0/2 h-Algorithm for Rapid Triage of Suspected Myocardial Infarction Using a Novel High-Sensitivity Cardiac Troponin I Assay

Clin Chem. 2022 Feb 1;68(2):303-312. doi: 10.1093/clinchem/hvab203. ABSTRACT BACKGROUND: We aimed to derive and validate a 0/2 h-algorithm using the new high-sensitivity cardiac troponin I (hs-cTnI)-VITROS assay (VITROS® Immunodiagnostic Products hs-Troponin I Reagent Pack, Ortho Clinical Diagnostics) for rapid rule-out/in of non-ST-segment elevation myocardial infarction (NSTEMI). METHODS: The final diagnosis was centrally adjudicated by 2 … Read more

Diagnosis of Drug-Resistant Tuberculosis: Rapid Evaluation of Drug Susceptibility with Nanopore Targeted Sequencing

Clin Chem. 2025 May 27:hvaf061. doi: 10.1093/clinchem/hvaf061. Online ahead of print. ABSTRACT BACKGROUND: Whole-genome sequencing (WGS) has limitations in clinical diagnostics due to host DNA interference and lower pathogen load in clinical samples compared to cultured isolates, which reduce the effective sequencing depth and compromise the detection of resistance-associated mutations. As our understanding of the … Read more

Full-Length Clonal Immunoglobulin Rearrangements in cfDNA: Improved Recovery and Sequencing

Clin Chem. 2025 May 26:hvaf064. doi: 10.1093/clinchem/hvaf064. Online ahead of print. ABSTRACT BACKGROUND: Circulating tumor DNA present in cell-free DNA (cfDNA) serves as diagnostic, predictive, and prognostic markers in cancer patients. In lymphoma patients, clonal immunoglobulin (cIg) sequences enable accurate identification of disease states. Despite its importance, there is sparse literature surrounding the preanalytical and … Read more

Challenges in Hb A1c Point-of-Care Testing: Only 6 of 19 Hb A1c Point-of-Care Devices Meet IFCC and NGSP Certification Criteria on Independent Evaluation

Clin Chem. 2025 May 26:hvaf059. doi: 10.1093/clinchem/hvaf059. Online ahead of print. ABSTRACT BACKGROUND: Access to Hb A1c testing in low- and middle-income countries (LMICs) can be limited, especially in rural areas. This has led to an increased interest in the potential role of point-of-care testing (POCT) for Hb A1c. The analytical performance of many of … Read more

Plasma Neprilysin in Heart Failure: Response Dynamics and Clinical Associations Are Immunoassay Dependent

Clin Chem. 2025 May 21:hvaf056. doi: 10.1093/clinchem/hvaf056. Online ahead of print. ABSTRACT BACKGROUND: Discordance among published findings on the plasma concentrations, response dynamics, and clinical associations of plasma neprilysin (NEP) in health and heart failure (HF) require clarification. METHOD: Using a newly developed glycosylation-sensitive monoclonal antibody sandwich ELISA (NEPCVRI), plasma NEP was measured in 99 … Read more

Automated and Decentralized Genomic Profiling of Plasma Cell-Free DNA for Identification of Targetable and Resistance Alterations in Advanced Solid Tumors

Clin Chem. 2025 May 5:hvaf045. doi: 10.1093/clinchem/hvaf045. Online ahead of print. ABSTRACT BACKGROUND: Existing circulating cell-free DNA (cfDNA) assays are primarily centralized, requiring specialized sample handling and transportation. Implementing a flexible, decentralized sequencing system at point of care, with minimal technical oversight, can enhance turnaround times and patient access to genomic profiling. In this study, … Read more

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