Equivalent results for the same measurand in clinical samples (CSs), measured using different end-user in-vitro diagnostic medical devices (IVD-MDs), are essential for the application of clinical practice guidelines for diagnosis, treatment, monitoring, or risk assessment. The International Organization for Standardization (ISO) document 17511:2020 specifies how to establish metrological traceability to the highest available reference system component to enable equivalent results among IVD-MDs. Commutability with CSs is an essential property of a reference material used as a calibrator in a calibration hierarchy. However, not all calibrators in a calibration hierarchy are required to be commutable; different calibration hierarchies have different requirements for which calibrators must be commutable with CSs. Because assessment of commutability is a substantial effort, it is therefore important to determine which calibrators need to be commutable when implementing a calibration hierarchy. We provide guidance on which calibrators must be commutable with CSs, when a correction for any noncommutability bias is appropriate, and when commutability of a calibrator with CSs is not required for various types of calibration hierarchies described in ISO 17511:2020.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1093/clinchem/hvac226 | DOI Listing |
Biomed Opt Express
January 2025
Center for Biomedical-photonics and Molecular Imaging, Advanced Diagnostic-Therapy Technology and Equipment Key Laboratory of Higher Education Institutions in Shaanxi Province, School of Life Science and Technology, Xidian University, Xi'an, Shaanxi 710126, China.
The study aimed to identify differences in the biochemical composition of corneal stroma lenses across varying degrees of myopia using Raman spectrum characteristics. Corneal stroma lens samples from 38 patients who underwent small incision lens extraction (SMILE) surgery, were categorized into low (n = 9, spherical power -3.00D), moderate (n = 23, spherical power < -3.
View Article and Find Full Text PDFActa Neuropathol Commun
January 2025
Institute of Cancer Research, London, UK.
Histone mutations (H3 K27M, H3 G34R/V) are molecular features defining subtypes of paediatric-type diffuse high-grade gliomas (HGG) (diffuse midline glioma (DMG), H3 K27-altered, diffuse hemispheric glioma (DHG), H3 G34-mutant). The WHO classification recognises in exceptional cases, these mutations co-occur. We report one such case of a 2-year-old female presenting with neurological symptoms; MRI imaging identified a brainstem lesion which was biopsied.
View Article and Find Full Text PDFBMC Med Inform Decis Mak
January 2025
Department of Orthopedics, the First Hospital of Jilin University, Changchun, Jilin Province, 130021, China.
Purpose: Identifying patients who may benefit from multiple drilling are crucial. Hence, the purpose of the study is to utilize radiomics and deep learning for predicting no-collapse survival in patients with femoral head osteonecrosis.
Methods: Patients who underwent multiple drilling were enrolled.
Heliyon
January 2025
Chest Clinical College of Tianjin Medical University, Tianjin, 300270, China.
Backgroud: Fluid volume abnormalities are a major cause of exacerbations in heart failure patients. However, there is few efficient, rapid, or cost-effective clinical approach for determining volume status, resulting in inadequate or unsatisfactory treatment. The aim was to develop an early fluid volume detection model for heart failure patients utilizing a machine learning stratification.
View Article and Find Full Text PDFEnviron Sci Technol
January 2025
Eawag, Swiss Federal Institute of Aquatic Science and Technology, Dübendorf 8600, Switzerland.
Recent emphasis on the development of safe-and-sustainable-by-design chemicals highlights the need for methods facilitating the early assessment of persistence. Activated sludge experiments have been proposed as a time- and resource-efficient way to predict half-lives in simulation studies. Here, this persistence "read-across" approach was developed to be more broadly and robustly applicable.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!