BACKGROUND : Pathogen inactivation (PI) is a new approach to blood safety that may introduce additional costs. This study identifies costs that could be eliminated, thereby mitigating the financial impact.
STUDY DESIGN AND METHODS : Cost information was obtained from five institutions on tests and procedures (e.g., irradiation) currently performed, that could be eliminated. The impact of increased platelet (PLT) availability due to fewer testing losses, earlier entry into inventory, and fewer outdates with a 7-day shelf life were also estimated. Additional estimates include costs associated with managing 1) special requests and 2) test results, 3) quality control and proficiency testing, 4) equipment acquisition and maintenance, 5) replacement of units lost to positive tests, 6) seasonal or geographic testing, and 7) health department interactions.
RESULTS : All costs are mean values per apheresis PLT unit in USD ($/unit). The estimated test costs that could be eliminated are $71.76/unit and a decrease in transfusion reactions corresponds to $2.70/unit. Avoiding new tests (e.g., Babesia and dengue) amounts to $41.80/unit. Elimination of irradiation saves $8.50/unit, while decreased outdating with 7-day storage can be amortized to $16.89/unit. Total potential costs saved with PI is $141.65/unit. Costs are influenced by a variety of factors specific to institutions such as testing practices and the location in which such costs are incurred and careful analysis should be performed. Additional benefits, not quantified, include retention of some currently deferred donors and scheduling flexibility due to 7-day storage.
CONCLUSIONS : While PI implementation will result in additional costs, there are also potential offsetting cost reductions, especially after 7-day storage licensing (read more)
martedì 19 maggio 2015
Routine filtration of hematopoietic stem cell products: the time has arrived
BACKGROUND : Most blood products are infused at the time of transfusion through a standard blood filter, designed to capture macroaggregates and cellular debris that might be harmful to the patient if infused. Hematopoietic stem cell products are not universally filtered, likely due to concern about loss of viable stem cells in the filtration process.
STUDY DESIGN AND METHODS : We conducted a two-phase study to better understand the safety of routine filtration. First, surplus cryopreserved stem cell products were thawed and filtered, with markers of viability and potency measured. Second, routine filtration was implemented as part of routine practice at our center, and date of neutrophil and platelet (PLT) recovery was compared to historical controls.
RESULTS : In the first phase, there was no difference seen in any markers of viability or potency for products after routine filtration. Based on those results, routine filtration was implemented. There was no difference in neutrophil or PLT engraftment. Thus, in this study, routine filtration did not impact the number of viable stem cells and did not delay engraftment.
CONCLUSION : Given the very real harm posed by infusion of macroaggregates and cellular debris, and no clear disadvantage to filtration, routine filtration of stem cell products should be considered the standard of care (read more).
STUDY DESIGN AND METHODS : We conducted a two-phase study to better understand the safety of routine filtration. First, surplus cryopreserved stem cell products were thawed and filtered, with markers of viability and potency measured. Second, routine filtration was implemented as part of routine practice at our center, and date of neutrophil and platelet (PLT) recovery was compared to historical controls.
RESULTS : In the first phase, there was no difference seen in any markers of viability or potency for products after routine filtration. Based on those results, routine filtration was implemented. There was no difference in neutrophil or PLT engraftment. Thus, in this study, routine filtration did not impact the number of viable stem cells and did not delay engraftment.
CONCLUSION : Given the very real harm posed by infusion of macroaggregates and cellular debris, and no clear disadvantage to filtration, routine filtration of stem cell products should be considered the standard of care (read more).
When blood transfusion medicine becomes complicated due to interference by monoclonal antibody therapy
BACKGROUND : Monoclonal antibodies (MoAbs) are increasingly integrated in the standard of care. The notion that therapeutic MoAbs can interfere with clinical laboratory tests is an emerging concern that requires immediate recognition and the development of appropriate solutions. Here, we describe that treatment of multiple myeloma patients with daratumumab, a novel anti-CD38 MoAb, resulted in false-positive indirect antiglobulin tests (IATs) for all patients for 2 to 6 months after infusion. This precluded the correct identification of irregular blood group antibodies for patients requiring blood transfusion.
STUDY DESIGN AND METHODS : The IAT was performed using three- and 11-donor-cell panels. Interference of daratumumab and three other anti-CD38 MoAbs was studied using fresh-frozen plasma spiked with different MoAb concentrations. Additionally it was tested whether two potentially neutralizing agents, anti-idiotype antibody and recombinant soluble CD38 (sCD38) extracellular domain, were able to inhibit the interference.
RESULTS : The CD38 MoAbs caused agglutination in the IAT in a dose-dependent manner. Addition of an excess of anti-idiotype antibodies or sCD38 protein to the test abrogated CD38 MoAb interference and successfully restored irregular antibody screening and identification.
DISCUSSION : CD38 MoAb therapy causes false-positive results in the IAT. The reliability of the test could be restored by adding a neutralizing agent against the CD38 MoAb to the patient's plasma. This study emphasizes that during drug development, targeted therapeutics should be investigated for potential interference with laboratory tests. Clinical laboratories should be informed when patients receive MoAb treatments and matched laboratory tests to prevent interference should be employed (read more)
STUDY DESIGN AND METHODS : The IAT was performed using three- and 11-donor-cell panels. Interference of daratumumab and three other anti-CD38 MoAbs was studied using fresh-frozen plasma spiked with different MoAb concentrations. Additionally it was tested whether two potentially neutralizing agents, anti-idiotype antibody and recombinant soluble CD38 (sCD38) extracellular domain, were able to inhibit the interference.
RESULTS : The CD38 MoAbs caused agglutination in the IAT in a dose-dependent manner. Addition of an excess of anti-idiotype antibodies or sCD38 protein to the test abrogated CD38 MoAb interference and successfully restored irregular antibody screening and identification.
DISCUSSION : CD38 MoAb therapy causes false-positive results in the IAT. The reliability of the test could be restored by adding a neutralizing agent against the CD38 MoAb to the patient's plasma. This study emphasizes that during drug development, targeted therapeutics should be investigated for potential interference with laboratory tests. Clinical laboratories should be informed when patients receive MoAb treatments and matched laboratory tests to prevent interference should be employed (read more)
Anti-A and anti-B titers in donor plasma, plasma pools, and immunoglobulin final products
BACKGROUND : High-dose intravenous immunoglobulin (IVIG) treatments are implicated in hemolytic events in some patients receiving treatment. The passive transfer of IgG anti-A and anti-B agglutinin is thought to play a role in the development of these events. The purpose of this study was to determine the prevalence of high-titer IgG anti-A and anti-B in plasma donors and investigate if there is any advantage of excluding these donors from the donor pool to limit anti-A and anti-B content in IVIG product.
STUDY DESIGN AND METHODS : IgG anti-A and anti-B levels were assessed from group O donor plasma, manufacturing IgG plasma pools, and finished IVIG product (Gammagard Liquid). Antibody level in group O donors was also assessed by sex and age for their relative contribution of antibody to the plasma pool.
RESULTS : The majority of group O donors (80%) had antibody titers of less than 1000. Of those with titers of at least 1000, theoretical estimates provide further evidence that the effects of high-titer donors are minimal. Antibody levels in plasma pools both during the manufacturing process and from the final IVIG product also support that anti-A and anti-B levels are low. In general, there were more females than males with higher antibody titer levels, with significantly more females than males with anti-A.
CONCLUSION : Excluding donors with high anti-A and anti-B titers has minimal impact on the finished IVIG product titers due to ABO antibody neutralization and the dilution factor in the manufacturing pool (read more).
STUDY DESIGN AND METHODS : IgG anti-A and anti-B levels were assessed from group O donor plasma, manufacturing IgG plasma pools, and finished IVIG product (Gammagard Liquid). Antibody level in group O donors was also assessed by sex and age for their relative contribution of antibody to the plasma pool.
RESULTS : The majority of group O donors (80%) had antibody titers of less than 1000. Of those with titers of at least 1000, theoretical estimates provide further evidence that the effects of high-titer donors are minimal. Antibody levels in plasma pools both during the manufacturing process and from the final IVIG product also support that anti-A and anti-B levels are low. In general, there were more females than males with higher antibody titer levels, with significantly more females than males with anti-A.
CONCLUSION : Excluding donors with high anti-A and anti-B titers has minimal impact on the finished IVIG product titers due to ABO antibody neutralization and the dilution factor in the manufacturing pool (read more).
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