Comparison of Maglumi X3 SNIBE With Other Analytical Methods in Laboratory Medicine for 25-(OH)D Quantification

NCT07337499 | Recruiting

• 1 other identifier: Snibe(L4174)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quantification of 25-(OH)D in Physiological Condition

Keywords

25-(OH)D; vitamin D; analytical methods; immunoassay

Outcome Measures

Primary Outcomes (1)

• Comparison of 25-(OH) vitamin D quantification with LC-MS/MS and Maglumi X3 SNIBE

  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.

  The study requires a single time point

Secondary Outcomes (1)

• Comparison of 25-(OH) vitamin D quantification with Maglumi X3 SNIBE and other immunoassay based analytival methods

  The study requires a single time point

Study Arms (1)

200 subjects: healthy volunteers and patients scheduled for orthopedic and cardiothoracic surgery

Two hundred subjects will include healthy volunteer individuals, employees of the Galeazzi-Sant'Ambrogio Hospital, and patients at the time of pre-admission or admission who are scheduled for major orthopedic surgery involving hip or knee prostheses, or for cardiothoracic surgery, as these represent the largest cohorts within our institution. All subjects will be older than 18y, without cancer, obesity, not pregnant, and able to understand or make decisions.

Other: blood sampling

Interventions

blood sampling OTHER

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.

200 subjects: healthy volunteers and patients scheduled for orthopedic and cardiothoracic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two hundred subjects will be recruited, including healthy individuals who are employees of the Galeazzi-Sant'Ambrogio Hospital, as well as patients at the time of pre-admission or admission who are referred for major orthopedic surgery (hip and knee replacement) or for cardiothoracic surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Laboratory of Experimental Biochemistry and Advanced Diagnostic

Milan, Milano, 20175, Italy

RECRUITING

Related Publications (5)

• Fraser CG. The 1999 Stockholm Consensus Conference on quality specifications in laboratory medicine. Clin Chem Lab Med. 2015 May;53(6):837-40. doi: 10.1515/cclm-2014-0914.

  PMID: 25720125 BACKGROUND

• Leung KS, Fong BM. LC-MS/MS in the routine clinical laboratory: has its time come? Anal Bioanal Chem. 2014 Apr;406(9-10):2289-301. doi: 10.1007/s00216-013-7542-5. Epub 2013 Dec 15.

  PMID: 24337187 BACKGROUND

• Terzapulo X, Kassenova A, Bukasov R. Immunoassays: Analytical and Clinical Performance, Challenges, and Perspectives of SERS Detection in Comparison with Fluorescent Spectroscopic Detection. Int J Mol Sci. 2024 Feb 8;25(4):2080. doi: 10.3390/ijms25042080.

  PMID: 38396756 BACKGROUND

• Plebani M. Harmonization in laboratory medicine: Requests, samples, measurements and reports. Crit Rev Clin Lab Sci. 2016;53(3):184-96. doi: 10.3109/10408363.2015.1116851. Epub 2015 Dec 15.

  PMID: 26667798 BACKGROUND

• Zaninotto M, Graziani MS, Plebani M. The harmonization issue in laboratory medicine: the commitment of CCLM. Clin Chem Lab Med. 2022 Nov 16;61(5):721-731. doi: 10.1515/cclm-2022-1111. Print 2023 Apr 25.

  PMID: 36383396 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Giovanni Lombardi, PhD

  IRCCS Ospedale Galeazzi-Sant'Ambrogio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Lombardi, PhD

CONTACT

+390283502222; giovanni.lombardi@grupposandonato.it

Martina Faraldi, PhD

CONTACT

+390283502248; martina.faraldi@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: September 15, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)