TY  - JOUR
A1  - Geisen, Christof
A1  - North, Anne
A1  - Becker, Lisa
A1  - Brixner, Veronika
A1  - Goetz, Melissa von
A1  - Corash, Laurence
A1  - Benjamin, Richard J.
A1  - Mufti, Nina
A1  - Seifried, Erhard
T1  - Prevalence of natural and acquired antibodies to amustaline/glutathione pathogen reduced red blood cells
T2  - Transfusion
N2  - Background: The INTERCEPT™ Blood System for Red Blood Cells (RBCs) utilizes amustaline (S‐303) and glutathione (GSH) to inactivate pathogens and leukocytes in transfused RBCs. Treatment‐emergent low titer non‐hemolytic antibodies to amustaline/GSH RBC were detected in clinical trials using a prior version of the process. The amustaline/GSH process was re‐formulated to decrease S‐303 RBC adduct formation.
Study Design and Methods: A standard three‐cell antibody screening panel was modified to include reagent red cells (RRC) with high (S‐303H) or low (S‐303L) S‐303 adduct density as assessed by flow cytometry, representative of the original and current amustaline/GSH treatment processes, respectively. General hospital and RBC transfusion‐dependent patients never exposed, and clinical trial subjects exposed to amustaline/GSH RBC were screened for antibodies to amustaline/GSH RBC using a standardized agglutination assay.
Results: Twelve (0.1%) of 10,721 general hospital and 5 (0.5%) of 998 repeatedly‐transfused patients not previously exposed to amustaline/GSH RBCs expressed natural, low titer (2‐32) IgM and/or IgG (non‐IgG1 or IgG3 isotype) antibodies with acridine (a structural element of amustaline) (n = 14) or non‐acridine (n = 3) specificity. 11 of 17 sera reacted with S‐303L panel RRCs. In clinical studies 81 thalassemia and 25 cardiac surgery patients were transfused with a total of 1085 amustaline/GSH RBCs and no natural or treatment‐emergent S‐303 antibodies were detected.
Conclusion: Standardized RRC screening panels are sensitive for the detection of natural and acquired S‐303‐specific antibodies. Natural low titer antibodies to amustaline/GSH RBC are present in 0.15% of naïve patients. The clinical relevance of these antibodies appears minimal but is under further investigation.
Y1  - 2020
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/56536
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-565362
SN  - 1537-2995
SN  - 0041-1132
VL  - 60
IS  - 10
SP  - 2389
EP  - 2398
PB  - Wiley-Blackwell
CY  - Oxford [u.a.]
ER  -