Scandinavian Journal of Clinical & Laboratory Investigation最新文献

{"title":"Diagnostic discordance and performance of third-generation competitive TRAb vs. sandwich TSI ELISA in the diagnosis of Graves' disease.","authors":"Mohammed Naser Abed, Roua Jamal Abdul Khaliq","doi":"10.1080/00365513.2026.2669918","DOIUrl":"10.1080/00365513.2026.2669918","url":null,"abstract":"<p><strong>Background: </strong>Autoantibodies against the TSH receptor (TRAb) mediate hyperthyroidism in Graves' disease (GD). While 3rd-generation competitive immunoassays are the standard screening tool, the performance of accessible, sandwich ELISA-based TSI remains understudied in specific populations. This study evaluated the diagnostic utility of a sandwich TSI ELISA compared to a competitive TRAb ELISA in Iraqi patients with untreated hyperthyroidism.</p><p><strong>Methods: </strong>A case-control study on 60 newly diagnosed, untreated GD patients and 30 age-matched healthy controls. Serum samples were analyzed using a competitive inhibition ELISA for TRAb and a double-antigen sandwich ELISA for TSI. Clinical severity and disease duration were compared between concordant and discordant groups.</p><p><strong>Results: </strong>The competitive TRAb assay showed a superior performance (Sensitivity 90.0%, Specificity 86.7%, AUC = 0.95) compared to the TSI sandwich ELISA (Sensitivity 70.0%, Specificity 76.7%, AUC = 0.62). Diagnostic discordance was observed in 30% of patients who tested positive for TRAb but negative for TSI. The sub-analysis revealed that these discordant patients did not differ in biochemical severity from those detected by both assays. However, the discordant group presented with a shorter median duration of symptoms (1 vs. 3 months, <i>p</i> = 0.053).</p><p><strong>Conclusion: </strong>The competitive TRAb ELISA significantly outperformed the sandwich TSI ELISA. The observed discordance does not seem to be related to disease severity. We hypothesize that this discordance may result from the sandwich assay's limited ability to detect low-affinity or polyclonal antibodies, which are often present in early Graves' disease. Thus, the competitive TRAb assay remains the more robust and reliable primary screening tool.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"355-360"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147869540","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":"One-year cancer risk after detection of blast cells in peripheral blood.","authors":"Pernille Just Vinholt, Rasmus Bank Lynggaard, Katrine Sølling Borlund Mortensen, Maria Boysen Sandberg, Kim Oren Gradel, Anne Stidsholt Roug, Henrik Frederiksen","doi":"10.1080/00365513.2026.2632326","DOIUrl":"10.1080/00365513.2026.2632326","url":null,"abstract":"<p><p>Haematologists are often consulted on the need for additional diagnostic workup in patients with blast cells in peripheral blood. However, cancer risk (including solid tumors) after detection of blast cells in peripheral blood is lacking. Therefore we evaluated the 1-year cancer risk following detection of blast cells in peripheral blood. We used population-based retrospective data from the Region of Southern Denmark (2014-2021), including 2,187 individuals aged ≥20 years with blast cells in blood samples, excluding those with prior cancer. Results from haematological parameters derived from the laboratory information system, while diagnoses and vital status were from administrative registers. Natural language processing assisted review of clinical notes for individuals without cancer codes. We estimated age-standardised cancer incidence rates and compared observed versus expected cancers using standardised incidence ratios (SIR). We found that the overall 1-year cancer risk was 23% [95% CI: 21-24], with 19% [95% CI: 18-21] for haematological cancers and 3% [95% CI: 2-3] for solid cancers, compared to 0.87% in the background population. The age-adjusted SIR was 22 [95% CI: 21-24] and was highest for haematological cancers at 199 [95% CI: 184-214]. Although 78% of individuals had no blast cells upon repeated testing, 27% still developed cancer within a year. In conclusion the presence of blast cells in peripheral blood may warrant consideration of further diagnostic evaluation, particularly in the presence of other haematological abnormalities.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"141-149"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147290615","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":"Less testing, more yield: a multicomponent intervention halves inpatient biochemistry.","authors":"Malene S Jacobsen, Andi E Albertsen, Christian Trolle","doi":"10.1080/00365513.2026.2659590","DOIUrl":"10.1080/00365513.2026.2659590","url":null,"abstract":"<p><p>Routine inpatient biochemical testing is often repeated without clinical indication. This quality improvement project aimed to reduce low-value biochemical testing in a Danish cardiology ward, targeting a 5% reduction within 6 months and sustainment for 12 months, without adverse changes in length of stay, discharges after noon, or 30-day readmissions.</p><p><p>In a quality improvement project using the Model for Improvement and conducted through Plan-Do-Study-Act cycles, a multidisciplinary team implemented the following interventions: (i)targeted education for physicians and nurses e.g. clarifying of ordering responsibility; (ii)refinement of default biochemical profiles by removing non-essential tests (e.g. leukocyte count with differential, urea, hemoglobin) and curbing premature orders placed before the minimum re-testing interval; and (III)a centrally placed feedback dashboard. The primary outcome was the number of biochemical tests, adjusted for hours of hospitalization and caseload. Secondary outcomes were the proportion of results outside reference intervals and re‑testing intervals for common biochemical tests. Safety balancing measures were length of stay, discharges after noon, and 30-day readmissions. The pre-intervention period ran from February 27th, 2022, to February 26th, 2023, post-intervention period from March 5th, 2023, to February 2nd, 2025.</p><p><p>After biochemical profile refinement in June 2023, median number of biochemical tests decreased 54% (hours of hospitalization adjusted) and 48% (caseload adjusted). The proportion of test results outside reference ranges increased 21%. Re-testing intervals lengthened for hemoglobin and troponin-I. Balancing measures showed no adverse signals, and effects persisted into February 2025.</p><p><p>A pragmatic, simple bundle halved routine biochemical tests and increased diagnostic yield without measurable harm.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"285-292"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147723714","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":"Measurements of plasma melatonin by rapid LC-MS/MS enables insight into diurnal variation in healthy humans.","authors":"Jakob Albrethsen, Jonas Korsgaard Andreasen, Jennifer Anton, Henriette P Sennels, Henrik L Jørgensen, Jens Hannibal, Ditte Hermann, Nicolai J Wewer Albrechtsen","doi":"10.1080/00365513.2026.2660758","DOIUrl":"10.1080/00365513.2026.2660758","url":null,"abstract":"<p><p>Measurement of plasma melatonin is important in studies of sleep disorders and neurodegenerative diseases and is also increasingly associated with cardiometabolic diseases and cancer. There is currently an increase in the usage of melatonin in the population. However, commercially available and reliable melatonin assays are lacking. Here we present a rapid and simple LC-MS/MS-based method for plasma melatonin in a clinical laboratory. The method demonstrates a limit of detection of 5 ng/L and inter-assay imprecision < 16%. This newly developed LC-MS/MS method was applied to 216 plasma samples collected from 24 men as part of The Bispebjerg study of diurnal variation. The results showed increased melatonin concentrations during the nighttime and fitted well to a diurnal rhythm curve (<i>p</i> < 0.0001). The LC-MS/MS assay correlated significantly with commercial RIA (<i>p</i> < 0.03) but demonstrated a substantial bias. We conclude that our simple LC-MS/MS method can detect biologically relevant changes in plasma melatonin and may enable insight into circadian biology in humans. We propose that the observed differences between melatonin assays could be clarified by the distribution of reference plasma melatonin material and that additional studies are needed to fully understand the minimum circulating levels of melatonin in the daytime.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"306-312"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147729789","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":"Performance of Sysmex SP-50 automated slidemakers and stainers in three hematology laboratories.","authors":"Anni-Mari Tuori, Johanna Kultti, Eeva-Liisa Paattiniemi, Päivi Helminen-Pacius, Kari Pulkki","doi":"10.1080/00365513.2026.2686252","DOIUrl":"10.1080/00365513.2026.2686252","url":null,"abstract":"<p><p>Manual differential count and morphological evaluation of leukocytes remain the gold standard for white blood cell differential (WBC DIFF). However, the accuracy of manual WBC DIFF depends on the quality of the blood slide and the observer's expertise. Nowadays, automated slide preparation and staining systems, such as Sysmex SP-50, have been introduced to improve the quality of this method. In this study, we evaluated the quality of peripheral blood smears prepared and stained using the SP-50 automated system, with a particular focus on variables affecting cell distribution and morphology. This study evaluates the performance of five Sysmex SP-50 systems, from analyzer installation to final verification. The verification protocol included a preliminary performance check of all analyzer setups, followed by a conclusive verification. Conclusive verification was initiated after the performance checks were considered acceptable by laboratory professionals. The results demonstrated cell maldistribution across the film and the presence of smudge cells, both of which were linked to the pressure and height/angle of the spreader glass. In addition, inadequate staining of the blood film was observed, which was influenced by staining conditions and the use of fans. Together, these findings highlight critical quality issues with blood smear preparation that compromise accurate morphological analysis. The results suggest that while automation may offer some advantages, the quality and reliability of Sysmex SP-50-generated smears need laboratory-specific adjustment to meet the quality standards required for diagnostic evaluation.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"452-462"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148309370","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 in the interpretation of amphetamine results: differences of reactivity between immunoassay and immunochromatography.","authors":"Nerea Sainz-Pastor, Edgar Martín, Estel Julià, Loredana Cosmina Sabau, Elías Navas, José Alcaraz Quiles, Bernardino González de la Presa, Marina Parra-Robert","doi":"10.1080/00365513.2026.2694040","DOIUrl":"10.1080/00365513.2026.2694040","url":null,"abstract":"<p><p>Urine drug screening is a valuable diagnostic tool for assessing acute intoxications in the emergency department. Enzyme immunoassay (IA) and immunochromatography (IC) are the two main techniques routinely used due to their rapid turnaround, low cost, and high sensitivity. However, results must be interpreted with caution, as structural cross-reactivity may cause false-positive (FP) findings. We retrospectively analyzed 55 urine samples from emergency patients initially screened for amphetamines by IA and confirmed by gas chromatography-mass spectrometry (GC-MS). Samples containing amphetamine derivatives or potentially cross-reactive substances (tetracaine, trazodone, methylphenidate, ritalinic acid, phentermine, procainamide, ephedrine, bisoprolol, and synthetic cathinones) were subsequently analyzed using an IC assay. Diagnostic performance and cross-reactivity were compared between both screening methods. Of the 55 samples selected by IA, 34 were true positives (TP), 8 true negatives (TN), 2 false negatives (FN), and 11 FP. FP by IA were mainly due to tetracaine, trazodone, phentermine, ephedrine, and procainamide. In comparison, IC yielded 32 TP, 17 TN, 2 FP (phentermine and bisoprolol), and 4 FN. No cross-reactivity with methylphenidate and synthetic cathinones was observed in either technique. IC showed frequent misclassifications between amphetamine and methamphetamine while MDMA detection was more specific. IC is a reliable and rapid alternative for amphetamine screening in the emergency setting, providing improved specificity and fewer false positives than IA. Given its limited discrimination between amphetamine and methamphetamine, IC results should be reported as 'amphetamine derivatives'. These findings highlight assay-dependent cross-reactivity and the importance of understanding methodological limitations for an accurate interpretation.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"471-479"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148339957","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":"Statement of Retraction.","authors":"","doi":"10.1080/00365513.2026.2723659","DOIUrl":"10.1080/00365513.2026.2723659","url":null,"abstract":"","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"702"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148920862","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 HbA1c stability in refrigerated blood samples: for how long are samples fit for use?","authors":"Alessandro Terreni, Fiamma Balboni, Renata Paleari, Paola Pezzati, Giuseppe Lippi","doi":"10.1080/00365513.2026.2734744","DOIUrl":"10.1080/00365513.2026.2734744","url":null,"abstract":"<p><p>HbA1c is a key biomarker for diagnosing and monitoring diabetes, but its reliability may be affected by preanalytical conditions, including sample storage. This study evaluated the stability of HbA1c in whole-blood EDTA samples stored at 2-8 °C. A pooled blood sample from 65 anonymized leftover specimens was aliquoted and measured in triplicate using capillary electrophoresis (Minicap Flex Piercing, Sebia) over 20 days, with an additional measurement at day 35. Total Allowable Error (TEa ±4.9%) and Reference Change Value (RCV ±2.32 mmol/mol) were used to determine molecular stability. HbA1c remained analytically stable for up to 13 days in this specific setting. This finding, when validated in different conditions, may help laboratories to optimize the routine workflow.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"642-646"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148991225","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":"Could the combination of fibrinogen and D-dimer improve risk assessment for acute type A aortic dissection in the emergency department?","authors":"Karl Teurneau-Hermansson, Emilia Norén, Jacob Ede, Mårten Larsson, Anders Björkelund, Johan Sjögren, Shahab Nozohoor, Ulf Ekelund, Igor Zindovic","doi":"10.1080/00365513.2026.2630321","DOIUrl":"10.1080/00365513.2026.2630321","url":null,"abstract":"<p><p>D-dimer has been proven to be an excellent rule-out marker for acute type A aortic dissection (ATAAD) with a sensitivity exceeding 95% while specificity remains low. We hypothesized that the addition of fibrinogen, which is decreased in ATAAD patients due to consumption coagulopathy, would increase predictive ability. This was an exploratory, retrospective, single-region, observational study comparing ATAAD patients with available preoperative D-dimer and fibrinogen values who underwent surgery at our department between 2008 and 2023 (93 patients) to all patients who visited an emergency department (ED) in a region of southern Sweden during 2017 and 2018 and whose D-dimer and fibrinogen values were obtained within 24 h (202 patients). The discriminative capacity of ATAAD was evaluated by comparing the area under the curve (AUC) from receiver operating characteristics (ROC) curves calculated for each biomarker alone and for the D-dimer/fibrinogen ratio. The AUC for the ability of D-dimer and fibrinogen to discriminate ATAAD from other diagnoses was 0.784 (95% CI 0.733-0.836) and 0.756 (95% CI 0.701-0.811), respectively. The AUC for the D-dimer/fibrinogen ratio was 0.812 (95% CI 0.764-0.860). In this exploratory study, we could show that the D-dimer/fibrinogen ratio increased the ability to predict ATAAD compared to the biomarkers alone. The improvement in discriminative ability was small, however, and needs further validation to be clinically useful.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"110-116"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146182077","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":"A log-adjusted t-statistic for large clinical laboratory datasets: a simulation study and real-world application.","authors":"Mehmet Güven Günver, Mehmet Fatih Sert, Eray Yurtseven, Mine Sezgin, Uğurcan Sayılı, Mert Canbaz, Hazal Cansu Çulpan, Günay Can, Ethem Erginöz, Mehmet Yusuf, Mustafa Şenocak","doi":"10.1080/00365513.2026.2681040","DOIUrl":"10.1080/00365513.2026.2681040","url":null,"abstract":"<p><p>In large datasets, conventional t-tests may identify statistically significant but practically trivial differences because statistical significance increases with sample size. A log-adjusted t-statistic, defined as an empirical sample-size-aware modification of the classical t-statistic, was evaluated to reduce this oversensitivity. Performance was assessed by Monte Carlo simulations of two-sample comparisons across sample sizes from 10 to 50,000 and effect sizes from <i>δ</i> = 0 to 1.0, and by application to a real clinical laboratory dataset comprising 464,145 participants. In simulations, the <math><mrow><mrow><mrow><msub><mrow><mtext>log</mtext></mrow><mrow><mn>10</mn></mrow></msub></mrow></mrow><mo>⁡</mo><mrow><mo>(</mo><mrow><mtext>Df</mtext></mrow><mo>)</mo></mrow></mrow></math>-adjusted statistic showed null rejection rates close to 0.05 across sample sizes, whereas the classical t-test became increasingly oversized at very large n. The adjustment was more conservative for small effects (<i>δ</i> = 0.2-0.4) while high rejection rates were retained for larger effects (<i>δ</i> = 0.6-1.0). In the real-data analysis, several sex differences that were highly significant by the classical t-test had small effect sizes and yielded reference <i>p</i>-values above the conventional 0.05 threshold after adjustment; platelet count (Cohen's <i>d</i> = 0.13) changed from <i>p</i> < 10^-300 to reference <i>p</i> = 0.052, and potassium (<i>d</i> = 0.05) from <i>p</i> = 10-51 to reference <i>p</i> = 0.104. In contrast, larger effects such as hematocrit (<i>d</i> = 0.83) and HDL cholesterol (<i>d</i> = 0.77) continued to yield reference <i>p</i>-values below that threshold. These reference <i>p</i>-values were compared with the conventional <i>α</i> = 0.05 threshold for illustrative purposes only and were not intended to imply formal Type I error control. These findings suggest that the log-adjusted t-statistic may serve as a useful empirical decision aid for interpreting large clinical laboratory datasets by attenuating sample-size-driven significance while preserving detection of substantively meaningful effects.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"401-414"},"PeriodicalIF":1.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148138904","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}