chemistry may reveal non-trivial ontological details of the system under study.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"452-461"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145192660","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}

{"title":"Analytical performance and user-friendliness of cobas pulse glucose meter in the hands of the intended users.","authors":"Christine Morken, Joakim Hekland, Johan Olausson, Johan Baden Birk-Korch, Heidi Berghäll, Johannes Østrem Fjøse, Gunhild Øygard Fosse, Sander Johannes Thorbjørnsen Guttorm, Gustav Hallén, Anne Haapala, Tine-Lise Kalleklev, Stiina Kamula, Dår Kristian Kur, Kristiina Kurg, Cindhya Sithiravel, Anne Elisabeth Solsvik, Ricardas Stonys, Kristel Virtanen, Elisabeth Wiik Vigerust, Anne Stavelin","doi":"10.1080/00365513.2025.2565732","DOIUrl":"10.1080/00365513.2025.2565732","url":null,"abstract":"<p><p>Diabetes is a growing global health concern affecting millions worldwide. Glucose measurement remains a cornerstone in the diagnosis, monitoring, and management of this disease. Considering that numerous point-of-care (POC) devices for glucose measurements are available, systematic evaluation of their analytical performance and user-friendliness is essential. This study presents the findings of an independent evaluation of the cobas pulse glucose meter (Roche Diagnostics GmbH) conducted by the Scandinavian evaluation of laboratory equipment for point of care testing (SKUP). The study, which assessed both the analytical performance and user-friendliness, included 217 participants with diabetes and was conducted in both a hospital laboratory and primary healthcare settings. Capillary whole blood measurements were compared to a plasma glucose hexokinase method at Vejle hospital, Denmark. Certified reference materials from the National Institute of Standards and Technology (NIST) were used to correct all sample results. Repeatability and accuracy were assessed against predefined analytical performance specifications, and user-friendliness was evaluated using a structured questionnaire developed by SKUP. The cobas pulse demonstrated good repeatability (CV: 1.8-4.0%) and fulfilled the specification for accuracy, with minimal bias (maximum +0.16 mmol/L in the 7-10 mmol/L range). Haematocrit had no significant effect within the tested range (5-70%). User-friendliness was rated satisfactory, attributed to intuitive operation, rapid analysis times, and effective quality control features. In conclusion, the cobas pulse glucose meter met the performance criteria for professional use in clinical and primary care settings, supporting its suitability in near-patient glucose monitoring.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"500-508"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145200674","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}

{"title":"Interference from haemolysis on serum protein electrophoresis in the identification and quantification of monoclonal immunoglobulins.","authors":"Anne-Birgitte Garm Blavnsfeldt, Anders Mønsted Abildgaard","doi":"10.1080/00365513.2025.2511303","DOIUrl":"10.1080/00365513.2025.2511303","url":null,"abstract":"","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"305-307"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209411","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}

{"title":"Guide for the classification of porphyrias using state-of-the-art reverse-phase high-performance liquid chromatography.","authors":"Javier Laguna, Robin Wijngaard, Lourdes Marés, Marina Parra-Robert, Gregori Casals, Jordi To-Figueras","doi":"10.1080/00365513.2025.2524714","DOIUrl":"10.1080/00365513.2025.2524714","url":null,"abstract":"<p><p>The biochemical diagnosis of porphyria is based on the analysis of porphyrins in urine, feces, and blood using fluorometry and spectrometry. High-performance liquid chromatography (HPLC) with fluorescence detection has been used since the 1980s as standard procedure for separation of porphyrin isomers and classification of the different types of porphyria since each type of porphyria presents a characteristic HPLC isomer distribution either in urine, plasma or feces. We present a unified collection of chromatograms as an aid for porphyria classification in laboratories using HPLC equipment. Biological samples were collected according to approved hospital protocols, and analyzed by reverse-phase HPLC with fluorescence detection, using an unused dedicated chromatographic column BDS-Hypersil^™ C18 and reproducing, with minor variations, the conditions originally reported by Lim and Peters in 1984. With the chromatograms, we include a concise explanation of the changes observed. When inter-individual variation is frequent, we include for clarification chromatograms of two different individual samples. Additionally, we present chromatograms showing abnormalities of porphyrin metabolism in patients without porphyria. We add our collection to the literature, as a visual guide to facilitate porphyria diagnosis and classification though understanding of the key metabolic changes. Our aim is to support education of new experts in the porphyria field increasing diagnostic accuracy and ultimately leading to improved patient outcomes and management.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"327-339"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144542105","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}

{"title":"Is it necessary to request testing for antibodies against extractable nuclear antigens in case of antinuclear antibody negativity?","authors":"Emrah Salman, Bedia Dinç","doi":"10.1080/00365513.2025.2547049","DOIUrl":"10.1080/00365513.2025.2547049","url":null,"abstract":"<p><strong>Background: </strong>Inappropriate or unnecessary test requests are one of the reasons for the increase in laboratory utilization. We aimed to investigate the frequency of simultaneous antinuclear antibody (ANA) and extractable nuclear antigens (ENA) test orders and to investigate whether ENA test ordering is necessary in the presence of negative ANA in terms of criteria for rational test selection.</p><p><strong>Methods: </strong>We examined 2 years of data from a Turkish tertiary hospital in this retrospective cohort analysis. ANA and other autoimmune test data and clinical information of all patients with a negative ANA but positive ENA were obtained from the hospital record system.</p><p><strong>Results: </strong>32,800 patients had 37,584 ANA tests between January 2019 and January 2021. 4136 patients were tested for ANA simultaneously. Out of 2279 negative ANA tests, 371 (16.2%) were positive for ENA. Out of 307 individuals with negative ANA but positive ENA and clinical information, 23 were newly diagnosed with ANA-associated rheumatic disease (AARD), a 7.4% positive predictive value. The most common autoantibody causing ANA/ENA discordant results was anti-Ro52 (61 [19.9%]), followed by anti-DFS70 (53 [17.3%] and anti Jo-1 (48 [15.6%]).</p><p><strong>Conclusions: </strong>The results of our study support proposals to reduce ENA testing after a negative ANA test and gradually increase it after a positive test or clinical indication. It will eliminate inaccurate test requests, expenditures, and unnecessary patient assessments.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"402-408"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144822461","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}

{"title":"Platelet indices at admission and their performance associated with predicting all-cause mortality in the ICU: a large cross-sectional cohort study.","authors":"Usman Ali","doi":"10.1080/00365513.2025.2500029","DOIUrl":"10.1080/00365513.2025.2500029","url":null,"abstract":"<p><p>Platelet indices at admission offer the most opportune time for clinical decision-making, as they provide earliest insights, unlike later assessments during the intensive care unit (ICU) stay. There is emerging evidence suggesting the utility of platelet indices in predicting mortality. The objective of this study was, for the first time as far as the literature indicates, to elucidate the utility of seven platelet indices at admission in a large ICU cohort using Sysmex XN-series analysers. This cross-sectional study enrolled 592 ICU patients. The association of platelet indices at admission with the in-ICU and 90-day mortality was evaluated using logistic regression and receiver operating characteristic curve analysis. Of the platelet indices studied, absolute-immature platelet fraction (A-IPF), and mean platelet volume (MPV) and percentage-immature platelet fraction (%-IPF) were shown to be independently associated with predicting the in-ICU and 90-day mortality, respectively. The A-IPF cut-off value for predicting the in-ICU mortality was >6.4 × 10⁹/L (adjusted area under the curve (aAUC) 0.736, and adjusted Odds Ratio (aOR) 1.04), and the MPV and %-IPF cut-off values for predicting the 90-day mortality were >9.5 fL (aAUC 0.759, and aOR 1.26) and >6.3% (aAUC 0.762, and aOD 1.06), respectively (all <i>p</i> < 0.05). Admission A-IPF was the best predictor of in-ICU mortality, while admission MPV and %-IPF were the best predictors of 90-day mortality. These indices, all measured at admission, provide the earliest possible data relevant to mortality prediction. These are routinely available indices which deserve to be considered for new future ICU scoring systems.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"248-258"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976607","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}