Clin Chem. 2026 Jan 28:hvaf176. doi: 10.1093/clinchem/hvaf176. Online ahead of print. ABSTRACT BACKGROUND: Real-time reverse transcription quantitative PCR (RT-qPCR) is utilized in many areas of the life sciences, diagnostics, and forensics, yet concerns about methodological quality and reporting transparency persist. Diagnostic testing during the recent pandemic brought those concerns into the public domain. The Minimum … Read more

Clin Chem. 2026 Jan 21:hvag011. doi: 10.1093/clinchem/hvag011. Online ahead of print. ABSTRACT BACKGROUND: Measurement of cardiac troponin (cTn) using high-sensitivity assays is recommended for the diagnosis of myocardial infarction. We determined sex-specific and uniform 99th percentile upper reference limits (URLs) using the new Elecsys® Troponin T high-sensitivity Gen 6 assay in a global, healthy reference … Read more

Clin Chem. 2026 Jan 19:hvaf185. doi: 10.1093/clinchem/hvaf185. Online ahead of print. NO ABSTRACT PMID:41553864 | DOI:10.1093/clinchem/hvaf185

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

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

Clin Chem. 2026 Jan 7:hvaf189. doi: 10.1093/clinchem/hvaf189. Online ahead of print. NO ABSTRACT PMID:41499264 | DOI:10.1093/clinchem/hvaf189

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

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

Clin Chem. 2026 Jan 7:hvaf173. doi: 10.1093/clinchem/hvaf173. Online ahead of print. NO ABSTRACT PMID:41499260 | DOI:10.1093/clinchem/hvaf173

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