Clinical Chemistry

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

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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

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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

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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

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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

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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

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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

Can NT-proBNP Enhance the Accuracy of Angiogenic Factors in the Short-Term Prediction of Preeclampsia?

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Clin Chem. 2025 Dec 30;72(1):206-216. doi: 10.1093/clinchem/hvaf135. ABSTRACT BACKGROUND: Angiogenic biomarkers aid in short-term prediction of preeclampsia (PE) but are often limited by false-positive results. N-terminal pro-B-type natriuretic peptide (NT-proBNP), which is elevated in PE due to cardiovascular dysfunction, may enhance diagnostic precision. This study evaluated whether adding NT-proBNP to the soluble fms-like tyrosine kinase-1 … Read more

From Diagnostics to Data Analytics: A Strategic Approach to Closing Care Gaps in Pregnancy

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Clin Chem. 2025 Dec 30;72(1):39-46. doi: 10.1093/clinchem/hvaf146. ABSTRACT BACKGROUND: Persistent disparities in prenatal care contribute to preventable maternal and fetal morbidity and mortality, particularly among high-risk and underserved populations. Clinical laboratories play a central role in early detection of prenatal gaps in care and stratifying pregnancy-related risk factors linked to other health conditions, yet their … Read more

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