Measurement of Serum Ferritin With a Cryo Detector Mass Spectrometer (CDMS)

Study Overview
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Brief Summary
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The study will explore the performance of the CDMS (Cryo Detector Mass Spectrometer) method in measuring SF (serum ferritin) in human serum of healthy individuals. This will be the first experience of testing SF with this method using biologic material of human origin.

Detailed Description
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A clear interpretation of hyperferritinemia is difficult in many clinical situations. Crucial for the correct treatment of patients is the differentiation between reactively elevated ferritin and effective iron overload.The measurement methods that are routinely used provide quantitative results of the measurement of total ferritin molecules independent of their actual iron content.With a modified mass spectrometric method (CDMS), this should be possible. In this study the investigators would like to apply this measurement technique for the first time with human serum as the investigators would like to test healthy blood donors with known normal, low or elevated ferritin levels.

Official Title
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Measurement of Serum Ferritin With a Cryo Detector Mass Spectrometer (CDMS): Pilot Study and First Experience in Testing Human Serum

Conditions
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Serum Ferritin

Intervention / Treatment
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* Diagnostic Test: Collection of Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75 years SF (serum ferritin) values known from a previous determination that must not be older than twelve months and not followed by a blood donation fulfillment of the eligibility criteria for blood donation negative serology for HBV (hepatitis B virus), HCV (hepatitis C virus), HIV (human immunodeficiency virus) as assessed in the context of a blood donation Exclusion Criteria: acute illness chronic inflammatory disease Since pregnancy is a contraindication for blood donation, no pregnant women will be included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Collection of Blood samples|The following samples will be drawn from each study participant immediately after the venipuncture performed for the whole blood donation: 1 sample with no anticoagulant (5 ml) for SF measurement with the CDMS method 1 EDTA (Ethylendiamintetraazetat) sample (7,5 ml) for a complete blood count with red blood cell indices and reticulocytes 1 EDTA sample (2,7 ml) for the measurement of hepcidin 1 Li-Heparin-Gel sample (4.7 ml) for the measurement of SF with the ECLIA (Electrochemiluminescence-enzymeimmunoassay) and of the complete set of iron biomarkers (Transferrin Saturation, serum iron, Soluble Transferrin Receptor) 1 Li-Heparin-Gel sample (4.7 ml) for the measurement of CRP (C-reactive Protein) 1 sample with no anticoagulant (5 ml) for the measurement of SF with the CMIA (Chemiluminescence Immunoassay) 1 sample with no anticoagulant (5 ml) for storage|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the mass of serum ferritin molecules (kDa) | The primary outcome is the mass of SF molecules measured using the CDMS method | one time assessment at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryo Detector Mass Spectrometer