Cindhya Sithiravel, Tor A Strand, Ingunn Tjelde Fauskrud, Ine Kathrine Granberg, Hege K Tjølsen Hermansen, Ragnhild Røysland, Kjersti S Bakken
{"title":"Converting waste into value. Stability of leftover EDTA whole blood: serum <i>vs.</i> plasma for nine clinical chemistry analyses.","authors":"Cindhya Sithiravel, Tor A Strand, Ingunn Tjelde Fauskrud, Ine Kathrine Granberg, Hege K Tjølsen Hermansen, Ragnhild Røysland, Kjersti S Bakken","doi":"10.1080/00365513.2025.2494261","DOIUrl":"10.1080/00365513.2025.2494261","url":null,"abstract":"<p><p>This study evaluates the utility of leftover EDTA whole blood from a diagnostic biobank for determining concentrations of ferritin, cobalamin, homocysteine, hCG, and thyroid-related hormones and antibodies (TSH, fT4, fT3, TRAb, and anti-TPO). Twenty participants were included. Pre-analytical bias in their blood samples was assessed as per European Federation of Clinical Chemistry and Laboratory Medicine Milano performance specifications. We evaluated the stability of EDTA whole blood stored at various intervals (days 0, 1, 6, and 13), and compared plasma derived from these samples with serum samples. Bland Altman plots and Paired <i>t</i>-test were used to identify statistically significant differences. We found good quantitative agreement, with biases within set performance specifications for cobalamin (14%), fT4 (3.5%), fT3 (3.6%), TSH (15%), and ferritin (7.4%). The calculated biases for serum <i>vs.</i> EDTA plasma day 6 were as follows: cobalamin 1.9%, fT4 2.6%, fT3 0.4%, TSH -2.1%, and ferritin -4.5%. The biases for homocysteine exceeded limits in all comparisons, except serum <i>vs.</i> EDTA plasma on day 0 and between EDTA plasma from day 0 and day 1. The calculated bias of 41% exceeded the set limit of 13% when comparing serum with EDTA plasma day 6. For hCG, anti-TPO, and TRAb, limited measurable levels restricted bias calculations. As per the diagnostic biobank protocols, EDTA blood stored for up to 6 days provides plasma suitable for analyzing cobalamin, fT4, fT3, TSH, and ferritin. Our study confirms previous findings that homocysteine has poor stability in whole blood.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":"85 3","pages":"214-219"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144044425","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":"Laboratory reference intervals - history and modern approaches for improved utility.","authors":"Tony Badrick, Joe M El-Khoury, Elvar Theodorsson","doi":"10.1080/00365513.2025.2512995","DOIUrl":"10.1080/00365513.2025.2512995","url":null,"abstract":"<p><p>Diagnosing using laboratory results is commonly based on whether the concentration of a biomarker is outside of the reference limits following the currently dominating statistical decision theoretical approach. Such dichotomization disregards several crucial factors, including the uncertainty of the measurement result, how extreme the concentration of the biomarker is, the prevalence of the condition in the tested population, and the costs of false positives and false negatives. The history, properties, pros, and cons of reference intervals are discussed, including promising alternatives such as standard scores, percentiles, and likelihood ratios.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"229-241"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144235042","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}
Johann Sigurjonsson, Ulf Nyman, Henrik Bjursten, David Grubb
{"title":"Renal elimination and eGFR prediction of proenkephalin.","authors":"Johann Sigurjonsson, Ulf Nyman, Henrik Bjursten, David Grubb","doi":"10.1080/00365513.2025.2512383","DOIUrl":"10.1080/00365513.2025.2512383","url":null,"abstract":"<p><p>Proenkephalin (PENK) is assumed to be freely filtered by the glomerulus, thus potentially useful for estimating glomerular filtration rate (eGFR). Recently developed eGFR-equation based on PENK and creatinine has not been validated against existing cystatin C-based equations. This study aimed to test the hypothesis of free filtration of PENK. Also, the PENK-creatinine based eGFR-equation was validated against cystatin C. Plasma concentrations of PENK, creatinine and cystatin C were determined in arterial and renal venous blood samples collected from 70 patients undergoing transcatheter aortic valve implantation (TAVI). The renal elimination ratio (RER) of PENK (RER<sub>PENK</sub>) was calculated and compared to the RER of creatinine (RER<sub>crea</sub>). RER constitutes the single-pass renal elimination of a molecule, calculated as the arteriovenous concentration difference divided by the arterial concentration. For eGFR validations, the CAPA (cystatin C) and LMR (creatinine) equations were used. RER<sub>PENK</sub> (23.7 ± 9.6%) was approximately 10% higher than RER<sub>crea</sub> (21.4 ± 5.8%). The PENK-creatinine equation overestimated GFR by 26,1% on average, compared to the mean of the LMR and CAPA equations. The relationship between RER<sub>PENK</sub> and RER<sub>crea</sub> suggests free filtration and a slight degree of non-glomerular elimination of PENK. There was poor agreement between PENK and cystatin C derived eGFR-equations. PENK needs further evaluation as a predictor of GFR.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"281-286"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267232","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}
Anni Kelkka, Christel Pussinen, Lotta Joutsi-Korhonen, Kari Pulkki, Marja-Kaisa Koivula, Anna Lempiäinen
{"title":"Preanalytical factors of enhanced liver fibrosis (ELF™) laboratory testing: the score is affected by hemolysis.","authors":"Anni Kelkka, Christel Pussinen, Lotta Joutsi-Korhonen, Kari Pulkki, Marja-Kaisa Koivula, Anna Lempiäinen","doi":"10.1080/00365513.2025.2546316","DOIUrl":"https://doi.org/10.1080/00365513.2025.2546316","url":null,"abstract":"<p><p>Liver fibrosis is a common condition that potentially leads to cirrhosis, liver dysfunction, and hepatocellular carcinoma. The Enhanced Liver Fibrosis (ELF™) test is a validated tool for assessing fibrosis. The influence of preanalytical factors on ELF™ test has not been described in previous literature. Thus, this study aims to investigate preanalytical factors affecting the ELF™ score. We evaluated the effects of hemolysis, icterus, and lipemia on the ELF™ score by measuring hyaluronic acid (HA), aminoterminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of matrix metalloproteinase-1 (TIMP-1) concentrations and calculating the ELF™ scores in samples with interfering substances. The ELF™ scores and parameters were also compared between serum and lithium heparin plasma samples. Measurements were performed using a Siemens Healthineers Atellica IM 1600 analyzer. Hemolysis decreased PIIINP concentration by -21.3% and -40.5% in samples containing 1 and 2 g/L hemoglobin, respectively. Correspondingly, ELF™ scores decreased by 2.0% and 4.4%. By contrast, bilirubin and lipemia did not affect the ELF™ score. No difference in ELF™ scores was found between serum and plasma, but PIIINP concentration was 23.1% higher and TIMP-1 concentration was -38.3% lower in plasma compared with serum. Moderate hemolysis affects ELF™ scores, which might lead to a misinterpretation of patient results. Thus, we recommend automated hemolysis index testing for the ELF™ test. Significant differences in PIIINP and TIMP-1 concentrations between plasma and serum could affect individual patient results.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":"85 5","pages":"379-386"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144967061","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}
Tianzhu Zhang, Huan Bai, Bin Wang, Dengju Li, Ning Tang
{"title":"The implication of abnormal routine coagulation parameters in Dabie bandavirus infection.","authors":"Tianzhu Zhang, Huan Bai, Bin Wang, Dengju Li, Ning Tang","doi":"10.1080/00365513.2025.2548013","DOIUrl":"10.1080/00365513.2025.2548013","url":null,"abstract":"<p><p>Prolonged activated partial thromboplastin time (APTT) and thrombin time (TT), normal prothrombin time (PT) and elevated D-dimer level are typical manifestation of routine coagulation parameters in patients infected with Dabie bandavirus (DBV), infection-induced coagulation activation and consumption, and a heparin-like effect due to endogenous heparan are the common explanations. To understand the exact implication of abnormal coagulation parameters in patients infected with DBV and their correlation with bleeding tendency and prognosis. One hundred and twenty-one consecutive DBV-infected patients were enrolled in this prospective, single-center, observational study. Routine coagulation parameters, levels of heparan sulfate (HS) and thrombin-antithrombin (TAT) complex, and thrombin generation (TG) test of these patients on admission were detected, and their hemorrhagic events during hospitalization were recorded. In the enrolled patients, both of APTT and TT were significantly positively correlated with HS, while significantly negatively correlated with endogenous thrombin potential (ETP) of TG test (<i>p</i> < .05). In addition, there was a strong correlation between D-dimer and TAT (<i>r</i> = 0.841). The patients with hemorrhagic events during hospitalization had significantly higher APTT and D-dimer and lower platelet count and ETP on admission than those without, and only ETP was the independent predictor (<i>p</i> < .05). The prolongation of APTT and TT of DBV-infected patients reflected decreased TG potential, and increased D-dimer level reflected an increase in thrombin activity. An accurate understanding of the implication of these coagulation parameters is helpful for the rational management of DBV infection.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"430-435"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144875035","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}
Lei Zhang, Mingjian Lian, Yufan Wang, Jiandong Zhang
{"title":"Serum metabolic profiling in patients with hypothyroidism in pregnancy.","authors":"Lei Zhang, Mingjian Lian, Yufan Wang, Jiandong Zhang","doi":"10.1080/00365513.2025.2546318","DOIUrl":"10.1080/00365513.2025.2546318","url":null,"abstract":"<p><strong>Objective: </strong>To explore the potential metabolic markers related to gestational hypothyroidism in early diagnosis, to find new intervention targets, and to provide metabolic pathway information for elucidating the pathogenesis of gestational hypothyroidism.</p><p><strong>Methods: </strong>Sixteen patients with gestational hypothyroidism treated in a tertiary hospital of China were enrolled. 20 normal pregnant women and 20 healthy women of childbearing age were also selected as control groups. Fasting serum samples were collected from all participants. The platform of liquid chromatography and mass spectrometry was applied for detecting. The principal component analysis (PCA) and orthogonal partial least square discriminant analysis (OPLS-DA) models were constructed for metabolic profile analysis. Characteristic metabolites were screened and statistically studied by Mann-Whitney test, and the biological functions and metabolic pathways of characteristic metabolites were further analyzed.</p><p><strong>Results: </strong>13 characteristic metabolites were screened. Palmitic acid, phytosphingosine, sphinganine, phytanic acid, palmitic amide, behenic acid, cetoleic acid, cerebronic acid, N-Palmitoylsphingosine, octadecanamidein in gestational hypothyroidism group were significantly higher than those in normal pregnancy group and healthy control group (<i>p</i> < 0.05). The serum levels of three kinds of lysophosphatidylcholine in gestational hypothyroidism group were significantly lower than those in normal pregnancy group and healthy control group (<i>p</i> < 0.05).</p><p><strong>Conclusions: </strong>A total of 13 characteristic metabolites were screened, whose serum levels in the gestational hypothyroidism group had the same changing trend compared to those in the normal pregnancy group and the healthy control group, with statistical differences. This may provide new ideas for early diagnosis and finding new treatment targets for gestational hypothyroidism.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"387-394"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144848596","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":"The frequency of JAK2 V617F mutation and its association with low EPO levels in polycythemia vera patients.","authors":"Recai Aci, Adem Keskin, Özlem Sezer, Taner Karakaya, Samet Semiz, Halit Kızılet","doi":"10.1080/00365513.2025.2502945","DOIUrl":"10.1080/00365513.2025.2502945","url":null,"abstract":"<p><p>Myeloid cell overgrowth in polycythemia vera (PV) is identified by a clonal disorder. The mutation in the Janus tyrosine kinase 2 (JAK2) gene known as V617F has been demonstrated to be responsible for the molecular development of the illness. This study investigates how frequently the JAK2 V617F mutation occurs and its association with erythropoietin (EPO) and hematological parameters in PV patients. Two hundred and forty-five patients who presented to the genetic outpatient clinic with a prediagnosis of PV were included in this study. Blood samples from all patients were screened for the G-T point mutation (V617F) in the JAK2 gene on chromosome 9 by allele-specific polymerase chain reaction (PCR). In addition, EPO levels, biochemical and hematological parameters of the patients were analyzed. JAK-2 mutation was detected in 28.9% (71) of patients diagnosed with PV. The mean age of the JAK2 V617F positive group was 64.09 ± 13.66 years, negative group was 66.62 ± 16.60 years. No statistically significant difference was found between the groups in terms of age and gender. When laboratory parameters were analyzed, ferritin, Fe, MCV, MCH, MCHC and EPO values were found to be lower in the JAK2 V617F positive group compared to the negative group, while RBC, RDW, MPV, PLT, HGB and UIBC values were found to be higher. The main observation of the study was that the JAK2 V617F mutation was present in 71 out of 215 PV patients (28.98%), confirming the observation of lower EPO levels in PV patients, and the results of the study are in close agreement with previous studies.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"259-262"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996153","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":"The effect of common blood sampling types on metabolic screening.","authors":"Ceylan Bal, Esra Özyurt, Gülsen Yılmaz","doi":"10.1080/00365513.2025.2490936","DOIUrl":"10.1080/00365513.2025.2490936","url":null,"abstract":"<p><p>Capillary blood is often used for dried blood spot samples in metabolic screening tests. This study's objective is to examine the amino acid and acylcarnitine levels in the commonly used sampling types from the same subjects and compare the findings with capillary whole blood samples as the reference. Thirty adult patipicants' blood samples were collected into four different tubes: citrated tubes, serum separating tubes, heparin tubes, and EDTA tubes, respectively and additionally into the syringe. 50 μL blood from each tube and syringe was absorbed onto filter papers. Additionally, capillary whole blood taken from each person's fingertip was absorbed onto the filter paper. All measurements were performed with flow-injection analysis tandem mass spectrometry. In the pairwise comparison of fingertip group and other groups, almost all results were different from the reference group (<i>p</i> < 0.05), except for glutamine and methionine for amino acid analysis. The difference in acylcarnitine levels is not as obvious as in amino acid levels. If other sampling types are used for metabolic screening instead of capillary whole blood, it may lead to low results, especially in amino acid measurements. Additionally, cut-off values should be interpreted, taking into consideration the sampling type, and laboratories should be informed about the sampling type used.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":"85 3","pages":"196-201"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144006355","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":"Evaluation of point-of-care instrument for quantification of infliximab and adalimumab.","authors":"Mark Ainsworth, Torben Knudsen, Karina Vogn Koch, Mads Nybo, Morten Beck Trelle","doi":"10.1080/00365513.2025.2559355","DOIUrl":"10.1080/00365513.2025.2559355","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment with infliximab (IFX) and adalimumab (ADL) are used in a range of inflammatory diseases. Measurement of drug levels is warranted, but can be challenged by turn-around-times at the laboratories. Consequently, point-of-care testing (POCT) technology is becoming increasingly relevant. We evaluated the precision and comparability of results obtained with ProciseDx (Biosynex) when used in outpatient gastroenterology clinics monitoring IFX and ADL.</p><p><strong>Materials and methods: </strong>In this prospective multi-center study, capillary and venous blood samples were collected by trained nurses from patients with inflammatory bowel disease on maintenance therapy with either IFX or ADL. Fourteen different nurses performed blood sampling and IFX measurements using ProciseDx on 64 patients, while 11 different nurses performed ADL measurements on 48 patients. Venous samples were sent to the laboratory for routine testing using Promonitor ELISA kit on a Triturus (Grifols).</p><p><strong>Results: </strong>Across all patients and all sites, a variation of 18.9% and 11.4% was observed for IFX and ADL measurements, respectively. Peak variance was in the 5-10 mg/L IFX concentration range, while peak variance for ADL measurements was above 12 mg/L. Compared to the routine ELISA, the <i>r</i>-value was 0.82 for IFX with a mean total deviation of 2.10 mg/L (27.1%). For ADL, the <i>r</i>-value was 0.91 with a mean total deviation of 2.93 mg/L (39.7%).</p><p><strong>Conclusion: </strong>We find the efficacy and accuracy of the ProciseDx acceptable, but when performed by non-laboratory personnel, the differences to routine measurements are considerable and could have a clinical impact. Clinical implementation would at least require reevaluation of the therapeutic intervals.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"480-488"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145041410","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}
Laura Pighi, Davide Negrini, Marco Tosi, Giuseppe Lippi
{"title":"Performance assessment of ChatGPT in classification of urine particles.","authors":"Laura Pighi, Davide Negrini, Marco Tosi, Giuseppe Lippi","doi":"10.1080/00365513.2025.2496265","DOIUrl":"https://doi.org/10.1080/00365513.2025.2496265","url":null,"abstract":"","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":"85 3","pages":"223-227"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144043885","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}