Clinical Chemistry

Unmet Clinical Needs and Remaining Challenges of Pregnancy Reference Intervals

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Clin Chem. 2025 Dec 30;72(1):47-60. doi: 10.1093/clinchem/hvaf150. ABSTRACT BACKGROUND: Pregnancy is characterized by dynamic physiological changes that alter the concentrations of many maternal blood biomarkers. Reporting results against nonpregnant reference values can lead to misinterpretation, diagnostic error, and inappropriate clinical management. The use and reporting of pregnancy-specific reference intervals (RIs) by laboratories is not yet … Read more

Environmental Contaminants and Congenital Heart Defects: Focus on PFAS, PAHs, and Other Emerging Exposures

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Clin Chem. 2025 Dec 30;72(1):133-139. doi: 10.1093/clinchem/hvaf158. ABSTRACT BACKGROUND: Congenital heart defects (CHDs) are the most prevalent birth defects, contributing significantly to infant morbidity and mortality. While genetic factors account for a subset of CHDs, environmental exposures during critical periods of cardiac development are increasingly recognized as potential contributors. CONTENT: This review synthesizes current evidence … Read more

From PKU to Genome Sequencing: The Past, Present, and Future of Newborn Screening

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Clin Chem. 2025 Dec 30;72(1):123-132. doi: 10.1093/clinchem/hvaf148. ABSTRACT BACKGROUND: Newborn screening (NBS) is a foundational public health program designed to identify severe but treatable conditions in presymptomatic newborns. Since Robert Guthrie introduced the phenylketonuria test in the 1960s, NBS has evolved from single-condition assays to multiplex platforms, enabling early diagnosis, intervention, and long-term follow-up. Understanding … Read more

Universal Screening of Cytomegalovirus Viral Load by Low-Pass Whole-Genome Sequencing in First-Trimester Pregnancy: Clinical Validation

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Clin Chem. 2025 Dec 30;72(1):173-182. doi: 10.1093/clinchem/hvaf159. ABSTRACT BACKGROUND: Congenital cytomegalovirus (cCMV) infection is a leading cause of sensorineural hearing loss in children. Recent evidence that high-dose valacyclovir reduces vertical transmission following primary maternal infection has renewed the urgency for screening. We investigated the utility of quantifying cell-free CMV DNA from noninvasive prenatal screening (NIPS) … Read more

Fecal Microbiota Therapy: Clinical Laboratory Testing and Metabolomic Approaches for Donor Screening, Product Assessment, and Patient Monitoring

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Clin Chem. 2025 Dec 19:hvaf156. doi: 10.1093/clinchem/hvaf156. Online ahead of print. ABSTRACT BACKGROUND: The safety and efficacy of fecal microbiota transplantation for prevention of recurrent Clostridioides difficile infection relies on complex interactions between the donor and recipient microbiome. CONTENT: Screening of donor stool has largely aimed to ensure safety; however, metagenomic and metabolic features of … Read more

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