{"title":"Within- and between-subject biological variation data for whole blood HbA<sub>1c</sub> from 38 apparently healthy Turkish subjects.","authors":"Murat Keleş, Gönül Ünver Şeker","doi":"10.1080/00365513.2024.2439394","DOIUrl":"10.1080/00365513.2024.2439394","url":null,"abstract":"<p><p>HbA<sub>1c</sub> plays an important role in the diagnosis and treatment of diabetes and is a valuable biomarker for evaluating glycemic control and predicting the risk of vascular complications. The study aimed to determine the biological variation (BV) for HbA<sub>1c</sub> and thereby contribute to analytical performance specifications, reference change values, and index of individuality. Fasting venous whole blood samples were collected from 38 presumably healthy subjects (20 females, 18 males) once a week for ten weeks, and analyzed in duplicate using the Roche Cobas c501 analyzer. BioVar, an online R-based biological variation analysis tool, was used for the statistical analysis. BV values were obtained by analysis of variance (ANOVA) after outlier detection, normality tests, steady-state, and homogeneity checks. The within-subject biological variation for HbA<sub>1c</sub> was 2.9%, and the between-subject biological variation was 7.9%. The index of the individuality of HbA<sub>1c</sub> was 0.37. Derived desirable analytical goals for imprecision, bias, total allowable error, and maximum expanded allowable measurement uncertainty were 1.4%, 1.8%, 4.2%, and 2.9% respectively. The reference change value is more appropriate for interpreting HbA1c results than a population-based reference interval.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"535-539"},"PeriodicalIF":1.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142829569","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}
Paul Kjetel Soldal Lillemoen, Kristin Holstad, Anne-Lise Bjørke-Monsen
{"title":"Reference intervals for 23 common biochemical parameters during pregnancy and the first six postpartum months.","authors":"Paul Kjetel Soldal Lillemoen, Kristin Holstad, Anne-Lise Bjørke-Monsen","doi":"10.1080/00365513.2024.2406006","DOIUrl":"10.1080/00365513.2024.2406006","url":null,"abstract":"<p><p>The concentration of many biochemical parameters changes significantly during pregnancy and the postpartum period, causing a need for specific reference values for biochemical parameters in these life periods. We have collected blood samples in pregnancy week 18, 28 and 36 and six weeks, four months and six months postpartum from 139 healthy women. Blood samples from 59 healthy never-pregnant women were included as controls. Serum samples were analyzed for 23 common biochemical parameters and reference intervals for pregnancy and postpartum periods were computed with the non-parametric method in accordance with recommendations from IFCC and CLSI. The dynamics of different biochemical parameters during and after pregnancy vary considerably between parameters. Some analytes like serum amylase and HDL cholesterol do not differ from never-pregnant values. Of the 23 parameters, serum alkaline phosphatase, chloride, gamma-glutamyl transferase and sodium and urea which were still significantly changed at six months postpartum compared to never-pregnant women. The physiological changes related to pregnancy and lactation have profound effects on biochemical parameters, denoting the use of specific reference intervals for both pregnancy and the postpartum period.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"429-440"},"PeriodicalIF":1.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644717","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}
Carsten Metzsch, Oscar Lindahl, Martina Klarén, Edgars Grins, Annika Ekroth, Stefan R Hansson, Bo Åkerström, Alain Dardashti
{"title":"The course of plasma alpha-1-microglobulin and haemolysis during cardiac surgery and the relationship to acute kidney injury, a pilot study.","authors":"Carsten Metzsch, Oscar Lindahl, Martina Klarén, Edgars Grins, Annika Ekroth, Stefan R Hansson, Bo Åkerström, Alain Dardashti","doi":"10.1080/00365513.2024.2442022","DOIUrl":"10.1080/00365513.2024.2442022","url":null,"abstract":"<p><p>Haemolysis occurring during cardiac surgery with cardiopulmonary bypass (CPB) is assumed to be a risk factor for postoperative acute kidney injury (AKI). Plasma alpha-1 microglobulin (A1M) may have a protective role as haem scavenger. The aim of this study was to evaluate the association between AKI and the degree of haemolysis and the course of A1M concentrations during cardiac surgery, respectively. We analysed plasma concentrations of free haemoglobin (pfHb) and A1M in 25 patients undergoing cardiac surgery: before CPB; during CPB in 15 min intervals; after CPB; and at four additional time points until 24 h after surgery. Markers of kidney function were followed until 4 days after surgery. Detection of AKI was based on the KDIGO (Kidney Disease, Improving Global Outcome) criteria. The plasma concentration of free haemoglobin during CPB was found to be significantly higher in patients with postoperative AKI at 60 min after start of CPB [mean 1379 µg/mL (95% CI: 1037-1721)]; compared to [820 µg/mL (622-1018)]; <i>p</i> = 0.034, in patients without AKI, and at one hour post-CPB [2600 µg/mL (969-4230)] vs [1037 µg/mL (722-1353)]; <i>p</i> = 0.044]. There was no significant difference found for pA1M levels between the groups with and without postoperative AKI development. Haemolysis during cardiac surgery with CPB increases the risk of postoperative AKI. Levels of pA1M did not differ for patients who developed postoperative AKI compared with those who did not. The data did not allow conclusions regarding the hypothesis that pA1M has a reno-protective effect.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"557-563"},"PeriodicalIF":1.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142897169","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}
Sandra R Dahl, Liv Hanne Bakke, Per M Thorsby, Svetlana N Zykova
{"title":"An LC-MS/MS assay for simultaneous determination of 13 steroid hormones and two synthetic steroids in saliva: potential utility for paediatric population and beyond.","authors":"Sandra R Dahl, Liv Hanne Bakke, Per M Thorsby, Svetlana N Zykova","doi":"10.1080/00365513.2024.2437620","DOIUrl":"10.1080/00365513.2024.2437620","url":null,"abstract":"<p><p>Saliva samples offer the possibility to obtain stress-free non-invasive samples, also for home-testing, especially useful when blood collection is either undesirable or difficult. The aim of this work was to develop an LC-MS/MS method to determine clinically relevant steroid hormones cortisol, cortisone, 11-deoxycortisol, 21-deoxycortisol, 17OH-progesterone, aldosterone, corticosterone, deoxycorticosterone, testosterone, androstenedione, DHEAS, DHEA, 17OH-pregnenolone, betamethasone and dexamethasone. A special effort was made to adapt the method to neonatal population with respect to choice of saliva as matrix, low sample volumes, selection of analytes and multiplexing. Validation included selectivity, interferences, matrix effects, lower and upper limit of quantification, linearity of calibration, dilution of samples, trueness, within-run and total analytical repeatability, robustness, carry-over, stability and recovery from sample collection swab. Ten microliters were acceptable but 50 µL preferable sample volume, except for 21-deoxycortisol. Cortisol, cortisone, aldosterone, 11-deoxycortisol, deoxycorticosterone, dexamethasone, betamethasone, 17OH-pregnenolone and DHEAS could be determined in as little as 2-5µL saliva. Total analytical variation was <15%, except for 17OH-progesterone, deoxycorticosterone, 17OH-pregnenolone, 21-deoxycortisol, androstenedione, DHEA and betamethasone, that could only be determined semi-quantitatively or qualitatively. The minimum turnaround time was 3-4 h. Recovery from the best performing sample collection swab SalivaBio ranged from 83 to 127%. Aldosterone, cortisone and DHEA were more stable in saliva compared to serum when stored at ambient temperature for one week. Corticosterone and 17OH-progesterone needed immediate freezing. The non-invasiveness, small saliva volume requirement, on-swab stability and analytical performance make the method relevant for both research and diagnostics, above all in the setting of neonatal intensive care unit.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"527-534"},"PeriodicalIF":1.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142855299","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}
Nashwa Farouk Mohamed, Ola Galal Ali Behairy, Manal Sadek El Defrawy, Samar Ahmed Mohamed Elsheraki, Rana Atef Khashaba
{"title":"Evaluation of serum human epididymis protein 4 in children with chronic liver diseases.","authors":"Nashwa Farouk Mohamed, Ola Galal Ali Behairy, Manal Sadek El Defrawy, Samar Ahmed Mohamed Elsheraki, Rana Atef Khashaba","doi":"10.1080/00365513.2024.2437612","DOIUrl":"10.1080/00365513.2024.2437612","url":null,"abstract":"<p><p>The aim of this study was to evaluate the role of serum human epididymis protein 4 (HE4) as a non-invasive biomarker for the diagnosis of liver fibrosis in children with chronic liver diseases (CLD). This case-control study was conducted at Benha University Hospital, Egypt, involving 60 children with CLD and 60 healthy children as a control group. HE4 levels were measured by ELISA and compared with liver biopsy results. The CLD group had significant higher HE4 (median: 110.7, IQR: 96.7-120.4 pmol/L) compared to control group (median 42.07, IQR: 41.67-43.05 pmol/L), <i>p</i> < .001. HE4 levels increased significantly with the degree of fibrosis and histological activity index. At a cutoff point >48.3 pmol/L, HE4 diagnosed cases with mild fibrosis with a sensitivity of 95% and specificity of 91.3%. At a cutoff point >144.3 pmol/L, HE4 diagnosed cases with severe fibrosis with a sensitivity of 98% and specificity of 93.1%. Serum HE4 is a potential non-invasive marker for detecting liver fibrosis and its severity in children with CLD.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"515-520"},"PeriodicalIF":1.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786846","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 eGFR<sub>cystatin C</sub>/eGFR<sub>creatinine</sub>-ratio is associated with maternal morbidity in hypertensive disorders in pregnancy and may indicate optimal timing of delivery.","authors":"Danielle Damm, Anders Grubb, Helena Strevens","doi":"10.1080/00365513.2024.2417379","DOIUrl":"10.1080/00365513.2024.2417379","url":null,"abstract":"<p><p>A low eGFR<sub>cystatin C</sub>/eGFR<sub>creatinine</sub>-ratio is characteristic of a group of serious kidney disorders called 'Selective Glomerular Hypofiltration Syndromes'. This study examines if such a low ratio can also be used to evaluate the risk for women with hypertensive disorders in pregnancy to develop severe maternal morbidity. All women discharged from the perinatal ward at the Skåne University Hospital in Lund during the period of 1-9-2016 to 31-8-2017 under one of the diagnoses within hypertensive disorders in pregnancy were considered for inclusion in the study. After delivery and discharge from the hospital, records from included patients were reviewed and all registered measures of renal function were analysed. An eGFR<sub>cystatin C</sub>/eGFR<sub>creatinine</sub>-ratio ≤0.60 in a sample drawn not earlier than three days before delivery was considered as defining a high risk for severe maternal morbidity. A strong association (p-value: 0.035) between severe maternal morbidity and an eGFR<sub>cystatin C</sub>/eGFR<sub>creatinine</sub>-ratio ≤0.60 was found in a subgroup of 32 women diagnosed with 'preeclampsia with severe features'. A total of 69 women were included in the study. Fifty were defined as high-risk and seventeen of them (34%) developed severe maternal morbidity. Among the nineteen women defined as low-risk only two (10.5%) developed severe maternal morbidity (p-value: 0.051). A low eGFR<sub>cystatin C</sub>/eGFR<sub>creatinine</sub>-ratio seems promising as a predictive marker for maternal morbidity in hypertension in pregnancy. Its performance as a tool in the monitoring of progressing disease should be evaluated further in larger cohorts. Delivery before the eGFR<sub>cystatin C</sub>/eGFR<sub>creatinine</sub>-ratio decreases to, or below, 0.60 might help avoid maternal complications.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"441-446"},"PeriodicalIF":1.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142473787","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":"Challenges of preanalytical variables in erythrocyte sedimentation rate: a CUBE 30 touch evaluation.","authors":"Flaminia Tomassetti, Roberto Guerranti, Roberto Leoncini, Carolina Pieroni, Daniela Diamanti, Michele Cirianni, Caterina Silvestrini, Lucrezia Galasso, Martina Pelagalli, Eleonora Nicolai, Alfredo Giovannelli, Massimo Pieri, Sergio Bernardini","doi":"10.1080/00365513.2024.2422397","DOIUrl":"10.1080/00365513.2024.2422397","url":null,"abstract":"<p><p>The erythrocyte sedimentation rate (ESR) is a widely used diagnostic test, influenced by all physiological and pathological conditions that can bias blood rheology by interfering factors. This study aimed to evaluate the performance of the CUBE 30 touch ESR analyzer in samples with preanalytical variables, as lipemia, hemolysis, and icterus or in presence of fibrinogen., Moreover we focused to define the maximum time limits to ensure a reliable ESR measure. Accuracy, intra-run and inter-run precision, and stability studies were performed. Moreover, hemolytic, jaundiced, lipemic samples and fibrinogen sensitivity were analyzed for interference study. Statistical analyses were performed. CUBE 30 touch and Westergren method comparison showed no statistical differences (Spearman Coefficient, R<sup>2</sup>=0,95). In the intra-run precision, the CV% mean obtained on samples with normal ESR level was 8,9%; with middle ESR level was 5,9% and with high ESR level the CV% was 4,3%. Inter-run precision test showed CV% of for single samples and overall samples in the range (12,3% for normal level and 4,8% for abnormal level). The samples stored at 4 °C showed good stability up to 3 h from collecting time. ESR samples showing lipemia, hemolysis or jaundice showed good correlations with the gold standard method (R<sup>2</sup> 0,901, 0,940, 0,911; <i>p</i> < 0,0001), however, Westergren tests were more sensitive than CUBE 30 touch to fibrinogen additions. The high comparability with the Westergren method, both in normal and interfering samples, and the good precision, support the usefulness of CUBE 30 touch in the clinical routine laboratory.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"477-485"},"PeriodicalIF":1.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626120","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}
Slavka Penickova, Sara Benyaich, Ibrahim Ambar, Frédéric Cotton
{"title":"Reliability of albumin bromocresol green colorimetric method and clinical impact.","authors":"Slavka Penickova, Sara Benyaich, Ibrahim Ambar, Frédéric Cotton","doi":"10.1080/00365513.2024.2420311","DOIUrl":"10.1080/00365513.2024.2420311","url":null,"abstract":"<p><p>Measuring plasma albumin is a common and important laboratory test. We compared the results obtained with the bromocresol green (BCG) colorimetric, immunoturbidimetric (IT), and capillary electrophoresis (CE) methods and evaluated the clinical reliability of the colorimetric test. Samples from 320 patients including 227 patients with hypoalbuminemia (albumin levels <35 g/L) were analyzed. Results were compared between different patient groups. The BCG method indicated significantly higher plasma albumin levels than the CE and IT methods, especially in patients with elevated C-reactive protein, alpha-1 globulin (a1G), and alpha-2 globulin (a2G) values. A significant proportion of patients with mild hypoalbuminemia tested using the BCG method (alb<sub>BCG</sub>) and were classified as severely hypoalbuminemic (albumin <20 g/L) when switching to the CE or IT method (alb<sub>CE</sub> and alb<sub>IT</sub>). These patients had elevated a1G and/or a2G levels. This change of result implied an additional indication for albumin replacement therapy. The BCG method significantly overestimates albumin levels in patients with inflammation and hypoalbuminemia, which may lead to inappropriate therapeutic decisions.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"452-458"},"PeriodicalIF":1.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142584273","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}
Marcus Clarin, Alexandra Hellberg, Kaj Blennow, Ulf Andreasson, Henrik Zetterberg
{"title":"Stability of bilirubin and oxyhaemoglobin in cerebrospinal fluid.","authors":"Marcus Clarin, Alexandra Hellberg, Kaj Blennow, Ulf Andreasson, Henrik Zetterberg","doi":"10.1080/00365513.2024.2442511","DOIUrl":"10.1080/00365513.2024.2442511","url":null,"abstract":"<p><p>Cerebrospinal fluid (CSF) is routinely investigated to diagnose subarachnoid haemorrhage (SAH) in cases with unclear neuroimaging findings. Using spectrophotometry, the levels of bilirubin and oxyhaemoglobin are analysed. This study investigates the stability for bilirubin and oxyhaemoglobin in CSF samples for up to 3 weeks measured with a spectrophotometer. The absorbances corresponding to bilirubin (455 nm) and oxyhaemoglobin (415 nm) remained fairly stable for up to 3 weeks when samples were stored at +4 °C with light protection. There was a statistically significant trend of decreased absorbance for both oxyhaemoglobin and bilirubin already after exposure to light within 120 min from sampling. It is therefore advisable to protect CSF from light until spectrophotometric analysis.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"564-568"},"PeriodicalIF":1.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882929","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}