PIDgeon: An Explainable AI Model for Improved Flow Cytometry-Based Screening of Lymphoid Primary Immunodeficiencies

Clin Chem. 2026 Jan 29:hvaf190. doi: 10.1093/clinchem/hvaf190. Online ahead of print. ABSTRACT BACKGROUND: Primary immunodeficiencies (PIDs) are rare disorders caused by immune system defects that are commonly screened using multi-parameter flow cytometry (FCM). To counter the subjective and time-consuming manual data analysis of FCM data, we present PIDgeon, a fully automated computational pipeline based on … Read more

Disseminated Coccidioidomycosis in Immunocompetent Hosts: Opportunities for Increased Recognition and Timely Diagnosis

Clin Chem. 2026 Jan 28:hvaf187. doi: 10.1093/clinchem/hvaf187. Online ahead of print. ABSTRACT BACKGROUND: While most pulmonary infections with Coccidioides spp. are self-limited, a subset of patients is at higher risk for severe disease and extrapulmonary dissemination, including individuals with certain ethnic backgrounds. Disseminated disease can involve soft tissues, bones, and the central nervous system with … Read more

Evaluation of a New Antibody-Based NT-proBNP Assay for Acute Dyspnea in the Emergency Department

Clin Chem. 2026 Jan 28:hvaf168. doi: 10.1093/clinchem/hvaf168. Online ahead of print. ABSTRACT BACKGROUND: Diagnosis and risk stratification of acute heart failure (HF) in the emergency department (ED) remains challenging. N-terminal pro-B type natriuretic peptide (NT-proBNP) measurement is useful in evaluating acute dyspnea. The objective of this study was to evaluate the diagnostic performance of a … Read more

Real-Time Reverse Transcription Quantitative PCR (RT-qPCR) Methodological Standards and Reporting Practices

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

Establishing Reference Values in Healthy Participants for the Cardiac Troponin T High-Sensitivity Gen 6 Assay: REF-TSIX Global Reference Study

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

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

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