Analytical Performance Comparison of Three Quantitative Hepatitis B Surface Antigen Assays

Clin Chem. 2026 Jan 16:hvaf191. doi: 10.1093/clinchem/hvaf191. Online ahead of print. ABSTRACT BACKGROUND: Quantitative hepatitis B surface antigen (qHBsAg) assays are important tools for monitoring hepatitis B virus (HBV) infection and treatment response and constitute the primary endpoint in most HBV antiviral trials. To date, no qHBsAg assay has been authorized by the FDA for … Read more

Six-Color Multiplex Digital PCR Assays for Comprehensive Screening and Identification of Multiple Driver Mutations Associated with Pancreatic Carcinogenesis

Clin Chem. 2026 Jan 9:hvaf181. doi: 10.1093/clinchem/hvaf181. Online ahead of print. ABSTRACT BACKGROUND: Digital polymerase chain reaction (dPCR) is widely recognized for its high sensitivity in detecting low-frequency variants; however, conventional 2-color systems have limited multiplex capacity. Expanding this capability is essential for simultaneous detection of multiple driver mutations in cancer-related genes. KRAS and GNAS … Read more

Methods to Improve Confidence in the Accuracy of Molecular Testing for Multidrug-Resistant Tuberculosis

Clin Chem. 2026 Jan 7:hvaf178. doi: 10.1093/clinchem/hvaf178. Online ahead of print. ABSTRACT BACKGROUND: Diagnosis of tuberculosis (TB) and multidrug-resistant tuberculosis (MDR-TB) is increasingly performed using molecular tools that detect Mycobacterium tuberculosis DNA. To ensure accurate and reliable results from the molecular tests, appropriate quality assessment is required. This involves implementing reference measurement procedures (RMPs) to … Read more

Development of a Novel Liquid Chromatography Coupled to Multiple Reaction Monitoring (LC-MRM) Assay for the Quantification of Neurofilament Light Chain in Cerebrospinal Fluid and Comparison with Ultra-Sensitive Immunoassay: A Step toward Standardization

Clin Chem. 2026 Jan 7:hvaf180. doi: 10.1093/clinchem/hvaf180. Online ahead of print. ABSTRACT BACKGROUND: Neurofilament light chain (Nf-L) is a key early biomarker for axonal damage and neurodegeneration, increasingly used in clinical practice for diagnosis, prognosis, and treatment monitoring. To ensure reliable clinical implementation, standardized measurement procedures and calibrators traceable to the International System of Units … Read more

Splicing Predictions, Splicing Assays, and Variant Classification Using ACMG/AMP Guidelines: Challenges Observed with BRCA1 and BRCA2 Variants

Clin Chem. 2026 Jan 7:hvaf177. doi: 10.1093/clinchem/hvaf177. Online ahead of print. ABSTRACT BACKGROUND: Germline loss-of-function variants in BRCA1 and BRCA2 are established drivers of hereditary breast and ovarian cancer, often acting through aberrant splicing. However, not all spliceogenic changes are pathogenic, and many variants remain classified as uncertain due to insufficient experimental evidence and challenges … Read more

Towards Clinical Integration of Deep Learning-Based Classification of Urinary Sediment Particles from Digital Microscopy Images: A Prospective Study

Clin Chem. 2026 Jan 7:hvaf182. doi: 10.1093/clinchem/hvaf182. Online ahead of print. ABSTRACT BACKGROUND: Urinalysis is a standard clinical test that includes the microscopic examination of urinary sediment to identify formed elements. Manual evaluation by laboratory technicians is time-intensive and subject to human error. Automated analysis using digital microscopy images presents a potential alternative. This study … Read more

Copy-Number Profiling and Methylation-Based Tumor Typing during Prenatal Cell-Free DNA Screening

Clin Chem. 2026 Jan 7:hvaf167. doi: 10.1093/clinchem/hvaf167. Online ahead of print. ABSTRACT BACKGROUND: Prenatal cell-free DNA (cfDNA) screening is primarily designed to detect fetal chromosomal abnormalities, but can also identify aneuploidies derived from other tissues, including cancer. The identification of aneuploidies of unknown origin during prenatal cfDNA screening can lead to time-consuming multistage investigations and … Read more

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