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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Neoplastic diseases (until remission)

Grade I, II, and III obesity

Age < 18 years

Women who are pregnant or breastfeeding, based on self-declaration

Trial 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.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • blood sampling

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: 200 subjects: healthy volunteers and patients scheduled for orthopedic and cardiothoracic surgery1 intervention

Trial outcomes

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.

Time frame
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

Time frame
The study requires a single time point

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.