Journal of Applied Laboratory Medicine最新文献

{"title":"Regulatory Approved Point-of-Care Diagnostics (FDA & Health Canada): A Comprehensive Framework for Analytical Validity, Clinical Validity, and Clinical Utility in Medical Devices.","authors":"Moustafa Kardjadj","doi":"10.1093/jalm/jfaf106","DOIUrl":"https://doi.org/10.1093/jalm/jfaf106","url":null,"abstract":"<p><strong>Background: </strong>Point-of-care (POC) diagnostic devices deliver rapid, near-patient results that drive timely clinical decisions across diverse settings (from emergency departments to home care). Their decentralized deployment mandates a rigorous, multi-phase validation strategy to ensure analytical accuracy, clinical reliability, and real-world utility before both regulatory clearance and reimbursement.</p><p><strong>Content: </strong>We propose an expanded, integrated framework comprising 4 pillars:Analytical validity: Quantification of sensitivity, specificity, predictive values adjusted for prevalence, limits of detection, bias/imprecision, and reproducibility using Receiver Operating Characteristic (ROC) curve analysis, Bland-Altman comparison, Passing-Bablok/Deming regression, and nonparametric techniques for semiquantitative outputs.Clinical validity: Demonstration of substantial equivalence via FDA 510(k) (Class II), de novo (novel low/moderate risk), or premarket approval (PMA; Class III with Investigational Device Exemption (IDE)-supported pivotal trials) pathways, supported by prospective, multicenter clinical studies, and human-factors usability assessments in intended use environments.Clinical utility: Evidence of improved patient care from outcome-based trials (e.g., time-to-treatment and readmission rates), health-economic analyses (cost per quality-adjusted life year and budget-impact models), and patient-reported outcome measures capturing usability, satisfaction, and adherence.Regulatory alignment: Harmonization of FDA and Health Canada requirements, including ISO 14971 risk management, post-market surveillance (21 CFR 820; Medical Device Licence [MDL] vigilance), to streamline market access and payer coverage decisions.</p><p><strong>Summary: </strong>This comprehensive, staged validation pathway, from analytical benchmarks through clinical performance and utility to regulatory and reimbursement strategies, provides a practical roadmap for innovators, clinicians, and regulators. Embedding real-world evidence and coordinating US and Canadian frameworks accelerates the adoption of safe, effective, and value-based POC diagnostics, fostering better patient outcomes, and supporting modern precision medicine.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144838138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Abnormal Thyroid Function Test in a Patient Taking Carbamazepine.","authors":"Mirjana Barjaktarovic, K Aaron Geno, Andrew R Crawford","doi":"10.1093/jalm/jfaf077","DOIUrl":"https://doi.org/10.1093/jalm/jfaf077","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commentary on Abnormal Thyroid Function Test in a Patient Taking Carbamazepine.","authors":"Christopher W Farnsworth","doi":"10.1093/jalm/jfaf105","DOIUrl":"https://doi.org/10.1093/jalm/jfaf105","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to: Associations between Growth Differentiation Factor 15, Cardiac Troponin T, and N-terminal pro-B-type Natriuretic Peptide, and Future Myocardial Fibrosis Assessed by Cardiac Magnetic Resonance Imaging: Data from the Akershus Cardiac Examination 1950 Study.","authors":"","doi":"10.1093/jalm/jfaf086","DOIUrl":"https://doi.org/10.1093/jalm/jfaf086","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Evolving Role of Anti-Müllerian Hormone Measurements in Clinical Practice.","authors":"Xiaochun Susan Zhang, Jaime H Noguez","doi":"10.1093/jalm/jfaf096","DOIUrl":"https://doi.org/10.1093/jalm/jfaf096","url":null,"abstract":"<p><strong>Background: </strong>Anti-Müllerian hormone (AMH), a glycoprotein belonging to the transforming growth factor-beta superfamily, plays a pivotal role in reproductive physiology. Initially recognized for its function in male sexual differentiation, AMH has since emerged as a key biomarker with broad clinical applications in both endocrinology and oncology. As research continues to elucidate the physiological roles of AMH, its clinical utility is expanding, necessitating careful assay selection, integration with complementary diagnostic markers, and context-specific interpretation.</p><p><strong>Content: </strong>A thorough understanding of AMH physiology, assay variability, and clinical interpretation is essential for its effective integration into routine clinical practice. This review provides a concise overview of AMH physiology, explores its diverse clinical applications, examines the evolution and limitations of AMH assays, and presents a comparative analysis of commercially available AMH assays commonly used in clinical laboratories.</p><p><strong>Summary: </strong>This review highlights the increasing clinical relevance of AMH testing in laboratory medicine, focusing on its expanding applications and the practical analytical considerations essential for accurate interpretation and optimal utilization.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Measurement Uncertainty and the Prostate Health Index-A Review.","authors":"Ian Farrance, Robert Frenkel","doi":"10.1093/jalm/jfaf080","DOIUrl":"https://doi.org/10.1093/jalm/jfaf080","url":null,"abstract":"<p><strong>Background: </strong>Not all quantity values determined in a medical laboratory are obtained by direct analytical measurement. In many situations, a quantity value is calculated from other measurements through a functional relationship, where the output quantity is derived from one or more input quantities by applying a defined mathematical equation. Even though important for clinical interpretation, the measurement uncertainty (MU) of calculated quantities may not always be considered.</p><p><strong>Content: </strong>The prostate health index (phi) has been shown to improve the clinical assessment of prostate cancer. Estimates for the MU of phi have been recently provided by a novel approach in which the uncertainty of phi was directly calculated from internal quality control (IQC). However, this method for determining MU generally provides a higher estimate than the procedure recommended by the \"Evaluation of Measurement Data-Guide to the Expression of Uncertainty in Measurement\" (GUM) and does not allow for the incorporation of a correlation term. A full evaluation of the MU for phi by the GUM procedure is provided.</p><p><strong>Summary: </strong>The importance of the GUM approach with the inclusion of correlation terms is clearly shown by the phi calculation. By comparison, the relative standard uncertainty obtained by the direct IQC procedure for a mean phi value of 24.48 was given as 7.2%, while by GUM, the relative standard uncertainty for the same mean phi was 3.60% with correlation included and 5.99% without correlation. The influence of correlation terms within the GUM equations is clearly shown for the phi calculation.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144609878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of the Choosing Wisely Campaign on Folate Test Utilization: An Observational Study in a National Reference Laboratory.","authors":"Ato Aikins, Sanjai Nagendra, Zahra Shajani-Yi, David Alfego, Pratistha Ranjitkar","doi":"10.1093/jalm/jfaf058","DOIUrl":"10.1093/jalm/jfaf058","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1065-1068"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144051789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Persistent Microcytosis in a Young Woman with Bone Pain.","authors":"Seema Khattri Bhandari, Shu-Ling Fan","doi":"10.1093/jalm/jfaf007","DOIUrl":"10.1093/jalm/jfaf007","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1033-1037"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144052877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Review on Toxicology Testing in Hair.","authors":"Jacqueline A Hubbard","doi":"10.1093/jalm/jfaf026","DOIUrl":"10.1093/jalm/jfaf026","url":null,"abstract":"<p><strong>Background: </strong>Hair toxicology is a useful tool for detecting long-term drug use. This method offers several advantages, including the ability to trace historical patterns of drug intake. However, drug incorporation into hair is complex, influenced by numerous factors such as hair structure, physiological differences, external contamination, and the chemical properties of drugs. A comprehensive understanding of these factors is critical to accurately interpret hair toxicology results in both clinical and forensic settings.</p><p><strong>Content: </strong>The anatomy of hair plays a vital role in drug incorporation. Drugs can enter the hair via diffusion from the bloodstream, by passive deposition through sweat or sebum bathing the hair, or through external contamination. The analysis of drug incorporation has evolved significantly over time, and it is now possible to detect drug exposure even after a single ingestion. However, several factors such as decontamination protocols, extraction methods, melanin content (hair color), growth rates, contamination from drug particulates, and cosmetic hair treatments may affect the accuracy of hair toxicology results. Guidelines by expert societies have been published, but variations in sample preparation and analysis techniques remain.</p><p><strong>Summary: </strong>While hair toxicology holds promise for detecting long-term drug exposure, many variables must be considered to ensure accurate interpretation. Differences in physiological properties and external factors can complicate the results. Harmonized protocols and advanced techniques are necessary to minimize biases, particularly regarding racial differences in drug incorporation. Future research should aim to further harmonize methodologies and address these challenges to enhance the reliability of hair toxicology testing.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"983-1000"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effect of Clinical Decision Support Intervention on Monitoring for Donor Specific Antibodies.","authors":"Aja Aravamudhan, Carolynn Scalf, Michael P Greenwood, Penn Muluhngwi","doi":"10.1093/jalm/jfaf030","DOIUrl":"10.1093/jalm/jfaf030","url":null,"abstract":"<p><strong>Background: </strong>Following transplantation, it is recommended that human leukocyte antigen (HLA) donor specific antibody (DSA) monitoring for allograft surveillance be tailored to the patient's antibody-mediated rejection (AMR) risk and immunosuppression needs. However, at our institution, DSA orders were placed more frequently than recommended, with daily duplications due to inconsistent ordering across departments (outpatient, emergency, and inpatient). We evaluated the effectiveness of a non-interruptive clinical decision support (CDS) system integrated with computerized provider order entry (CPOE) in reducing redundant DSA orders.</p><p><strong>Methods: </strong>CDS included an indication prompt and test status indicator to help providers review test rationale and flag active orders. We then evaluated its impact of this intervention in 5-month periods before and after implementation, using statistical analyses to assess the differences with a t-test.</p><p><strong>Results: </strong>In the pre-implementation period, 82.5% (1504/1824) of DSA orders from 473 of 792 patients were duplicates, compared to 79.6% (1415/1778) from 463 of 826 patients post-implementation. After excluding cases without reported DSA and overlapping patients, each group had 466 unique patients. Duplicate orders decreased within 50 days post-implementation but increased beyond this period. Among renal transplant recipients, the fraction of duplicate orders within a week significantly dropped (pre-implementation n = 9, post-implementation n = 26, P = 0.009). DSA levels remained stable, suggesting the intervention did not impact detection rates.</p><p><strong>Conclusion: </strong>The CDS implemented reduced unwarranted duplicate orders within 2 weeks of a prior order without affecting long-term (>50 days) monitoring protocols, demonstrating the effectiveness of non-interruptive CDS-CPOE in improving HLA test ordering.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"863-873"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}