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External Quality Assessment on Molecular Tumor Profiling with Circulating Tumor DNA-Based Methodologies Routinely Used in Clinical Pathology within the COIN Consortium Clin. Chem. (IF 9.3) Pub Date : 2024-03-14 Paul van der Leest, Pim Rozendal, John Hinrichs, Carel J M van Noesel, Karen Zwaenepoel, Birgit Deiman, Cornelis J J Huijsmans, Ronald van Eijk, Ernst Jan M Speel, Rick J van Haastert, Marjolijn J L Ligtenberg, Ron H N van Schaik, Maurice P H M Jansen, Hendrikus J Dubbink, Wendy W de Leng, Mathie P G Leers, Menno Tamminga, Daan van den Broek, Léon C van Kempen, Ed Schuuring
Background Identification of tumor-derived variants in circulating tumor DNA (ctDNA) has potential as a sensitive and reliable surrogate for tumor tissue-based routine diagnostic testing. However, variations in pre(analytical) procedures affect the efficiency of ctDNA recovery. Here, an external quality assessment (EQA) was performed to determine the performance of ctDNA mutation detection work flows
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Plasma Biomarker Profiles for Premature and Nonpremature Coronary Heart Disease in Women Clin. Chem. (IF 9.3) Pub Date : 2024-03-13 Sagar B Dugani, M Vinayaga Moorthy, Olga V Demler, Chunying Li, Paul M Ridker, Robert J Glynn, Samia Mora
Background Premature coronary heart disease (CHD) is a major cause of death in women. We aimed to characterize biomarker profiles of women who developed CHD before and after age 65 years. Methods In the Women’s Health Study (median follow-up 21.5 years), women were grouped by age and timing of incident CHD: baseline age <65 years with premature CHD by age 65 years (25 042 women; 447 events) and baseline
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Inaccurately Reported Statin Use Affects the Assessing of Lipid Profile Measures and Their Association with Coronary Artery Disease Risk Clin. Chem. (IF 9.3) Pub Date : 2024-03-02 Anna A Ivanova, Michael S Gardner, Jennifer D Kusovschi, Bryan A Parks, David M Schieltz, Akshay Bareja, Robert W McGarrah, William E Kraus, Zsuzsanna Kuklenyik, James L Pirkle, John R Barr
Background Lipid profiling is central for coronary artery disease (CAD) risk assessment. Nonadherence or unreported use of lipid-lowering drugs, particularly statins, can significantly complicate the association between lipid profile measures and CAD clinical outcomes. By combining medication history evaluation with statin analysis in plasma, we determined the effects of inaccurately reported statin
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Applying Machine Learning to Blood Count Data Predicts Sepsis with ICU Admission Clin. Chem. (IF 9.3) Pub Date : 2024-03-02 Daniel Steinbach, Paul C Ahrens, Maria Schmidt, Martin Federbusch, Lara Heuft, Christoph Lübbert, Matthias Nauck, Matthias Gründling, Berend Isermann, Sebastian Gibb, Thorsten Kaiser
Background Timely diagnosis is crucial for sepsis treatment. Current machine learning (ML) models suffer from high complexity and limited applicability. We therefore created an ML model using only complete blood count (CBC) diagnostics. Methods We collected non-intensive care unit (non-ICU) data from a German tertiary care centre (January 2014 to December 2021). Using patient age, sex, and CBC parameters
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Exposure to Synthetic Psychoactive Substances: A Potential Cause for Increased Human Hepatotoxicity Markers Clin. Chem. (IF 9.3) Pub Date : 2024-03-01 Aurora Balloni, Anastasio Tini, Emilia Prospero, Francesco Paolo Busardò, Marilyn Ann Huestis, Alfredo Fabrizio Lo Faro
Background Approximately 30 million people worldwide consume new psychoactive substances (NPS), creating a serious public health issue due to their toxicity and potency. Drug-induced liver injury is the leading cause of liver disease, responsible for 4% of global deaths each year. Content A systematic literature search revealed 64 case reports, in vitro and in vivo studies on NPS hepatotoxicity. Maximum
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Analytical Performance Specifications for Input Variables: Investigation of the Model of End-Stage Liver Disease Clin. Chem. (IF 9.3) Pub Date : 2024-02-28 Eline S Andersen, Richard Röttger, Claus L Brasen, Ivan Brandslund
Background Artificial intelligence models constitute specific uses of analysis results and, therefore, necessitate evaluation of analytical performance specifications (APS) for this context specifically. The Model of End-stage Liver Disease (MELD) is a clinical prediction model based on measurements of bilirubin, creatinine, and the international normalized ratio (INR). This study evaluates the propagation
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Mechanisms of Resistance to Tyrosine Kinase Inhibitors in ROS1 Fusion-Positive Nonsmall Cell Lung Cancer Clin. Chem. (IF 9.3) Pub Date : 2024-02-28 Xinmin Zhao, Xin Zhang, Hanlin Chen, Hairong Bao, Xianghua Wu, Huijie Wang, Hua Bao, Jiaohui Pang, Sha Wang, Jialei Wang
Background ROS1 fusion-positive (ROS1+) nonsmall cell lung cancer (NSCLC) patients are highly sensitive to tyrosine kinase inhibitor (TKI) treatments. However, acquired TKI resistance remains the major hurdle preventing patients from experiencing prolonged benefits. Methods 107 advanced or metastatic ROS1+ NSCLC patients who progressed on crizotinib and lorlatinib were recruited. Tissue and plasma
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Adjustment for Renal Function Improves the Prognostic Performance of Urinary Thromboxane Metabolites Clin. Chem. (IF 9.3) Pub Date : 2024-02-28 Bruce A Barton, Shari S Kronsberg, Essa Hariri, Ramachandran S Vasan, Grace A Rade, Vanessa Xanthakis, Thomas S Kickler, Jeffrey J Rade
Background Systemic thromboxane A2 generation, assessed by quantifying the concentration of stable thromboxane B2 metabolites (TXB2-M) in the urine adjusted for urinary creatinine, is strongly associated with mortality risk. We sought to define optimal TXB2-M cutpoints for aspirin users and nonusers and determine if adjusting TXB2-M for estimated glomerular filtration rate (eGFR) in addition to urinary
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Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A Feasibility Study Clin. Chem. (IF 9.3) Pub Date : 2024-02-22 Huub H van Rossum, Stefan Holdenrieder, Bart E P B Ballieux, Tony C Badrick, Yeo-Min Yun, Chuanbao Zhang, Dina Patel, Marc Thelen, Junghan Song, Nathalie Wojtalewicz, Nick Unsworth, Hubert W Vesper, Wei Cui, Lakshmi V Ramanathan, Catharine Sturgeon, Qing H Meng
Background The harmonization status of most tumor markers (TMs) is unknown. We report a feasibility study performed to determine whether external quality assessment (EQA) programs can be used to obtain insights into the current harmonization status of the tumor markers α-fetoprotein (AFP), prostate specific antigen (PSA), carcinoembryonic antigen (CEA), cancer antigen (CA)125, CA15-3 and CA19-9. Methods
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Biomarkers vs Machines: The Race to Predict Acute Kidney Injury Clin. Chem. (IF 9.3) Pub Date : 2024-02-01 Lama Ghazi, Kassem Farhat, Melanie P Hoenig, Thomas J S Durant, Joe M El-Khoury
Background Acute kidney injury (AKI) is a serious complication affecting up to 15% of hospitalized patients. Early diagnosis is critical to prevent irreversible kidney damage that could otherwise lead to significant morbidity and mortality. However, AKI is a clinically silent syndrome, and current detection primarily relies on measuring a rise in serum creatinine, an imperfect marker that can be slow
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Circulating Cell-Free SHOX2 DNA Methylation Is a Predictive, Prognostic, and Monitoring Biomarker in Adjuvant and Palliative Anti-PD-1-Treated Melanoma Clin. Chem. (IF 9.3) Pub Date : 2024-02-01 Simon Fietz, Eric Diekmann, Luka de Vos, Romina Zarbl, Alina Hunecke, Ann-Kathrin Glosch, Moritz Färber, Judith Sirokay, Friederike Hoffmann, Anne Fröhlich, Alina Franzen, Sebastian Strieth, Jennifer Landsberg, Dimo Dietrich
Background The majority of metastatic melanoma patients initially do not respond or acquire resistance to anti-programmed cell death 1 (PD-1) immunotherapy. Liquid biopsy biomarkers might provide useful early response information and allow for personalized treatment decisions. Methods We prospectively assessed circulating cell-free SHOX2 DNA methylation (SHOX2 ccfDNAm) levels and their dynamic changes
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A Retrospective Study of Factors Contributing to the Performance of an Interferon-Gamma Release Assay Blood Test for Tuberculosis Infection Clin. Chem. (IF 9.3) Pub Date : 2024-02-01 Junhyup Song, Sinyoung Kim, Younhee Park
Background Tuberculosis (TB) remains a significant global health concern. Accurate detection of latent TB infection is crucial for effective control and prevention. We aimed to assess the performance of an interferon-gamma release assay blood test (QuantiFERON-TB Gold Plus [QFT-Plus]) in various clinical contexts and identify conditions that affect its results. Methods We conducted a retrospective
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High-Sensitivity Cardiac Troponin and the Management of Congenital Heart Disease in Newborns and Infants Clin. Chem. (IF 9.3) Pub Date : 2024-01-05 Simona Ferraro, Elia Biganzoli, Savina Mannarino, Monica Lanzoni, Gianvincenzo Zuccotti, Mario Plebani, Peter Kavsak
Background Early cardiac interventions in newborns and infants suspected for congenital heart disease (CHD) decrease morbidity and mortality. After updating current evidence on the use of cardiac troponins (cTn) in the context of CHD for risk stratification at early ages, we discuss relevant issues, starting from the evidence that only the measurement of the cTnT form is useful in this population.
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Detection of Multiple HPV Types in Liquid Biopsies of Cervical Neoplasia Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Johanna Herbst, Vanessa Vohl, Maroje Krajina, Markus Leffers, Jolanthe Kropidlowski, Katharina Prieske, Anna Jaeger, Leticia Oliveira Ferrer, Barbara Schmalfeldt, Yvonne Goy, Eike Burandt, Klaus Pantel, Caren Vollmert, Alexander Sartori, Linn Woelber, Katharina Effenberger, Harriet Wikman
Background More than 95% of cervical cancers and their precancerous lesions are caused by human papillomavirus (HPV). Cell-free (cf) HPV DNA detection in blood samples may serve as a monitoring tool for cervical cancer. Methods In our methodological study, an HPV panel for simultaneous detection of 24 types using mass spectrometry-based analysis was developed for liquid biopsy approaches and tested
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Critical Factors in the Analytical Work Flow of Circulating Tumor DNA-Based Molecular Profiling Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Paul van der Leest, Ed Schuuring
Background Liquid biopsy testing, especially molecular tumor profiling of circulating tumor DNA (ctDNA) in cell-free plasma, has received increasing interest in recent years as it serves as a reliable alternative for the detection of tumor-specific aberrations to guide treatment decision-making in oncology. Many (commercially available) applications have been developed, however, broad divergences in
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Circulating Tumor Cells: From Basic to Translational Research Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Luis Enrique Cortés-Hernández, Zahra Eslami-S, Klaus Pantel, Catherine Alix-Panabières
Background Metastasis is the leading cause of cancer-related deaths. Most studies have focused on the primary tumor or on overt metastatic lesions, leaving a significant knowledge gap concerning blood-borne cancer cell dissemination, a major step in the metastatic cascade. Circulating tumor cells (CTCs) in the blood of patients with solid cancer can now be enumerated and investigated at the molecular
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Meta-Analysis of Circulating Tumor Cell PD-L1 Expression and the Association with Clinical Outcomes in Non-Small Cell Lung Cancer Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Emmanuel Acheampong, Rebecca C Allsopp, Karen Page, Marc K Wadsley, Aaron B Beasley, R Charles Coombes, Jacqui A Shaw, Elin S Gray
Background Programmed death ligand-1 (PD-L1) expression on circulating tumor cells (CTCs) has been suggested to provide prognostic information in non-small cell lung cancer (NSCLC), but consensus relative to treatment outcomes is lacking. We conducted the first comprehensive meta-analysis exploring its potential as a prognostic and predictive marker, and assessed the concordance between PD-L1 + CTCs
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Deciphering the Exact Sequence of Endogenous Soluble B Cell Maturation Antigen and Unbiased Quantitation in Multiple Myeloma Patient Samples by LC-MS Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Xiaomeng Shen, Xue Dong, Jianxia Shi, Hao Chen, Yun Lan, Ai Ching Lim, Fang Xie, Agnes Ang, Andrea Kratzer, Dan A Rock, Brooke M Rock
Background B-cell maturation antigen is a pivotal therapeutic target for multiple myeloma (MM). Membrane-bound BCMA can be cleaved by γ-secretase and shed as soluble BCMA (sBCMA). sBCMA can act as a neutralizing sink to compete with drug, as well as serve as a diagnostic/prognostic biomarker for MM. Antibody-capture based methods, such as enzyme-linked immunosorbent assay (ELISA) and immunoaffinity-liquid
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A Practical Approach to Interpreting Circulating Tumor DNA in the Management of Gastrointestinal Cancers Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Zexi Allan, David S Liu, Margaret M Lee, Jeanne Tie, Nicholas J Clemons
Background There is accumulating evidence supporting the clinical use of circulating tumor DNA (ctDNA) in solid tumors, especially in different types of gastrointestinal cancer. As such, appraisal of the current and potential clinical utility of ctDNA is needed to guide clinicians in decision-making to facilitate its general applicability. Content In this review, we firstly discuss considerations surrounding
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Contributions of the Microbiome-Derived Metabolome for Risk Assessment and Prognostication of Pancreatic Cancer Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Ricardo A León-Letelier, Rongzhang Dou, Jody Vykoukal, Michele T Yip-Schneider, Anirban Maitra, Ehsan Irajizad, Ranran Wu, Jennifer B Dennison, Kim-An Do, Jianjun Zhang, C Max Schmidt, Samir Hanash, Johannes F Fahrmann
Background Increasing evidence implicates microbiome involvement in the development and progression of pancreatic ductal adenocarcinoma (PDAC). Studies suggest that reflux of gut or oral microbiota can lead to colonization in the pancreas, resulting in dysbiosis that culminates in release of microbial toxins and metabolites that potentiate an inflammatory response and increase susceptibility to PDAC
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Chronic Lymphocytic Leukemia IGHV Somatic Hypermutation Detection by Targeted Capture Next-Generation Sequencing Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Jennifer M Grants, Christina May, Josh Bridgers, Shujun Huang, Sierra Gillis, Barbara Meissner, Merrill Boyle, Susana Ben-Neriah, Stacy Hung, Gerben Duns, Laura Hilton, Alina S Gerrie, Marco Marra, Robert Kridel, Peter J B Sabatini, Christian Steidl, David W Scott, Aly Karsan
Background Somatic hypermutation (SHM) status of the immunoglobulin heavy variable (IGHV) gene plays a crucial role in determining the prognosis and treatment of patients with chronic lymphocytic leukemia (CLL). A common approach for determining SHM status is multiplex polymerase chain reaction and Sanger sequencing of the immunoglobin heavy locus; however, this technique is low throughput, is vulnerable
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Breast Cancer Circulating Tumor Cells: Current Clinical Applications and Future Prospects Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Andi K Cani, Daniel F Hayes
Background Identification and characterization of circulating tumor markers, designated as “liquid biopsies,” have greatly impacted the care of cancer patients. Although more recently referring to circulating tumor DNA (ctDNA), the term liquid biopsy initially was coined to refer to any blood-borne biomarker related to malignancy, including circulating tumor cells (CTCs) in blood. In this manuscript
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Screening in Multiple Myeloma and Its Precursors: Are We There Yet? Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Sæmundur Rögnvaldsson, Sigrún Thorsteinsdóttir, Sigurður Yngvi Kristinsson
Background Multiple myeloma (MM) is a hematological malignancy that develops over years from the asymptomatic precursors, monoclonal gammopathy of undetermined significance, and smoldering multiple myeloma. Recent evidence shows that by initiating treatment at an asymptomatic stage, outcomes in MM can be significantly improved. However, a vast majority of MM patients are diagnosed after the development
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Towards the Clinical Implementation of Extracellular Vesicle-Based Biomarker Assays for Cancer Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Sofie Van Dorpe, Philippe Tummers, Hannelore Denys, An Hendrix
Background Substantial research has been devoted to elucidating the role of extracellular vesicles (EVs) in the different hallmarks of cancer. Consequently, EVs are increasingly explored as a source of cancer biomarkers in body fluids. However, the heterogeneity in EVs, the complexity of body fluids, and the diversity in methods available for EV analysis, challenge the development and translation of
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Spatial and Temporal Relationship between Epithelial–Mesenchymal Transition (EMT) and Stem Cells in Cancer Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Petra den Hollander, Joanna Joyce Maddela, Sendurai A Mani
Background Epithelial–mesenchymal transition (EMT) is often linked with carcinogenesis. However, EMT is also important for embryo development and only reactivates in cancer. Connecting how EMT occurs during embryonic development and in cancer could help us further understand the root mechanisms of cancer diseases. Content There are key regulatory elements that contribute to EMT and the induction and
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Epidemiology of Cancer Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Stephen M Schwartz
Background Cancers are a large and heterogeneous group of malignant tumors that collectively accounted for approximately 600 000 US deaths in 2020; only heart disease claimed more lives. A large amount of knowledge has accumulated regarding the epidemiology of most cancer types, including their causes. Content The cancer types most frequently diagnosed among adults in most high-income countries are
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Emerging Strategies in Lung Cancer Screening: Blood and Beyond Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Sheena Bhalla, Sofia Yi, David E Gerber
Background Although low dose computed tomography (LDCT)-based lung cancer screening (LCS) can decrease lung cancer-related mortality among high-risk individuals, it remains an imperfect and substantially underutilized process. LDCT-based LCS may result in false-positive findings, which can lead to invasive procedures and potential morbidity. Conversely, current guidelines may fail to capture at-risk
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Screening for Colorectal Cancer: The Role of Clinical Laboratories Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Joseph F Toth, Mehul Trivedi, Samir Gupta
Background Colorectal cancer (CRC) is a leading cause of cancer incidence and mortality. Screening can result in reductions in incidence and mortality, but there are many challenges to uptake and follow-up. Content Here, we will review the changing epidemiology of CRC, including increasing trends for early and later onset CRC; evidence to support current and emerging screening strategies, including
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Emerging Biomarkers for Monitoring Chimeric Antigen Receptor T-Cell Therapy Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Theodros Mamo, Alexandra Dreyzin, David Stroncek, David H McKenna
BACKGROUND Chimeric antigen receptor (CAR) T-cell therapy has revolutionized treatment of hematologic malignancies and holds promise for solid tumors. While responses to CAR T-cell therapy have surpassed other available options for patients with refractory malignancies, not all patients respond the same way. The reason for this variability is not currently understood. Therefore, there is a strong need
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Extracellular Vesicles as Liquid Biopsy Biomarkers across the Cancer Journey: From Early Detection to Recurrence Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Sagar Rayamajhi, Jared Sipes, Ashley L Tetlow, Souvik Saha, Ajay Bansal, Andrew K Godwin
Background Cancer is a dynamic process and thus requires highly informative and reliable biomarkers to help guide patient care. Liquid-based biopsies have emerged as a clinical tool for tracking cancer dynamics. Extracellular vesicles (EVs), lipid bilayer delimited particles secreted by cells, are a new class of liquid-based biomarkers. EVs are rich in selectively sorted biomolecule cargos, which provide
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Frequency and Prognostic Value of Circulating Tumor Cells in Cancer of Unknown Primary Clin. Chem. (IF 9.3) Pub Date : 2024-01-04 Maria Pouyiourou, Tilmann Bochtler, Cornelia Coith, Harriet Wikman, Bianca Kraft, Thomas Hielscher, Albrecht Stenzinger, Sabine Riethdorf, Klaus Pantel, Alwin Krämer
BACKGROUND Cancer of unknown primary (CUP) is defined as a primary metastatic malignancy, in which the primary tumor remains elusive in spite of a comprehensive diagnostic workup. The frequency and prognostic value of circulating tumor cells (CTCs), which are considered to be the source of metastasis, has not yet been systematically evaluated in CUP. METHODS A total of 110 patients with a confirmed
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DFS70 Autoantibodies: Clinical Utility in Antinuclear Antibody Testing Clin. Chem. (IF 9.3) Pub Date : 2023-12-12 Xavier Bossuyt
Background Screening for antinuclear antibodies (ANA) by indirect immunofluorescence (IIF) on HEp-2 cells is helpful for the diagnosis and classification of ANA-associated rheumatic diseases, including systemic lupus erythematosus, Sjögren syndrome, mixed connective tissue disease, systemic sclerosis, and inflammatory myopathies. The dense fine speckled (DFS) pattern is a special HEp-2 IIF pattern
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Automating the Detection of IV Fluid Contamination Using Unsupervised Machine Learning Clin. Chem. (IF 9.3) Pub Date : 2023-12-12 Nicholas C Spies, Zita Hubler, Vahid Azimi, Ray Zhang, Ronald Jackups, Ann M Gronowski, Christopher W Farnsworth, Mark A Zaydman
Background Intravenous (IV) fluid contamination is a common cause of preanalytical error that can delay or misguide treatment decisions, leading to patient harm. Current approaches for detecting contamination rely on delta checks, which require a prior result, or manual technologist intervention, which is inefficient and vulnerable to human error. Supervised machine learning may provide a means to
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High-Sensitivity Cardiac Troponins I and T and Cardiovascular Outcomes: Findings from the Systolic Blood Pressure Intervention Trial (SPRINT) Clin. Chem. (IF 9.3) Pub Date : 2023-12-12 Xiaoming Jia, Vijay Nambi, Jarett D Berry, Djhenne Dalmacy, Simon B Ascher, Addison A Taylor, Ron C Hoogeveen, James A de Lemos, Christie M Ballantyne
Background Cardiac troponins are associated with adverse cardiovascular disease (CVD) outcomes. The value of high-sensitivity cardiac troponin I (hs-cTnI) independently and in concert with troponin T (hs-cTnT) in the management of hypertension has not been well studied. Methods We assessed the utility of hs-cTnI independently and with hs-cTnT in identifying the highest risk individuals in the Systolic
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Hereditary Alpha Tryptasemia: Validation of a Single-Well Multiplex Digital Droplet PCR Assay in a Cohort of Symptomatic Patients Clin. Chem. (IF 9.3) Pub Date : 2023-12-11 Abdulrazzaq Alheraky, Albertus T J Wierenga, Arjan Simpelaar, Lucy B Hesp, Isidor Minovic, Niusha Bagheri, Caroline Roozendaal, Lambert F R Span, Hanneke N G Oude Elberink, Ido P Kema, André B Mulder
Background Hereditary alpha tryptasemia (HαT) has significant prevalence and potential morbidity in the general population. However, it remains largely undiagnosed in routine clinical diagnostics due to low availability of efficient assessment methods. To address this issue, we developed a reliable and efficient single-well multiplex digital droplet PCR assay. Methods The assay was based on the reconstruction
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Multiple Cardiac Biomarkers to Improve Prediction of Cardiovascular Events: Findings from the Generation Scotland Scottish Family Health Study Clin. Chem. (IF 9.3) Pub Date : 2023-12-09 Paul Welsh, Dorien M Kimenai, Anoop S V Shah, Danni A Gadd, Riccardo E Marioni, Mark Woodward, Cathie L M Sudlow, Archie Campbell, John G F Cleland, Pierpaolo Pellicori, Caroline Hayward, Nicholas L Mills, Naveed Sattar
Background Many studies have investigated whether single cardiac biomarkers improve cardiovascular risk prediction for primary prevention but whether a combined approach could further improve risk prediction is unclear. We aimed to test a sex-specific, combined cardiac biomarker approach for cardiovascular risk prediction. Methods In the Generation Scotland Scottish Family Health Study, N-terminal
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MAESTRO-Pool Enables Highly Parallel and Specific Mutation-Enrichment Sequencing for Minimal Residual Disease Detection in Cohort Studies Clin. Chem. (IF 9.3) Pub Date : 2023-12-09 Timothy Blewett, Justin Rhoades, Ruolin Liu, Kan Xiong, Sainetra Sridhar, Andjela Crnjac, Ju Cheng, Aleigha R Lawless, Dennie T Frederick, Keith T Flaherty, Gerassimos Mike Makrigiorgos, Viktor A Adalsteinsson
Background Tracing patient-specific tumor mutations in cell-free DNA (cfDNA) for minimal residual disease (MRD) detection is promising but challenging. Assaying more mutations and cfDNA stands to improve MRD detection but requires highly accurate, efficient sequencing methods and proper calibration to prevent false detection with bespoke tests. Methods MAESTRO (Minor Allele Enriched Sequencing Through
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Commentary on Positive Syphilis Serologies after Intravenous Immunoglobulin Treatment: A Diagnostic Confusion That Needs Emphasis. Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Simmi Patel,Sarah E Wheeler
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Positive Syphilis Serologies after Intravenous Immunoglobulin (IVIG) Treatment: A Diagnostic Confusion That Needs Emphasis. Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Mingfei Yan,Xiaochun Susan Zhang,Jaime Noguez
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Commentary on Positive Syphilis Serologies after Intravenous Immunoglobulin Treatment: A Diagnostic Confusion That Needs Emphasis. Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Christopher W Farnsworth
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Congenital Disorder of Glycosylation in a Child with Macrosomia. Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Suneeta Madan-Khetarpal,Maio He,Parith Wongkittichote,Steven F Dobrowolski
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Unexpected Negative Zolpidem Urine Drug Test in a Compliant Patient. Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Emily Shang,Ibrahim Choucair,Joe M El-Khoury
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Hybridization Protection Reaction for Sensitive and Robust Gene Expression Profiling of Clinical Formalin-Fixed Paraffin-Embedded Samples. Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Feng-Ming Hsu,Yih-Leong Chang,Chung-Yung Chen,Shu-Rung Lin,Jason Chia-Hsien Cheng
BACKGROUND RNA profiling of formalin-fixed paraffin-embedded (FFPE) tumor tissues for the molecular diagnostics of disease prognosis or treatment response is often irreproducible and limited to a handful of biomarkers. This has led to an unmet need for robust multiplexed assays that can profile several RNA biomarkers of interest using a limited amount of specimen. Here, we describe hybridization protection
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Exploration of a Novel Noninvasive Prenatal Testing Approach for Monogenic Disorders Based on Fetal Nucleated Red Blood Cells. Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Xiaoge Li,Dejun Zhang,Xing Zhao,Shasha Huang,Mingyu Han,Guojian Wang,Yingzhuo Li,Dongyang Kang,Xin Zhang,Pu Dai,Yongyi Yuan
BACKGROUND Due to technical issues related to cell-specific capture methods, amplification, and sequencing, noninvasive prenatal testing (NIPT) based on fetal nucleated red blood cells (fNRBCs) has rarely been used for the detection of monogenic disorders. METHODS Maternal peripheral blood was collected from 11 families with hereditary hearing loss. After density gradient centrifugation and cellular
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Data Analytics in Clinical Laboratories: Advancing Diagnostic Medicine in the Digital Age. Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Anna E Merrill,Thomas J S Durant,Jason Baron,J Stacey Klutts,Amrom E Obstfeld,David Peaper,Michelle Stoffel,Sarah Wheeler,Mark A Zaydman
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Clinical Assessment of SARS-CoV-2 Antibodies in Oral Fluids Following Infection and Vaccination Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Christopher D Heaney, Heidi Hempel, Kate L DeRosa, Ligia A Pinto, Nicholas J Mantis
Background SARS-CoV-2 variants continue to circulate globally, even within highly vaccinated populations. The first-generation SARS-CoV-2 vaccines elicit neutralizing immunoglobin G (IgG) antibodies that prevent severe COVID-19 but induce only weak antibody responses in mucosal tissues. There is increasing recognition that secretory immunoglobin A (SIgA) antibodies in the upper respiratory tract and
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The Next Clinical Decision Frontier: How to Efficiently and Safely Combine Machine Learning and Human Expertise. Clin. Chem. (IF 9.3) Pub Date : 2023-11-29 Damien Gruson,David Gruson,Benoit Macq
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Eye Catching Advancement for Creutzfeldt-Jakob Disease Diagnostics. Clin. Chem. (IF 9.3) Pub Date : 2023-11-29 Cyril Helbling,Mari L DeMarco
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Assessment of Sigma Error Metrics Associated with Manual Secondary Result Review and Subsequent Artificial Intelligence-Driven Quality Assurance Review-Application to Kidney Stone Analysis. Clin. Chem. (IF 9.3) Pub Date : 2023-11-25 Joshua Bornhorst,Denise Rokke,Patrick Day,Sarah Erdahl,Mikolaj A Wieczorek,Rickey E Carter,Paul J Jannetto
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In Reply to A Comment about Analytical Performance Specifications for the Combined Measurement Uncertainty Budget in the Implementation of Metrological Traceability of Parathyroid Hormone. Clin. Chem. (IF 9.3) Pub Date : 2023-11-25 Etienne Cavalier,Jordi Farré-Segura
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The Sampson-NIH Equation Is the Preferred Calculation Method for LDL-C. Clin. Chem. (IF 9.3) Pub Date : 2023-11-25 Maureen Sampson,Anna Wolska,Jeff W Meeusen,James Otvos,Alan T Remaley
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Circulating Tumor DNA Clinical Applications in Hepatocellular Carcinoma: Current Trends and Future Perspectives Clin. Chem. (IF 9.3) Pub Date : 2023-11-14 Thomas Bardol, Georges-Philippe Pageaux, Eric Assenat, Catherine Alix-Panabières
Background Globally, liver cancers are the second most lethal malignancy after lung cancer (0.83 million deaths in 2020). Hepatocellular carcinoma (HCC) is the predominant type of primary liver cancer and is typically associated with liver fibrosis or cirrhosis. HCC diagnosis relies on histologic examination of surgical specimens or conventional tissue biopsy material. However, standard tissue biopsies
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Sensitive Blood-Based Detection of HIV-1 and Mycobacterium tuberculosis Peptides for Disease Diagnosis by Immuno-Affinity Liquid Chromatography–Tandem Mass Spectrometry: A Method Development and Proof-of-Concept Study Clin. Chem. (IF 9.3) Pub Date : 2023-11-13 Lin Li, Christopher J Lyon, Sylvia M LaCourse, Wenshu Zheng, Joshua Stern, Jaclyn N Escudero, Wilfred Bundi Murithi, Lilian Njagi, Grace John-Stewart, Thomas R Hawn, Videlis Nduba, Wael Abdelgaliel, Thomas Tombler, David Horne, Li Jiang, Tony Y Hu
Background Novel approaches that allow early diagnosis and treatment monitoring of both human immunodeficiency virus-1 (HIV-1) and tuberculosis disease (TB) are essential to improve patient outcomes. Methods We developed and validated an immuno-affinity liquid chromatography–tandem mass spectrometry (ILM) assay that simultaneously quantifies single peptides derived from HIV-1 p24 and Mycobacterium
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Mining the Gap: Deriving Pregnancy Reference Intervals for Hematology Parameters Using Clinical Datasets Clin. Chem. (IF 9.3) Pub Date : 2023-11-10 Vilte E Barakauskas, Mary Kathryn Bohn, Emma Branch, Amelie Boutin, Arianne Albert, Sabrina Luke, Michelle Dittrick, Victoria Higgins, Khosrow Adeli, Hilary Vallance, Benjamin Jung, Kent Dooley, Leanne Dahlgren-Scott, Wee-Shian Chan
Background Physiological changes during pregnancy invalidate use of general population reference intervals (RIs) for pregnant people. The complete blood count (CBC) is commonly ordered during pregnancy, but few studies have established pregnancy RIs suitable for contemporary Canadian mothers. Prospective RI studies are challenging to perform during pregnancy while retrospective techniques fall short
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An Effective and Universal Long-Read Sequencing-Based Approach for SMN1 2 + 0 Carrier Screening through Family Trio Analysis Clin. Chem. (IF 9.3) Pub Date : 2023-11-07 Shuyuan Li, Xu Han, Liang Zhang, Yan Xu, Chunxin Chang, Li Gao, Jiahan Zhan, Renyi Hua, Aiping Mao, Yanlin Wang
Background Population-wide carrier screening for spinal muscular atrophy (SMA) is recommended by professional organizations to facilitate informed reproductive options. However, genetic screening for SMN1 2 + 0 carriers, accounting for 3%–8% of all SMA carriers, has been challenging due to the large gene size and long distance between the 2 SMN genes. Methods Here we repurposed a previously developed
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A Longitudinal Study of Plasma Glycated Albumin across Pregnancy and Associations with Maternal Characteristics and Cardiometabolic Biomarkers Clin. Chem. (IF 9.3) Pub Date : 2023-11-07 Wei Wei Pang, Stefanie N Hinkle, Jing Wu, Paulina Stallcup, Michael Y Tsai, David B Sacks, Cuilin Zhang
Background Glycated albumin (GA) has recently been proposed as a screening marker for diabetes among non-pregnant individuals. However, data on GA during pregnancy are sparse and lacking among women of diverse race/ethnicity. We investigated longitudinal concentrations of GA among multiracial pregnant women in the National Institute of Child Health and Human Development (NICHD) Fetal Growth Studies–Singletons
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Discrepancies in Four Algorithms for the Calculation of Free and Bioavailable Testosterone. Clin. Chem. (IF 9.3) Pub Date : 2023-12-01 Jianbo Yang,Christopher Hamilton,Kimberly Robyak,Yusheng Zhu
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A Patient with Hypokalemia and Hypoxemia-What Is the Culprit? Clin. Chem. (IF 9.3) Pub Date : 2023-11-02 Yin Ye Lai,Chee Hoe Lim,Muhamad Syahmi Nazli,Intan Nureslyna Samsudin,Subashini Chellappah Thambiah
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Commentary on A Patient with Hypokalemia and Hypoxemia-What Is the Culprit? Clin. Chem. (IF 9.3) Pub Date : 2023-11-02 Andrew S Davison
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Commentary on A Patient with Hypokalemia and Hypoxemia-What Is the Culprit? Clin. Chem. (IF 9.3) Pub Date : 2023-11-02 Mark D Kellogg