Serum Ferritin
Conditions
Keywords
Cryo Detector Mass Spectrometer
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTCollection 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
Sponsors
Metromol SA
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the mass of serum ferritin molecules (kDa) | one time assessment at baseline | The primary outcome is the mass of SF molecules measured using the CDMS method |
Countries
Switzerland
Outcome results
None listed