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Updated: Aug 28, 2025

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
Published on: September 10, 2018
Effective Neutralization of Daratumumab Effects on Pre-Transfusion Testing: a Method Modification
Background:
The anti-CD38 antibody daratumumab is a common multiple myeloma treatment. As the erythrocyte's membrane expresses CD38, Daratumumab-treated samples show agglutination in serological pre-transfusion tests, hindering detection of erythrocyte alloantibodies. Dithiothreitol interferes with erythrocyte antigens, affecting investigation of unexpected antibodies. DARAEx®, an anti-CD38 neutralizing agent, overcomes daratumumab-induced effects, without dithiothreitol's interferences. DARAEx® is applied only in Biorad columns. This study aimed to provide a DARAEx® protocol for application with the Grifols platform.
Methods:
We introduced a modified DARAEx® protocol (AssutaBB protocol) and performed antibody screenings on samples from nineteen daratumumab-treated patients.
Results:
The AssutaBB protocol provided antibody screen results for all patients, exactly as established in the default manufacturing protocol. Eleven patients presented natural negative antibody screens; eight presented positive K/E antibodies.
Conclusions:
AssutaBB allows the use of the more widespread Grifols platform in daratumumab-treated patients.
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