E!10602 Plasma ferritin immunoassay for whole blood samples

PLASMA FERRITIN IMMUNOASSAY FOR WHOLE BLOOD SAMPLES FERRITIN Ferritins are a family of nano-cage proteins that store iron and are crucial in iron retention and transport in the body. In blood ferritin occurs in red blood cells and in blood plasma. Ferritin level in blood is an indirect measure of the total iron in the body. BLOOD DONATION Blood donors are mainly volunteers. 10% of blood collected comes from new donors and it is estimated that a new donor costs EUR 100-200 to recruit. Blood donation depletes the body?s iron reserves and it is well documented that deferred donors frequently fail to return, which leads to costly recruitment of replacement donors. Iron deficiency is endemic in regular blood donors. In a typical study of a regular donor group, 66% of the women and 49% of the men were iron deficient, excluding those already deferred for low hemoglobin concentration. Plasma ferritin is an indirect marker of the total iron stored in the body; hence plasma ferritin is used to diagnose iron deficiency anemia (IDA). Currently, blood collection centers do not routinely measure ferritin levels in their blood donors, as the procedure is too time-consuming. THE PROBLEM AND THE SOLUTION A standard plasma ferritin test requires a centrifugation step, which is too long to obtain a result prior to blood donation. Gentian is developing an immunoassay for measuring plasma ferritin in capillary samples of whole blood. Ferritin measurement will take place without interference from ferritin in erythrocytes. A whole blood plasma ferritin assay takes less than 10 minutes and avoids the centrifugation step. PROJECT RESULTS - Gentians immunoassay will give a fast and cost-effective method for the status of blood donors prior to donation - Blood donors will get immediate recommendations for improving their iron status - Blood collection centers will have a new tool to address the problem of donors that fail to return following deferral

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Blood donors are mainly volunteers who receive no payment for their donation. 10% of blood collected comes from new donors and it is estimated that a new donor costs EUR 100-200 to recruit. The blood collection center measures the donor's blood pressure, pulse and temperature, and measures the hemoglobin level in a drop of blood. If hemoglobin level is too low then the donor is deferred to a later date. Blood donation depletes the body's iron reserves and it is well known that deferred donors frequently fail to return, which leads to costly recruitment of replacement donors. Iron deficiency is endemic in regular blood donors. For example in one representative study of a regular donor group, 66% of the women and 49% of the men were iron deficient, excluding those deferred for low hemoglobin concentration. About 70% of the body's iron is bound to hemoglobin. When red blood cells die, their iron is released and carried by transferrin to the bone marrow and to other organs such as the liver and spleen. In the bone marrow, iron is stored and used to make new red blood cells. Because free iron is toxic it is bound in the protein ferritin. Plasma ferritin is an indirect marker of the total amount of iron stored in the body; hence serum/plasma ferritin is used as a diagnostic test for iron deficiency anemia (IDA). The target market is the blood donor industry, where routine use of plasma ferritin measurements will have a significant impact on the quality of donor health. A study by O'Meara A, Infanti L, et al in 2011, showed that the introduction of routine ferritin testing resulted in the following: 1. An increase of mean Hb levels in blood donors and particularly of women of childbearing age. 2. A decrease in ineligibility incidence due to pre-donation anemia. 3. A decrease in ineligibility incidence due to low Hb. 4. A significant shortening of the return interval of donors rejected on account of low Hb levels.