Additional validation of Osaka method (0.01 mol/L dithiothreitol) for negating the daratumumab interference

Hosokawa, Mika; Kashiwagi, Hirokazu; Nakayama, Keizo; Sakuragi, Mikiko; Nakao, Michiyasu; Morikawa, Tamayo; Kiyokawa, Tomoko; Aochi, Hiroshi; Nagamine, Keisuke; Shibayama, Hirohiko; Tomiyama, Yoshiaki

doi:10.1111/trf.15305

Cited by 5 publications

(5 citation statements)

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“…The most commonly used strategy to eliminate DARA interference in the provision of compatible blood for transfusion consists of treating reagent RBCs used in antibody screening and antibody identification with the reducing agent DTT. [3][4][5][6][11][12][13][14] This method, although efficient to negate the interference, also allowing for identification of potentially clinically significant alloantibodies underlying DARA, however, results in the loss of some clinically significant antigens, including those that make up the entire KEL blood group system. Herein we show that Daudi cell stroma can efficiently deplete DARA from plasma samples without affecting the detection of alloantibodies of interest whose antigens may be denatured by use of DTT or trypsin.…”

Section: Discussionmentioning

confidence: 99%

“…Recently Hosokawa et al 11,12 showed that in contrast to the AABB standard procedure, their Osaka method that uses 10 mM DTT instead of 200 mM DTT could negate detection of anti-CD38 while sparing the K antigen and allow for detection of anti-K. We have compared this newly proposed technique to both the standard AABB method and the use of Daudi stroma as capture reagent. Our results showed, as expected, that the AABB standard method completely abrogated the ability to detect anti-K while results of the Osaka method although showing significant reduction of the DARA interference still resulted in some K antigen loss and a less strong serologic reaction with anti-K than without 10 mM DTT treatment (Table 3).…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, in contrast to the AABB standard procedure employing 200 mM DTT, it has recently been proposed by Hosokawa et al 11,12 using the so-called Osaka method that a concentration of 10 mM DTT does not denature the K antigen and allows for the detection of anti-K while in the presence of the DARA interference. Based on this report, we have compared our method to both the AABB standard and the Osaka method.…”

Section: Daudi Cell Stroma Efficiently Depletes Dara Without Affectmentioning

confidence: 99%

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Daudi cell stroma: An alternative to dithiothreitol to resolve daratumumab interference in pretransfusion testing

2020

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Background Treatment of red blood cells with dithiothreitol (DTT) or trypsin effectively denatures CD38; however, this treatment damages other antigens, some of which are of clinical importance. Thus, other avenues to deplete daratumumab (DARA) from plasma samples should be explored. Study Design and Methods The Daudi B‐cell line was found to express high levels of CD38 and was sonicated in a sonication buffer to achieve complete cell lysis. The resulting stroma preparation was centrifuged at 20 000g for 20 minutes and then mixed with 250 μL of DARA–plasma and incubated for 10 minutes at 37°C. The stroma–DARA–plasma mixture was centrifuged again, and the supernatant was collected and subjected to four additional rounds of adsorption with fresh stroma. DARA‐depleted plasma was tested by gel indirect antiglobulin test (IAT). Results CD38 expression on Daudi cells was confirmed by flow cytometry. Gel IAT analysis showed that the incubation of plasma from DARA‐treated patients with Daudi cells stroma resulted in a significant depletion of DARA but allowing detection of other alloantibodies of interest such as anti‐K, anti‐Yta, and anti‐Gya. Conclusions Daudi cell stroma is inexpensive, easy to prepare in large batches, and can be used as an off‐the‐shelf reagent. Incubation of plasma from DARA‐treated patients with Daudi cell stroma can efficiently overcome DARA interference in serologic testing without affecting DTT‐ or trypsin‐sensitive antigens.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Daudi Cell Stroma Efficiently Depletes Dara Without Affectmentioning

confidence: 99%

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Daudi cell stroma: An alternative to dithiothreitol to resolve daratumumab interference in pretransfusion testing

2020

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“…In a follow up article, the authors validated the Osaka method by using commercially available IgM anti-B (or anti-A) antibody as a quality control indicator instead of loss of Kell. 29 They also investigated the ability to detect anti-K and anti-Ku in daratumumab treated individuals. Anti-K reactivity was detected and daratumumab interference was negated.…”

Section: Methodologies To Negate Daratumumab Interference During Pre-transfusion Testingmentioning

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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“…7 When using 0.2 M DTT-treated screening cells, anti-K cannot be detected, nor can other (less commonly encountered) antibody specificities such as anti-k, anti-Yt a , anti-Do a , and anti-Do b . Lower concentrations of DTT (e.g., 0.01 M, as in the Osaka method 8,9 ) can be used to preserve K antigen expression. 10 Other approaches to mitigate the anti-CD38 interference include: denaturing RBC CD38 with other thiol reagents 11 or trypsin; 3,12 using phenotyped cord blood cells 13 or In(Lu) cells, 14 which express low or no serologically detectable CD38; blocking RBC CD38 using F(ab') 2 fragments 15 or antihuman globulin 16 ; using the manual polybrene method; 17 adsorbing plasma with Daudi cell stroma 18 or MEL-745A cells engineered to express high levels of CD38; 19 or providing phenotypically or genotypically matched RBC units.…”

Section: Introductionmentioning

confidence: 99%

Efficient neutralization of daratumumab in pretransfusion samples using a novel recombinant monoclonal anti‐idiotype antibody

Aung

Spencer²,

Potter

et al. 2022

Transfusion

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Background Anti‐CD38 antibodies such as daratumumab (DARA) are critical therapies for multiple myeloma and other diseases. Unfortunately, anti‐CD38 antibodies cause panreactivity in indirect antiglobulin tests (IATs), complicating blood compatibility testing. The anti‐CD38 interference is most often mitigated by treating reagent red blood cells (RBCs) with dithiothreitol (DTT). However, when using the DTT method, not all RBC antibody specificities can be detected (e.g., anti‐K), and the DTT method is impractical for some transfusion services. We evaluated the ability of a new anti‐idiotype antibody to neutralize DARA in vitro and eliminate the anti‐CD38 interference. Study Design and Methods A recombinant monoclonal rabbit anti‐DARA idiotype antibody (“anti‐DARA”) was generated. The ratio of anti‐DARA required to neutralize DARA in spiked samples was evaluated in IATs performed in gel. IATs performed in tube were used to demonstrate that anti‐DARA allows alloantibody detection in the presence of DARA. Plasma samples from 29 patients receiving DARA were treated with a fixed quantity of anti‐DARA (120 μg) before performing antibody detection tests (screens) in tube. Results Anti‐DARA used at or above a 1:1 ratio with DARA eliminated the DARA interference with IATs. Anti‐DARA allowed detection of both alloanti‐E and alloanti‐K in the presence of DARA. In 27/29 (93.1%) clinical samples, 120 μg anti‐DARA was sufficient to neutralize the DARA in 100 μl patient plasma. Discussion An anti‐DARA:DARA ratio as low as 1:1 is sufficient to neutralize DARA in solution. A fixed amount of anti‐DARA eliminates the anti‐CD38 interference in most patient samples.

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Additional validation of Osaka method (0.01 mol/L dithiothreitol) for negating the daratumumab interference

Cited by 5 publications

References 4 publications

Daudi cell stroma: An alternative to dithiothreitol to resolve daratumumab interference in pretransfusion testing

Daudi cell stroma: An alternative to dithiothreitol to resolve daratumumab interference in pretransfusion testing

Overcoming Drug Interference in Transfusion Testing: A Spotlight on Daratumumab

Efficient neutralization of daratumumab in pretransfusion samples using a novel recombinant monoclonal anti‐idiotype antibody

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