Clinical Biochemistry[JOURNAL]
Sun
200 papers
Elevated IL-27 and altered anti-inflammatory cytokine levels in SLE patients with end-stage renal disease.
Bayati P, Neamah DH, Bagheri Y … +5 more , Sadani S, Emtiazi N, Saeidi M, Ghorbani S, Amirkhanlou S
Clin Biochem · 2026 Jun · PMID 41722716 · Publisher ↗
OBJECTIVES: IL-10, TGF-β, IL-4, IL-27, and EBI3 are cytokines that regulate inflammation, tissue repair, and fibrosis in the kidney and other organs. These cytokines may contribute to different aspects of chronic kidney...
OBJECTIVES: IL-10, TGF-β, IL-4, IL-27, and EBI3 are cytokines that regulate inflammation, tissue repair, and fibrosis in the kidney and other organs. These cytokines may contribute to different aspects of chronic kidney disease (CKD), end-stage renal disease (ESRD), and systemic lupus erythematosus (SLE), which are associated with renal dysfunction and aberrant immune regulation. This study investigates the role of these cytokines in patients with concurrent kidney disease and SLE to understand their contribution to the pathogenesis and progression of this complex condition. DESIGN & METHODS: Cytokine levels were measured in five groups of CKD/ESRD patients with concurrent SLE, CKD/ESRD patients without SLE, and healthy controls. We conducted a cross-sectional modest size study with 78 patients and 40 healthy controls (n = 118 total). Serum levels of IL-10, TGF-β, IL-4, IL-27, and EBI3 were measured using the ELISA. The data were analyzed and compared using theKruskal-Wallis test. RESULTS: Significant differences in cytokine patterns were observed. IL-10, IL-4, and EBI3 levels were elevated in CKD/ESRD patients with SLE compared to healthy controls, indicating immune dysregulation. TGF-β levels were significantly lower, suggesting a deficiency in immune regulation. IL-27 levels were found to be increased in ESRD patients with SLE compared to those without SLE, indicating its potential role in disease activity. CONCLUSION: Our study suggests that cytokines like IL-27 may be associated with disease status in patients with both ESRD and SLE. However, its utility for monitoring disease activity or guiding treatment requires validation in larger, prospective cohorts to establish sensitivity, specificity, and a causal role.
TUG1 and miR-145 as potential biomarkers associating hypothyroidism to cardiovascular risk.
Motawi TK, Shaker OG, Saied H … +1 more , Sayed NH
Clin Biochem · 2026 Mar · PMID 41722715 · Publisher ↗
OBJECTIVES: RNA based epigenetic modifications and their relations with chronic diseases have been widely studied. The current study aimed to determine the role of long noncoding RNA (lncRNA) TUG1 and microRNA 145 (miR-1...
OBJECTIVES: RNA based epigenetic modifications and their relations with chronic diseases have been widely studied. The current study aimed to determine the role of long noncoding RNA (lncRNA) TUG1 and microRNA 145 (miR-145) in the pathophysiology and progression of hypothyroidism as well as their impact on subsequent cardiovascular disorders. DESIGN & METHODS: Serum levels of TUG1 and miR-145 were measured in three different groups, 40 overt hypothyroid (OHT) patients, 40 subclinical hypothyroid (SHT) patients and 45 healthy controls. All individuals were subjected to a full history investigation and clinical examination. Flow mediated vasodilation of the brachial artery was measured to evaluate endothelial function. Serum samples were also tested for T4, TSH, TG, TC, HDL, LDL, HbA1c, glucose and insulin. RESULTS: TUG1 level was significantly increased in OHT and SHT patients compared to the healthy controls. TUG1 correlated positively with TC, LDL levels and endothelial dysfunction, while correlated negatively with HDL. Regarding miR-145, its expression level was downregulated only in OHT patients as compared to controls and SHT patients. There were significant negative correlations with TC, LDL and endothelial dysfunction and significant positive correlation with HDL. A significant negative correlation existed between TUG1 and miR-145. CONCLUSIONS: TUG1 could be considered a powerful diagnostic tool to distinguish HT patients, while miR-145 could serve as a negative independent predictor for the progression of HT among subclinical patients. TUG1/miR-145 trajectory could affect the progression of hypothyroidism and the incidence of cardiovascular diseases through impacting patients' lipid profile and endothelial integrity. They could be potential biomarkers and predictors for hypothyroidism pathophysiology.
Novel fibrinogen mutations in pediatric patients: implications for neonatal coagulation screening and family genetic counseling.
Jiang J
Clin Biochem · 2026 Mar · PMID 41707825 · Publisher ↗
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Interference and failure: The challenge of high-concentration IgM monoclonal protein in capillary zone electrophoresis.
Zhao Y, Zhang M, Gan W
Clin Biochem · 2026 Mar · PMID 41702487 · Publisher ↗
BACKGROUND: Capillary zone electrophoresis (CZE) is a standard method for serum protein separation, but its performance can be compromised by IgM monoclonal proteins, leading to false-negative results. METHODS: We report...
BACKGROUND: Capillary zone electrophoresis (CZE) is a standard method for serum protein separation, but its performance can be compromised by IgM monoclonal proteins, leading to false-negative results. METHODS: We report a case of Waldenström macroglobulinemia (IgM 56.05 g/L) with repeated CZE failure. Immunofixation electrophoresis (IFE) confirmed an IgM kappa monoclonal protein. Four pretreatment protocols were evaluated: 1) 37°C incubation; 2) dilution with distilled water; 3) dilution with 0.9% saline; and 4) pretreatment with β‑mercaptoethanol (BME). Gel-based serum protein electrophoresis (SPE) and immunosubtraction CZE were also performed to investigate the interference mechanism. RESULTS: Initial CZE failed to yield an interpretable electrophoretogram. Incubation at 37°C showed no improvement. Dilution with distilled water induced visible precipitation and resulted in a false-negative electrophoretic pattern with a marked drop in measured total protein. Dilution with saline prevented precipitation but still failed to reveal a distinct monoclonal spike, despite biochemical measurements consistent with high globulin levels. In contrast, pretreatment with BME successfully restored a clear monoclonal spike in the β‑γ region on CZE, demonstrating restored solubility and proper migration. IFE corroborated the presence of the IgM kappa monoclonal protein. Gel-based SPE successfully showed a distinct M-protein band without interference, while immunosubtraction CZE failed under both temperature conditions, supporting cryoglobulin-related interference. CONCLUSIONS: Very high IgM concentrations, particularly with cryoglobulin activity, can cause complete CZE failure not resolved by standard dilution or heating. The interference likely involves capillary obstruction from protein aggregation or temperature-dependent re-precipitation within the capillary. BME pretreatment is a critical intervention for unmasking IgM monoclonal proteins when CZE results are inconsistent with other laboratory findings, thereby preventing diagnostic errors.
Indirect reference intervals for thyroid function tests: refineR, RefLim and effects of pathological test results.
Aas FE, Westbye AB, Husøy MAR … +3 more , Kelp OE, Zykova SN, Thorsby PM
Clin Biochem · 2026 Mar · PMID 41702486 · Publisher ↗
BACKGROUND: Biochemical tests with reference intervals (RIs) are extensively used in medicine. RIs should reflect the population tested, and indirect methods for RI construction are increasingly used. Thyroid function te...
BACKGROUND: Biochemical tests with reference intervals (RIs) are extensively used in medicine. RIs should reflect the population tested, and indirect methods for RI construction are increasingly used. Thyroid function tests (TFTs) are used to diagnose and monitor thyroid disorders, that are especially common among women. We report investigations into factors that influence indirect TFT RIs using real world data. METHODS: Indirect RIs were calculated (refineR and RefLim) for two laboratories with very different proportions of pathological results for thyroid stimulating hormone (TSH), free thyroxine (FT4) and free triiodothyronine (FT3), all measured on Abbott Alinity i. For one laboratory total thyroxine (TT4) and total triiodothyronine (TT3) were also investigated. Effects of pathological results on indirect RIs were investigated and indirect RIs were compared to direct RIs from Abbott and from a reference population (HUNT4). RESULTS: Some TFT RIs differed markedly between the two laboratories, but removal of suspected pathological results reduced the discrepancy. Choice of algorithm for indirect RIs influenced the RIs, and indirect RIs were wider than the direct RIs from HUNT4. Most of our calculated RIs - from indirect (real world data) or direct (HUNT4) methods - were markedly narrower than Abbott-provided RIs, particularly for FT4 and FT3. CONCLUSIONS: Indirect RIs for TFT are easily calculated but are affected by several factors that laboratories should be aware of. Manufacturer-provided RIs can differ markedly from in-house RIs.
Best practice recommendations for laboratory analysis and reporting of cerebrospinal fluid oligoclonal banding and associated tests for multiple sclerosis (MS): a consensus report from the harmonized CSF analysis for MS investigation (hCAMI) subcommittee of the Canadian society of clinical chemists (CSCC).
Higgins V, Parker ML, Ahmed B … +18 more , Bhayana V, Booth RA, Chen Y, Collier C, Freedman MS, Gagné M, Ismail OZ, Gifford JL, Macri J, Moore CS, Newbigging A, Olayinka L, Poliakov I, Rodriguez-Capote K, Schneider R, Thebault S, Yang L, Beriault DR
Clin Biochem · 2026 Mar · PMID 41692184 · Publisher ↗
Cerebrospinal fluid (CSF) oligoclonal banding (OCB) analysis is an important component in the diagnosis of multiple sclerosis (MS). In the 2024 McDonald Criteria for MS diagnosis, CSF-specific OCB can support MS diagnosi...
Cerebrospinal fluid (CSF) oligoclonal banding (OCB) analysis is an important component in the diagnosis of multiple sclerosis (MS). In the 2024 McDonald Criteria for MS diagnosis, CSF-specific OCB can support MS diagnosis, including in those with relapsing or progressive presentations, as well as radiologically isolated syndrome and other non-specific presentations. Despite its clinical importance, laboratory guidelines for analysis and reporting of CSF OCB testing are largely lacking. To address this gap, the Harmonized CSF Analysis for MS Investigation (hCAMI) Subcommittee of the Canadian Society of Clinical Chemists (CSCC) was established to develop evidence-based best practice recommendations for CSF OCB and associated tests and indices. The hCAMI subcommittee is comprised of clinical chemists representing all Canadian laboratories performing CSF OCB testing, and neurologists and a neuroimmunologist from across Canada. Six key areas were identified for harmonization: quality assurance, specimen pairing and timing, reporting of CSF-specific bands, interpreting mirror patterns, band intensity mismatch, reported panel components, and reference intervals/decision limits. Recommendations were informed by national surveys on laboratory practices and clinician preferences, a comprehensive literature review, and original studies addressing evidence gaps. A modified Delphi process, conducted over three iterations, was used to refine and attempt to achieve consensus on 25 draft statements. Of these, 24 achieved consensus (≥80% agreement) and form the final set of hCAMI recommendations. These best practice recommendations aim to promote consistency, accuracy, and clinical utility of CSF OCB testing for MS diagnosis in Canada. While implementation will depend on local resources and workflows, alternative approaches are discussed where appropriate. This initiative establishes a foundation for national harmonization of CSF OCB analysis and supports future integration of best laboratory practices into clinical guidelines.
Choosing Wisely Canada recommendations for point of care testing utilization in the acute care setting: Expert-based Delphi consensus from the Canadian Society of Clinical Chemists.
Kaur S, Arnoldo S, Taher J … +15 more , Bailey D, Beach L, Beriault DR, Bouhtiauy I, Brun M, Elnenaei M, Huang Y, Khan AI, Kinniburgh D, Massicotte L, Rezvanpour A, Rodriguez-Capote K, Thakur V, Yip P, Venner AA
Clin Biochem · 2026 Mar · PMID 41692183 · Publisher ↗
INTRODUCTION: Point of care testing (POCT) offers a broader selection of clinical testing outside of a central laboratory due to its many benefits, such as accessibility and rapid turn-around-time. However, it does have...
INTRODUCTION: Point of care testing (POCT) offers a broader selection of clinical testing outside of a central laboratory due to its many benefits, such as accessibility and rapid turn-around-time. However, it does have disadvantages and challenges, so proper utilization of POCT is vital to its success. A common area for POCT use is in the acute care setting, and improving the use and quality of POCT in this setting remains clinically important. The Canadian Society of Clinical Chemists (CSCC) POCT Special Interest Group (SIG) and Utilization Management SIG aimed to develop Choosing Wisely Canada recommendations for POCT in the acute care setting. METHODS: A working group consisting of 17 experts from the CSCC POCT and Utilization Management SIGs formed to develop recommendations to be evaluated through a two-round modified Delphi consensus survey. Survey consensus was reached if > 80% of the experts rated recommendations with a score of 4 or 5. RESULTS: A final draft of 12 recommendations were developed, with accompanying rationale and references. Choosing Wisely Canada completed their review, including review by their stakeholder national societies, which led to a finalized seven recommendations. CONCLUSIONS: A collaborative adoption of the evidence-based, seven Choosing Wisely Canada POCT recommendations in acute care settings will help support improved patient care through strong diagnostic integrity, augmented safeguards to patients, and optimization of related healthcare resources. A strong quality management system framework embedded within the implementation of these recommendations will augment the value of POCT within a sustained patient-centered acute care healthcare setting.
Corrigendum to "Improving the environmental impact paradox of clinical medical laboratories" [Clin. Biochem. 141 (2026) 111063].
Sörme P, Weitze S
Clin Biochem · 2026 Mar · PMID 41688263 · Publisher ↗
Abstract loading — click title to view on PubMed.
Serum zinc, copper, and the Zn/Cu ratio across the glycemic spectrum: evidence from an automated clinical chemistry platform.
Sarıkaya U, Selek Ş, Sarıkaya A
Clin Biochem · 2026 Mar · PMID 41666991 · Publisher ↗
OBJECTIVES: The zinc-to-copper ratio (Zn/Cu) integrates the opposing redox and metabolic roles of zinc and copper and may offer additional value for stratifying glycemic risk in clinical practice. This study evaluated se...
OBJECTIVES: The zinc-to-copper ratio (Zn/Cu) integrates the opposing redox and metabolic roles of zinc and copper and may offer additional value for stratifying glycemic risk in clinical practice. This study evaluated serum zinc, copper, and the Zn/Cu ratio across the glycemic spectrum using a routine automated chemistry analyzer. DESIGN AND METHODS: In this cross-sectional study, 217 adults were categorized into control (n = 78), impaired fasting glucose (n = 60), insulin resistance (n = 48), and type 2 diabetes mellitus (T2DM; n = 31) groups based on fasting plasma glucose, hemoglobin A1c (HbA1c), and homeostatic model assessment of insulin resistance (HOMA-IR), using American Diabetes Association thresholds. Serum zinc and copper were measured on an ARCHITECT c16000 analyzer with validated colorimetric assays, and the Zn/Cu ratio was calculated. Group comparisons used ANOVA; correlations with glycemic indices were assessed using Pearson's r and multivariable linear regression adjusted for age and sex. Discrimination of T2DM was evaluated via receiver operator characteristic analysis. RESULTS: Serum copper increased and the Zn/Cu ratio decreased progressively from control to T2DM (p = 0.0148 and p = 0.0135, respectively), while zinc levels did not differ significantly between groups. Zn/Cu showed negative correlations with fasting glucose, insulin, HbA1c, and HOMA-IR, and was independently associated with lower HOMA-IR in regression models (β = - 6.81; 95% CI: -11.16 to - 2.46). Zn/Cu discriminated T2DM with an area under the curve of 0.675. CONCLUSIONS: The Zn/Cu ratio, derived from routine clinical chemistry assays, reflects glycemic dysregulation and insulin resistance. It may serve as a low-cost, pragmatic adjunct to standard markers such as fasting glucose and HbA1c in clinical laboratories.
Application of thrombosis-related biomarkers in the diagnosis and thrombosis risk stratification of heparin-induced thrombocytopenia patients.
Wang H, Lv P, Qu C … +1 more , Hu S
Clin Biochem · 2026 Mar · PMID 41655675 · Publisher ↗
OBJECTIVE: To evaluate thrombomodulin (TM), thrombin-antithrombin complex (TAT), plasmin-α2-plasmin inhibitor complex (PIC), tissue-plasminogen activator-inhibitor complex (t-PAIC), and D-dimer for diagnosing heparin-ind...
OBJECTIVE: To evaluate thrombomodulin (TM), thrombin-antithrombin complex (TAT), plasmin-α2-plasmin inhibitor complex (PIC), tissue-plasminogen activator-inhibitor complex (t-PAIC), and D-dimer for diagnosing heparin-induced thrombocytopenia (HIT) and stratifying thrombosis risk. METHODS: A total of 221 patients with suspected HIT were classified as HIT-positive (HIT+) or HIT-negative (HIT-), with HIT+ further stratified by thrombosis (HITT+/HITT - ). We collected clinical variables and identified HIT risk factors using multivariable logistic regression. Group differences in TM, TAT, PIC, t-PAIC, and D-dimer were assessed, diagnostic performance was examined using receiver operating characteristic (ROC) curves, and correlations were tested with Spearman's rank correlation. Kaplan-Meier analysis estimated the 15-day cumulative incidence of thrombosis in HIT patients stratified by TAT. RESULTS: Elevated 4T scores and HIT antibody levels were independent risk factors for HIT. TM, TAT, and D-dimer levels were higher in HIT+ versus HIT-. Only TAT was elevated in HITT+ versus HITT-, correlating positively with HIT antibodies. For diagnosing HIT, the areas under the curve (AUCs) for TM, TAT, and D-dimer were 0.712, 0.735, and 0.721, respectively. The combination of these three markers yielded the highest efficacy (AUC = 0.807). TAT showed predictive value for thrombosis among HIT patients; a threshold of 12.11 µg/L yielded the best performance. Kaplan-Meier analysis demonstrated a significantly higher 15-day thrombosis risk for patients with TAT ≥ 12.11 µg/L vs. < 12.11 µg/L. CONCLUSION: TM, TAT, and D-dimer can serve as auxiliary biomarkers for HIT diagnosis, with combined use improving accuracy. Notably, TAT may be useful in guiding risk-stratified anticoagulation therapy based on thrombotic risk.
Inter-laboratory variability in vancomycin measurement in an external quality assessment scheme 2016-2025.
Larsson A, Cedernaes J, Eriksson MB … +5 more , Helldén A, Skarin M, Ranta P, Karlsson M, Hamberg AK
Clin Biochem · 2026 Mar · PMID 41655674 · Publisher ↗
INTRODUCTION: Vancomycin is a critical antibiotic for treating severe Gram-positive infections. Due to its narrow therapeutic window, reliable plasma concentration measurements are essential for dose adjustment and avoid...
INTRODUCTION: Vancomycin is a critical antibiotic for treating severe Gram-positive infections. Due to its narrow therapeutic window, reliable plasma concentration measurements are essential for dose adjustment and avoiding toxicity. However, method-dependent analytical variability between immunoassay platforms may compromise result comparability. METHODS: Data from 78 external quality assurance (EQA) samples distributed between 2016 and 2025 by Labquality (Helsinki, Finland) and Equalis (Uppsala, Sweden) were analyzed. Results from laboratories using immunoassays from Abbott Laboratories (n = 1391), Beckman Coulter (n = 172), Roche Diagnostics (n = 3584), Ortho Clinical Diagnostics (n = 78), Siemens Healthineers (n = 1670), Thermo Fisher (n = 152), and ARK Diagnostics (n = 33) were included (total = 7104). The mean consensus value for each sample was used as reference. RESULTS: Across the study period, Abbott Laboratories (+4.7%), Thermo Fisher (+12%), Ortho Clinical Diagnostics (-4.6%), and Siemens Healthineers (-4.9%) showed systematic biases relative to the consensus mean, whereas Beckman Coulter (-0.3%), Roche Diagnostics (<0.1%), and ARK Diagnostics (-2.4%) displayed good agreement. Temporal trends indicated method-specific drifts, most notably for Beckman Coulter (-20.2%) and Siemens Healthineers (+12.5%). Coefficients of variation ranged from 0.9% (ARK Diagnostics) to 12.1% (Beckman Coulter). CONCLUSION: Considerable intermethod bias and temporal drift exist among commonly used vancomycin immunoassays, underscoring the need for improved calibration harmonization and traceability to ensure consistent therapeutic drug monitoring.
Evidence-based extension of reagent shelf-life beyond expiry using patient-based moving averages, westgard sigma rules, and CLSI EP25.
Khelil MM, Badrick T
Clin Biochem · 2026 Mar · PMID 41633499 · Publisher ↗
BACKGROUND: Reagent stability is a significant determinant of analytical reliability in clinical laboratories. Post-expiry reagent use is often discouraged due to the potential risk of systematic bias; however, empirical...
BACKGROUND: Reagent stability is a significant determinant of analytical reliability in clinical laboratories. Post-expiry reagent use is often discouraged due to the potential risk of systematic bias; however, empirical data supporting or refuting such restrictions are limited. METHODS: This study evaluated the post-expiry performance of free T3 (FT3) and free T4 (FT4) immunoassays on the Abbott Architect i1000SR analyzer using an integrated framework combining three complementary approaches: (i) a simulation-optimized moving average (MA) model based on real patient data (ii) Westgard Sigma rules quality control, and (iii) Clinical and Laboratory Standards Institute EP25-A drift analysis. The MA was optimised via Monte Carlo simulations using a step-shift bias model, which defined the optimal window size (N) for 90% detection power and 0% false rejection rate. Stability was then assessed across three reagent lots per analyte, spanning both pre- and post-expiration phases. RESULTS: Westgard rules provided the earliest analytical alerts, while EP25 confirmed sustained drift relative to allowable total error. The MA detected progressive instability, showing strong concordance with EP25 after lag correction (N × cadence). FT4 indicated extended stability of up to 19 months post-expiry, while FT3 showed limited stability (<4 months). These differences reflected distinct assay robustness and kinetics. CONCLUSIONS: The combination of Westgard sigma rules, EP25, and simulation-optimized MA provides a reproducible, data-driven framework for post-expiry reagent stability assessment. Optimizing MA with real patient data enhances detection performance, bridging theoretical quality-control design and routine laboratory application. This integrated approach enables laboratories to make scientifically justified, cost-effective decisions regarding reagent reuse beyond manufacturer expiry dates.
Autoantibody testing in neuromuscular medicine: assay technologies, interpretation, and clinical utility.
Zhang T, Mills JR, Dubey D … +1 more , Klein CJ
Clin Biochem · 2026 Mar · PMID 41633498 · Publisher ↗
Neuromuscular autoantibody testing is an essential component in the diagnosis and management of autoimmune neuromuscular disorders. These immune-mediated diseases target antigens found in nerves, muscles, and neuromuscul...
Neuromuscular autoantibody testing is an essential component in the diagnosis and management of autoimmune neuromuscular disorders. These immune-mediated diseases target antigens found in nerves, muscles, and neuromuscular junctions, and may occasionally involve the central nervous system, resulting in complex clinical presentations. Developments in antibody identification and validation have provided clinically relevant biomarkers for diagnostic, therapeutic, and prognostic purposes. Among antibody-associated neuromuscular disorders, paraneoplastic onconeural autoantibodies are of particular significance, as their presence may direct search for specific underlying malignancies. Appropriate ordering and interpretation of these tests should be integrated with clinical and electrodiagnostic (CEDX) findings. Given that these disorders are often rare, estimating an optimal pre-test probability is important to improve test accuracy and reduce false positive outcomes. Online clinical calculators are available to help clinicians determine appropriate testing strategies for some disorders. This review summarizes principal neuromuscular antibodies, current testing approaches, and the influence of laboratory data on patient care.
α-Synuclein seed amplification assay methodology and performance in Parkinson's disease, lewy body dementia, and multiple system atrophy: A meta-analysis.
Helbling C, Yeung S, DeMarco ML
Clin Biochem · 2026 Mar · PMID 41621636 · Publisher ↗
Seed amplification assays have shown promise in research for accurate diagnosis of synucleinopathies. In consideration of clinical implementation, gaps in the literature include that performance data are frequently deter...
Seed amplification assays have shown promise in research for accurate diagnosis of synucleinopathies. In consideration of clinical implementation, gaps in the literature include that performance data are frequently determined using clinically unrelated controls (e.g., healthy controls or phenotypically unrelated conditions [UC]), and a lack of emphasis on methodological variability, including required replicates and positivity thresholds. A review and meta-analysis were performed to assess the methodological parameters and diagnostic performance of seed amplification assays for detecting synucleinopathies and, where necessary, cohorts were adjusted to be more representative of the populations in which the testing would be deployed in clinical practice. A search was conducted for α-synuclein seed amplification assay studies on Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy, for matrices including cerebrospinal fluid (CSF), skin, and olfactory mucosa (OM). Assay methodological details were extracted, as were diagnostic performance data. For the latter, negative controls were divided into two distinct groups: disease mimics (DM) and UC. A total of 55 studies met the inclusion/exclusion criteria. Methodological parameters varied including the concentration, sequence and source of the assay substrate, as well as required assay replicates and determination of the positivity threshold. Median sensitivities and specificities relative to DM groups for CSF were 0.92 (95% confidence interval: 0.88-0.96) and 0.90 (0.89-0.96), for skin were 0.94 (0.79-1.0) and 0.86 (0.83-1.0), and for OM were 0.69 (0.33-1.0) and 0.94 (0.83-1.0), respectively. Although diagnostic performance was slightly reduced when adjusting for clinically relevant populations, it remained encouragingly high. Towards broader clinical implementation, valuable research directions include further streamlining of analytical workflows, and characterizing diagnostic performance by stage of disease and co-pathologies.
Silent electrolyte imbalance unmasked by paralysis: a case of hypokalemia in a middle-aged woman.
Advani A, Ahmed H, Shabbir MA … +2 more , Ahmed M, Khan T
Clin Biochem · 2026 Mar · PMID 41616965 · Publisher ↗
BACKGROUND: Hypokalemic periodic paralysis is a rare autosomal dominant muscle channelopathy often misdiagnosed due to its atypical presentation. It is characterized by episodic flaccid paralysis with low serum potassium...
BACKGROUND: Hypokalemic periodic paralysis is a rare autosomal dominant muscle channelopathy often misdiagnosed due to its atypical presentation. It is characterized by episodic flaccid paralysis with low serum potassium levels and may be triggered by factors such as high carbohydrate intake, infections, or medications. CASE PRESENTATION: We report the case of a 25-year-old female who presented with acute ascending flaccid paralysis and was initially misdiagnosed with Guillain-Barré syndrome. Despite biochemical and electrocardiographic evidence of hypokalemia (serum K: 2.7 mEq/L; electrocardiogram showing U waves and flattened T waves), potassium correction was not initiated. The patient rapidly deteriorated, required mechanical ventilation, and ultimately succumbed to her condition. Thyroid function testing was not performed despite clinical red flags, including a history of anxiety and depression, raising suspicion for thyrotoxic periodic paralysis. DISCUSSION: This case highlights the diagnostic challenges of hypokalemic paralysis, particularly when presenting as a neurological emergency without classic features. The failure to promptly correct hypokalemia and investigate its underlying etiology contributed to a preventable fatal outcome. A systematic "hypokalemia-first" approach is recommended to avoid such diagnostic delays in similar clinical settings. CONCLUSION: Timely recognition and correction of hypokalemia, alongside targeted evaluation of underlying causes such as thyrotoxicosis, are critical in patients presenting with acute flaccid paralysis. Standardized emergency protocols could significantly improve outcomes and prevent avoidable fatalities.
Fibroblast growth factor 23-induced hypophosphatemia in a malignant phosphaturic mesenchymal tumor: presentation of a rare case.
Chicangana Tuquerres DA, Sastre Martínez AD, Barrios Herrera CM … +4 more , Torres Pérez PA, Acuña Roldán CF, Varela Aguirre GJ, García Ramos AF
Clin Biochem · 2026 Mar · PMID 41592664 · Publisher ↗
INTRODUCTION: Tumor-induced osteomalacia is a rare paraneoplastic disorder caused by excess fibroblast growth factor 23 (FGF23), most often produced by phosphaturic mesenchymal tumors. Delayed diagnosis may result in sev...
INTRODUCTION: Tumor-induced osteomalacia is a rare paraneoplastic disorder caused by excess fibroblast growth factor 23 (FGF23), most often produced by phosphaturic mesenchymal tumors. Delayed diagnosis may result in severe metabolic and skeletal complications. CASE PRESENTATION: We report the case of a 32-year-old woman with a three-year history of progressive weakness and a rapidly enlarging thoracic mass. Imaging revealed an 18 × 13 cm highly vascularized thoracic lesion with multiple lytic bone metastases. Laboratory evaluation showed severe hypophosphatemia (0.9 mg/dL), renal phosphate wasting (fractional excretion of phosphate 24.5%), elevated intact parathyroid hormone, low vitamin D levels, and markedly increased serum FGF23 (7926 kRU/L). Histopathological examination and immunohistochemistry demonstrated a malignant phosphaturic mesenchymal tumor with positivity for CD56, SATB2, and SSTR2A. DISCUSSION: This case highlights the aggressive clinical behavior that malignant phosphaturic mesenchymal tumors may exhibit, including extensive local invasion, metastatic disease, and profound metabolic derangements. The diagnosis of tumor-induced osteomalacia requires a high index of suspicion and an integrated approach combining biochemical evaluation, functional imaging, and detailed pathological assessment. CONCLUSIONS: Tumor-induced osteomalacia should be considered in patients with persistent hypophosphatemia and phosphate wasting. Early recognition is essential, as complete surgical resection remains the only curative option. In advanced or unresectable disease, management is challenging and may be limited by tumor burden and access to targeted therapies, including anti-FGF23 agents, which offer biochemical and symptomatic benefit in selected cases.
The CDKN2A/B rs10811661 polymorphism is associated with metabolic syndrome, insulin resistance, and lipid levels in individuals with obesity and impaired fasting glucose.
de Luis D, Izaola O, Primo D
Clin Biochem · 2026 Mar · PMID 41587582 · Publisher ↗
BACKGROUND & AIMS: A significant association has been confirmed between the rs10811661 polymorphism in the CDKN2 gene, and increased susceptibility to type 2 diabetes. The present study aimed to investigate the associati...
BACKGROUND & AIMS: A significant association has been confirmed between the rs10811661 polymorphism in the CDKN2 gene, and increased susceptibility to type 2 diabetes. The present study aimed to investigate the association of the rs10811661 polymorphism with metabolic syndrome (MS) in individuals with obesity and impaired fasting glucose (IFG). METHODS: This research was conducted on 110 individuals diagnosed with obesity and IFG. Data collection included anthropometric measurements, arterial blood pressure, biochemical profiles, and the assessment of the prevalence of MS among participants. In addition, the study examined the genotypic distribution of the CDKN2 gene polymorphism (rs10811661) RESULTS: There were 73 women (66.4%) and 37 men (33.6%) with an average body mass index of 40.1 ± 1.9 kg/m (range: 35.7-42.4). When comparing the two genotype groups under a recessive model framework (CC + CT versus TT), several differences emerged. Specifically, individuals carrying both T alleles exhibited higher systolic blood pressure levels, waist circumference, fasting glucose, triglycerides, low-density lipoprotein cholesterol, hemoglobin A1c, insulin, and HOMA-IR. Logistic regression analysis showed an increased risk of MS in TT subjects (OR = 2.99, 95% CI = 1.08-18.11; p = 0.03) after adjusting. CONCLUSIONS: The CDKN2A/B rs10811661 TT genotype is associated with a higher prevalence of MS and adverse metabolic traits in individuals with obesity and IFG.
Clinical Labs: Working with planetary health for patient health.
Mattman A, Simons J
Clin Biochem · 2026 Mar · PMID 41587581 · Publisher ↗
This article reflects on the relationship between Planetary Health and healthcare workers in 2025. As clinical chemistry specialists working within the healthcare system, attention to the health of the patients who utili...
This article reflects on the relationship between Planetary Health and healthcare workers in 2025. As clinical chemistry specialists working within the healthcare system, attention to the health of the patients who utilize our portion of the healthcare system now extends beyond provision of information. How we provide that information, how often we provide this information, and how extensive the information is that we do provide impacts Planetary Health - the major determinant of health for our patients born this year and thereafter. We summarize the importance of looking at this broader view of health as lab specialists have agency in effecting how clinical labs operate in the remainder of this century. Our position is that this agency should be in alliance with Planetary Health for the benefit of our patient's health in the next generations. We recognize the patient born today, a 50 year old in 2075, as a Patient Advocate Virtual (PAV) who could symbolically be present in decision making in the clinical lab - and throughout the healthcare system - to remind us of the importance of caring for Planetary health tomorrow while we care for patients today.
Acquired bisalbuminemia: A case report.
Addesso R, Sarpa S, Ferrandino M … +4 more , Giorgione C, Marrone A, Savoia M, Castaldo G
Clin Biochem · 2026 Mar · PMID 41579921 · Publisher ↗
BACKGROUND: Bisalbuminemia is a rare condition characterized by the presence of two distinct albumin peaks with different mobilities on serum protein electrophoresis (SPE). It may be inherited or acquired. In several cas...
BACKGROUND: Bisalbuminemia is a rare condition characterized by the presence of two distinct albumin peaks with different mobilities on serum protein electrophoresis (SPE). It may be inherited or acquired. In several cases it can result from interactions with different metabolites. METHODS: A 36-year-old woman, with a history of intrahepatic cholestasis of pregnancy and a subsequent episode of severe cholestatic jaundice, underwent biochemical and haematological tests. SPE profile at capillary electrophoresis (CE) revealed an abnormal peak in the alpha1 region, suggestive of acquired bisalbuminemia. To investigate the nature of the 'atypical' SPE profile, we performed PEG treatment on the patient's serum. RESULTS: The experiments performed after PEG treatment confirmed that the iatrogenic bisalbuminemia was due to the albumin-bile acids complex. Furthermore, neither standard nor high-resolution (HR) agarose gel electrophoresis (AGE) revealed bisalbuminemia, detected by CE. The patient's treatment with odevixibat reduced bile acid and other cholestasis parameters, led to the disappearance of bisalbuminemia. CONCLUSION: In this case we demonstrated that acquired bisalbuminemia is related to the formation of albumin-bile acids complex. We observed that bisalbuminemia was absent on AGE, both in classical and HR electrophoresis, leading us to conclude that the interference due to albumin-bile acids complex was detected only in CE technique. A critical laboratory approach is essential to distinguish analytical interferences from clinically relevant abnormalities, allowing clinicians to make informed diagnostic and therapeutic decisions.
Advantages and application of a decision tree algorithm combined with the Harris-Boyd criterion in the construction of dynamic reference intervals for coagulation indicators during pregnancy.
Lin X, Lin Z, Xu L … +2 more , Zhao F, Weng Y
Clin Biochem · 2026 Mar · PMID 41565094 · Publisher ↗
INTRODUCTION: Reference intervals (RIs) based on fixed gestationals may not accurately reflect the dynamic changes of the hypercoagulable state. This study aimed to evaluate the rationality of integrating a decision tree...
INTRODUCTION: Reference intervals (RIs) based on fixed gestationals may not accurately reflect the dynamic changes of the hypercoagulable state. This study aimed to evaluate the rationality of integrating a decision tree algorithm (DTA) with the Harris-Boyd criterion (DTAHBC) to establish dynamic RIs for coagulation indicators during pregnancy. MATERIALS AND METHODS: Dynamic data of prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (Fib), D-dimer (D-d), and fibrin degradation product (FDP) were retrospectively analyzed in 4,698 healthy pregnant women. Scatter plots were drawn to observe changes regarding each indicator during pregnancy. DTAs were used to identify dynamic inflection points, which were validated using the Harris-Boyd criterion. Moreover, 2.5th and 97.5th percentiles and their 90% confidence intervals were calculated. New RIs were compared to traditional trimester-based RIs and validated by coincidence rates within the cohort. RESULTS: The study showed that PT, INR, APTT, and TT values were stable across gestation weeks. However, Fib, D-d, and FDP values increased rapidly. The DTA analysis found inflection points misaligned with traditional trimester-based nodes. Compared to traditional methods, the new method identified the initial stage of coagulation activation in the second trimester (FDP exceeding non-pregnant ranges at 14-21 weeks) and the aggravation stage of hypercoagulability in the late trimester (median FDP exceeding non-pregnant upper limits at 34-40 weeks). Validation in the same cohort revealed compliance rates >90% for new RIs, whereas traditional TT (82.11%) and D-d (87.89%) measurements obtained at 14-27 weeks failed validation. CONCLUSION: DTAHBC-based RIs do not follow the traditional trimester division, can effectively reflect dynamic changes in coagulation indicators, and provide a new solution for coagulation-function evaluation during pregnancy.
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