Clinical Biochemistry[JOURNAL]
Sun
200 papers
Prognostic value of human serum alpha-klotho concentrations in patients with heart failure with reduced ejection fraction.
Mahenthiran A, Nunes SA, Liu CF … +3 more , Leon S, Wilcox J, Tang WHW
Clin Biochem · 2026 Mar · PMID 41565093 · Publisher ↗
OBJECTIVE: Heart Failure (HF) is a major health problem with high prevalence and mortality. Identifying new biomarkers involved in controlling heart failure progression has become particularly important. This study evalu...
OBJECTIVE: Heart Failure (HF) is a major health problem with high prevalence and mortality. Identifying new biomarkers involved in controlling heart failure progression has become particularly important. This study evaluated the association between serum α-klotho concentrations and long-term all-cause mortality in patients with stable HF. DESIGN AND METHODS: We analyzed serum α-klotho levels in 230 adults (135 patients with HF with reduced ejection fraction and 95 age and sex-matched healthy controls). A classification and regression tree analysis was used to stratify patients by α-klotho concentration, using all-cause mortality within a 5-year follow-up as the primary endpoint. Differences in log-NT-proBNP levels across α-klotho groups were assessed using the Kruskal-Wallis test with Dunn's post-hoc comparisons. Kaplan-Meier survival analysis evaluated the association between α-klotho stratified groups and 5-year all-cause mortality. RESULTS: Patients with higher serum α-klotho levels had significantly lower mortality and lower log NT-proBNP across α-klotho groups (χ(2) = 8.05, p = 0.018) when compared to lower α-klotho concentration levels. Kaplan-Meier curves show the significant difference in survival across α-klotho stratification (log-rank p < 0.01). CONCLUSION: Patients with higher serum α-klotho concentrations were associated with lower log-NT-proBNP levels and better 5-year survival in all patients as well as in patients with heart failure, compared to those with lower. These findings support the role of α-klotho as a promising cardioprotective biomarker for risk stratification in patients with HF.
Fibrinogen-like protein 1 as a novel biomarker of rheumatoid arthritis and diagnostic basis for disease activity: a diagnostic test study.
Wang X, Wang G, Su J … +6 more , Lu Y, Lu L, Zhu L, Chen B, Gu W, Liu S
Clin Biochem · 2026 Mar · PMID 41558591 · Publisher ↗
BACKGROUND: Early, accurate diagnosis of Rheumatoid Arthritis (RA) is essential for timely intervention, yet a simple and precise method for assessing disease activity remains a challenge. Biomarkers offer a promising so...
BACKGROUND: Early, accurate diagnosis of Rheumatoid Arthritis (RA) is essential for timely intervention, yet a simple and precise method for assessing disease activity remains a challenge. Biomarkers offer a promising solution for disease prediction and monitoring. Consequently, the discovery of novel biomarkers for RA diagnosis and disease activity evaluation is imperative. OBJECTIVE: This study seeks to elucidate the diagnostic utility of fibrinogen-like protein 1 (FGL1, also referred to as HFREP1) in rheumatoid arthritis. METHODS: A total of 237 RA patients and 236 non-RA control subjects were enrolled in this clinical trial. Serum levels of rheumatoid factor (RF), anti-cyclic citrullinated peptide (CCP) antibodies, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were measured and compared against HFREP1 concentrations quantified via enzyme-linked immunosorbent assay (ELISA). RESULTS: Consistent with the established diagnostic gold standard, HFREP1 demonstrated higher sensitivity and negative predictive value compared to CRP and ESR. The area under the receiver operating characteristic curve (AUC) for HFREP1 was comparable to those of CRP and ESR. The combination of HFREP1, CCP antibody, and ESR yielded an AUC of 0.987, which indicates that HFREP1 does not enhance the diagnostic accuracy of the combination of CCP antibody and ESR. The mean serum concentration of HFREP1 was 71.87 ng/mL in patients with remission or low disease activity, compared to 175.47 ng/mL in those with moderate to high disease activity. CONCLUSION: HFREP1 demonstrates diagnostic potential for RA and the capability to assess disease activity. It has greater sensitivity than CRP and ESR and can better evaluate disease activity than RF and CCP. These findings support the potential use of HFREP1 as a diagnostic marker for the diagnosis and assessment of RA. This trial is registered with the Chinese Clinical Trial Registry (Registration No.: ChiCTR2400082686; Date: 2024/04/03).
Hemoglobin Chapel Hill masquerading as hemoglobin S in newborn sickle cell screening: A case study.
Volodko N, Parker ML, Ridsdale R … +9 more , MacNeil L, Sosova I, Estey MP, Proctor D, Olayinka L, Newbigging A, Bordeleau P, Powell M, Higgins V
Clin Biochem · 2026 Mar · PMID 41558590 · Publisher ↗
BACKGROUND: Newborn screening for hemoglobinopathies is an effective tool for the early detection of clinically significant conditions, such as sickle cell disease. High-performance liquid chromatography (HPLC) is broadl...
BACKGROUND: Newborn screening for hemoglobinopathies is an effective tool for the early detection of clinically significant conditions, such as sickle cell disease. High-performance liquid chromatography (HPLC) is broadly used as it enables high-throughput automation and detection of clinically significant variants using minimal sample volumes. However, it may misidentify hemoglobin variants due to overlapping retention times. CASE REPORT: Abnormal sickle cell screening results in a newborn female, including a peak in the hemoglobin S window, prompted hemoglobinopathy investigation. Capillary electrophoresis results suggested a possible alpha chain variant. Genetic testing revealed four distinct alterations, including a hemizygous HBA2 c.224A > G (p.Asp75Gly) variant, known as Hb Chapel Hill, and a 3.7 kb alpha-globin gene deletion consistent with an alpha-thalassemia silent carrier state. CONCLUSION: This case represents the first documented occurrence of Hb Chapel Hill in an infant. Gamma globin production alongside Hb Chapel Hill results in a HbS zone peak on both HPLC and capillary electrophoresis, posing an interpretive challenge. Considering the complete pattern of peaks observed in hemoglobin fractionation methods can help distinguish clinically relevant conditions from likely benign profiles. Molecular analysis in complex cases is essential for confirmation of the suspected diagnosis.
Unresolved issues of multiple citrulline similar-motif antigen in diagnosing rheumatoid arthritis: from specificity to clinical practice.
Chen N
Clin Biochem · 2026 Mar · PMID 41548862 · Publisher ↗
Abstract loading — click title to view on PubMed.
AMH levels and diagnosis in PCOS phenotype D.
Xuan X, Zhang M, Fang Y … +2 more , Su L, Xu K
Clin Biochem · 2026 Mar · PMID 41519190 · Publisher ↗
OBJECTIVES: To evaluate the diagnostic performance of serum anti-Müllerian hormone (AMH) for polycystic ovary syndrome (PCOS) phenotype D, to define overall and age-specific AMH cut-off values, and to explore the associa...
OBJECTIVES: To evaluate the diagnostic performance of serum anti-Müllerian hormone (AMH) for polycystic ovary syndrome (PCOS) phenotype D, to define overall and age-specific AMH cut-off values, and to explore the associations between AMH and other reproductive hormones. DESIGN & METHODS: In this cross-sectional study, serum AMH levels were measured in 169 women with PCOS phenotype D and 224 age-matched healthy controls using a magnetic microparticle acridinium ester chemiluminescence immunoassay. Follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone were assessed with immunoluminescence assays. Correlations between AMH and other hormones were analyzed, and receiver operating characteristic (ROC) curves were used to evaluate diagnostic performance and derive cut-off values, including age-stratified thresholds. RESULTS: Serum AMH, testosterone, and the LH/FSH ratio were significantly higher in the PCOS phenotype D group than in controls (p < 0.0001). AMH was positively correlated with testosterone (r = 0.233, p = 0.002) but not with the LH/FSH ratio. AMH discriminated phenotype D from controls with an area under the ROC curve of 0.779 (95 % CI 0.734-0.825); the optimal overall cut-off was 43.16 pmol/L (sensitivity 71.93 %, specificity 70.67 %). Age-stratified analyses showed robust diagnostic performance across reproductive ages, with cut-off values declining progressively (e.g., 54.16 pmol/L for ≤ 25 years; 35.59 pmol/L for 31-35 years). CONCLUSIONS: Serum AMH is a valuable biomarker for diagnosing PCOS phenotype D. The use of age-specific AMH cut-off values may improve diagnostic accuracy and facilitate earlier recognition of this frequently underdiagnosed PCOS subtype.
Laboratory medicine and sustainability: towards a green lab.
Mattman A, Simons J
Clin Biochem · 2026 Mar · PMID 41500377 · Publisher ↗
This article introduces the special issue of Clinical Biochemistry that focuses on sustainability in laboratory medicine.
This article introduces the special issue of Clinical Biochemistry that focuses on sustainability in laboratory medicine.
Impact of the implementation of the Sampson-NIH equation for the calculation of LDL-C in a large community cohort of adult and pediatric patients in Ontario.
White-Al Habeeb N, Agbor T, Sun D … +4 more , Wan A, Seaton M, Catomeris P, Konforte D
Clin Biochem · 2026 Jan · PMID 41448560 · Publisher ↗
INTRODUCTION: Low-density lipoprotein cholesterol (LDL-C), a known risk factor for cardiovascular disease, is commonly estimated using the Friedewald equation. Although the Sampson-NIH equation has been recommended by th...
INTRODUCTION: Low-density lipoprotein cholesterol (LDL-C), a known risk factor for cardiovascular disease, is commonly estimated using the Friedewald equation. Although the Sampson-NIH equation has been recommended by the Canadian Society of Clinical Chemists for its improved accuracy, particularly in cases of high triglyceride and low LDL-C concentration, its adoption across Canada has been limited. OBJECTIVE: Assess the impact of implementation of the Sampson-NIH equation for the calculation of LDL-C in a large community population in Ontario, including reporting frequency, reclassification and agreement with non-HDL-C. METHODS: Results for total cholesterol, HDL-C, non-HDL cholesterol and triglycerides were obtained from Dynacare and LifeLabs community samples (n = 474,911). LDL-C was calculated using Friedewald and Sampson-NIH equations, followed by regression and clinical impact analysis. RESULTS: Samples with triglycerides ≤ 4.52 mmol/L, showed excellent comparison between Friedewald and Sampson-NIH calculated results (R = 0.995, y = 1.00x + 0.08, both cohorts). Samples with triglycerides 4.53-9.04 mmol/L, showed worsening agreement between the two equations (R = 0.994, y = 0.81x + 0.79, both cohorts). The comparison results were similar when analyzed across ages (pediatric and adults) and fasting status. Implementation of the Sampson-NIH equation allowed reporting of an additional 1.49% patients (n = 7055). Minor reclassification was observed based on pediatric and adult LDL-C decision thresholds. The Sampson-NIH calculated LDL-C showed better agreement with non-HDL-C than Friedewald calculated LDL-C (86.0 % vs 84.2 %). CONCLUSION: There is excellent agreement between Sampson-NIH equation and Friedewald equations, resulting in reclassification of only a small proportion of patients. This study demonstrated the impact of the Sampson-NIH equation for LDL-C in a large pediatric and adult Canadian community population.
Comparison of mean platelet component and mean platelet mass in immune thrombocytopenia versus hypoproductive thrombocytopenias.
Melinscak H, Mirzoyev T, Hong YT … +1 more , Varma M
Clin Biochem · 2026 Jan · PMID 41443293 · Publisher ↗
INTRODUCTION: The Siemens (Bayer) ADVIA 120 has the capacity to calculate the mean platelet component (MPC), a measure of platelet density, and the mean platelet mass (MPM). In September 2013, we initiated a prospective...
INTRODUCTION: The Siemens (Bayer) ADVIA 120 has the capacity to calculate the mean platelet component (MPC), a measure of platelet density, and the mean platelet mass (MPM). In September 2013, we initiated a prospective study to determine if the MPC and MPM are significantly higher in immune thrombocytopenia than in hypoproductive thrombocytopenias. METHODS: Lavender tri-potassium EDTA tubes were filled and analyzed on the Siemens (Bayer) ADVIA 120 within a period not exceeding two hours from their collection. The student's t-test was used to compare these parameters in the patient groups. Coefficients of variation were used to study intra-individual variability and inter-individual variability. RESULTS: Twenty patients with immune thrombocytopenia and 20 patients with hypoproductive thrombocytopenias were enrolled. The MPC and MPM were significantly higher in immune thrombocytopenia than in hypoproductive thrombocytopenias. A unique patient was studied when he had immune thrombocytopenia and then when he had chemotherapy-induced thrombocytopenia during treatment of lymphoma. His MPC and MPM were significantly higher during immune thrombocytopenia than during chemotherapy-induced thrombocytopenia. Intra-individual variability and inter-individual variability were low in this study. CONCLUSION: A strength of our study is that the MPC and MPM assays were measured within 2 h of collection, since the MPC decreases over time. Our results attest to the clinical utility of MPC and MPM toward distinguishing immune thrombocytopenia from hypoproductive thrombocytopenias.
Simple lithium measurement in capillary dried plasma microsamples collected with the HealthID PSD device.
Reichert EM, Ferrareze CW, Bernardes M … +4 more , Peteffi GP, Bondan AP, Charão MF, Linden R
Clin Biochem · 2026 Jan · PMID 41423080 · Publisher ↗
BACKGROUND: Monitoring serum lithium concentrations is essential during bipolar disorder treatment. This study aimed to develop and validate a simple approach for estimating serum lithium concentrations using dried plasm...
BACKGROUND: Monitoring serum lithium concentrations is essential during bipolar disorder treatment. This study aimed to develop and validate a simple approach for estimating serum lithium concentrations using dried plasma spots (DPS) obtained from the HealthID PSD device after application of capillary blood. METHODS: Lithium was extracted using BSA solution and quantified with a colorimetric assay on an automated clinical analyzer. A chloride-based correction factor was applied to account for variable plasma volumes in DPS extracts. Analytical validation included linearity, extraction yield, imprecision, hematocrit and volume effects, chromatographic uniformity during plasma migration, and stability at different temperatures. A clinical comparison study was performed using paired serum samples and DPS from 40 patients undergoing lithium therapy. Serum-equivalent lithium concentrations were calculated by applying a multiplication factor derived from the serum-to-DPS ratio. Agreement was assessed by Passing-Bablok regression, Bland-Altman analysis, median percentage predictive error (MPPE), median absolute percentage error (MAPE), and total error (TE). RESULTS: Linearity was demonstrated from 0.1-2.5 mmol/L. Extraction yields were 93.2-95.7 %, and chloride correction significantly improved imprecision. Hematocrit (30-50 %) and applied volume (160-240 µL) showed minimal influence on corrected concentrations. Lithium remained stable for 21 days. Serum-equivalent DPS lithium showed strong correlation with serum (r = 0.984), no proportional or systematic bias, MPPE 0.91 %, MAPE 6.7 %, and TE 11.9 %. CONCLUSIONS: Lithium can be reliably quantified in DPS generated with the HealthID PSD device using a routine colorimetric assay. The method enables stable, minimally invasive capillary microsampling suitable for clinical monitoring of lithium therapy.
The influence of kidney function on the prognostic value of cardiac troponin.
Hasselbalch RB, Schultz M, Carlson N … +9 more , Strandkjær N, Knudsen SS, Kronborg AH, Kragholm KH, Andersen MP, Bundgaard H, Torp-Pedersen C, Aakre KM, Iversen KK
Clin Biochem · 2026 Jan · PMID 41412456 · Publisher ↗
BACKGROUND: Kidney function influences the concentration of cardiac troponin T (cTnT) and I (cTnI). We investigate how this impacts their prognostic ability. METHODS: This Danish nationwide study included patients from 2...
BACKGROUND: Kidney function influences the concentration of cardiac troponin T (cTnT) and I (cTnI). We investigate how this impacts their prognostic ability. METHODS: This Danish nationwide study included patients from 2013 to 2023 with at least two measurements of Roche hs-cTnT, Abbott hs-cTnI, or Siemens hs-cTnI Vista or Atellica during the index admission. Patients were stratified by estimated glomerular filtration rate (eGFR). We assessed prognostic ability by Cox models and area under the receiver operating characteristics curve (AUC). The primary endpoint was 30-day all-cause mortality. RESULTS: We included 277,723 patients (median age 69 years, 38.4 % female) of whom 19,565 (7.0 %) died within 30 days. Almost all patients with eGFR <30 ml/min/1.73 m had myocardial injury using hs-cTnT (99.4 %) compared to hs-cTnI (85.4 %). Hazard ratios (HRs) for overall myocardial injury were higher than for acute myocardial injury and declined with worsening eGFR, particularly for hs-cTnT: HR 15.58 (95 % CI 12.77-19.00) for eGFR ≥90 ml/min/1.73 m, while estimation was impossible at eGFR 15-30 ml/min/1.73 m due to few normal values. The highest HR for acute myocardial injury at eGFR ≥90 ml/min/1.73 m was for hs-cTnI Abbott, HR 3.50 (95 % CI 2.79-4.38). AUC decreased with worsening eGFR across assays, 0.68-0.76 for eGFR ≥90 ml/min/1.73 m to 0.59-0.63 for eGFR <15 ml/min/1.73 m. At eGFR ≥90 ml/min/1.73 m the optimal cutoff was 16.5 ng/l for hs-cTnT and below the sex-specific 99th percentile for all hs-cTnI assays, increasing 5-20-fold with lower eGFR for all assays. CONCLUSION: Kidney function affects cTn prognostic performance, with reduced predictive ability and higher optimal cutoff concentrations for lower eGFR.
Improving the environmental impact paradox of clinical medical laboratories.
Sörme P, Weitze S
Clin Biochem · 2026 Jan · PMID 41407249 · Publisher ↗
The global healthcare system is a substantial contributor to planetary greenhouse gas emissions and the climate crisis. Healthcare also has additional negative effects on the environment through the pollution of water, s...
The global healthcare system is a substantial contributor to planetary greenhouse gas emissions and the climate crisis. Healthcare also has additional negative effects on the environment through the pollution of water, soil, and air, and the generation of general and regulated biomedical waste. The healthcare system's lagging sustainability has both direct and indirect consequences for human health, these factors present a paradox. Healthcare Without Harm has estimated that global healthcare systems are emitting two gigatons of carbon dioxide yearly, accounting for 4.4% of total global net emissions. Healthcare systems should address their negative environmental impact, while still treating patients to the highest standards of care. Laboratories are resource-intensive spaces and should be a principal consideration when addressing the overall sustainability strategy of a healthcare system. Clinical medical laboratories, in particular, have often not optimised operations for sustainability, and have overlooked carbon emissions. The last decade has seen slow adoption of sustainable practices in clinical diagnostic laboratories even though numerous tools and programs are available for implementation, a disappointing result that also suggests an opportunity for rapid and dramatic improvement. This article will describe.
A novel fluorescent-labeled serum protein electrophoresis method for detection of monoclonal free light chains in serum.
Pang G, Kang X, Li Y … +2 more , Zhang X, Ren H
Clin Biochem · 2026 Jan · PMID 41407248 · Publisher ↗
BACKGROUND: Current guidelines recommend a combination of serum protein electrophoresis (SPE), immunofixation electrophoresis (IFE), and serum free light chain (FLC) assays for monoclonal immunoglobulin (M-protein) scree...
BACKGROUND: Current guidelines recommend a combination of serum protein electrophoresis (SPE), immunofixation electrophoresis (IFE), and serum free light chain (FLC) assays for monoclonal immunoglobulin (M-protein) screening. However, the high cost of this comprehensive panel limits its widespread use. In routine clinical practice in China, SPE alone is commonly employed for general population screening, but it suffers from low sensitivity for detecting monoclonal free light chains (LC-M-proteins), leading to a high rate of missed diagnoses. There is a clear clinical need for a novel method that enhances LC-M-protein detection while preserving the practicality of SPE. METHODS: We established a fluorescent-labeled serum protein electrophoresis (FSPE) technique. The method utilizes 2-(diphenylphosphino)ethylamine (DPEA) to selectively reduce the C-terminal thiols of LC-M-proteins (4 °C, 60 min, dark), followed by specific fluorescent labeling with sulfo-Cyanine5 maleimide (4 °C, 30 min, dark). After agarose gel electrophoresis separation, synchronous identification and quantification of LC-M-proteins and intact M-proteins are achieved via dual-channel (fluorescence and protein staining) imaging. RESULTS: Method validation demonstrated that DPEA enables efficient and selective reduction. The detection limit of FSPE for LC-M-proteins reached 400 mg/L. Quantitative analysis showed excellent performance (linearity: R2 = 0.9887; total precision: relative standard deviation, RSD = 6.61%). FSPE results were highly correlated with the reference Freelite™ FLC assay (Spearman's r = 0.895, p < 0.01), although Bland-Altman analysis revealed quantitative differences between individual samples. CONCLUSION: FSPE represents a significant upgrade to conventional SPE, effectively addressing its critical flaw of missing LC-M-proteins while achieving sensitivity comparable to IFE. It retains the key advantages of SPE, namely operational simplicity and low cost. Therefore, FSPE emerges as a potential standalone method for efficient M-protein screening.
Effect of microcollection tube fill volume on common acute care tests.
Cai F, Seiden-Long I, Venner AA … +4 more , Paul H, Gifford JL, Roshan T, de Koning L
Clin Biochem · 2026 Jan · PMID 41390148 · Publisher ↗
BACKGROUND: Microcollection tubes are frequently used in pediatric phlebotomy. We performed a pilot study to determine what clinical biochemistry and hematology tests can be reported on different microcollection tube fil...
BACKGROUND: Microcollection tubes are frequently used in pediatric phlebotomy. We performed a pilot study to determine what clinical biochemistry and hematology tests can be reported on different microcollection tube fill volumes. METHODS: Blood was collected from 11 volunteers into Becton Dickinson (BD) Vacutainers® and microcollection tubes (BD Microtainers® and the Sarstedt Microvette® 300 FH) at different fill volumes (Filled: top line; Intermediate: second line; Short: third line. If there was no second or third line, 200 µL was used for short fills) for 36 clinical biochemistry tests and the complete blood count (CBC) with differential (23 components). At each fill volume, tests were strong candidates to report if they did not have statistically significant biases compared to results in Vacutainers®. Potential candidates had statistically significant biases that were small (median absolute bias < 25 % of total allowable error and less than desirable bias from biological variation). Tests were not candidates if biases were significant and large (median absolute bias ≥ 25 % of TEa or ≥ desirable bias). Biases that increased or decreased across concentration ranges invalidated reporting candidacy. RESULTS: Twenty four clinical biochemistry tests were strong or potential candidates to report on all fill volumes, 7 were strong or potential candidates to report on some fill volumes and 5 were not candidates to report on any fill volumes. Seventeen CBC components were strong or potential candidates to report on all fill volumes, 2 were strong or potential candidates to report on some fill volumes and 4 were not candidates to report on any fill volumes. CONCLUSIONS: While most tests were valid to report on different fill volumes, some were not. We encourage laboratories to perform their own studies on fill volumes.
Evaluation of three NT-proBNP assays for heart failure.
Mensah IK, Roemmich B, Lawless S … +4 more , Wysocki A, Daghfal D, Hunter CJ, Farnsworth CW
Clin Biochem · 2026 Jan · PMID 41360296 · Publisher ↗
BACKGROUND: N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurement is recommended by guidelines for diagnosing and managing heart failure (HF). Accurate NT-proBNP measurement is critical for timely and effecti...
BACKGROUND: N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurement is recommended by guidelines for diagnosing and managing heart failure (HF). Accurate NT-proBNP measurement is critical for timely and effective treatment, but limited studies have compared NT-proBNP results from multiple platforms, and few studies have compared their concordance using commonly used clinical cutpoints. METHODS: The Alinity, PathFast, and Roche NT-proBNP assays were assessed in 276 patient samples, comprising 188 inpatients and 88 outpatients with normal renal function. Correlation and bias among the assays were assessed, and guideline-endorsed clinical cutpoints were used to evaluate concordance. RESULTS: Passing-Bablok regression revealed a slope of 1.00 (95% CI: 0.99-1.01) for Alinity vs. Roche, 1.14 (1.11-1.16) for PathFast vs. Roche, and 1.11 (1.01-1.13) for PathFast vs. Alinity. Bland-Altman analysis revealed minimal bias among the assays, with the closest agreement observed between PathFast and Alinity (-1.85%, -43.36 to 39.65). On inpatients, the concordance was 0.97 (0.94-0.99) for Alinity vs. Roche, 0.95 (0.92-0.99) for PathFast vs. Roche, and 0.94 (0.91-0.98) for PathFast vs. Alinity. For outpatients, the concordance was 0.92 (0.84-1.00) for Alinity vs. Roche, 0.90 (0.80-1.00) for PathFast vs. Roche, and 0.97 (0.92-1.00) for PathFast vs. Alinity. CONCLUSION: Three NT-proBNP assay platforms demonstrated high correlation, minimal bias, and high clinical concordance. The results support the clinical interchangeability of these assays at commonly used and guideline-endorsed cutpoints.
Comparability of venous and capillary blood measurements for a host-protein test differentiating bacterial from viral infections.
Hainrichson M, Shamir N, Senderovich N … +8 more , Levin M, Darawsha H, Raz A, Halabi S, Shaham O, Navon R, Gottlieb TM, Hershkovitz B
Clin Biochem · 2026 Jan · PMID 41360295 · Publisher ↗
BACKGROUND: MeMed BV is a host-protein test for discriminating bacterial and viral infections. It was analytically and clinically validated in serum and venous whole blood samples. Here we investigated the comparability...
BACKGROUND: MeMed BV is a host-protein test for discriminating bacterial and viral infections. It was analytically and clinically validated in serum and venous whole blood samples. Here we investigated the comparability of venous versus capillary blood measurements of the MeMed BV score and of tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-induced protein-10 (IP-10), and C-reactive protein (CRP) biomarkers. METHODS: Adult patients with suspected acute infection were enrolled prospectively at three medical centers. Eligibility criteria were based on MeMed BV instructions for use. Paired venous and capillary samples (50 µL) were collected and measured. Three predetermined acceptance criteria for comparability for MeMed BV score were: (1) Slope 0.9-1.1 and intercept -5 to 5 in Passing-Bablok regression; (2) 95 % confidence intervals (CI) for bias at score bin cutoffs fall within -12.5 to 12.5; and (3) <5 % of paired scores fall in non-adjacent clinical interpretation bins. RESULTS: Among 58 patients (median age 58.5 years), TRAIL, IP-10, and CRP measurements in venous and capillary blood were highly correlated (r = 0.98-0.99). For the MeMed BV score, slope was 1.00 (95 % CI: 0.99, 1.01), intercept 0.00 (-1.04, 0.08), 95 % CI for bias at each cutoff was within limits and no paired scores fell in non-adjacent bins. All three criteria were met and findings were consistent in a single replicates analysis. CONCLUSION: Venous and capillary blood yield comparable MeMed BV scores and biomarker values. The findings can serve as the basis for expanding MeMed BV's use to include capillary blood specimens, potentially widening its clinical utility.
Constructive critique on the development and validation of a multiplex LC-MS/MS DBS assay.
Aphale P, Dokania S, Shekhar H
Clin Biochem · 2026 Jan · PMID 41354284 · Publisher ↗
Abstract loading — click title to view on PubMed.
Novel and known fibrinogen gene mutations in Chinese pediatric patients with congenital dysfibrinogenemia: genetic and functional characterization.
Huang J, Wang D, Wang Y … +4 more , Yang Y, Peng D, Luo M, Fu X
Clin Biochem · 2026 Jan · PMID 41344552 · Publisher ↗
OBJECTIVES: Congenital dysfibrinogenemia (CD) is a rare inherited disorder caused by qualitative abnormalities in fibrinogen, leading to discordance between functional and antigenic fibrinogen levels. Genetic testing pla...
OBJECTIVES: Congenital dysfibrinogenemia (CD) is a rare inherited disorder caused by qualitative abnormalities in fibrinogen, leading to discordance between functional and antigenic fibrinogen levels. Genetic testing plays a pivotal role in confirming diagnosis and elucidating phenotypic heterogeneity. This study aims to emphasize the diagnostic value of combining coagulation assays with genetic testing and underscore the clinical heterogeneity of CD through clinical cases of novel mutations. DESIGN & METHODS: Five pediatric patients with incidentally identified CD were diagnosed at Shenzhen Children's Hospital. Peripheral blood samples were analyzed for coagulation parameters, including fibrinogen activity (FIB:C) by the Clauss method, fibrinogen derived from the prothrombin time (PT-dF), as well as activated partial thromboplastin time （aPTT）, PT, thrombin time (TT), and thromboelastography (TEG). Sanger sequencing was conducted to assess mutations in FGA, FGB, and FGG genes. RESULTS: Two unrelated patients harbored a known heterozygous mutation in FGG (c.902G > A; p.Arg301His). Two novel heterozygous mutations were identified: FGA (c.113G > A; p.Arg38Lys) and FGG (c.902G > T; p.Arg301Leu). A homozygous mutation in FGB (c.292G > A; p.Ala98Thr) was detected in another patient; this variant has been reported only twice before in the literature. All patients were asymptomatic. Coagulation testing revealed consistently decreased FIB:C with normal PT-dF, characteristic of CD. TEG analysis showed variable alterations in fibrinogen-related parameters, although no consistent genotype-phenotype correlation was observed. CONCLUSION: This study expands the genetic and phenotypic spectrum of CD in children, reporting two novel mutations and documenting the first pediatric cases of these variants in a Chinese cohort. Given the potential long-term risks and diagnostic complexity in asymptomatic pediatric patients, individualized surveillance and management strategies are warranted. Further research is needed to evaluate the functional consequences of novel mutations and their implications for pediatric hemostasis.
Reducing inappropriate vitamin D testing: an analysis of three sequential diagnostic stewardship interventions and the carbon footprint implications.
Hughes C, Myers MA, Tickell-Painter M … +3 more , Aitchison M, Roberts L, Shorten RJ
Clin Biochem · 2026 Jan · PMID 41314418 · Publisher ↗
INTRODUCTION: The climate crisis is a health crisis, and healthcare contributes to this via consumption of resources, the release of greenhouse gases, and the generation of waste. Pathology testing underpins most healthc...
INTRODUCTION: The climate crisis is a health crisis, and healthcare contributes to this via consumption of resources, the release of greenhouse gases, and the generation of waste. Pathology testing underpins most healthcare, and the vast number of tests performed in clinical laboratories come with an environmental cost. There is a growing body of evidence demonstrating that many pathology tests are unnecessary, utilising finite resources, potentially causing patient harm, and generating a carbon footprint. Vitamin D testing is one such example. METHODS: A quasi-experimental study of three real-world diagnostic stewardship interventions to reduce inappropriate vitamin D testing. The number of vitamin D test requests were measured pre- and post- each intervention, and cardon dioxide equivalent (COe) savings were estimated for any reduction in testing that was realised. RESULTS: An intervention that passively provided information on best practice did not reduce testing volumes. Interventions that removed automated reflex testing in the emergency department, and the implementation of a best-practice clinical decision tool utilising national testing guidelines resulted in a statistically significant reduction of vitamin D requests. These reductions cumulatively saved almost 44,000 g COe across the three diagnostic stewardship interventions. DISCUSSION: This study showed that diagnostic stewardship interventions can reduce testing volumes and generate COe savings. While these savings are modest, it is possible to consider that if such interventions were used widely to prevent inappropriate testing across multiple test types, laboratories, and healthcare settings, the cumulative carbon and financial savings could be substantial. Such 'soft stop' interventions do not prevent a clinician who is determined to send such tests, and future work should combine these tools with behavioural change interventions to maximise their benefit.
Diagnostic accuracy of biomarkers for irritable bowel syndrome: a systematic review and meta-analysis.
Mou J, Tao Q, Xu L … +2 more , Luo Y, Zheng H
Clin Biochem · 2026 Jan · PMID 41276148 · Publisher ↗
This study aimed to systematically assess the diagnostic performance of multiple biomarkers for irritable bowel syndrome (IBS). Systematic electronic searches were conducted in PubMed, Cochrane Central Register of Contro...
This study aimed to systematically assess the diagnostic performance of multiple biomarkers for irritable bowel syndrome (IBS). Systematic electronic searches were conducted in PubMed, Cochrane Central Register of Controlled Trials, Embase, and Web of Science, with the search updated through May 18, 2025. Studies were evaluated in accordance with the Diagnostic Test Accuracy systematic review manual and the PRISMA-DTA reporting guidelines. Methodological quality of included studies was assessed using the QUADAS-2 and QUADAS-C tools. We synthesized summary sensitivity and specificity using a bivariate random-effects model within a hierarchical summary receiver operating characteristic framework. Of 9,078 initially identified studies, 24 eligible studies involving 9,343 participants were ultimately included in the meta-analysis. Pooled analysis revealed that urinary metabolic markers exhibited high diagnostic accuracy, with a pooled sensitivity of 0.988 (95% CI: 0.804-1.000) and a pooled specificity of 0.934 (95% CI: 0.629-0.993). In biomarker-type subgroup analyses, fecal peptidase activity yielded a sensitivity of 0.905 (0.438-0.990) and specificity of 0.883 (0.513-0.978), while RAID-IBS showed a sensitivity of 0.935 (0.548-0.994) and specificity of 0.919 (0.444-0.986). When stratified by comparator groups, urinary metabolites exhibited a sensitivity of 0.981 (0.800-0.999) and specificity of 0.803 (0.271-0.981) against healthy controls, compared to a sensitivity of 0.995 (0.926-1.000) and specificity of 0.996 (0.944-1.000) against inflammatory bowel disease. These results suggest that urinary metabolites, fecal peptidase activity, and RAID-IBS may achieve high sensitivity and specificity in the studies available.
Association of hypertension and genetic variants in MYH9 and BMPR1B with increased proteinuria in sickle cell disease.
Malick Ndour EH, Mnika K, Ousmane Sene EH … +19 more , Tall FG, Nembaware V, Ly ID, Seck M, Sokhna M, Dione R, Kamby C, Demba Diop JP, Mbacke SS, Kesso Barry NO, Djité M, Kandji PM, Diallo RN, Diagne I, Diop S, Gueye PM, Sall PL, Cisse A, Wonkam A
Clin Biochem · 2026 Jan · PMID 41265744 · Publisher ↗
BACKGROUND: Sickle cell nephropathy (SCN) is a major chronic complication of sickle cell disease, and its progression may be influenced by genetic factors. This study aimed to investigate the association between variants...
BACKGROUND: Sickle cell nephropathy (SCN) is a major chronic complication of sickle cell disease, and its progression may be influenced by genetic factors. This study aimed to investigate the association between variants in the MYH9 and BMPR1B genes and increased total proteinuria in patients with sickle cell anemia. MATERIALS AND METHODS: This cross-sectional study included patients with homozygous (SS) sickle cell disease who were followed up in Dakar. Urinary albumin, total proteins, and creatinine levels, along with serum creatinine and urea concentrations, were measured. Genotyping of the single nucleotide variants MYH9-rs4821469, MYH9-rs3752462, MYH9-rs2032487, and BMPR1B-rs17022863 was performed using mass spectrometry (MassARRAY technology). Associations were evaluated using multivariate logistic regression analysis. RESULTS: The 150-patient cohort had a mean age of 20.44 ± 9.86 years, with a slight female majority (51 %). A high prevalence of increased total proteinuria (urine proteins-to-creatinine ratio ≥150 mg/g) was observed, affecting 50.67 % of this young population. Multivariate analysis identified relative systemic hypertension (blood pressure ≥130/80 mmHg) as a powerful and independent risk factor for increased total proteinuria. While an initial analysis suggested a protective association for the MYH9 - rs4821469 variant, this signal was unstable and lost statistical significance in more stringent models. CONCLUSION: Increased total proteinuria is highly prevalent in this young cohort, indicating early onset of kidney damage. Relative systemic hypertension is a major modifiable risk factor, underscoring the need for rigorous blood pressure control. The instability of the initial genetic signal for MYH9-rs4821469, coupled with its strong linkage disequilibrium with APOL1, suggests that the observed association is likely confounded by ungenotyped APOL1 variants. This highlights the critical importance of including APOL1 analysis in future SCN genetic studies in African-ancestry populations.
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