Clinica Chimica Acta; International Journal Of Clinical Chemistry[JOURNAL]
Sun
200 papers
Liquid biopsy in primary central nervous system tumors: Emerging biomarkers for precision oncology and real-time disease monitoring.
Sanoeva M, Konnova K, Nazarova N … +5 more , Zhumanov Z, Mozaffarov N, Moydinova E, Sultonova N, Ruziyeva G
Clin Chim Acta · 2026 Jun · PMID 42251924 · Publisher ↗
Central nervous system (CNS) tumors represent one of the most heterogeneous and clinically challenging groups of malignancies, largely due to their limited accessibility, complex molecular landscape, and the constraints...
Central nervous system (CNS) tumors represent one of the most heterogeneous and clinically challenging groups of malignancies, largely due to their limited accessibility, complex molecular landscape, and the constraints associated with conventional tissue biopsy. Liquid biopsy has emerged as a promising minimally invasive strategy for detecting and monitoring CNS tumors through the analysis of tumor-derived biomarkers in biofluids. These biomarkers include circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), extracellular vesicles (EVs), and tumor-educated platelets (TEPs). Advances in highly sensitive detection technologies, such as next-generation sequencing (NGS), digital polymerase chain reaction (dPCR), and multi-omics platforms, have improved the ability to identify tumor-specific genetic, epigenetic, and transcriptomic alterations in plasma and cerebrospinal fluid (CSF). This review summarizes the current progress in the application of liquid biopsy for primary CNS tumors, particularly gliomas and medulloblastomas. The clinical potential of different liquid biopsy analytes for tumor detection, molecular profiling, treatment selection, and real-time monitoring of therapeutic response and disease recurrence is discussed. In addition, the advantages and limitations of individual biomarkers are evaluated, highlighting the potential benefits of integrating multiple analytes to achieve a more comprehensive understanding of tumor biology. Key challenges, including the influence of the blood-brain barrier (BBB), low biomarker abundance, and the need for methodological standardization and large-scale clinical validation, are also addressed. Overall, liquid biopsy represents a rapidly evolving field with significant potential to advance precision oncology in neuro-oncology and enable more personalized and dynamic management of patients with CNS tumors.
Gut microbiome-derived metabolites as predictors of bariatric surgery outcomes.
Alum EU, Emeruwa AP, Obasi DC … +6 more , Okoroh PN, Aniokete UC, Akwari AA, Uzor S, Eji MO, Amadi EB
Clin Chim Acta · 2026 Jun · PMID 42251923 · Publisher ↗
BACKGROUND: Bariatric surgery remains the most effective treatment for severe obesity and obesity-associated metabolic disorders. However, substantial interindividual variability exists in postoperative weight loss and t...
BACKGROUND: Bariatric surgery remains the most effective treatment for severe obesity and obesity-associated metabolic disorders. However, substantial interindividual variability exists in postoperative weight loss and type 2 diabetes mellitus remission. Increasing evidence suggests that gut microbiome-derived metabolites may influence metabolic responses after bariatric surgery. OBJECTIVE: This narrative review synthesizes current evidence regarding the predictive role of gut microbiome-derived metabolites, particularly short-chain fatty acids, bile acids, and tryptophan-derived metabolites, in bariatric surgery outcomes. METHODS: A narrative literature review was conducted using PubMed, Web of Science, Embase, and ClinicalTrials.gov to identify studies published through May 2026. Studies examining associations between microbiome-derived metabolites and postoperative bariatric outcomes were reviewed and narratively synthesized. RESULTS: Available evidence suggests that higher preoperative levels of beneficial microbiome-derived metabolites are associated with improved postoperative weight loss, enhanced insulin sensitivity, and greater likelihood of type 2 diabetes mellitus remission. Short-chain fatty acids appear to influence satiety and glucose metabolism, bile acids regulate metabolic signaling through farnesoid X receptor and Takeda G protein receptor 5 pathways, and tryptophan metabolites modulate inflammation and gut-brain communication. Nevertheless, findings remain inconsistent because of methodological heterogeneity, limited cohort sizes, and differences in metabolomic profiling techniques. CONCLUSION: Gut microbiome-derived metabolites represent promising candidate biomarkers for predicting bariatric surgery outcomes. However, large-scale longitudinal studies using standardized metabolomic approaches are required before clinical implementation can be achieved.
Association between bile acid metabolism and sarcopenia in older adults.
Lv XG, Liu KW, Tian CY … +6 more , Wang C, Jin XY, Hu Y, Mao XQ, Zhang WW, Jing LP
Clin Chim Acta · 2026 Jun · PMID 42251922 · Publisher ↗
BACKGROUND: Sarcopenia poses a significant global health challenge, yet its metabolic underpinnings remain incompletely understood. Bile acids (BAs), acting as potent signaling molecules, are increasingly recognized for...
BACKGROUND: Sarcopenia poses a significant global health challenge, yet its metabolic underpinnings remain incompletely understood. Bile acids (BAs), acting as potent signaling molecules, are increasingly recognized for their role in skeletal muscle homeostasis. However, clinical evidence linking BA metabolic profiles to primary sarcopenia in older adults remains scarce. METHODS: We conducted a matched case-control study utilizing LC-MS/MS-based metabolomics to comprehensively characterize serum BA profiles in older adults with sarcopenia compared to healthy controls. RESULTS: We observed six differential BAs, among which 3β-hyodeoxycholic acid (3β-HDCA) and glycolithocholic acid (GLCA) showed significant elevation in the sarcopenia group compared to controls. In conditional logistic regression analyses, elevated 3β-HDCA levels exhibited an independent association with sarcopenia risk across multiple adjustment models. A combined biomarker model yielded an Area Under the Curve (AUC) of 0.738. Furthermore, 3β-HDCA levels were found to be correlated with physical performance, specifically 6-m gait speed. Notably, interaction analysis indicated that the risk of sarcopenia associated with elevated taurolithocholic acid (TLCA) levels was significantly higher in individuals with long sleep duration (>8 h) (OR = 8.244, P = 0.022). CONCLUSIONS: This study characterizes a distinct BA metabolic profile, identifying elevated 3β-HDCA and GLCA as potential biomarkers for sarcopenia. Moreover, our findings imply a potential interaction between sleep duration and BA metabolism (specifically TLCA) in the context of muscle loss. These observations may provide insights for future preventative strategies and warrant further investigation into the underlying mechanisms.
Electrochemical biosensors for the detection of urinary tract infections.
Abuhassan Q, Al-Nabulsi JI, Younis SMD … +4 more , Rizaev J, Mavlonov A, Salih RM, Jaber MA
Clin Chim Acta · 2026 Jun · PMID 42250677 · Publisher ↗
Electrochemical biosensors have emerged as promising tools to address major limitations of conventional urinary tract infection (UTI) diagnosis, which depends on slow culture and low-specificity dipsticks. By transducing...
Electrochemical biosensors have emerged as promising tools to address major limitations of conventional urinary tract infection (UTI) diagnosis, which depends on slow culture and low-specificity dipsticks. By transducing specific biorecognition events into electrical signals, these platforms can deliver rapid, sensitive, and potentially point of care results directly from urine. This narrative review synthesizes developments in pathogen directed and host response based electrochemical biosensors for UTI detection. DNA biosensor arrays targeting bacterial 16S rRNA enable species specific identification of common and polymicrobial uropathogens within ∼1 h, with reported sensitivities around 89-100% and specificities up to 100% in clinical urine samples. Integrated lab on chip and array systems further extend this approach to rapid phenotypic antimicrobial susceptibility testing and minimum inhibitory concentration determination, substantially shortening time to targeted therapy. In parallel, several platforms quantify urinary host biomarkers, such as lactoferrin and prostaglandin E2, as objective measures of pyuria and inflammatory response. These include impedance based aptasensors, sandwich immunosensors, and novel electrofluidic capacitor or lateral flow electrochemical formats that operate label free in small volumes of unprocessed urine and can discriminate UTI positive from UTI negative samples within minutes. Emerging designs also target specific pathogens (e.g., Klebsiella pneumoniae, Enterococcus faecium) or live bacteria via phage recognition, nanostructured electrodes, molecular imprinting, and DNAzyme based amplification. The review highlights analytical performance, clinical validation, and translational challenges including matrix effects, multiplexing needs, and integration for home or point of care use framing electrochemical biosensors as key candidates for next generation, rapid, and more informative UTI diagnostics.
Urinary Exosomal ATF3 as a non-invasive biomarker for early detection of acute kidney injury.
Arya DK, Verma A, Mishra R … +2 more , Mueller E, Verma N
Clin Chim Acta · 2026 Jun · PMID 42250676 · Publisher ↗
Acute kidney injury (AKI) is a major clinical and economic challenge worldwide. Furthermore, early identification of AKI remains difficult given that traditional biomarkers like serum creatinine and urine output (UOP) ha...
Acute kidney injury (AKI) is a major clinical and economic challenge worldwide. Furthermore, early identification of AKI remains difficult given that traditional biomarkers like serum creatinine and urine output (UOP) have shown to have limitations since they reflect later stages of injury and are unable to detect the initial cellular damage in AKI. This issue creates an important gap in diagnosis given that early diagnosis could prevent worsening conditions. More research is focusing on non-invasive novel biomarkers options for early and accurate detection of AKI. Urinary exosomes are emerging as a valuable source of kidney-specific biomarkers. These nanovesicles come from all nephron segments, encapsulating intracellular components and providing a unique view of kidney health. Activating transcription factor 3 (ATF3), a transcriptional regulator induced by stress conditions, has emerged as a promising candidate for early detection of AKI. Studies in animals and humans have found that ATF3 is encapsulated and released in urinary exosomes in response to kidney injury, appearing much earlier than traditional biomarkers. This review mainly examines ATF3's role as a new biomarker for the early detection of AKI, it discusses the current understanding of ATF3's molecular role in kidney disease, evaluates the evidence for its use as a biomarker, and outlines a plan for future research and development to realize its full clinical potential.
Low plasma vitamin B6 levels are independently associated with ischemic stroke risk in young south Indian adults: A case-control study.
Rudreshkumar KJ, Pandarisamy S, Nagaraja D … +1 more , Christopher R
Clin Chim Acta · 2026 Jun · PMID 42250675 · Publisher ↗
BACKGROUND: Ischemic stroke among young adults is a significant public health concern globally. Given vitamin B6's critical roles in homocysteine metabolism and oxidative stress regulation, we aimed to investigate the as...
BACKGROUND: Ischemic stroke among young adults is a significant public health concern globally. Given vitamin B6's critical roles in homocysteine metabolism and oxidative stress regulation, we aimed to investigate the association between plasma vitamin B6 levels and the risk of ischemic stroke in young South Indian adults. METHODS: This case-control study included 171 young ischemic stroke patients and 249 age-matched healthy controls. Plasma vitamin B6 and total homocysteine (tHcy) levels were quantified using ion-pairing reverse-phase high-performance liquid chromatography (RP-HPLC), while plasma vitamin B12 and folate were measured via chemiluminescence immunoassay. Serum malondialdehyde (MDA) and ferric reducing antioxidant power (FRAP) were determined by spectrofluorimetry and spectrophotometry, respectively. RESULTS: Median plasma vitamin B6 levels were significantly lower in ischemic stroke patients (40.9 nmol/L) than in controls (65.6 nmol/L; p < 0.0001). Vitamin B6 insufficiency (<30 nmol/L) was present in 12.3% of cases and 0.7% in controls. Lower vitamin B6 levels were independently associated with increased stroke risk (adjusted odds ratio = 1.53; p < 0.0001). In stroke cases, vitamin B6 levels correlated negatively with tHcy (r = -0.886) and MDA (r = -0.295). ROC analysis demonstrated excellent discriminative power for vitamin B6 (AUC = 0.929), indicating strong potential as a biomarker for ischemic stroke risk in young individuals. CONCLUSION: In conclusion, it was clearly observed that reduced levels of vitamin B6 had a significant association with ischemic stroke in young adults. To further extend this knowledge on the effects of vitamin B6 in young adults, additional studies need to be conducted.
The distinction between systematic and random measurement errors depends on context and perspective.
Johansen JV, Theodorsson E
Clin Chim Acta · 2026 Jun · PMID 42250674 · Publisher ↗
Measurement errors may be constant, change in predictable, systematic ways, or vary randomly and unpredictably. When discussing measurement errors, the distinction between systematic and random errors is often poorly cha...
Measurement errors may be constant, change in predictable, systematic ways, or vary randomly and unpredictably. When discussing measurement errors, the distinction between systematic and random errors is often poorly characterized. Both systematic and random errors can occur at any stage of the testing process. Errors that occur during the measurement phase can be formally evaluated and quantified, for example, using CLSI evaluation protocol guidelines. Here, we assert that the assignment of measurement error labels, random and systematic, depends on the perspective of the observer and the availability of information. Random errors are usually quantified as imprecision or measurement uncertainty (MU), whereas systematic errors that remain approximately constant over time are quantified as biases. As more information becomes available, errors that were previously perceived as random may become predictable and thus considered systematic. Manufacturers/developers, users, and regulators of measurement procedures (MP) can have very different perspectives, including different levels of available knowledge, and these differences can affect perceptions of which errors are predictable. Therefore, whenever a bias is reported or discussed, its scope must be clearly stated. Similarly, whenever an imprecision or an uncertainty is stated, the sources of variation included in the estimate must also be detailed. Determining whether a source of error is systematic or random in each scenario ensures it can be meaningfully quantified and expressed.
Clinicopathological response and survival outcomes of HER2-low versus HER2-zero early breast Cancer: A systematic review and Meta-analysis.
Liu L, Ma X, Liu C … +4 more , Liu G, Zhang M, Wang T, Sun C
Clin Chim Acta · 2026 Jun · PMID 42248318 · Publisher ↗
BACKGROUND: Breast cancer is the most common malignant tumor in women. Human epidermal growth factor receptor 2 (HER2) is a key biomarker for classification and treatment. A subgroup with HER2-low expression has been ide...
BACKGROUND: Breast cancer is the most common malignant tumor in women. Human epidermal growth factor receptor 2 (HER2) is a key biomarker for classification and treatment. A subgroup with HER2-low expression has been identified, but existing evidence is heterogeneous. This systematic review and meta-analysis compared pathological response and survival outcomes between HER2-low and HER2-zero early-stage breast cancer to clarify prognostic features. METHODS: This study followed PRISMA guidelines and was registered in PROSPERO (CRD420251120506). PubMed, Embase, Web of Science, ClinicalTrials.gov, and major oncology conferences were searched through September 2025. Cohort studies of early-stage breast cancer comparing HER2-low (IHC 1+/2+ and ISH-negative) vs. HER2-zero with extractable pCR, DFS, or OS data were included. Studies involving HER2-positive patients or inconsistent definitions were excluded. Meta-analyses were performed using RevMan 5.3. RESULTS: Twenty-eight studies involving 115,182 patients were included. HER2-low patients showed significantly lower pCR rates (OR = 0.58, 95% CI: 0.52-0.65). DFS favored HER2-low (multivariate HR = 0.75, 95% CI: 0.69-0.83), especially in HR+ tumors, with a weaker effect in HR- cases. OS also favored HER2-low (HR = 0.80, 95% CI: 0.72-0.89), mainly driven by the HR- subgroup; no OS difference was seen in HR+ tumors. Sensitivity analyses and funnel plots indicated robust results with no apparent publication bias. Overall study quality was high (17 high-quality, 11 moderate-quality). CONCLUSION: HER2-low early breast cancer shows lower pCR after neoadjuvant therapy but better long-term survival. These findings support the clinical relevance of HER2-low as a biologically meaningful subgroup within HER2-negative disease, while its status as a stable and independent subtype still requires further validation through prospective studies, standardized testing, and multi-omics investigation.
The role of exosomal microRNAs in detecting hepatocellular carcinoma: A systematic review and meta-analysis.
Zuo Z, Yang M, Yin X … +3 more , Tang W, Du L, Guo Y
Clin Chim Acta · 2026 Jun · PMID 42248317 · Publisher ↗
BACKGROUND: Exosomal microRNAs (miRNAs) have emerged as promising non-invasive biomarkers for hepatocellular carcinoma (HCC). Nevertheless, the overall diagnostic performance of exosomal miRNAs in HCC was still less repo...
BACKGROUND: Exosomal microRNAs (miRNAs) have emerged as promising non-invasive biomarkers for hepatocellular carcinoma (HCC). Nevertheless, the overall diagnostic performance of exosomal miRNAs in HCC was still less reported. Therefore, this meta-analysis aimed to systematically assess the pooled diagnostic efficacy of exosomal miRNAs for HCC. METHODS: A literature search was performed in accordance with the PRISMA guidelines, utilizing the PubMed, Web of Science, EMBASE, and CNKI databases up to December 22, 2024. The quality of the included studies was evaluated using the QUADAS-2 tool. A random-effects model was applied to calculate the pooled sensitivity and specificity. The overall diagnostic performance was assessed by generating a summary receiver operating characteristic (sROC) curve and calculating the area under the curve (AUC). All statistical analyses were conducted using Meta-Disc (version 1.4) and STATA (version 16). RESULT: A total of 1442 HCC patients, 761 health controls (HC), and 1091 chronic liver disease (CLD) were identified in 18 individual publications. The sROC analysis showed that the pooled AUC, sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR) with 95% confidence interval (CI) were 0.89 (0.86, 0.91), 0.84(0.80, 0.88), 0.79(0.71, 0.86), 4.1(2.8, 5.9), 0.20(0.15, 0.27), 21(11, 37), respectively. CONCLUSION: This meta-analysis confirms that exosomal miRNAs represent promising novel, non-invasive biomarkers for HCC screening. Furthermore, exosomal miRNAs demonstrate superior diagnostic accuracy in HCC patients with HBV or HCV infection compared to those with other etiologies.
Assessing the diagnostic performance of YiDiXie™ tests for detecting metastasis across multiple cancer types: A prospective observational single-center study.
Zhang P, Sun C, Ge Z … +12 more , Chen M, Zhong L, Chen S, Wang W, Wu Y, Lin S, Zhou H, Li X, Li W, Li J, Sun X, Lai Y
Clin Chim Acta · 2026 Jun · PMID 42242663 · Publisher ↗
BACKGROUND: PET-CT is widely used to determine whether solid malignant tumors have metastasized. However, its significant limitations, such as high radioactivity, high cost, and the risk of allergic reactions to contrast...
BACKGROUND: PET-CT is widely used to determine whether solid malignant tumors have metastasized. However, its significant limitations, such as high radioactivity, high cost, and the risk of allergic reactions to contrast agents, have clearly restricted its application. There is an urgent need to find a convenient, economical, and non-invasive diagnostic method to replace PET-CT for diagnosing cancer metastasis. The purpose of this study is to evaluate the diagnostic value of five YiDiXie™ tests in determining the metastatic status of multiple cancers. MATERIALS AND METHODS: A total of 2276 subjects were ultimately included in this study (preoperative metastatic group, n = 102; preoperative non-metastatic group, n = 1875; postoperative metastatic group, n = 24; postoperative non-metastasis group, n = 275). Residual serum samples of the subjects were collected and tested using the YiDiXie™ all-cancer detection kit to evaluate the sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of YiDiXie™-48, YiDiXie™-32, YiDiXie™-30, YiDiXie™-47, and YiDiXie™-41, respectively. The receiver operating characteristic (ROC) curve analysis was incorporated in this study. RESULTS: In the preoperative group, YiDiXie™-48, YiDiXie™-32, and YiDiXie™-30 were unable to distinguish the metastatic group from the non-metastatic group due to their low specificity. The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of YiDiXie™-47 were 97.1%, 82.9%, 5.7, and 0.04, respectively. The specificity of YiDiXie™-47 decreased as the stage of the non-metastatic group increased, and it had high sensitivity and high specificity for various cancer types. The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of YiDiXie™-41 were 75.5%, 95.1%, 15.4, and 0.26, respectively. The specificity of YiDiXie™-41 decreased as the stage of the non-metastatic group increased, and it had high sensitivity and high specificity for various cancer types. Therefore, YiDiXie™-47 and YiDiXie™-41 can well distinguish the metastatic group from the non-metastatic group in the preoperative group. All five YiDiXie™ tests effectively distinguished the metastatic group from the non-metastatic group in the postoperative group. CONCLUSION: The combined application of YiDiXie™-47 and YiDiXie™-41 shows considerable effectiveness in diagnosing multiple cancer metastases before surgery, while the combined application of YiDiXie™-30 and YiDiXie™-41 demonstrates considerable effectiveness in monitoring cancer metastases after surgery. The combined application of YiDiXie™-47 and YiDiXie™-41 is expected to serve as a non-invasive alternative or complementary tool to PET-CT for preoperative diagnosis of multiple cancer metastases, and the combined application of YiDiXie™-30 and YiDiXie™-41 can effectively monitor cancer metastases after surgery. REGISTRY: Chinese Clinical Trial Resgistry. CLINICAL TRIAL REGISTRATION: ChiCTR2200066840. Date of Registration:2022-12-19.
Corrigendum to "Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC working group on CGM" [Clin. Chim. Acta 580 (2026) 120728].
Pleus S, Eichenlaub M, Dabla PK … +17 more , Diem P, Boija EE, Fokkert M, Hinzmann R, Jendle J, Klonoff DC, Lu J, Makris K, Mohan V, Nichols JH, Pemberton JS, Selvin E, Slingerland RJ, Thomas A, Tran NK, Witthauer L, Freckmann G
Clin Chim Acta · 2026 Jul · PMID 42236408 · Publisher ↗
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Electrochemical biosensor-based strategies for sensitive detection of prostate cancer biomarkers.
Saha A, Sharma K
Clin Chim Acta · 2026 Jun · PMID 42235733 · Publisher ↗
Prostate Cancer (PCa) is one of the most common cancer and leading cause of mortality among men, resulting in deaths annually ∼396,000 worldwide. Recent advances in nanotechnology-assisted biosensors have enabled highly...
Prostate Cancer (PCa) is one of the most common cancer and leading cause of mortality among men, resulting in deaths annually ∼396,000 worldwide. Recent advances in nanotechnology-assisted biosensors have enabled highly sensitive detection of prostate cancer biomarkers which are prostate specific antigen (PSA), prostate cancer antigen 3 (PCA3), and microRNAs, across blood, urine, and tissue samples and provide promising alternatives for sensitive, rapid, and cost-effective prostate cancer detection and engaging the "ASSURED" (Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Equipment free and Deliverable) criteria as per WHO guidelines. This review systematically summarizes progress in biosensor platforms based on immunosensors, aptamer-based sensors, peptide-based sensors, nanopore technologies, and miRNA targeted biosensors by highlighting the nanomaterials such as graphene derivatives, carbon nanotubes, noble metal nanoparticles, and carbon dots in enhancing analytical performance. In this review we critically discussed about various biomarkers in details and multiple nano-materials with LOD, range and limitation for better material selection and current challenges, translational limitations, and future prospects toward point-of-care, and non-invasive prostate cancer diagnostics.
Interference of high dose ascorbate in blood gas, point-of-care, and automated clinical chemistry assays.
Williams GR, Gin G
Clin Chim Acta · 2026 Jun · PMID 42235732 · Publisher ↗
Ascorbic acid (AA) has been under investigation for a variety of therapeutic indications, including cancer treatment and sepsis. New investigational treatments utilize much higher concentrations than historical studies,...
Ascorbic acid (AA) has been under investigation for a variety of therapeutic indications, including cancer treatment and sepsis. New investigational treatments utilize much higher concentrations than historical studies, leading to uncertainty about the effects on clinical testing platforms. Published work indicates AA interferes with lipid and point-of-care glucometer measurements, however a comprehensive evaluation of potential interference at these higher concentrations with a unified experimental design is lacking. Additionally, many of the published studies use unbuffered AA spiked into blood which may cause spurious results due to pH disturbances. The objective of this study is an evaluation of high concentrations of sodium ascorbate interference on various analysis platforms. Sodium ascorbate was spiked into residual patient serum at 0-200 mg/dL. These samples were analyzed in triplicate on the Abbott ARCHITECT c8000 clinical chemistry and i2000SR immunoassay analyzers for a large menu of analytes. Whole blood studies were conducted at 0-200 mg/dL sodium ascorbate on the Nova STAT PROFILE pHOX Ultra system co-oximetry assays, Abbott i-STAT 1 System using the i-STAT Chem8+ cartridge, and a Roche Accu-Chek Inform II System glucometer. Assay interference by ascorbate was detected for lactate, lipase, cholesterol, triglycerides, and several glucose assay platforms. This multi-platform study at high concentrations of ascorbate for a variety of clinical chemistry assays will be of use to laboratorians and clinicians who have patients undergoing these treatments.
FLT3 mutations as diagnostic and prognostic biomarkers in acute myeloid leukemia.
Thapa R, Fuloria NK, Bhat AA … +7 more , Porwal O, Ansari MT, Narain K, Biswas A, Biswas S, Bhatia S, Fuloria S
Clin Chim Acta · 2026 Jun · PMID 42235731 · Publisher ↗
Acute myeloid leukemia (AML) is a diverse and complex haematological cancer that cannot be fully characterized, even with the combination of morphology and cytogenetics. As a result, molecular biomarkers have become the...
Acute myeloid leukemia (AML) is a diverse and complex haematological cancer that cannot be fully characterized, even with the combination of morphology and cytogenetics. As a result, molecular biomarkers have become the focus of diagnosis, risk stratification, therapeutic planning and monitoring of disease. Of these, FLT3 mutations have been identified as being clinically relevant, clinically important, and easily detected during various phases of AML care. This review examines the diagnostic, prognostic, predictive and monitoring role of FLT3 mutations in AML, with a focus on the clinical applications in the laboratory. We review the evidence for FLT3 internal tandem duplication (FLT3-ITD) and FLT3 tyrosine kinase domain (FLT3-TKD) mutations, their association with relapse risk, remission duration, survival, response to FLT3 inhibitors and measurable residual disease testing. The impact of allelic burden, variant allele frequency, insertion site, structural characteristics, co-mutational background, interpretation of FLT3 results in ELN 2022, and treatment exposure help clarify the clinical significance of FLT3 results. A particular focus is placed on laboratory assay implementation, including PCR-based assays, fragment analysis, next-generation sequencing and droplet digital PCR, as well as assay sensitivity, mutation quantification, structural annotation, and inter-platform standardization. FLT3 should be used as an integrated clinical laboratory biomarker and not a simple mutation-positive or mutation-negative result. Its mutation subtype, molecular context, treatment setting, assay performance and standardized reporting determine its diagnostic, prognostic, predictive and MRD-related value. This review offers a clinical laboratory perspective on how to interpret FLT3 mutations as actionable biomarkers in AML.
Inflammatory biomarkers in chronic kidney disease.
Oriquat G, Mohammed MH, Badraldin SQ … +4 more , Rizaev J, Abdusamiyeva N, Salih RM, Jaber MA
Clin Chim Acta · 2026 Jun · PMID 42235730 · Publisher ↗
Chronic kidney disease (CKD) is increasingly recognized not only as a state of declining renal function but also as a complex systemic disorder characterized by a persistent, low-grade inflammatory state. This chronic in...
Chronic kidney disease (CKD) is increasingly recognized not only as a state of declining renal function but also as a complex systemic disorder characterized by a persistent, low-grade inflammatory state. This chronic inflammation is now understood to be a central pathogenic driver that actively contributes to the progression of kidney damage, the high burden of cardiovascular morbidity and mortality, and overall poor patient survival. The investigation of the role of inflammatory biomarkers has therefore become a critical area of nephrology research, aiming to elucidate the underlying mechanisms, improve risk stratification, and identify novel therapeutic targets. This review provides a comprehensive analysis of the role of inflammatory biomarkers in CKD, covering established markers such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), as well as a growing array of emerging markers. This study synthesizes evidence from human observational studies and preclinical models to evaluate their associations with key clinical outcomes, including disease progression, cardiovascular events, and mortality, and critically examines their potential as targets for therapeutic intervention.
Novel biomarkers of diabetic kidney disease in type 1 diabetes.
Przezak A, Bielka W, Molęda P … +2 more , Plewa P, Pawlik A
Clin Chim Acta · 2026 Jun · PMID 42235729 · Publisher ↗
Diabetic kidney disease is a complication of inadequately controlled diabetes of any type. It is the main reason for end-stage renal disease and the need to start dialysis, leading to a great burden for health care syste...
Diabetic kidney disease is a complication of inadequately controlled diabetes of any type. It is the main reason for end-stage renal disease and the need to start dialysis, leading to a great burden for health care systems. Moreover, it strongly diminishes the quality of life and shortens life expectancy. The pathophysiology, diagnostics and treatment methods of diabetic kidney disease are not yet fully understood. This complication is underestimated and most often diagnosed in an advanced stage of renal deterioration. However, the sooner the disease is detected, the better the chance to slow down its progression. Patients with type 1 diabetes are especially vulnerable to the development of diabetic kidney disease mainly because they become diabetic in their early childhood. So, it seems to be extremely important to prevent kidney damage in these patients, or at least to diagnose this complication as soon as possible and to undertake appropriate medical intervention. In this article, we describe the current state of knowledge about diabetic kidney disease and its diagnostics. We also propose new biomarkers for the early recognition of diabetic kidney disease in patients with type 1 diabetes. These biomarkers appear to have very promising properties: they are detectable in blood and/or urine samples earlier than traditional markers, and they also seem to be more sensitive and specific biomarkers of diabetic kidney disease.
Influence of NAT2 genetic variability on glycemic control in type 2 diabetes.
Al-Azzam N, Al-Reshiq R, Elsalem L … +4 more , Abu Mousa BM, Mhedat K, Alfreahat Z, Saadeh N
Clin Chim Acta · 2026 Jun · PMID 42229710 · Publisher ↗
BACKGROUND: N-acetyltransferase 2 (NAT2) gene polymorphisms affect acetylation capacity and may influence metabolic traits including glycemic control. Research has shown variable associations between NAT2 variants and ty...
BACKGROUND: N-acetyltransferase 2 (NAT2) gene polymorphisms affect acetylation capacity and may influence metabolic traits including glycemic control. Research has shown variable associations between NAT2 variants and type 2 diabetes mellitus (T2DM) across populations. OBJECTIVE: To investigate the relationship between NAT2 polymorphisms and glycemic control among Jordanian patients with T2DM. METHODS: In this cross-sectional study, exon 2 of NAT2 was sequenced in 218 Jordanian adults with T2DM, classified as controlled (CDM; HbA1c < 7%) or uncontrolled (UCDM; HbA1c ≥ 7%). Seven common SNPs were genotyped; six with adequate MAF were used for linkage disequilibrium, and five formed the haplotype block. Logistic regression estimated odds ratios (ORs) with 95% confidence intervals (CIs), adjusted for age, sex, and BMI. RESULTS: Two NAT2 variants-rs1041983 (C > T) and rs1799930 (G > A)-showed significant allele-frequency differences between groups (p = 0.0292 and p = 0.0298, respectively). Under a dominant model, rs1041983 showed a suggestive association with UCDM after covariate adjustment (OR = 1.83; 95% CI: 1.03-3.26; p = 0.0404). A three-SNP haplotype (CTC; OR = 0.58; p = 0.038) suggested a protective effect, while a five-SNP haplotype showed borderline risk trend (TTCAA; OR = 1.54; p = 0.073). CONCLUSION: Two NAT2 variants showed nominally significant associations with glycemic control among Jordanian adults with T2DM. These exploratory findings suggest a potential role of NAT2 in metabolic variability that require validation in larger multiethnic cohorts.
Ferroptosis in cancer: integrating multi-omics, AI-driven biomarkers, and translational challenges.
Taki AG, Shareef A, Arora V … +10 more , Oweis R, Jyothi SR, Singh U, Sahoo S, Chauhan AS, Alimova F, Sameer HN, Yaseen A, Athab ZH, Adil M
Clin Chim Acta · 2026 Jun · PMID 42229709 · Publisher ↗
Ferroptosis, an iron-dependent regulated cell death driven by lipid peroxidation, has emerged as a potential target in cancers resistant to apoptosis and other programmed cell death pathways. This review integrates class...
Ferroptosis, an iron-dependent regulated cell death driven by lipid peroxidation, has emerged as a potential target in cancers resistant to apoptosis and other programmed cell death pathways. This review integrates classical mechanistic insights with multi-omics and artificial intelligence (AI) approaches to examine ferroptosis regulation, biomarker identification, and therapeutic potential across malignancies. Core regulators (GPX4, SLC7A11, ACSL4, FSP1, labile iron pool) interact with oncogenic pathways (RAS, p53, NRF2, YAP/TAZ) to influence sensitivity. Multi-omics integration and AI models have generated prognostic signatures and supported drug sensitivity predictions in retrospective cohorts, while circulating biomarkers (e.g., MDA, 4-HNE, exosomal FRGs) show promise for non-invasive monitoring. Ferroptosis also modulates the tumor microenvironment through immune-metabolic interactions, with preclinical evidence of synergy with immunotherapy and radiotherapy. However, clinical translation remains at an early stage, with major challenges in biomarker standardization, model generalizability, context-dependent effects, and the lack of mature prospective trials. AI-assisted multi-omics strategies offer opportunities for future precision oncology applications, but rigorous validation and standardization are required before routine clinical implementation.
Mass spectrometry in laboratory medicine: advances in automation, multiplex biomarker quantification, and diagnostics.
Khamidova F, Tatykayeva U, Reymnazarova G … +3 more , Davronova S, Tilyabov I, Khasanov S
Clin Chim Acta · 2026 Jun · PMID 42229708 · Publisher ↗
Mass spectrometry (MS) has evolved from a specialized research tool into an increasingly indispensable platform in laboratory medicine. Its clinical value is driven by molecular specificity, multiplex quantification, and...
Mass spectrometry (MS) has evolved from a specialized research tool into an increasingly indispensable platform in laboratory medicine. Its clinical value is driven by molecular specificity, multiplex quantification, and the ability to measure small molecules, peptides, proteins, drugs, metabolites, and microbial spectral fingerprints in workflows that are becoming more automated and standardized. The field is nevertheless heterogeneous: liquid chromatography-tandem mass spectrometry (LC-MS/MS), matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), gas chromatography-mass spectrometry (GC-MS), and emerging high-resolution or miniature instruments address different clinical questions and require different validation strategies. The review focuses on the realistic transition of MS from specialist reference laboratories to routine clinical practice. It summarizes fundamental principles of MS measurement, current clinical platforms, microbial identification by MALDI-TOF MS, automated monoclonal protein analysis, LC-MS/MS steroid and therapeutic drug monitoring, GC-MS applications, MassARRAY genotyping, pre-analytical vulnerabilities, and barriers to implementation. Fully automated MALDI-TOF MS platforms (e.g., EXENT) now achieve 92.6-95.7% concordance with conventional electrophoresis for monoclonal immunoglobulin detection while showing superior sensitivity for low-concentration M-proteins. Multiplex LC-MS/MS panels enable simultaneous quantification of 23 plasma steroids and 15 protein-bound uremic toxins with excellent linearity and precision, whereas MassARRAY-based genotyping has achieved 99.75% detection success in newborn screening for primary carnitine deficiency. Critical remaining limitations include incomplete inter-laboratory harmonization, high capital and maintenance costs, the need for trained personnel, matrix effects, pre-analytical instability, limited evidence for some biomarker panels, and uncertain regulatory pathways for laboratory-developed tests. The strongest near-term applicability is expected in high-volume, well-validated use cases - newborn screening, therapeutic drug monitoring, steroid profiling, toxicology, microbial identification, monoclonal protein testing, and selected multiplex biomarker panels - rather than unrestricted replacement of immunoassays. The future relevance of clinical MS is likely to remain strong, provided that automation is coupled with rigorous analytical validation, external quality assessment, and clear demonstration of clinical utility.
Direct-to-definitive urine drug screening in children unmasks false-negative immunoassay screening.
Lin Y, El-Khoury JM, Garg UC … +5 more , Jones PM, Lo SF, Patel K, Roper SM, Dietzen DJ
Clin Chim Acta · 2026 Jun · PMID 42229707 · Publisher ↗
BACKGROUND: Routine urine drug screening is performed using immunoassays. False-positive immunoassay results are well documented and confirmatory testing is essential. False-negative rates have not been rigorously quanti...
BACKGROUND: Routine urine drug screening is performed using immunoassays. False-positive immunoassay results are well documented and confirmatory testing is essential. False-negative rates have not been rigorously quantified. Our study estimates the false-negative rate of immunoassay screening in a pediatric population. METHODS: Drug screening in the St. Louis Children's laboratory employs a broad spectrum direct to LC-MS/MS approach. We selected 125 urine specimens over five months (4% of 3000 screens), that were weakly positive for amphetamines, benzoylecgonine, THC, opiates, fentanyl, benzodiazepines, and methadone using LC-MS/MS. These specimens were reanalyzed by immunoassay on a Roche Cobas platform (forward approach). Second, we collected 145 negative urine specimens from five pediatric settings using immunoassay platforms including Viva-ProE (Siemens), Vitros (Ortho), Atellica (Siemens) and Cobas (Roche). These specimens were subjected to our local LC-MS/MS analysis (reverse approach). RESULTS: Among the 125 LC-MS/MS positive samples, 112 (90%) contained at least one substance that was targeted but not detected by immunoassay. The most frequently missed substances were methamphetamine and benzoylecgonine. Among the 145 negative urine specimens from routine immunoassay, LC-MS/MS identified substances in 16 (11%) that were targeted and missed by immunoassay and identified substances in 34 (23%) that were not covered by immunoassay. CONCLUSIONS: Our study indicates that 4-11% of pediatric urine specimens contain substances targeted and missed by conventional immunoassays. Another quarter may contain substances not covered by immunoassay. These false negatives can lead to the discharge of a child into an unsafe environment. Direct to LC-MS/MS screening acts to minimize false-negative immunoassay drug screens.
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