Daratumumab (Anti-CD38) interference with serological testing: An emerging challenge for blood banks in developing countries

Setia, Rasika; Dogra, Mohit; Sachdeva, Prerna; Handoo, Anil; Choudhary, Deepak; Agarwal, Amit

doi:10.4103/gjtm.gjtm_42_17

Cited by 6 publications

(6 citation statements)

References 1 publication

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“…The authors also found that ABO and D typing were unaffected. Similarly, Setia et al 14 reported a case with panreactivity on antibody screening and identification panels that was resolved with use of 0.2 M DTT. This finding was similar to the present study, where no grouping discrepancy was observed, and panreactivity was observed with untreated screening RBCs.…”

Section: Discussionmentioning

confidence: 95%

Blood component administration to multiple myeloma patients treated with daratumumab: suggesting a novel approach with use of 0.1 M dithiothreitol

et al. 2020

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Storage of dithiothreitol (DTT)-treated red blood cells (RBCs) leads to hemolysis. The aim of this study was to compare 0.1 M DTT with 0.2 M DTT treatment of RBCs and to share our experience of providing components to seven patients on daratumumab (DARA). This prospective, observational study included patients who required RBC transfusion within 6 months of DARA administration. All patients underwent a baseline serologic evaluation followed by a repeat evaluation after DARA administration. In addition, use of 0.1 M DTT was compared with 0.2 M DTT in terms of concordance of results, hemolysis with storage of treated RBCs, and ease of use. A total of 22 RBC requisitions were received for seven patients. Antibody screen was positive for one patient (anti-C) at baseline; it was panreactive for all patients after DARA. Concordance of results between the two concentrations was 98.5 percent. Laboratory personnel found results obtained with use of 0.1 M DTT-treated RBCs easy to interpret. Supernatant hemoglobin was found to be significantly greater for 0.2 M DTT-treated RBCs at the sixth day of storage. In conclusion, component administration to patients on DARA can be done without delay if adequate policies and procedures are in place. Use of 0.1 M DTT-pretreated RBCs can be used to avoid delay in transfusion and reduce the burden on the laboratory of weekly preparation of 0.2 M DTT-treated RBCs.

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Section: Discussionmentioning

confidence: 95%

Blood component administration to multiple myeloma patients treated with daratumumab: suggesting a novel approach with use of 0.1 M dithiothreitol

et al. 2020

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“…Of note, there were differences in the strength of RBC agglutination caused by different anti‐CD38 molecules, with laboratory studies showing most isatuximab samples cause overall less frequent and weaker agglutination than daratumumab samples. Moreover, the collective results of 10 published blood bank studies of 88 patient samples after daratumumab therapy showed that all patients demonstrated IAT interference 2,8–10,12,21–25 . Isatuximab caused interference in 67.7% patients in the Phase 3 ICARIA‐MM 13 study and in 63.3% patients in the Phase 3 IKEMA study 14 …”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the collective results of 10 published blood bank studies of 88 patient samples after daratumumab therapy showed that all patients demonstrated IAT interference. 2,[8][9][10]12,[21][22][23][24][25] Isatuximab caused interference in 67.7% patients in the Phase 3 ICARIA-MM 13 study and in 63.3% patients in the Phase 3 IKEMA study. 14 Investigators have reported similar patterns of agglutination when IAT is performed on samples containing other experimental anti-CD38 mAbs.…”

Section: Isatuximab Interference In the Clinical Settingmentioning

confidence: 99%

Anti‐CD38 monoclonal antibody interference with blood compatibility testing: Differentiating isatuximab and daratumumab via functional epitope mapping

et al. 2022

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Background: There are two FDA-approved anti-CD38 monoclonal antibodies for treatment of multiple myeloma: isatuximab and daratumumab. Owing to expression of CD38 on reagent red blood cells (RBCs), these antibodies interfere with indirect antiglobulin tests (IATs). We sought to understand differences in such interference by performing binding experiments. Study Design and Methods: In vitro experiments to compare the binding to RBCs of isatuximab and daratumumab alone or in the presence of a mouse anti-human CD38 antibody (HB-7 or AT13/5) or a nicotinamide adenine dinucleotide-analog CD38 inhibitor were performed and quantified by flow cytometry, imaging, mass spectrometry, surface plasmon resonance, and LigandTracer technologies. Serologic testing was performed on plasma samples spiked with isatuximab or daratumumab. Results: CD38 expressed on RBCs can be directly bound by daratumumab, whereas isatuximab requires a co-factor, such as HB-7, AT13/5, or a CD38

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“…Cost-related considerations are especially important for mitigating daratumumab interference in national general blood bank services and for blood banks in developing countries where specialized reagent are not readily available. 48 …”

Section: Impact Of Daratumumab On Transfusion Service Costsmentioning

confidence: 99%

Overcoming Drug Interference in Transfusion Testing: A Spotlight on Daratumumab

Nedumcheril¹,

DeSimone²,

Racine‐Brzostek³

et al. 2021

JBM

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Daratumumab, a monoclonal antibody therapeutic, is highly efficacious and widely used in all stages of multiple myeloma and amyloidosis and has promising activity in other hematologic disorders. Daratumumab interacts with red blood cells, interfering with pre-transfusion testing. This interference can lead to compromising transfusion safety, extensive blood bank work ups and delays in provision of compatible units. Several methods have been developed to negate daratumumab interference with indirect antiglobulin testing. They are based on i) standard blood bank techniques including dithiothreitol and enzymatic treatment of reagent cells, using reagent red blood cells negative for CD38, ii) blocking CD38 antigens on reagent or donor cells, iii) neutralization of anti-CD38 antibody in patient plasma prior to testing, and iv) extended antigen typing of patient red blood cells in conjunction with provision of phenotypically matched units for transfusion. Implementation of those methods by the blood bank should be a planned effort coordinated with the patient's clinical team. Timely involvement of blood bank and transfusion services and educational efforts by both blood banks and clinical providers can improve the overall daratumumab safety profile in regard to blood transfusion.

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Daratumumab (Anti-CD38) interference with serological testing: An emerging challenge for blood banks in developing countries

Cited by 6 publications

References 1 publication

Blood component administration to multiple myeloma patients treated with daratumumab: suggesting a novel approach with use of 0.1 M dithiothreitol

Blood component administration to multiple myeloma patients treated with daratumumab: suggesting a novel approach with use of 0.1 M dithiothreitol

Anti‐CD38 monoclonal antibody interference with blood compatibility testing: Differentiating isatuximab and daratumumab via functional epitope mapping

Overcoming Drug Interference in Transfusion Testing: A Spotlight on Daratumumab

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