Quantification of 25-(OH)D in Physiological Condition
Investigational drug(s) / intervention(s)
blood sampling
blood sampling: No intervention, besides blood sampling for 25-(OH) vitamin D quantification, is required since this study intends to assess the agreement among the results obtained using the Maglumi X3 SNIBE method and other analytical methods for the measurement of 25-(OH) vitamin D.
Study summary
The aim of this study is to assess the agreement among the results obtained using the Maglumi X3 SNIBE method and other analytical methods for the measurement of 25-(OH) vitamin D. The comparison between analytical methods is essential for evaluating the analytical performance of different measurement techniques. Assessing the level of comparability between measurements of the same analyte obtained using different methods is fundamental for the harmonization and quality of procedures used in laboratory medicine, ensuring a correct clinical interpretation of results.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Healthy volunteer subjects:
Subjects who sign the informed consent to participate in the study Age ≥ 18 years Employees, in various roles, of the IRCCS Galeazzi-Sant'Ambrogio Hospital
-Patients:
Subjects who sign the informed consent to participate in the study Age ≥ 18 years Patients referred for major orthopedic surgery: hip and knee replacement (bicompartmental and unicompartmental) Patients referred for cardiothoracic surgery
Exclusion Criteria:
* Neoplastic diseases (until remission)
* Grade I, II, and III obesity
* Age \< 18 years
* Women who are pregnant or breastfeeding, based on self-declaration
* Individuals unable to understand and make decisions
Primary outcome measure(s)
Comparison of 25-(OH) vitamin D quantification with LC-MS/MS and Maglumi X3 SNIBE — The study requires a single time point The primary outcome of this study is to evaluate the agreement between the results obtained for the measurement of 25-(OH) vitamin D using the Maglumi X3 SNIBE method and other analytical methods . Serum level of 25-(OH) vitamin D will be measured in 200 subjects enrolled in Ospedale Galeazzi-Sant'Ambrogio and than analyzed using appropriate statistic test to define the maximum acceptable error among the measurements.
Trial sites (1)
Facility
City
Region
Status
Laboratory of Experimental Biochemistry and Advanced Diagnostic
Milan
Milano
Recruiting
More I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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