International validation of a dithiothreitol (DTT)‐based method to resolve the daratumumab interference with blood compatibility testing

作者：Claudia I. Chapuy, Maria Aguad, Rachel T. Nicholson, James P. AuBuchon, Claudia S. Cohn, Meghan Delaney, Mark Fung, Meredith Unger, Parul Doshi, Michael Murphy, Larry J. Dumont, Richard M. Kaufman, the DARA‐DTT Study Group* for the BEST Collaborative · 发表于：Transfusion · 年份：2016 · DOI：10.1111/trf.13789 · 被引用次数：102 · 研究领域：Biosimilars and Bioanalytical Methods、Blood groups and transfusion、Erythrocyte Function and Pathophysiology

BACKGROUND: Daratumumab (DARA) consistently interferes with routine blood bank serologic testing by directly binding to CD38 expressed on reagent red blood cells (RBCs). Treating RBCs with dithiothreitol (DTT) eliminates the DARA interference. We conducted an international, multicenter, blinded study aimed at validating the DTT method for use by blood bank laboratories worldwide. STUDY DESIGN AND METHODS: [n = 9], or anti-s [n = 10]). Sites were instructed to perform an antibody screen with and without DTT-treated RBCs and to use a DTT-treated RBC panel for antibody identification. Qualitative data about the DTT method were collected by online survey. The primary outcome was the proportion of study sites able to identify the antibody unknown in the presence of DARA. RESULTS: All sites observed the DARA interference with the antibody screen. The DARA interference was seen with all testing methods (gel, tube, or solid phase). Using the DTT method, 25 of 25 sites (100%) successfully identified the antibody unknown in the presence of DARA. Feedback on the DTT method was positive, with 17 of 19 (90%) sites responding to the survey indicating that they planned to use the DTT method to test clinical samples from DARA-treated patients. CONCLUSION: The DTT method is robust and reproducible and can be implemented by transfusion services worldwide to help provide safe blood products to patients treated with DARA.