Stela M. Radojska

Evaluation of concurrent collection of in‐line filtered platelets and packed red blood cells by multicomponent apheresis with three last‐generation apparatuses

Background and Objectives  Multicomponent apheresis enables the collection and procession of different blood products in a single donation. Different apparatuses vary in terms of principle and efficiency. Knowledge of them is essential to analyse cost effectiveness.

Prospective comparison of high-dose plateletpheresis with the latest apheresis systems on the same donors

BACKGROUND: To improve productivity of automated platelet (PLT) collection, the industry has introduced new instruments or modifications to existing equipment.

In vitro quality of red blood cells (RBCs) collected by multicomponent apheresis compared to manually collected RBCs during 49 days of storage

BACKGROUND: New technologic developments enable automated collection and preparation of red blood cells (RBCs). This studys aim was to evaluate quality of apheresis‐derived RBCs (ARBCs) collected as single units along with platelets (RBC‐Ps) or double units (2‐RBCs) with four different apheresis systems.

Comparison of three noninvasive methods for hemoglobin screening of blood donors

To prevent phlebotomy of anemic individuals and to ensure hemoglobin (Hb) content of the blood units, Hb screening of blood donors before donation is essential. Hb values are mostly evaluated by measurement of capillary blood obtained from fingerstick. Rapid noninvasive methods have recently become available and may be preferred by donors and staff. The aim of this study was to evaluate for the first time all different noninvasive methods for Hb screening.

Treatment of severe chronic ocular graft-versus-host disease using 100% autologous serum eye drops from a sealed manufacturing system: a retrospective cohort study

Background/Aims To analyse patients with chronic ocular graft-versus-host disease (GvHD) under treatment with 100% autologous serum eye drops from a sealed manufacturing system. Methods 17 patients with chronic ocular GvHD received 100% autologous serum eye drops from single use vials manufactured in a sealed system. Retrospective analysis included visual acuity, corneal staining, frequency of artificial tears, ocular symptoms by means of a questionnaire and information on subjective side effects and cost compensation. Results Data of prior to autologous serum eye drops therapy and at a 6-month follow-up were obtained. They demonstrated a significant increase in visual acuity (logMAR oculus dexter/right eye (OD) 0.5±0.32 to 0.4±0.3; oculus sinister/left eye (OS) 0.6±0.35 to 0.3±0.35; p=0.177/0.003) and significant improvement in corneal staining (Oxford grading scheme: OD from 3±1.03 to 2±1.43, OS from 4±1.0 to 2±1.09, p=0.004/0.001) and ocular symptoms (ocular surface disease index: 88±20.59 to 63±22.77; p=0.02). Frequency of artificial tears was reduced and no side effects were reported. Patient satisfaction was 100%, and cost compensation by health insurance reached 80%. Conclusions 100% autologous serum eye drops using a sealed manufacturing system were efficient in improving the ocular surface, patient symptoms and visual acuity without side effects. It seems to be safe to use 100% autologous serum despite earlier suspicions regarding immune complex accumulations and exacerbation of ocular surface inflammation. The potential effects of serum levels of systemic immunosuppressives through readministration onto the ocular surface need to be elucidated.

Protocol for the validation of microbiological control of cellular products according to German regulators recommendations--Boon and Bane for the manufacturer.

In order to generate standardized conditions for the microbiological control of HPCs, the PEI recommended defined steps for validation that will lead to extensive validation as shown in this study, where a possible validation principle for the microbiological control of allogeneic SCPs is presented. Although it could be demonstrated that automated culture improves microbial safety of cellular products, the requirement for extensive validation studies needs to be considered.

Comparison of in vitro Characteristics of Leukodepleted Red Blood Cells (RBCs) Derived from Apheresis: Impact of Filter Performance

Novel apheresis systems allow collection of packed red blood cells (RBCs) either by double RBC apheresis (2-RBCA) or along with platelet (PLT) concentrates (RBCPLT). The objective of this study was to evaluate filtration performance in connection with in vitro storage quality of filtered RBCs derived from the devices Baxter Amicus (AM), Baxter Alyx (AX), Haemonetics MCS Plus (MCS+) and Gambro Trima Accel (TA). Materials and Methods: 66 2-RBCA (15 AX, 10 MCS+, 8 TA) and 33 RBC-PLT collections (15 AM, 9 MCS+, 9 TA) were analyzed. RBC filtration was performed at room temperature within 2-4 h of collection using white blood cell (WBC) reduction filters either integrated in the disposable sets or provided by a filtration device. In vitro parameters were measured after filtration and after 42 days of storage. Results: Except for 1 paired AX unit, all RBCs contained residual WBCs of < 1 × 106/unit. TA provided the best log reduction in WBCs and PLTs but demonstrated the longest filtration times and smallest RBC recoveries. AX and MCS+ had significantly shorter filtration times than AM, however, AM obtained the best RBC recoveries. After filtration, all packed RBCs showed similar in vitro characteristics. At the end of storage, lower values for hemolysis (TA) and ATP preservation (AX) were related to the post-filtration WBC amount, with TA demonstrating the lowest and AX the highest values. Conclusion: While differences in RBC loss were noted, satisfactory filter performance in terms of WBC and PLT removal was observed with most RBC units. In AX procedures, leukodepletion could be improved.

A Prospective Crossover Trial Comparing Performance and in vitro Platelet Quality of Three New Apheresis Devices with Current Equipment

Background: To improve productivity of automated platelet (PLT) collection, the industry has introduced new instruments or modifications to existing equipment. Materials and Methods: Data obtained from 8 regular PLT apheresis donors randomized to double- (DDC) or triple-dose PLT collection (TDC) with the BAXTER Amicus (AM), the HAEMONETICS MCS Plus (MCS+), and the GAMBRO Trima Accel (TA) were evaluated focusing on duration, citrate infusion and product quality, and statistically compared to data obtained from the same donors during DDC on our current equipment (GAMBRO Trima V4 (TV4) and Spectra LRS-Turbo V7 (SPC)). Results: All units were sufficiently leukoreduced to below 1 × 106 white blood cells (WBCs). Apart from statistically significant lower pH values and higher CD62P expression observed with AM units, no differences in in vitro function were noted during storage. Compared to our current equipment, the new devices had advantages for whole blood processed, and, except for MCS+, for needle time, collection volume, collection rate, and collection efficiency. PLT yield and processing time were equivalent, except for TA which was the fastest machine. MCS+ was the slowest device owing to statistically significant lower draw and collection rates which were, however, compensated by fewer citrate reactions due to only moderate citrate infusion rates. Conclusion: Despite equal or better efficiencies, collection procedures with the new devices did not automatically increase the number of units per day, particularly if quick donation was counteracted by long overall performance (AM). TA was the fastest and hence offered the highest potential to optimize productivity. MCS+ showed better donor comfort, as reflected by lower draw and citrate infusion rates, but was also the slowest.

Impact of Molecular ABO Typing in Case of Serologic Discrepancies in Myeloid Malignancies – a Case Report

Background: A case with discrepancies between ABO antigens on red blood cells (RBCs) and isoagglutinins in the serum of a 49-year-old woman suffering from acute myeloid leukaemia is described. The blood group was typed as A D neg in a previous pregnancy. Material and Methods: 2 monoclonal anti-A, -B and -AB reagents of different manufacturers using different techniques (NaCl suspension in seroplates and in gel columns) were applied for the detection of the patient’s ABO blood group. Suspensions of commercial test erythrocytes (A1, A2, B, AB) were incubated with the patient’s serum for isoagglutinin detection. Results: The antigen A was serologically undetectable. Apart from very weak reactions with B RBCs, isoagglutinins were not detectable even if sensitive methods (tube-spin method) were used. These discrepancies between direct and indirect antigen determinants led to molecular genetic blood group typing based on PCR-SSP. By this method the blood group was typed as A D neg. This result confirmed the previous blood group typing and the serological result obtained after complete remission. Conclusion: Despite excellent monoclonal reagents for the detection of the ABO blood group, the complementary reactions of the isoagglutinins must be observed carefully. In case of serological discrepancies molecular blood group typing should be performed.