Clinical Biochemistry[JOURNAL]
Sun
200 papers
Plasma trimethylamine levels predict adverse cardiovascular events in sudden cardiac arrest Survivors: A prospective cohort study.
Huang H, Cheng S, Long T … +8 more , Fu B, Yang J, Cai C, Gu M, Niu H, Chen X, Hua W, Yang S
Clin Biochem · 2025 Jun · PMID 40228618 · Publisher ↗
BACKGROUND: The trimethylamine N-oxide (TMAO) pathway has been associated with multiple cardiovascular diseases, yet its prognostic value for sudden cardiac arrest (SCA) survivors remains unknown. METHODS: Patients who s...
BACKGROUND: The trimethylamine N-oxide (TMAO) pathway has been associated with multiple cardiovascular diseases, yet its prognostic value for sudden cardiac arrest (SCA) survivors remains unknown. METHODS: Patients who survived SCA and received implantable cardioverter defibrillators (ICDs) were prospectively enrolled. We evaluated the associations between plasma concentrations of TMAO-related metabolites and long-term adverse clinical events, including recurrent lethal ventricular arrhythmia (VA). RESULTS: A total of 75 SCA survivors were included in the study. During a median follow-up of 1099 days, 34 (45.3 %) patients experienced adverse clinical events, including 24 (32.2 %) with life-threatening VA, 12 (16.0 %) with heart failure rehospitalization, and 5 (6.7 %) with cardiovascular death. Trimethylamine (TMA), carnitine, choline, and creatinine showed strong correlations with clinically significant parameters such as left ventricular ejection fraction (LVEF), New York Heart Association functional class, and N-terminal pro-brain natriuretic peptide (NT-proBNP). These four metabolites demonstrated positive associations with adverse clinical events, with higher median level of TMA associated with more than a threefold increased risk after adjusting for age, sex, LVEF, kidney function, and NT-proBNP levels (hazard ratio = 3.36, 95 % confidence interval [CI]: 1.18-9.59; P = 0.024). A scoring system, VT-C3, incorporating LVEF, TMA, and the weighted sum of TMA-related metabolites (Choline, Carnitine, Creatinine), showed significant predictive capacity for both adverse events (area under the curve [AUC]: 0.75, 95 % CI: 0.64-0.85) and recurrent lethal VA (AUC: 0.73, 95 % CI: 0.62-0.84). No significant prognostic values were observed for TMAO and betaine. CONCLUSIONS: Our findings suggest that plasma concentrations of TMA, choline, carnitine, and creatinine are associated with an increased risk of subsequent adverse clinical events among SCA survivors. A simple scoring system comprising LVEF and these biomarkers could enhance current risk stratification and improve secondary prevention strategies based on ICD implantation.
Tumor-associated antigens are associated with primary Sjögren's syndrome-related interstitial lung disease and disease activity.
Huang X, Li X, Zhou W … +7 more , Huang L, Zhu H, Lao Y, Jiang Y, Deng Z, Tang Y, Wang J
Clin Biochem · 2025 Jun · PMID 40210147 · Publisher ↗
OBJECTIVES: Tumor-associated antigens (TAAs) have been shown to be associated with a variety of connective tissue diseases. However, the role of TAAs in primary Sjögren's syndrome (pSS) patients is still unclear. This st...
OBJECTIVES: Tumor-associated antigens (TAAs) have been shown to be associated with a variety of connective tissue diseases. However, the role of TAAs in primary Sjögren's syndrome (pSS) patients is still unclear. This study aims to explore the correlation between TAA levels and systemic clinical manifestations and disease activity in pSS patients. METHODS: Data were retrospectively collected from 108 patients with pSS (pSS group) and 100 healthy subjects (HCs group). Comparison of clinical characteristics and serological parameters between the TAA-positive group and the TAA-negative group. The independent risk factors of TAAs positivity were analyzed by univariate and multivariate regression, and the receiver operating characteristic curve was used to analyze the diagnostic performance of TAAs for pSS-associated interstitial lung disease (pSS-ILD). RESULTS: Compared with the control group, the positivity rates of CEA, CA125, CA15-3, and CYFRA21-1 were higher, and the levels of serum CA125, CA15-3, and CYFRA21-1were higher in the pSS group. The incidence of ILD, pleural effusion, pericardial effusion, and ESSDAI ≥5 in the TAA-positive group was higher than in the TAA-positive group. Multivariate logistic regression analysis showed that the incidence of ILD was identified as an independent risk factor for TAA positivity. The AUC of CEA, CYFRA21-1, and NSE in the diagnosis of pSS-ILD were 0.690, 0.840, and 0.872, respectively, and the combined diagnosis could reach 0.952. CONCLUSION: Certain TAA-positive rates and serum levels were increased in pSS patients. The TAA-positive group is correlated with the ESSDAI scores. ILD was an independent risk factor for TAA positivity, and CYFRA21-1 and NSE had the best diagnostic value in patients with pSS-ILD.
Building a sustainable laboratory culture: The power of awareness and strategic training programs.
Aykal G, Kartal KK, Yıldız G … +1 more , Ellidağ HY
Clin Biochem · 2025 Jun · PMID 40199456 · Publisher ↗
INTRODUCTION: Climate change, driven by human activities, poses a critical threat to global ecosystems and public health. Healthcare facilities, responsible for 4.4% of global carbon emissions, must adopt sustainable pra...
INTRODUCTION: Climate change, driven by human activities, poses a critical threat to global ecosystems and public health. Healthcare facilities, responsible for 4.4% of global carbon emissions, must adopt sustainable practices to mitigate their environmental impact. Laboratories, as significant energy consumers within this sector, play a pivotal role in promoting sustainability. This study aimed to enhance sustainability awareness through a targeted training program focusing on climate change, carbon footprint reduction, and green chemistry. METHOD: A four-session training program covered topics such as energy efficiency, waste management, and eco-friendly laboratory practices. Delivered in both face-to-face and online formats, the program targeted diverse groups, including academicians, resident doctors, technicians, and administrative staff. Participants' baseline knowledge was assessed using a pre-test, with training effectiveness evaluated through a post-test. A 14-question survey assessed knowledge gains, and statistical analyses were performed using SPSS. RESULTS: Post-training assessments revealed significant knowledge and awareness improvements across all participants, particularly among resident doctors and technicians. Resident doctors excelled in both pre-test and post-test scores. The training format (face-to-face or online) did not significantly impact learning outcomes (p=0.137). DISCUSSION: The program effectively increased sustainability awareness, demonstrating the value of structured educational interventions. These findings support integrating climate change education into healthcare curricula and highlight the equal effectiveness of flexible learning models. CONCLUSION: This initiative underscores the importance of education in advancing sustainable laboratory practices. Its success led to the Antalya Training and Research Hospital's Medical Biochemistry Laboratory receiving the Green and Sustainable Laboratory Certification from EFLM. Empowering laboratories through innovative training fosters environmental stewardship, supporting global efforts to combat climate change.
Limited incremental value of growth differentiation factor 15 in the initial evaluation of low and intermediate risk acute chest pain patients.
Karaji I, Steiro OT, Myrmel GM … +12 more , Omland T, Tjora HL, Langørgen J, Bjørneklett R, Skadberg Ø, Bonarjee VV, Mjelva ØR, Collinson P, Vikenes K, Larsen TH, Aakre KM, Pedersen ER
Clin Biochem · 2025 Jun · PMID 40188929 · Publisher ↗
INTRODUCTION: Expression of the cytokine growth differentiation factor 15 (GDF-15) is up-regulated in conditions of tissue injury and stress. We evaluated if GDF-15 predicts obstructive coronary artery disease (CAD) or n...
INTRODUCTION: Expression of the cytokine growth differentiation factor 15 (GDF-15) is up-regulated in conditions of tissue injury and stress. We evaluated if GDF-15 predicts obstructive coronary artery disease (CAD) or need for revascularization within 30 days and 12 months in low/intermediate risk patients with acute chest pain. MATERIALS AND METHODS: We included 537 hospitalized patients who had high-sensitivity troponin T (hs-cTnT) < 99th percentile and underwent coronary CT angiography (CCTA). Odds ratios (ORs) and 95 % confidence intervals (CI) were calculated by logistic regression analyses and are reported per standard deviation increment of GDF-15 (log-transformed). RESULTS: The median (25th-75th percentile) age was 56 (49-65) years, 217 (40.4 %) were women, 83 (15.5 %) had obstructive CAD at CCTA. In total 49 (9.1 %) patients underwent revascularization within 30 days and 52 (9.7 %) within 12 months. In age and sex adjusted analysis GDF-15 was a significant predictor with ORs (95 % CI) of 1.35 (1.05-1.73), 1.39 (1.06-1.83) and 1.41 (1.07-1.84) for obstructive CAD, revascularization within 30 days and 12 months, respectively. However, after adjustment for clinical covariables, the ORs of GDF-15 were no longer statistically significant for either outcome (P ≥ 0.07). Adding hs-cTnT levels alone to the age and sex adjusted model also rendered the ORs of GDF-15 non-significant (P ≥ 0.31). CONCLUSIONS: In patients with acute chest pain but without acute myocardial infarction, GDF-15 did not substantially improve the identification of obstructive CAD or need for revascularization within 30 days and 12 months. Our findings question the clinical usefulness of GDF-15 for prognostication of low-risk patients with acute chest pain.
Serum levels of advanced glycation end products negatively correlates with activity of Paraoxonase1 and Lecithin-Cholesterol Acyltransferase in diabetic retinopathy; A cross-sectional case-control study.
Arabi A, Rabizadeh S, Mirmoosavi S … +5 more , Mirmiranpour H, Heidari F, Mohammadi F, Esteghamati A, Nakhjavani M
Clin Biochem · 2025 Jun · PMID 40187629 · Publisher ↗
BACKGROUND: Development of diabetic retinopathy (DR) is closely linked to oxidative stress triggered by various metabolic pathways. Paraoxonase 1 (PON1) and Lecithin-Cholesterol Acyltransferase (LCAT) have protective rol...
BACKGROUND: Development of diabetic retinopathy (DR) is closely linked to oxidative stress triggered by various metabolic pathways. Paraoxonase 1 (PON1) and Lecithin-Cholesterol Acyltransferase (LCAT) have protective roles in DR that remain poorly understood. Higher AGEs levels and its role in vascular complications of type 2 diabetes has been shown in previous studies. This case-control study aimed to assess LCAT and PON1 activity and their correlation with advanced glycation end products (AGEs) in patients with diabetes with or without retinopathy. METHOD: 45 healthy individuals and 88 diabetic patients were enrolled, categorized as No Diabetic Retinopathy (NDR), Non-Proliferative Diabetic Retinopathy (NPDR), and Proliferative Diabetic Retinopathy (PDR). RESULTS: PON1 and LCAT activity conversely correlated with serum levels of advanced glycation end products in patients with diabetic retinopathy. There was not such a correlation in patients without DR nor in controls. The correlation was stronger between PON1 and AGEs in comparison to LCAT. PON1 activity was significantly lower in type 2 diabetes patients compared to healthy controls (45.39 ± 16.48 and 203.75 ± 8.92, respectively, P < 0.001). Activity further decreased in NPDR and PDR compared to NDR (23.99 ± 9.79 and 21.28 ± 8.22, respectively, P < 0.001). LCAT activity was significantly lower in diabetic patients compared to controls (33.16 ± 5.98 and 44.35 ± 2.26, respectively, P < 0.001). However, LCAT activity was not lower in diabetic retinopathy compared to NDR (P > 0.05). CONCLUSION: Serum PON1 activity negatively correlated with AGEs levels in patients with diabetes but not in controls. The LCAT-AGEs correlation however was only significant in PDR patients. These findings emphasize the potential importance of AGES and PON1 in diabetic retinopathy development and progression.
The diagnostic value of citrullinated antigens with multiple citrulline similar motif in patients with rheumatoid arthritis.
Wu G, Cai L, Liu L … +3 more , Liu Y, Zhang L, Li Z
Clin Biochem · 2025 Jun · PMID 40180146 · Publisher ↗
BACKGROUND AND AIMS: Anti-cyclic citrulline peptide (anti-CCP) antibodies are among the most critical biomarkers for the diagnosis of rheumatoid arthritis (RA), with citrullinated antigens being pivotal in triggering the...
BACKGROUND AND AIMS: Anti-cyclic citrulline peptide (anti-CCP) antibodies are among the most critical biomarkers for the diagnosis of rheumatoid arthritis (RA), with citrullinated antigens being pivotal in triggering their production. This study aimed to explore the potential diagnostic value of multiple citrulline similar-motif antigen (MCSM) in RA. MATERIAL AND METHODS: A retrospective study was conducted on 135 patients with RA, 112 patients with other joint diseases (non-RA group), and 67 healthy controls from the Hangzhou Red Cross Hospital. The levels of MCSM in the peripheral blood were measured. The diagnostic value of MCSM in RA patients was assessed by receiver operating characteristic (ROC) curve analysis. RESULTS: MCSM in serum were significantly higher in RA patients than in non-RA patients (Signal-to-Cutoff ratio (S/CO): 3.2 vs 0.5, P < 0.0001) and healthy controls (S/CO: 3.2 vs 0.4, P < 0.0001). ROC analysis showed an area under the curve (AUC) of 0.932 for MCSM. Individually, MCSM outperformed anti-CCP and rheumatoid factor (RF), achieving sensitivity of 91.1 % and specificity of 95.5 %. Notably, MCSM detection rates were significantly higher in RA patients with pain duration under one year compared to anti-CCP (89.47 % vs. 52.65 %, P < 0.05). CONCLUSION: MCSM demonstrate high sensitivity and specificity in diagnosing RA, with significant complementary value to anti-CCP and RF, and can increase the detection rate among RA patients with a disease duration of less than one year.
Reference intervals for serum immunoglobulin A, G, and M in a Danish paediatric population-based cohort.
Løk M, Dandanell FE, Frithioff-Bøjsøe C … +7 more , Lund MAV, Fraulund MM, Lausten-Thomsen U, Sandau N, Baker JL, Hansen T, Holm JC
Clin Biochem · 2025 Jun · PMID 40174761 · Publisher ↗
OBJECTIVES: To determine age- and sex-specific reference values for serum immunoglobulins (IgA, IgG, and IgM) in a population-based cohort of 6 to 18 years old Danish children and adolescents and investigate if immunoglo...
OBJECTIVES: To determine age- and sex-specific reference values for serum immunoglobulins (IgA, IgG, and IgM) in a population-based cohort of 6 to 18 years old Danish children and adolescents and investigate if immunoglobulin concentrations vary with body mass index standard deviation score (BMI SDS). MATERIALS AND METHODS: A total of 2171 school children and adolescents (median age 12.0 years) were recruited. BMI SDS was calculated, and health status was assessed by questionnaire and blood samples. Fasting serum concentrations of IgA, IgG, and IgM were determined by immunonephelometry. Sex- and age-specific percentiles were generated and partitioned following the Clinical and Laboratory Standards Institute (CLSI) EP28-A3c guidelines. Multiple linear regression models were used to investigate associations betweenIgA, IgG, IgM, and BMI SDS adjusted for age and sex. RESULTS: Concentrations of IgA increased with age but did not differ between boys and girls. An age-dependent increase was also detected for concentrations of IgG and IgM, although for IgG it was more pronounced in boys than girls. Girls had higher concentrations of IgG and IgM than boys at all ages. Concentrations of IgM were inversely associated with BMI SDS independent of age and sex. CONCLUSIONS: We generated age- and sex-specific reference intervals for IgA, IgG, and IgM based on children and adolescents from a Danish/North-European Caucasian population-based cohort. The findings can help evaluate alterations seen in primary and secondary immunodeficiencies and autoimmune diseases.
Vascular endothelial growth factor A, a potential non-invasive biomarker for metabolic dysfunction-associated steatotic liver disease progression.
Jönsson C, Ma'ayeh S, Zhang B … +5 more , Kechagias S, Liljeblad M, Nasr P, Hansson SF, Ekstedt M
Clin Biochem · 2025 Jun · PMID 40127834 · Publisher ↗
INTRODUCTION AND OBJECTIVES: Liver fibrosis is the primary predictor of complications in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). However, there are currently no non-invasive progno...
INTRODUCTION AND OBJECTIVES: Liver fibrosis is the primary predictor of complications in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). However, there are currently no non-invasive prognostic tests to stratify patients at risk for hepatic fibrosis progression. This study aimed to explore whether plasma proteins could serve as non-invasive biomarkers for monitoring MASLD disease progression. MATERIALS AND METHODS: Blood plasma protein analysis was performed on samples from a long-term follow-up study of patients with MASLD with repeated liver biopsies. Over 1100 proteins covering a broad range of biological processes were analyzed using 13 Olink® Target 96 panels. Protein level changes were compared between the different time points and between patients with or without an increase in the liver fibrosis stage between the two biopsies. RESULTS: Increased vascular endothelial growth factor A (VEGFA) plasma levels were significantly associated with liver fibrosis progression in patients with a histologically assessed increase in the fibrosis stage. CONCLUSIONS: These findings suggest that the plasma protein VEGFA may be an effective biomarker for monitoring fibrosis progression in patients with MASLD.
Reducing unnecessary free thyroid hormone testing by the reinforcement of a reflexive algorithm in an outpatient environment.
Murthy S, Scott J, Lu S … +9 more , Zhang D, Vanstone JR, Berry WE, Magee F, Kalra J, Houdek D, Dokouhaki P, Mostafa A, Wu F
Clin Biochem · 2025 Jun · PMID 40118238 · Publisher ↗
BACKGROUND: Thyroid dysfunction is one of the most common endocrine disorders. Thyroid function tests, including TSH, Free T4, and Free T3, are essential for diagnosis and patient management. Current guidelines recommend...
BACKGROUND: Thyroid dysfunction is one of the most common endocrine disorders. Thyroid function tests, including TSH, Free T4, and Free T3, are essential for diagnosis and patient management. Current guidelines recommend TSH as the first-line test, with additional testing for Free T4 and Free T3 only when TSH is abnormal or in specific clinical scenarios. Despite guideline recommendations, inappropriate ordering of free hormone tests is prevalent, leading to increased healthcare costs, diagnostic inefficiencies, and potential patient burden. In this study, we aimed to assess thyroid function testing utilization in the Saskatoon Health Region and identify opportunities to enhance test appropriateness. METHODS: A retrospective analysis of thyroid function test utilization was conducted in the Saskatoon Health Region to identify gaps in guideline adherence. Inappropriate Free T4 and Free T3 testing was defined as tests ordered with TSH results in the laboratory reference range. Interventions were developed, including reinforcing the reflexive testing algorithm in outpatient settings and restricting free hormone testing to pre-approved specialists. Metrics for evaluation included testing volume trends, physician satisfaction, and cost savings. RESULTS: Pre-intervention analysis revealed significant increases in thyroid function testing volumes from 2016 to 2019: TSH orders increased by 34.5 %, Free T4 by 36.4 %, and Free T3 by 18.8 %. A substantial proportion of tests involved normal TSH ordered in combination with Free T4 and/or Free T3, which is unnecessary. Compared to baseline volumes, post-intervention Free T4 and Free T3 testing volumes decreased by approximately 60 % and 40 %, respectively. CONCLUSION: Implementing and reinforcing a reflexive thyroid testing algorithm substantially reduced inappropriate Free T4 and Free T3 testing. Utilization management improved diagnostic efficiency, reduced unnecessary healthcare costs, and minimized patient harm.
Small dense low-density lipoprotein as biomarker in the elderly.
Katajamäki TT, Koivula MK, Salminen MJ … +11 more , Vahlberg T, Heikkilä ETM, Viljanen AM, Löppönen MK, Isoaho RE, Kivelä SL, Viitanen M, Viikari J, Viikari L, Pulkki KJ, Irjala KM
Clin Biochem · 2025 Jun · PMID 40107376 · Publisher ↗
OBJECTIVES: Small dense low-density lipoprotein (sdLDL) is atherogenic and associated with atherosclerotic cardiovascular diseases (ASCVD). The aim of this study was to perform the prospective evaluation of sdLDL-c in ne...
OBJECTIVES: Small dense low-density lipoprotein (sdLDL) is atherogenic and associated with atherosclerotic cardiovascular diseases (ASCVD). The aim of this study was to perform the prospective evaluation of sdLDL-c in new ASCVD over 18 years of follow up, and to compare the association of sdLDL-c and conventional lipids and apolipoproteins with ASCVD in the elderly. METHODS: This prospective study included a total of 1770 subjects ≥ 64 years of age with an 18-year follow-up period. The determination of sdLDL-c was measured by a homogenous, selective enzymatic method. Levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-c) and triglycerides (TG) were determined by enzymatic methods. Apolipoproteins, ApoA1 and ApoB, were analyzed by immunonephelometric methods. Low-density lipoprotein cholesterol (LDL-c) levels were calculated using the Friedewald formula. RESULTS: According to Pearson's correlation coefficients, sdLDL-c concentration was positively correlated with LDL-c, nonHDL-c, TC and ApoB concentrations. During follow up, sdLDL-c was significantly associated with new ASCVD in men aged 64-76 years in both unadjusted and adjusted Cox regression models. The adjusted hazard ratio (95 % CI) for sdLDL-c was 1.61 (1.13-2.28). No significant associations between sdLDL-c and ASCVD were observed in men aged 77-97 years, nor in women aged 64-79 or 80-100 years. CONCLUSIONS: Lipid and apolipoprotein concentrations of the elderly were high compared to the recommended target values. In addition, lipid and apolipoprotein baseline concentrations were not higher in the ASCVD group than in the control group. Our results indicated that sdLDL-c is as good a marker as ApoB and better than LDL-c.
Establishing ELISA-derived 99th percentile reference ranges for aCL and anti-β2GPI antibodies in northern Chinese population: Diagnostic value assessed through P-APS/SLE case-control study.
Shi X, Zhang Z, Ji L … +1 more , Li X
Clin Biochem · 2025 Jun · PMID 40107043 · Publisher ↗
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Evaluating accelerations across multiple routes of a pneumatic tube system to ensure sample integrity for LDH measurement.
Huang Y, Adewale C, O'Sullivan R … +1 more , Pocius D
Clin Biochem · 2025 Jun · PMID 40101889 · Publisher ↗
OBJECTIVES: Lactate dehydrogenase (LDH) concentrations can falsely increase due to the acceleration forces generated in the pneumatic tube system (PTS) during blood sample transport, potentially leading to altered medica...
OBJECTIVES: Lactate dehydrogenase (LDH) concentrations can falsely increase due to the acceleration forces generated in the pneumatic tube system (PTS) during blood sample transport, potentially leading to altered medical decisions. This study evaluated the accelerations and elevated LDH concentrations in 11 routes during PTS transport in an academic hospital. METHODS: Three blood samples were collected from each healthy volunteer and transported via hand carrier, PTS carrier, and PTS carrier with an additional foam insert. Five samples were included in the same carrier for every transport. An accelerometer was placed with the samples to record pressure, acceleration and transport time for each PTS route. The samples were then tested for hemoglobin and LDH concentrations on core laboratory chemistry analyzers. Three acceleration parameters were calculated. RESULTS: Transport time across the 11 routes varied widely from 78 to 455 s. Hemoglobin concentrations showed a slight increase during PTS transport, which was associated with a significant increase in LDH concentrations (r 0.716, p < 0.001). On average, LDH increased from 9.5 to 59.2 % during PTS transport. Total accelerations, percentages of acceleration > 5 g, and maximum accelerations ranged from 172.7 to 617.9 g, 3.5 to 14.7 %, and 15.31 to 24.28 g, respectively. When routes were scored based on any of the three parameters exceeding their average, routes with an LDH increase > 15 % had higher scores than those with an LDH increase ≤ 15 %. CONCLUSIONS: This study supports using accelerometers to validate and monitor the accelerations of each route generated during PTS blood sample transport and to identify the routes unsuitable for LDH measurement. Further studies are warranted to determine appropriate acceleration parameters and their thresholds to ensure sample integrity.
Establishing sustainable quality improvement in the clinical laboratory: Redesign of the total testing process and digital transformation of routine quality assurance activities.
Fung AWS
Clin Biochem · 2025 Jun · PMID 40090396 · Publisher ↗
Healthcare services contribute 5 to 10% of global carbon emissions and environmental burden on the planet. Sustainability in health care and laboratory medicine is gaining global momentum emphasizing a holistic approach...
Healthcare services contribute 5 to 10% of global carbon emissions and environmental burden on the planet. Sustainability in health care and laboratory medicine is gaining global momentum emphasizing a holistic approach to reduce carbon footprint, improve the delivery and quality of care, while optimizing operational efficiency and effectiveness. Digital transformation has the potential of achieving these goals simultaneously. Clinical laboratories should assess and mitigate their environmental impact through digital technologies. In this article, opportunities and challenges in establishing sustainable quality improvement in the clinical laboratory will be discussed with a focus on the redesign of the total testing process and digital transformation of routine quality assurance activities.
Therapeutic drug monitoring of levetiracetam - Is dried blood spot sampling suitable?
Linder C, Barclay V, Romanitan MO … +2 more , Beniaminov S, Ekheden I
Clin Biochem · 2025 Jun · PMID 40090395 · Publisher ↗
BACKGROUND: Therapeutic drug monitoring helps prevent seizures and minimize side effects in epilepsy patients. Phlebotomy is the gold standard for blood collection but can be difficult for children, pregnant women, and p...
BACKGROUND: Therapeutic drug monitoring helps prevent seizures and minimize side effects in epilepsy patients. Phlebotomy is the gold standard for blood collection but can be difficult for children, pregnant women, and patients in remote areas. We previously validated dried blood spot (DBS) sampling for carbamazepine, lamotrigine, levetiracetam (LEV), and valproic acid. Uncertainties in LEV comparisons from the previous validation were further investigated in this study by increasing sample numbers and comparing results using both immunochemistry and LC-MS/MS methods. Additionally, capillary and venous DBS were compared, and the stability of samples during mail transport was assessed. AIM: To compare LEV concentrations in capillary DBS and plasma, and to assess the stability of capillary DBS during transportation. METHOD: Capillary and venous blood samples were collected from 40 LEV-treated patients. Concentrations were measured using immunochemistry and liquid chromatography tandem mass spectrometry methods. Comparisons between matrices and methods were analyzed with Passing-Bablok regression and Bland-Altman plots. RESULTS: No proportional bias was found in regression analysis and Bland-Altman plots showed no bias between methods. For capillary DBS versus plasma concentrations, 92.1 % of values were within 20 % of the mean. No bias was detected between capillary and venous DBS, with deviations within acceptable limits. Sample stability was maintained during mail transport. CONCLUSION: The concentrations obtained for LEV in capillary DBS versus plasma showed that therapeutic drug monitoring of LEV can be performed as at-home self-sampling with DBS mailed to the laboratory for analysis.
The case of a bloody mess - Bictegravir/emtricitabine/tenofovir alafenamide induced colitis.
Asare-Werehene M, Bohn MK, Ming-Freckleton A … +1 more , Selvaratnam R
Clin Biochem · 2025 Jun · PMID 40089176 · Publisher ↗
BACKGROUND: Fecal calprotectin is a marker used to differentiate inflammatory bowel disease versus irritable bowel syndrome and is relevant in the diagnosis of ulcerative colitis and Crohn's disease. Markedly elevated ca...
BACKGROUND: Fecal calprotectin is a marker used to differentiate inflammatory bowel disease versus irritable bowel syndrome and is relevant in the diagnosis of ulcerative colitis and Crohn's disease. Markedly elevated calprotectin from stool samples provides evidence of colonic inflammation to support the diagnosis of pancolitis. This report is the first to demonstrate the clinical significance of fecal calprotectin in supporting the diagnosis of pancolitis induced by the anti-viral drug, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). CASE REPORT: A 62-year-old male on Biktarvy for his HIV diagnosis was admitted to internal medicine with abdominal pain, bloody diarrhea and pancolitis. His white blood cell count was 15.8 (4.0-11.0x10/L), neutrophil count was 9.7 (2.0-7.5 × 10/L), monocyte count was 1.2 (0.2-0.8 × 10/L), granulocyte count was 1.5 (≤0.1 × 10/L) and hemoglobin was 163 (140-180 g/L). The patient had a C-reactive protein of 229 (≤11.0 mg/L). Serology and blood culture were negative for microbial testing and abdomino-pelvic computed tomography findings were unremarkable. A bloody stool collected had a fecal calprotectin level of 1,159 (<50 µg/g). CONCLUSIONS: This case highlights how anti-retroviral therapies such as Biktarvy may elicit medication-induced gastrointestinal symptoms, which may underlie the cause of bloody diarrhea and pancolitis, and consequently a grossly elevated fecal calprotectin.
The pitfalls and significance of using ratios and calculated parameters in laboratory medicine.
Langman LJ, Snozek CL, Mattman A
Clin Biochem · 2025 Jun · PMID 40089175 · Publisher ↗
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Assessment of accuracy, clinical validity, and analytical linearity in point-of-care glucose monitoring devices for diabetes mellitus: A systematic review and meta-analysis.
Ukpe MP, Ezeanuka AC
Clin Biochem · 2025 Jun · PMID 40086777 · Publisher ↗
Point-of-care technology (POCT) is utilized in diabetes management due to its fast turnaround time. However, the accuracy and reliability of its results are of concern. This review aims to evaluate the (i) accuracy, (ii)...
Point-of-care technology (POCT) is utilized in diabetes management due to its fast turnaround time. However, the accuracy and reliability of its results are of concern. This review aims to evaluate the (i) accuracy, (ii) clinical validity and (iii) linearity of POCT for blood glucose concentration following ISO 15197. The study was conducted following the PRISMA framework. Searches with the search term "point of care test" OR "POCT" AND "Accuracy" AND "glucose" were made on Scopus, PubMed, DOAJ, and Cochrane Library. Quality assessments were performed using the QUADAS-2 tool. Proportion and Coefficient meta-analyses were used. Recent studies (2019-2023) evaluating the accuracy of POC devices in blood glucose estimation were included. 4918 participants and 56 POC brands were identified from the 30 included studies. The pooled percentage of POCT results within ±15 mg/dL (±0.83 mmol/L) for glucose concentrations <100 mg/dL (<5.6 mmol/L) was 98.83 % (95 % CI: 96.52-99.92) for professional use and 87.70 % (95 % CI: 62.65-99.65) for home-use glucometers. For glucose concentrations ≥100 mg/dL (≥5.6 mmol/L), the pooled percentages were 98.59 % (95 % CI: 95.90-99.88) and 88.79 % (95 % CI: 67.35-99.44), respectively. Measurements in zones A and B of the consensus error grid analysis were 98.06 % (95 % CI: 94.59-99.80) for professional-use and 98.70 % (95 % CI: 95.85-99.95) for home-use glucometers. The pooled correlation coefficient for professional-use glucometers was 0.988 (95 % CI: 0.980-0.993) while home-use was 0.930 (95 % CI: 0.869-0.963). While professional-use glucometers met ISO 15197 accuracy criteria but not clinical validity standards, home-use devices failed to meet both accuracy and clinical validity criteria. Professional-use glucometers demonstrated superior accuracy compared to home-use glucometers. Based on the variability in analytical performance of POC devices, it is recommended that proper care be taken when selecting POCT devices for optimal use in diabetic management.
Rising illicit drug Adulterants: Xylazine and levamisole.
Amaral PEM, Beane SO, Albarouki A … +8 more , Tan MJ, Schoenberger MJ, Yao Y, Liu L, Uljon SN, Zhu Y, Hall DC, Qiu Y
Clin Biochem · 2025 Jun · PMID 40081518 · Publisher ↗
The increasing prevalence of xylazine and levamisole as adulterants in illicit drugs presents significant challenges for medical professionals. This review aims to provide an overview of the mechanisms of action, prevale...
The increasing prevalence of xylazine and levamisole as adulterants in illicit drugs presents significant challenges for medical professionals. This review aims to provide an overview of the mechanisms of action, prevalence of adulteration, and detection methods for xylazine and levamisole. Clinical implications associated with xylazine and levamisole-contaminated drugs are also discussed. It provides a comprehensive examination of methodologies for analyzing these emerging contaminants, shedding light on the challenges faced by toxicology laboratories in accurately identifying and quantifying these substances. Various analytical techniques, including but not limited to GC-MS, HPLC-MS, and HPLC-MS/MS, are explored in detail, with a focus on their strengths and limitations. This serves as a valuable resource for clinicians seeking to navigate the complexities of analyzing xylazine and levamisole in illicit drug samples. It also contributes to the existing knowledge on illicit drug adulteration by xylazine and levamisole, providing insights that can inform public health interventions, law enforcement efforts, and treatment strategies aimed at mitigating the risks associated with contaminated substances.
Phosphatidylethanol clearance after packed red blood cell transfusion.
Iverson OC, Smith KA, Sharma P … +8 more , Buras MR, Quillen JK, Showkeir DL, Alegria KN, Langman LJ, Jannetto PJ, Kinard TN, Snozek CL
Clin Biochem · 2025 Jun · PMID 40054829 · Publisher ↗
OBJECTIVES: Phosphatidylethanol (PEth) is a long-term marker of alcohol consumption used clinically for evaluating abstinence in patients including transplant candidates. Packed red blood cell (pRBC) transfusion can intr...
OBJECTIVES: Phosphatidylethanol (PEth) is a long-term marker of alcohol consumption used clinically for evaluating abstinence in patients including transplant candidates. Packed red blood cell (pRBC) transfusion can introduce exogenous PEth to recipients, complicating interpretation. This study evaluated the kinetics and duration of PEth 16:0/18:1 positivity post-transfusion. DESIGN & METHODS: This study evaluated liver transplant recipients (n = 76) who received ≥ 1 pRBC during transplantation surgery. PEth 16:0/18:1 concentrations were monitored up to 2 weeks post-transfusion to determine clearance kinetics. RESULTS: Post-transfusion PEth was ≥ 10 ng/mL (range 10.0 - 79.7 ng/mL [0.014-0.113 µmol/L]) in 37 (48.7 %) recipients. Approximately 24 h after transfusion, pRBC-derived PEth decreased by a mean of 19 %, consistent with pRBC turnover post-transfusion. After 24-36 h, the apparent half-life of PEth was 6.6 d but was highly variable (SD 3.6 d). Correction for hemoglobin or hematocrit improved variability, with mean half-life estimated at 4.9 d (SD 1.6 d) and 4.6 d (SD 1.4 d), respectively. Time to clearance of PEth < 10 ng/mL ([<0.014 µmol/L]) ranged from < 1 d to > 19 d; 15 (40.5 %) pRBC recipients cleared PEth within 5 d post-transfusion. Using the consensus cutoff for PEth interpretation, only 10 had PEth > 20 ng/mL (>0.028 µmol/L) at 5 d and all had 14 d values < 20 ng/mL (<0.028 µmol/L). CONCLUSIONS: These findings suggest that PEth positivity after pRBC transfusion might be more common than previously recognized, and that higher decision-making thresholds (e.g., 20 ng/mL [<0.028 µmol/L]) are appropriate. Post-transfusion kinetics are not identical to clearance of endogenously-produced PEth after alcohol consumption (half-life 5-8 d), likely due to both patient and pRBC characteristics. Transplant care teams should recognize the risk for pRBC transfusion to impact PEth concentrations in recipients, and interpret PEth cautiously for 2-3 weeks after transfusion.
CA19-9, CEA and PIVKA-Ⅱ as a novel panel of serum markers for diagnosis of pancreatic cancer.
Wang M, Bu H, Luo W … +4 more , Zeng X, Chen G, He Y, Cao D
Clin Biochem · 2025 Jun · PMID 40024361 · Publisher ↗
AIM: This retrospective study was aimed to evaluate the diagnostic value of a combination of carbohydrate antigen 19-9 (CA19-9), carcinoembryonic antigen (CEA) and protein induced by vitamin K absence or antagonist-Ⅱ (PI...
AIM: This retrospective study was aimed to evaluate the diagnostic value of a combination of carbohydrate antigen 19-9 (CA19-9), carcinoembryonic antigen (CEA) and protein induced by vitamin K absence or antagonist-Ⅱ (PIVKA-II) in pancreatic cancer. METHODS: Clinical data were collected from 111 pancreatic cancer patients and 158 patients with benign pancreatic diseases (BPD). Serum CA19-9, CEA and PIVKA-II were subjected to receiver operating characteristic curve (ROC) analysis alone and in combination for the diagnosis of pancreatic cancer. RESULTS: Serum CA19-9, CEA, and PIVKA-II were higher in pancreatic cancer patients than in BPD patients (P < 0.001). ROC analysis indicated that the cutoff values were 99.390 for CA19-9, 3.065 for CEA, and 42.965 for PIVKA-II, at which the positive rate in pancreatic cancer was 78.38 % for CA19-9, 43.24 % for CEA and 48.65 % for PIVKA-Ⅱ. When serum CA19-9, CEA, and PIVKA-II were used alone, the areas under the curves (AUC), sensitivity and specificity were 0.821, 68.47 % and 89.24 % for CA19-9, 0.763, 61.26 % and 85.44 % for CEA, and 0.681, 45.95 % and 87.34 % for PIVKA-II. When serum CA19-9, CEA, and PIVKA-II were used in combination, the positivity rate was 94.59 % in pancreatic cancer with AUC of 0.903, sensitivity of 81.10 % and specificity of 88.00 %. CONCLUSION: PIVKA-II is a potential serum marker of pancreatic cancer and the combination of CA19-9, CEA, and PIVKA-II is a novel panel of serum markers with promising diagnostic value for pancreatic cancer.
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