Clinical Biochemistry[JOURNAL]
Sun
200 papers
A mixed methods service improvement project to investigate the motivational reasons why swab and urine samples are sent for microbiological analysis.
Brown EM, Ghosh M, Heath V … +2 more , Mukerji S, Shorten RJ
Clin Biochem · 2025 Aug · PMID 40447211 · Publisher ↗
BACKGROUND: Excessive urine and swab sampling has a direct impact on environmental health, resource availability, sample turnaround time and patient care. Positive cultures from unnecessary samples can lead to inappropri...
BACKGROUND: Excessive urine and swab sampling has a direct impact on environmental health, resource availability, sample turnaround time and patient care. Positive cultures from unnecessary samples can lead to inappropriate antimicrobial use and a cascade of further investigations. This project aims to identify the motivational reasons behind swab and urine sample requests in the hospital and community setting, with the aim of reducing unnecessary testing. METHODS: A mixed methods approach using a survey followed by qualitative interviews was used. A 16-part online questionnaire was distributed among various health care professionals in primary and secondary care. Upon completion participants were offered the opportunity to volunteer to participate in structured follow up interviews. A number of participants were selected for qualitative interviews. RESULTS: Eighty eight participants completed the questionnaire and five were interviewed. Both the questionnaire and interviews highlighted a wide diversity in the practice of how and why swabs and urine samples are submitted for microbiological analysis. The interviews yielded many ideas for improvements to practice including training and protocol recommendations. CONCLUSION: The results show a lack of clarity with regards to the primary responsibility for requesting samples. The study identified that this decision is often based on clinical experience, rather than protocol. The time at which a sample is reviewed and treatment, for example antibiotics, is started can vary among the healthcare professionals. Interview participants expressed a need for training, so long as this was tailored to different specialties' patient populations.
Circulating plasma RNY1 as a potential biomarker of breast cancer: a case-control study.
Taleb RSZ, Moez PE, Khedr MI … +4 more , Elwany YN, Sultan MH, Omar EM, Moftah RF
Clin Biochem · 2025 Aug · PMID 40447210 · Publisher ↗
BACKGROUND: Breast cancer (BC) is the most common cancer in women globally, with early detection playing a crucial role in improving treatment outcomes and survival rates. There is an urgent need for novel biomarkers to...
BACKGROUND: Breast cancer (BC) is the most common cancer in women globally, with early detection playing a crucial role in improving treatment outcomes and survival rates. There is an urgent need for novel biomarkers to aid in early diagnosis, prognosis, and treatment prediction. YRNAs, small non-coding RNAs, have been explored as biomarkers in various cancers, but their role in BC remains under-investigated. This study aimed to explore the expression of circulating plasma YRNAs in BC patients and evaluate their potential as diagnostic and prognostic biomarkers. METHODS: Plasma samples were collected from 50 BC patients and 50 age-matched healthy controls. The expression levels of four YRNAs (RNY1, RNY3, RNY4, and RNY5) were measured using quantitative real-time PCR. We also examined the association between YRNA expression and TNM staging, along with their predictive value for disease-free survival. RESULTS: RNY1 was significantly upregulated in BC patients compared to healthy controls, while RNY3, RNY4, and RNY5 did not show significant differences. The area under the receiver operating characteristic curve (AUC) for RNY1 was 0.816 (95% CI: 0.732-0.901), demonstrating good discriminatory power. High RNY1 expression correlated with advanced TNM stage and poor prognosis. Additionally, RNY1 expression predicted disease-free survival, as shown by Kaplan-Meier and univariate Cox regression analyses. CONCLUSION: The altered expression of RNY1 in BC patients is associated with advanced TNM stage and poor prognosis, suggesting its potential as a diagnostic and prognostic biomarker in BC.
Improving laboratory stewardship through benchmarking: A focus on thyroid function tests ordering.
Chan KK, Kim S, Mathias PC … +2 more , Dickerson J, Liao HC
Clin Biochem · 2025 Aug · PMID 40436088 · Publisher ↗
OBJECTIVES: Thyroid function tests, particularly thyroid-stimulating hormone (TSH) and free thyroxine (fT4), are among the most frequently ordered laboratory tests. This study evaluates longitudinal trends in thyroid tes...
OBJECTIVES: Thyroid function tests, particularly thyroid-stimulating hormone (TSH) and free thyroxine (fT4), are among the most frequently ordered laboratory tests. This study evaluates longitudinal trends in thyroid testing utilization, assesses the impact of TSH-first reflex testing, and examines specialty-specific differences in test ordering patterns under the PLUGS (Patient-Centered Laboratory Utilization Guidance Services) benchmarking guidelines. METHODS: We analyzed TSH and fT4 test volumes from the year 2009 to 2023. A TSH reflex algorithm, which automatically orders fT4 following an abnormal TSH, was implemented in 2016. The metrics were evaluated using the TSH to fT4 ratio (TSH/fT4) and the percentage of fT4 tests associated with abnormal TSH. Specialty-specific differences were assessed by categorizing providers' specialty, comparing benchmark patterns and diagnostic codes. RESULTS: Both TSH and fT4 testing volume increased significantly from 2009 to 2023. After the implementation of TSH-first reflex algorithm, TSH/fT4 stabilized (∼3.7) and the percentage of fT4 tests associated with abnormal TSH increased significantly from 26 % to 39 %. Providers from primary care demonstrated stronger adherence to the reflex testing, whereas endocrinology and oncology required more tailored approaches. CONCLUSIONS: This first longitudinal analysis of thyroid testing under the PLUGS benchmark guidelines highlights improved efficiency following reflex test implementation, though specialty-specific differences persist. Consensus-based benchmarks and laboratory stewardship initiatives further enhance test utilization efficiency, optimize workflow, and ensure appropriate thyroid function testing across diverse clinical settings.
Implementing minimal request intervals for laboratory tests: a utilization management study across eight hospitals in South Iran.
Shirazi Yeganeh B, Rabet Z, Afsar Z … +4 more , Amiri S, Ahmadkhani A, Keshavarzi A, Lotfi F
Clin Biochem · 2025 Aug · PMID 40419136 · Publisher ↗
INTRODUCTION: Effective utilization management in medical laboratories is a challenge. To address this, strategies such as clinical guidelines, minimum requesting intervals (MRIs), and test request limits integrated into...
INTRODUCTION: Effective utilization management in medical laboratories is a challenge. To address this, strategies such as clinical guidelines, minimum requesting intervals (MRIs), and test request limits integrated into hospital information system (HIS) have been proposed. MATERIALS AND METHODS: A guideline was developed to establish MRIs for 15 high-demand laboratory tests in collaboration with an expert panel. It was implemented across eight public hospitals, affiliated with Shiraz University of Medical Sciences, Shiraz, southern Iran. Following institutional approval, the HIS was programmed to notify healthcare providers of deviations from guideline. Several metrics, including requested test counts, hospitalized patient counts, and total hospitalization days, were extracted from the HIS for one year pre- and post-intervention. Then, rates of change in test utilization and associated financial savings were calculated. RESULTS: A total of 414,475 unnecessary tests were averted during the first post-intervention year. In addition, a 12.26% decrease was observed in the test-to-hospitalization-day ratio. The highest decreases obtained for serum calcium (25.87%), serum albumin (22.17%), and alanine aminotransferase (21.03%) testing. CONCLUSION: Implementing MRI guidelines into the HIS to flag deviations is an effective strategy for laboratory utilization management. Its benefits are multi-faceted, including financial savings (decreased patient and insurer costs), clinical advantages (minimizing diagnostic ambiguity and patient mismanagement), and optimized laboratory resource allocation (staff workload, instrument usage, reagent efficiency).
Diagnosing protein S deficiency - Navigating challenges.
Hansen RS, Nissen PH, Larsen JB … +1 more , Bor MV
Clin Biochem · 2025 Aug · PMID 40419135 · Publisher ↗
OBJECTIVE: Describe challenges in diagnosing protein S deficiency. METHODS: A women in her late 20 s and pregnant in third trimester (G1P0) suffered non-hemorrhagic adrenal infarction. Thrombophilia testing was performed...
OBJECTIVE: Describe challenges in diagnosing protein S deficiency. METHODS: A women in her late 20 s and pregnant in third trimester (G1P0) suffered non-hemorrhagic adrenal infarction. Thrombophilia testing was performed five months post-partum and included analyses for the factor V Leiden (FVL; NM_000130:c.1601G > A; rs6025) and prothrombin c.20210G > A (NM_000506:c.*97G > A; rs1799963) variants, and measurement of antiphospholipid antibodies, protein C (PC) activity and antigen, protein S (PS) activity and antigen, and antithrombin. Initial testing suggested PS deficiency of unknown type. Therefore, targeted genetic screening of the PROS1 gene was performed using Sanger sequencing and multiplex ligation-dependent probe amplification to rule out large structural DNA rearrangements, along with repeated thrombophilia testing. RESULTS: The first round of thrombophilia testing found low PS and PC, and heterozygosity for the FVL variant. FVL is known to falsely reduce PS activity up to 15 %, but not influence antigen assays (free and total PS levels). A PROS1 variant was identified (c.698G > A; p.(Arg233Lys)), but as this is relatively common, we classified the variant as likely benign. The final round of thrombophilia testing was performed 8 months after the first, and showed normal PC activity, normal PS total, PS free at the lower normal threshold and low PS activity. CONCLUSION: The patient does not meet the criteria for PS deficiency based on either coagulation assays or PROS1 gene genotyping. This case highlights the necessity for clear guidelines to define the role of PROS1 genetic testing in routine clinical practice.
Choosing Wisely Canada recommendations for clinical biochemistry: test ordering for sustainable and high-quality patient care.
Beriault DR, Chen Y, Yip P … +28 more , Blasutig I, Bhayana V, Rutledge AC, Parker M, Kinniburgh D, Thomas D, Colbourne P, Langman L, Delaney SR, Bennett M, Oleschuk C, Huang Y, Rodriguez-Capote K, Hauff K, Konforte D, Kalra J, Bouhtiauy I, El Hassan MA, Elnenaei M, Thorlacius L, Venner AA, Randell EW, Sohn KY, Leung F, Taher J, Lou A, Arnoldo S, CSCC Utilization Special Interest Group
Clin Biochem · 2025 Aug · PMID 40409393 · Publisher ↗
Laboratory Medicine is growing at a rapid rate in both the breadth of unique tests and the total number of tests performed per year. Inappropriate overutilization of laboratory tests can lead to patient harm, excessive e...
Laboratory Medicine is growing at a rapid rate in both the breadth of unique tests and the total number of tests performed per year. Inappropriate overutilization of laboratory tests can lead to patient harm, excessive environmental waste and increased carbon emissions. A focus on reducing inefficiencies in healthcare is needed to ensure a robust and sustainable healthcare system. To promote laboratory sustainability, the Canadian Society of Clinical Chemists (CSCC) has developed ten recommendations related to medical tests within clinical biochemistry. These recommendations are designed as 'low-hanging fruit' that should be adopted by both hospital and community laboratories. By implementing automated strategies and/or educational approaches to reduce misuse of laboratory resources, clinical laboratories can move toward a more sustainable model that improves patient care. This list of recommendations, created for Choosing Wisely Canada, covers tests for diabetes, celiac disease, monoclonal gammopathies, iron disorders, liver disorders, kidney disorders, substance use disorders, and allergen testing.
Wide-range and high-throughput quantification of anamorelin in human plasma using ultra-high-performance liquid chromatography coupled to tandem mass spectrometry.
Sumimoto T, Tanaka R, Sato A … +2 more , Tatsuta R, Itoh H
Clin Biochem · 2025 Aug · PMID 40373991 · Publisher ↗
OBJECTIVE: Cancer cachexia is characterized by weight loss, muscle mass loss, and reduced food intake. Anamorelin is a ghrelin receptor agonist approved for the treatment of cancer cachexia. In this study, we established...
OBJECTIVE: Cancer cachexia is characterized by weight loss, muscle mass loss, and reduced food intake. Anamorelin is a ghrelin receptor agonist approved for the treatment of cancer cachexia. In this study, we established and validated an assay for quantification of anamorelin in human plasma. METHODS: For quantification of anamorelin, samples were pretreated with solid-phase extraction and analyzed by ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UHPLC-MS/MS). This analytical method was validated in accordance with the Food and Drug Administration (FDA) bioanalytical method validation guidance. We used the established assay to quantify plasma anamorelin concentrations in five patients with cancer cachexia treated with anamorelin. RESULTS: The validation results of this assay method met the acceptance criteria recommended by the FDA guidance. Within-batch and batch-to-batch precision at the lower limit of quantification and three quality control levels were within 6.20 % and 6.55 % coefficient of variation, respectively. Within-batch and batch-to-batch accuracies ranged from -2.58 to -1.33 % and -3.78 to -1.69 %, respectively. Recovery rates and matrix effects corrected by internal standard were 82.7-84.2 % and 102.7-104.6 %, respectively. Using the established assay with a calibration range of 0.1-2500 ng/mL, plasma anamorelin concentrations were successfully quantified in all 15 plasma samples from 5 patients with cancer cachexia. CONCLUSIONS: We established and validated a method to measure plasma anamorelin concentrations using UHPLC/MS-MS combined with SPE, and successfully applied the novel method to measure plasma anamorelin concentrations in patients with cancer cachexia. By measuring plasma anamorelin concentrations in large scale studies, the established quantitative method is expected to contribute to the pharmacokinetic study of anamorelin.
The comparison of miRNA expression levels in Type 2 diabetes and diabetic peripheral neuropathy patients.
Ayaz A, Kuras S, Erdogan B … +3 more , Aktas HS, Pence ME, Pence HH
Clin Biochem · 2025 Aug · PMID 40360018 · Publisher ↗
OBJECTIVES: We aimed to investigate the correlation between miRNA expression levels in patients with type 2 diabetes mellitus (T2DM) and diabetic peripheral neuropathy (DPN) and determine their potential functions in DPN...
OBJECTIVES: We aimed to investigate the correlation between miRNA expression levels in patients with type 2 diabetes mellitus (T2DM) and diabetic peripheral neuropathy (DPN) and determine their potential functions in DPN. MATERIAL AND METHODS: The study participants were between 30 and 75 years old and divided into three groups: 30 patients with Type 2 T2DM without DPN (group 1), 30 patients with DPN (group 2), and 30 healthy controls (group 3). Whole blood samples were obtained from the individuals forming the groups, and the expression of the miR-128a, miR-146a, miR-155, and miR-375 genes in these samples was determined by real-time polymerase chain reaction (PCR). RNU6 was used as the housekeeping gene. RESULTS: No significant differences were observed in the expression levels of miR-128a, miR-146a, and miR-155 among all groups (p > 0.05). However, miR-375 expression levels differed significantly between the group 2 and the group 3 (p < 0.05). No significant differences in miR-375 expression levels were found between the group 1 and the group 3, nor between the group 1 and the group 2 (p > 0.05). CONCLUSIONS: miR-375 may be linked to the progression of diabetic peripheral neuropathy (DPN).
Sustainable healthcare and medical laboratories: The impact of global collaborations between frameworks and initiatives.
Uras F
Clin Biochem · 2025 Aug · PMID 40360017 · Publisher ↗
Climate change is a pressing global challenge that requires urgent action. The Paris Agreement and the 2030 Agenda of United Nations (UN) set clear global targets for emission reduction and sustainability to limit warmin...
Climate change is a pressing global challenge that requires urgent action. The Paris Agreement and the 2030 Agenda of United Nations (UN) set clear global targets for emission reduction and sustainability to limit warming to 1.5 °C. Partnerships between standardization organizations are crucial in accelerating climate action. The Geneva Sustainability Centre (GSC) is at the forefront of healthcare sustainability, launching the Sustainability Accelerator Tool (SAT) in 2023 to help hospitals assess their environmental impact. In partnership with GSC, Joint Commission International (JCI) has integrated sustainability into its accreditation standards and will introduce the JCI-GSC Healthcare Sustainability Certification in 2025, built on the SAT. To accelerate the achievement of the Sustainable Development Goals (SDGs), ISO and the UN formed a strategic partnership in 2023 to create the first global SDG standard. ISO has published the IWA 42:2022 Net Zero Guidelines and is developing its first global Standard on Net Zero, set for release in 2025. Additionally, ISO introduced the Climate Change Amendments, embedding climate considerations into over 30 existing management system standards, including ISO 9001. With these amendments now shaping all newly developed or revised standards, future updates to ISO 15189 will likely incorporate sustainability requirements, especially as ISO 9001 is an essential part of ISO 15189. Reducing operational emissions from healthcare and medical laboratories alone will not achieve net zero. A sector-wide approach is essential, tackling supply chain emissions from energy, pharmaceuticals, and medical devices. Combating climate change requires a coordinated, cross-sector effort, making international collaboration indispensable. This review highlights key global frameworks, standards, guidelines, and initiatives that have evolved through collaboration to help healthcare organizations, including medical laboratories, to advance sustainability and climate resilience.
Biomarker profiling for infection diagnosis in emergency departments: A diagnostic study evaluating C-reactive protein, procalcitonin, Club Cell Protein 16, interleukin-6, chitinase-like protein, and soluble urokinase-type plasminogen activator receptor.
Bruhn R, Skjøt-Arkil H, Skovsted TA … +8 more , Brasen CL, Andersen ES, Heltborg A, Hertz MA, Petersen ERB, Mogensen CB, Torres A, Cartuliares MB
Clin Biochem · 2025 Aug · PMID 40354888 · Publisher ↗
INTRODUCTION: Diagnosing infections in emergency departments (EDs) is vital for prompt and effective treatment. This study evaluates the diagnostic accuracy of six inflammatory biomarkers-CC16, CRP, IL-6, PCT, suPAR, and...
INTRODUCTION: Diagnosing infections in emergency departments (EDs) is vital for prompt and effective treatment. This study evaluates the diagnostic accuracy of six inflammatory biomarkers-CC16, CRP, IL-6, PCT, suPAR, and YKL-40-in ED patients with suspected infections. MATERIALS AND METHODS: This was a multicenter diagnostic accuracy study. Adult patients suspected of infections at four Danish EDs were included. We measured biomarker levels at admission and analyzed their diagnostic performance. RESULTS: The study included 966 patients, with 789 (81.7%) confirmed infections. CRP, IL-6, and PCT demonstrated the highest positive predictive values, recorded at 93% (95% CI, 91-95), 92% (95% CI, 90-94), and 91% (95% CI, 88-93), respectively. However, the negative predictive values of these markers were low, at 35.5 (95% CI, 30.8-40.5), 38.3 (95% CI, 32.5-44.3) and 34.2 (95% CI, 28.9-39.9) respectively at Youden Index. CRP, IL-6, and PCT were the most predictive, with CRP demonstrating an area under the curve (AUC) of 0.79. IL-6 and PCT showed similar levels of accuracy. CC16, suPAR, and YKL-40 displayed AUCs in the range of 0.53-0.64. CRP levels peaked three days after symptoms appeared, whereas PCT levels were highest upon symptom onset at admission. The influence of fever enhanced the sensitivity of IL-6 and PCT. CONCLUSION: CRP, IL-6, and PCT showed the best diagnostic accuracy among the biomarkers tested but are influenced by the timing of symptom onset and fever presence. CC16, suPAR, and YKL-40 had poor diagnostic accuracy and were considered poor discriminators. Overall, no single biomarker was sufficient to conclusively rule in or rule out infection. These findings support the need for nuanced interpretation when using biomarkers to diagnose infections in ED settings.
Venous lactate as a tool for the Risk-Stratification of patients with acute pulmonary embolism: A retrospective cohort study.
Lee ES, Chang KE, Prucnal CK … +11 more , Stannek K, Koetter P, Stubblefield WB, Dhar I, Birrenkott DA, Wang G, Matthews TM, Horick N, Peters GA, Brown T, Kabrhel C
Clin Biochem · 2025 Aug · PMID 40348120 · Publisher ↗
INTRODUCTION: Prognostication in pulmonary embolism (PE) is crucial due to the broad range of clinical severity, and biomarkers such as arterial lactate are considered helpful markers for illness severity. Venous lactate...
INTRODUCTION: Prognostication in pulmonary embolism (PE) is crucial due to the broad range of clinical severity, and biomarkers such as arterial lactate are considered helpful markers for illness severity. Venous lactate is more readily accessible, but its prognostic value in acute PE has not been widely evaluated. We aimed to determine optimal cutoffs for venous lactate in predicting adverse outcomes in patients with PE. METHODS: We performed a retrospective study of normotensive (systolic blood pressure > 100 mmHg) patients presenting with imaging-confirmed PE severe enough to require Pulmonary Embolism Response Team (PERT) activation and a venous lactate measured clinically within 24 h of activation. Data were extracted from an ongoing registry of PERT patients at a single, tertiary academic medical center. The primary outcome was clinical deterioration defined by a composite of clinical events occurring within 7 days, including death, catheter-based intervention, systemic thrombolysis, extracorporeal membrane oxygenation (ECMO), or intubation. We performed a receiver operating characteristic (ROC) curve analysis, calculated the area under curve (AUC), and calculated optimal cutoff value using the least distance from (0,1). RESULTS: We included 145 patients in the final analysis. Mean age was 64 years and 61 (43 %) were female. 36 patients (26 %) met the composite outcome. The AUC of the ROC curve was 0.56, and the optimal cutoff for venous lactate was 1.8 mmol/L, corresponding to 58 % sensitivity and 61 % specificity. CONCLUSION: In a cohort of normotensive patients with severe acute PE, venous lactate was not significantly associated with acute deterioration. Our findings do not support the use of venous lactate for prognostication of clinical deterioration in patients with PE severe enough to warrant PERT activation.
Shortcoming of serum B-cell maturation antigen measurement by enzyme-linked immunosorbent assay in one laboratory's experience: Unsatisfactory assay reproducibility.
Cheong I, Liang C, Bhayana V … +4 more , Stevic I, Louzada M, Chin-Yee I, Rutledge AC
Clin Biochem · 2025 Aug · PMID 40345317 · Publisher ↗
INTRODUCTION: Serum protein electrophoresis and serum free light chain (SFLC) assays are standard methods for monitoring patients with multiple myeloma (MM). However, patients with non-secretory MM often require invasive...
INTRODUCTION: Serum protein electrophoresis and serum free light chain (SFLC) assays are standard methods for monitoring patients with multiple myeloma (MM). However, patients with non-secretory MM often require invasive bone marrow biopsies to monitor treatment response and disease progression. Recently, serum soluble B-cell maturation antigen (sBCMA) has been proposed as an alternative biomarker for monitoring of MM, including non-secretory disease. We aimed to optimize the performance of and validate a serum sBCMA enzyme-linked immunosorbent assay (ELISA) from R&D Systems for research and eventual clinical use. METHODS AND RESULTS: A total allowable error of 25 % was used, with one-third (8.3 %) budgeted for imprecision, one-third for bias, and one-half (12.5 %) as the allowable deviation from linearity. For imprecision, the repeatability coefficient of variation (CV) was acceptable, but the within-laboratory CV was not. We were limited in our ability to assess accuracy, but recovery of the ELISA standards was acceptable, and the sBCMA concentrations determined in various patient populations compared well to previous publications. The sBCMA concentration also correlated significantly with the M-protein concentration and the involved/uninvolved SFLC ratio. The sBCMA ELISA was verified to be linear within the allowable deviation between 99.04-1179.36 pg/mL. We attempted to confirm stability of serum sBCMA stored at room temperature, 4 °C, and -20 °C for up to 50 weeks, but the assay reproducibility was too poor for this to be assessed adequately. CONCLUSION: Despite efforts to optimize the performance of the ELISA, the results were not reproducible enough over time to allow us to implement this sBCMA ELISA for clinical use.
Hook effect although rare, still exists.
Napoli G, Leggeri S, Lombardi C … +3 more , Mazzuccato G, Urbani A, Baroni S
Clin Biochem · 2025 Aug · PMID 40339977 · Publisher ↗
BACKGROUND: The hook effect occurs when extremely high concentrations of an analyte in the sample, saturate the antibodies used in the method, leading to falsely low results. CASE: We describe a case observed with the At...
BACKGROUND: The hook effect occurs when extremely high concentrations of an analyte in the sample, saturate the antibodies used in the method, leading to falsely low results. CASE: We describe a case observed with the Atellica IM 1600 (Siemens) analyzer for the measurement of human chorionic gonadotropin (β-HCG) in serum of a pregnant woman at the thirteenth week of pregnancy. DISCUSSION: The β-HCG result was inconsistent with the gestational age and helped us to highlight the hook effect and supported the clinical diagnosis of vesicular mole in the patient. The same sample was also analyzed using the Alinity-i Total β-hCG kit (Abbott), and the authors highlight how differences between diagnostic kits can significantly affect the analytical result. CONCLUSIONS: In cases of discrepancies between laboratory data and clinical findings, it is essential to consult with laboratory specialists to rule out analytical interferences. To minimize the risk of the hook effect, we modified the analytical procedure and submitted a report to Siemens European Support.
Determining susceptibility of routine clinical biochemistry assays to methylene blue interference.
Stevic I, Kllapi T, Bhayana V … +2 more , Jasani A, Rutledge AC
Clin Biochem · 2025 Jun · PMID 40320108 · Publisher ↗
INTRODUCTION: Methylene blue (MB) is a blue-coloured treatment for multiple indications, including methemoglobinemia. Its interference potential with spectrophotometric and/or colorimetric clinical assays has not been we...
INTRODUCTION: Methylene blue (MB) is a blue-coloured treatment for multiple indications, including methemoglobinemia. Its interference potential with spectrophotometric and/or colorimetric clinical assays has not been well studied. OBJECTIVE AND METHODS: We determined an MB absorbance spectrum and identified spectrophotometric assays in our core laboratory with interference potential based on their wavelengths. We identified twelve Roche cobas c502/c702 chemistry assays and co-oximetry on the Werfen GEM Premier 4000 blood gas analyzers as potentially susceptible. We also tested colorimetric urinalysis performed on a Roche cobas u601 urine analyzer. For Roche cobas c502/c702 assays or urinalysis, we performed an initial study with MB mostly at concentrations of 10 or 100 mg/L (or water as a control) in leftover patient specimens with relevant analyte concentrations. For co-oximetry, venous whole blood from healthy donors was spiked with MB. For assays with differences between MB-spiked samples and controls exceeding total allowable error, dose-response studies were performed to better characterize the MB concentrations causing interference. RESULTS: MB >0.1, >0.01, and >0.08 mg/L, respectively, caused negative interference with the cobas c502 hemolysis index, positive interference with the cobas c502 lipemia index, and positive interference with the cobas c702 urine amphetamines assay. MB at ≥50-70 mg/L in venous whole blood yielded incalculable co-oximetry results on the GEM Premier 4000. These interferences were not felt to be clinically concerning. However, a urine MB concentration of ≥5 mg/L interfered with most urinalysis parameters on the cobas u601 analyzer. Automated comments based on colour detection were introduced to make clinicians aware of potential MB interference with urinalysis. CONCLUSION: We identified the assays in our core laboratory susceptible to MB interference and addressed them where clinically indicated.
Green laboratory practice: Top 2 environmental recommendations for clinical laboratories.
Arnoldo S, Bailey D, Leung F … +4 more , Bouhtiauy I, El Hassan MA, Oleschuk C, Beriault DR
Clin Biochem · 2025 Aug · PMID 40320107 · Publisher ↗
Choosing Wisely Canada has made significant contributions to diagnostic stewardship and appropriate test ordering. Given that laboratories play a crucial role in advancing healthcare efficiency and sustainability, it is...
Choosing Wisely Canada has made significant contributions to diagnostic stewardship and appropriate test ordering. Given that laboratories play a crucial role in advancing healthcare efficiency and sustainability, it is imperative to continue advocating for Choosing Wisely laboratory initiatives to minimize unnecessary testing and mitigate the associated environmental impact. Herein, we recommend the focus on two environmental impacts associated with the overuse of diagnostic laboratory tests. Firstly, collaboration with healthcare providers is essential to raise public awareness about the waste generated by performing lab tests in the absence of a clear clinical indication. Not only does unnecessary testing come with clinical and financial costs, but it also contributes significantly to a substantial carbon footprint. Patients also have a role in reducing waste by understanding when tests are truly necessary and when they might be redundant or even harmful. Secondly, laboratories should partner with in vitro diagnostic device manufacturers to prioritize environmentally conscientious solutions. This includes minimizing the use of single-use consumables, toxic chemicals, and high-energy consumption processes. Laboratories should adopt a holistic, "environmental lens" approach, scrutinizing every stage of the laboratory total testing workflow- from sample collection and transportation, to testing, reporting, and disposal-to identify areas where waste reduction and process efficiencies can be achieved. The optimization of testing workflows to eliminate unnecessary steps can lead to both environmentally sound and cost-effective operations. In summary, laboratories are in a unique position to lead the way in both improving clinical care and driving eco-friendliness in healthcare. By aligning with Choosing Wisely initiatives and focusing on greener practices, laboratories can lead the way in improving both patient care and environmental sustainability.
Critical appraisal of the MPER model: Validation rigor and clinical translation considerations.
Yuan S, Han W
Clin Biochem · 2025 Jun · PMID 40288480 · Publisher ↗
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Performance of the Siemens' thyroid stimulating immunoglobulin assay in the diagnosis of hyperthyroidism: Prospective cohort study.
Kline GA, Proctor DT, Moledina N … +5 more , Paul HA, Robinson JL, Lewis C, Donovan L, Sadrzadeh HSM
Clin Biochem · 2025 Jun · PMID 40286898 · Publisher ↗
BACKGROUND: Auto-antibody testing is recommended for Graves' Disease (GD). The thyroid-stimulating-immunoglobulin (TSI) bridge method is designed to provide specificity for stimulatory antibodies to the TSH receptor whic...
BACKGROUND: Auto-antibody testing is recommended for Graves' Disease (GD). The thyroid-stimulating-immunoglobulin (TSI) bridge method is designed to provide specificity for stimulatory antibodies to the TSH receptor which may translate to differences in performance in diagnosis of GD compared to TSH-receptor-antibody (TRAb) assays that don't distinguish between TSH-receptor antibody subclasses. The objective of this study was to prospectively compare the performance of a TSI assay to a TRAb assay for diagnosis of GD. METHODS: A total of 158 non-pregnant patients with new-onset hyperthyroidism were recruited into the study by endocrinologists. Final diagnosis of GD or non-GD was made by endocrinologists after clinical assessment and diagnostic work-up (TSH, free T4, TRAb and imaging). TSI results were blinded. Sensitivity/specificity of TRAb and TSI were determined; receiver operating characteristic (ROC) curve analysis was used to compare overall accuracy and optimal diagnostic thresholds for each assay. RESULTS: Complete assessment was available for 131/158 patients (95 GD and 36 non-GD). A strong correlation between TRAb and TSI existed (r = 0.92 (0.89-0.94), p < 0.0001). There was no significant difference between tests, area under the curve (AUC) (0.935 vs 0.929, p = 0.86) using manufacturer's recommended thresholds. Both assays had sensitivity around 88 % and specificity 80-90 %. The ROC-determined threshold for 95 % GD specificity was 3.63 IU/L (TRAb) and 0.98 IU/L (TSI) with corresponding sensitivities 77.5 % and 86.2 %. Assuming nuclear tracer thyroid scanning for results below 95 % specificity, 14 (14.7 %) GD patients would require a scan after TRAb, and 7 (7.4 %) after TSI. CONCLUSIONS: TRAb and TSI performed similarly in the work up of hyperthyroidism; an optimized specificity threshold might permit TSI testing to reduce nuclear tracer thyroid scan requirements, without losing diagnostic sensitivity.
Lp(a): A Clinical Review.
Anchouche K, Baass A, Thanassoulis G
Clin Biochem · 2025 Jun · PMID 40258460 · Publisher ↗
Elevated lipoprotein(a) (Lp[a]) is a genetically determined cardiovascular risk factor, linked to both atherosclerotic cardiovascular disease and aortic stenosis. Elevated Lp(a) is widely prevalent, and consequently, sev...
Elevated lipoprotein(a) (Lp[a]) is a genetically determined cardiovascular risk factor, linked to both atherosclerotic cardiovascular disease and aortic stenosis. Elevated Lp(a) is widely prevalent, and consequently, several cardiovascular societies now recommend performing Lp(a) screening at least once in all adults. While there are presently no approved drugs specifically aimed at lowering Lp(a), several promising candidates are currently in the drug development pipeline, and many of these are now undergoing late phase clinical trials. In this comprehensive review, we outline Lp(a) biology and genetics, describe Lp(a)'s relationship to various cardiovascular clinical phenotypes of interest, highlight novel Lp(a)-lowering therapies, and outline what role these may have in future clinical practice.
Linking gestational RBP4 to bone resorption via postprandial glycemic pathways: A cross-sectional mediation analysis.
Feng X, Tang Y, Li Q … +2 more , Zhang Y, Yu F
Clin Biochem · 2025 Jun · PMID 40253049 · Publisher ↗
BACKGROUND: Retinol-binding protein 4 (RBP4), a key adipokine associated with glucose metabolism, is elevated during pregnancy and linked to gestational diabetes mellitus (GDM). However, its relationship with gestational...
BACKGROUND: Retinol-binding protein 4 (RBP4), a key adipokine associated with glucose metabolism, is elevated during pregnancy and linked to gestational diabetes mellitus (GDM). However, its relationship with gestational bone resorption remains unclear. This study aimed to investigate the association between RBP4 and bone resorption (measured by β-C-terminal telopeptide of type I collagen [β-CTX]) and explore potential mediation pathways involving glycemic dysregulation in pregnancy. METHODS: In this cross-sectional study, we analyzed serum RBP4, β-CTX, glucose metrics (fasting blood glucose, 1-hour [GLU1h], 2-hour [GLU2h] post-load glucose), insulin resistance indices (IR), and GDM status in pregnant women. Mediation analyses were performed to identify statistical pathways connecting RBP4 and β-CTX. RESULTS: After adjusting for maternal age, gestational age, and body mass index, each 1 mg/L increase in RBP4 was associated with a 10.7 ng/L rise in β-CTX (explaining 7 % of variance). Single-mediator models indicated that GLU1h and GLU2h independently accounted for approximately 50 % of the RBP4-β-CTX association (indirect effects: 5.33 and 5.40, respectively). In serial mediation, the combined glycemic pathways mediated 0.502 of the total association (Indirect_All = 5.42), while individual paths were non-significant, suggesting potential interplay between postprandial phases. Notably, GDM status and IR showed no mediation, likely reflecting limitations of dichotomous diagnostic thresholds and pregnancy-adapted insulin resistance. CONCLUSION: The association between RBP4 and bone resorption in pregnancy is largely linked to dynamic postprandial glucose fluctuations rather than categorical GDM. These findings highlight the importance of continuous glucose monitoring and tailored interventions in women with elevated RBP4, even below GDM thresholds, to address potential bone health risks.
Advancing cardiovascular risk assessment: Real-time SCORES2 calculation through CDSS in primary care patients.
Salinas M, Flores E, Ahumada M … +4 more , Leiva-Salinas M, Blasco A, Leiva-Salinas C, PRIMLAB working group
Clin Biochem · 2025 Jun · PMID 40250522 · Publisher ↗
BACKGROUND: Individualized cardiovascular risk stratification is recommended to guide treatment. The objective was to report the 10-year cardiovascular disease (CVD) risk in primary care patients without previous CVD or...
BACKGROUND: Individualized cardiovascular risk stratification is recommended to guide treatment. The objective was to report the 10-year cardiovascular disease (CVD) risk in primary care patients without previous CVD or diabetes using the SCORE2 risk prediction algorithms, SCORE2 (age 40-69 years), and SCORE2-OP (age 70-89 years) scales, as per the European Society of Cardiology guidelines. The risk levels were categorized as low-moderate (<5 %), high (5-10 %), or very high (>10 %), with recommendations for treatment, through the clinical decision support system (CDSS). METHODS: A cross-sectional study was designed in collaboration with general practitioners. The CDSS, integrated with computerized patient order entry, facilitated the calculation for CVD-free individuals after electronic medical record consultation. We counted the patients offered SCORES calculation, the number of acceptances and calculations, the results obtained, risk factors, along with adherence to recommended treatment. RESULTS: SCORES were offered to 971 patients, 635 SCORE2 and 336 SCORE2-OP, and 614 (96.7 %) SCORE2 and 160 (47.6 %). SCORE2-OP calculations were accepted, showing a significantly different acceptance rate. There was a significantly higher prevalence of smoking habit (P < 0.01) and hypertension (P < 0.01) among SCORE2 patients. Half of the SCORE2 patients were classified as low risk, more than 80 % of SCORE2-OP as high or very high risk. The adherence to treatment recommendations was 90.4 % overall, with a significant difference between SCORE2 (93.9 %) and SCORE2-OP (74.0 %) (P < 0.01). CONCLUSION: The laboratory, in collaboration with clinicians and utilizing CDSS, plays a central role in clinical decision-making by reporting SCORE2 risk prediction algorithms and treatment recommendations.
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