Clinical Chemistry

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

The Unique Utility of Newborn Dried Blood Spots for Driving Discovery in Childhood Cancer Research

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Clin Chem. 2025 Dec 30;72(1):82-100. doi: 10.1093/clinchem/hvaf169. ABSTRACT BACKGROUND: Childhood cancer, though rare, remains the leading cause of disease-related death among children in the United States. The overall incidence has been rising for the past several decades, and the factors underlying the increasing rates are unclear. This unexplained increase underscores the critical need for high-quality, … Read more

Uterus Transplantation-Current Evaluation, Monitoring, and Emerging Diagnostics

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Clin Chem. 2025 Dec 30;72(1):18-26. doi: 10.1093/clinchem/hvaf143. ABSTRACT BACKGROUND: Uterus transplantation (UTx) is uniquely positioned at the transition from experimental to clinical reality for women with absolute uterine factor insufficiency. As the technique gains wider clinical adoption, there is a growing need for standardization in both protocols and diagnostics. CONTENT: This review describes the current … Read more

The Mutational Epidemiology of Childhood Cancer

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Clin Chem. 2025 Dec 30;72(1):140-151. doi: 10.1093/clinchem/hvaf154. ABSTRACT BACKGROUND: Childhood cancers comprise a variety of liquid and solid tumors that display different patterns of incidence than adult cancers. Most have distinct molecular subtypes characterized by specific genomic driver events. The mutational processes that influence the somatic landscape of cancers also generate distinctive mutational signatures (mutSig). … Read more

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