Comparing the Maglumi X3 SNIBE test and other lab methods for measuring 25-(OH) vitamin D
Official title: Comparison of the Maglumi X3 SNIBE Method With Other Analytical Methods in Laboratory Medicine
Run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · NCT07337499 · Data updated 2026-11-12
This project tests how well the Maglumi X3 SNIBE method measures 25-(OH) vitamin D compared with other common lab methods using blood from adults, including healthy volunteers and surgical patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, Milano) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | January 30, 2026 |
| Study ends | March 31, 2026 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT07337499 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults (age ≥18) able to give informed consent, including healthy volunteers (hospital employees) and patients scheduled for hip or knee replacement or cardiothoracic surgery at the Milan site.
✕Probably not a fit
Patients with active neoplastic disease, grade I–III obesity, pregnant or breastfeeding women, individuals under 18, or those unable to understand or consent are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project compares 25-(OH)D results produced by the Maglumi X3 SNIBE immunoassay to results from other analytical methods using blood samples collected at a single hospital laboratory. LC-MS/MS, the reference method, will be used as a comparator and results will be analyzed for agreement and variability across platforms. Participants include adults (≥18) who are healthy volunteers, hospital employees, or patients undergoing major orthopedic or cardiothoracic surgery, with blood sampling performed for vitamin D quantification. The aim is to quantify method-to-method differences that may affect clinical interpretation and to support harmonization of laboratory procedures.
Why it matters
Potential benefit: If successful, this work could make vitamin D test results more consistent across laboratories, improving diagnostic accuracy and treatment decisions.
How similar studies have gone: Previous comparisons of immunoassays with LC-MS/MS have consistently shown method-dependent differences, so while LC-MS/MS is an established reference much work on harmonization is still ongoing.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Laboratory of Experimental Biochemistry and Advanced Diagnostic
Milan, Milano, Italy Recruiting
Study contacts
- Principal investigator: Giovanni Lombardi, PhD — IRCCS Ospedale Galeazzi-Sant'Ambrogio
- Study coordinator: Giovanni Lombardi, PhD
- Email: giovanni.lombardi@grupposandonato.it
- Phone: +390283502222
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.