Quantification of 25-(OH)D in Physiological ConditionNCT07337499
Comparison of Maglumi X3 SNIBE With Other Analytical Methods in Laboratory Medicine for 25-(OH)D Quantification
An observational study of Quantification of 25-(OH)D in Physiological Condition, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quantification of 25-(OH)D in Physiological Condition
- What is being tested?
- blood sampling
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Laboratory of Experimental Biochemistry and Advanced Diagnostic
Milan, Milano, 20175
Giovanni Lombardi, PhD, +390283502222, giovanni.lombardi@grupposandonato.it
Martina Faraldi, PhD, +390283502248, martina.faraldi@grupposandonato.it
About this study
Official title: Comparison of the Maglumi X3 SNIBE Method With Other Analytical Methods in Laboratory Medicine
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.
Read the detailed description
The analytical methods most commonly used in clinical laboratories and for which harmonization/standardization of procedures is required are immunoassays, which enable the quantification of an analyte.
Currently, the reference method for immunoassays is liquid chromatography tandem mass spectrometry (LC-MS/MS). LC-MS/MS is increasingly used in clinical laboratories. Its high specificity, sensitivity, and multi-analyte capability make it an ideal alternative to immunoassays or conventional high-performance liquid chromatography (HPLC). LC-MS/MS also provides greater flexibility than immunoassays, as LC-MS/MS assays are typically developed in-house. In addition, a single LC-MS/MS run can generate a large amount of quantitative or qualitative data.
All of these methods are essential in clinical diagnostics because they allow the detection and quantification of a wide range of biomarkers, including hormones, proteins, and antibodies across numerous areas of medicine. Despite their widespread use and importance, variability between different methods, within the same laboratory or across laboratories, represents a significant challenge, with considerable impact on results, clinical decisions, and ultimately on patient care. This variability may depend on various factors, including the quality and source of reagents, the quality of calibrators critical for analyte quantification, detection methods, and testing protocols.
Every clinical laboratory is therefore required to assess the agreement of results whenever new instruments or analytical procedures are introduced, compared with a method already in use. Method comparison is indeed one of the principals of the International Standard (ISO 15189:2012) for the accreditation of medical laboratories and of the IVD Directive 98/79 EC, which defines the requirements for in vitro diagnostic devices (IVDs) at the European level.
The comparison of two methods requires defining a maximum acceptable difference between the concentrations of an analyte obtained using the analytical techniques of interest; therefore, two methods may be considered comparable if the differences between the results are below a predefined acceptable limit: the maximum acceptable error. The definition of the maximum acceptable error is based on analytical quality specifications established according to five hierarchical models defined at the 1999 Stockholm Conference:
- a model based on the evaluation of the effect of analytical performance on clinical outcomes under specific clinical conditions;
- a model based on the evaluation of the effect of analytical performance on clinical decisions;
- a model based on the biological variability of the analyte;
- a model based on published expert recommendations;
- a model based on the current state of the art (of instruments and/or methods), derived for example from EQA programs.
Therefore, the study will be structured into several phases, beginning with the collection of information on the analytical characteristics and performance of the instruments being compared, verifying method repeatability. For each analyte, the maximum acceptable error will be defined a priori, based on analytical quality specifications, such as analytical imprecision and inaccuracy.
Statistical tests will be performed to assess the error between the analyte measurements obtained using the different methods and, if comparability is not achieved, additional evaluations will be carried out to rule out methodological errors.
- Being tested
- blood sampling
- Keywords
- 25-(OH)D, vitamin D, analytical methods, immunoassay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 secondary outcomes of this study are to evaluate the agreement among 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 obtained using the diffente methods
Measured: The study requires a single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start15 Sep 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Quantification of 25-(OH)D in Physiological ConditionStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Lombardi, PhD, Principal investigator, IRCCS Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337499
- Sponsor's protocol ID
- Snibe(L4174)
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data generated in this study may be made available upon reasonable request after the primary results have been published.
Publications
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.
PubMed 25720125Leung 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.
PubMed 24337187Terzapulo 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.
PubMed 38396756Plebani 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.
PubMed 26667798Zaninotto 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.
PubMed 36383396
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Maglumi X3 SNIBE Method With Other Analytical Methods in Laboratory Medicine
- ClinicalTrials.gov ID
- NCT07337499
- Acronym / sponsor ID
- Snibe(L4174)
- Keywords
- 25-(OH)D, vitamin D, analytical methods, immunoassay
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The analytical methods most commonly used in clinical laboratories and for which harmonization/standardization of procedures is required are immunoassays, which enable the quantification of an analyte.
Currently, the reference method for immunoassays is liquid chromatography tandem mass spectrometry (LC-MS/MS). LC-MS/MS is increasingly used in clinical laboratories. Its high specificity, sensitivity, and multi-analyte capability make it an ideal alternative to immunoassays or conventional high-performance liquid chromatography (HPLC). LC-MS/MS also provides greater flexibility than immunoassays, as LC-MS/MS assays are typically developed in-house. In addition, a single LC-MS/MS run can generate a large amount of quantitative or qualitative data.
All of these methods are essential in clinical diagnostics because they allow the detection and quantification of a wide range of biomarkers, including hormones, proteins, and antibodies across numerous areas of medicine. Despite their widespread use and importance, variability between different methods, within the same laboratory or across laboratories, represents a significant challenge, with considerable impact on results, clinical decisions, and ultimately on patient care. This variability may depend on various factors, including the quality and source of reagents, the quality of calibrators critical for analyte quantification, detection methods, and testing protocols.
Every clinical laboratory is therefore required to assess the agreement of results whenever new instruments or analytical procedures are introduced, compared with a method already in use. Method comparison is indeed one of the principals of the International Standard (ISO 15189:2012) for the accreditation of medical laboratories and of the IVD Directive 98/79 EC, which defines the requirements for in vitro diagnostic devices (IVDs) at the European level.
The comparison of two methods requires defining a maximum acceptable difference between the concentrations of an analyte obtained using the analytical techniques of interest; therefore, two methods may be considered comparable if the differences between the results are below a predefined acceptable limit: the maximum acceptable error. The definition of the maximum acceptable error is based on analytical quality specifications established according to five hierarchical models defined at the 1999 Stockholm Conference:
- a model based on the evaluation of the effect of analytical performance on clinical outcomes under specific clinical conditions;
- a model based on the evaluation of the effect of analytical performance on clinical decisions;
- a model based on the biological variability of the analyte;
- a model based on published expert recommendations;
- a model based on the current state of the art (of instruments and/or methods), derived for example from EQA programs.
Therefore, the study will be structured into several phases, beginning with the collection of information on the analytical characteristics and performance of the instruments being compared, verifying method repeatability. For each analyte, the maximum acceptable error will be defined a priori, based on analytical quality specifications, such as analytical imprecision and inaccuracy.
Statistical tests will be performed to assess the error between the analyte measurements obtained using the different methods and, if comparability is not achieved, additional evaluations will be carried out to rule out methodological errors.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 200 subjects: healthy volunteers and patients scheduled for orthopedic and cardiothoracic surgery | – | Other: blood samplingTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingNo 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. | Other | 200 subjects: healthy volunteers and patients scheduled for orthopedic and cardiothoracic surgery |
Primary outcome
Comparison of 25-(OH) vitamin D quantification with LC-MS/MS and Maglumi X3 SNIBE
Time frame: 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.
1 secondary outcome
Comparison of 25-(OH) vitamin D quantification with Maglumi X3 SNIBE and other immunoassay based analytival methods
Time frame: The study requires a single time point
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 25720125Fraser 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.
- Background: PubMed 24337187Leung 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.
- Background: PubMed 38396756Terzapulo 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.
- Background: PubMed 26667798Plebani 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.
- Background: PubMed 36383396Zaninotto 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.
- Individual participant dataSharing planned: No. The data generated in this study may be made available upon reasonable request after the primary results have been published.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Lombardi, PhD principal investigator
IRCCS Ospedale Galeazzi-Sant'Ambrogio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quantification of 25-(OH)D in Physiological Condition, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Lombardi, PhD (+390283502222, giovanni.lombardi@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of 25-(OH) vitamin D quantification with LC-MS/MS and Maglumi X3 SNIBE (time frame: The study requires a single time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07337499, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.