Optical iron deficiency diagnostics - evaluation of a fiber optic fluorescence measurement for the determination of zinc protoporphyrin in blood donors
- Conditions
- E61.1D50Iron deficiencyIron deficiency anaemia
- Registration Number
- DRKS00013102
- Lead Sponsor
- IFE-Zentrum, Klinikum der Universität München
- Brief Summary
Background: Frequent blood donors are at high risk of developing iron deficiency. Currently, there is no potent screening during blood donation to detect iron deficient erythropoiesis (IDE) before anemia develops and deferral from donation is inevitable. Study Design and Methods: In addition to capillary and venous hemoglobin, the iron status of 99 frequent blood donors was assessed by various venous blood parameters and zinc protoporphyrin IX (ZnPP). ZnPP was determined by high-performance liquid chromatography (HPLC) and a new prototype fiber-optic device was employed for non-invasive measurements of ZnPP through the blood collection tubing (NI-tubing) and on lip tissue (NI-lip). We aimed to evaluate the feasibility and diagnostic value of the NI-tubing measurement for early detection of severe iron deficiency in blood donors. Results: NI-tubing and HPLC reference measurements of ZnPP showed narrow limits of agreement of 12.2 µmol ZnPP/mol heme and very high correlation (Spearman’s Rho = 0.938). Using a cutoff of 65 µmol ZnPP/mol heme, NI-tubing measurements (n = 93) identified 100% of donors with iron deficiency anemia (IDA) and an additional 38% of donors with IDE. Accordingly, NI-tubing measurements would allow detection and selective protection of particularly vulnerable donors. Conclusion: NI-tubing measurements are an accurate and simple method to implement ZnPP determination into the routine blood donation process. ZnPP was able to identify the majority of subjects with IDE and IDA and might therefore be a valuable tool to provide qualified information to donors about dietary measures and adjustments of the donation interval and thereby help to prevent IDA and hemoglobin deferral in the future.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Frequent blood donors (male and female) who are admitted to blood donation or who are rejected because of a too low Hb value. Frequent blood donors are persons who verifiably donated blood within the last 12 months at least 3 times (female) or 4 times (male). Written informed consent after informative discussion.
Blood donors who are rejected from blood donation because of other reasons than a low Hb value. Transfusion of blood products within the last 12 months. Known iron supplementation (on-going or finished within the last 3 months). Known hemochromatosis.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the applicability of the measurement procedure at the blood donation tube (questionnaire in the CRF and statistical evaluation of raw data) and stability of the measured zinc protoporphyrin values (repetitive measurements).
- Secondary Outcome Measures
Name Time Method Comparison of the measurements on the blood donation tube and of the non-invasive measurements on the lower lip with the measurement on whole blood. In addition, other blood parameters of iron metabolism are determined from an available blood sample (i.a. Hb, MCV, Hct, ferritin, transferrin, transferrin saturation, CRP, soluble transferrin receptor) and correlated with the measurements of zinc protoporphyrin. About 6 months after recruitment of the participant, latest 6 months after recruitment of the last participant, the principal investigator or deligate evaluates, if the respective participant has donated blood during these 6 months and which hemoglobin value was measured.