Evidence map›Paper›PMID 42009611›Full record

ArticleVox sanguinis2026

International multicentre evaluation of a new anti-idiotypic anti-daratumumab for resolving pre-transfusion interferences.

Arnaud Reggiani, Sofia Lejon Crottet, Sophie Waldvogel, Charlotte Engström, Serelina Coluzzi, Antonella Matteocci, Janis R Hamilton, Levent Tufan Kumas, Karen M K de Vooght, Jill R Storry and 21 more

Abstract readMulticenter Study
In one paragraph

Article in Vox sanguinis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Arnaud ReggianiBio-Rad Laboratories, DiaMed GmbH, Cressier, Switzerland.
Sofia Lejon CrottetInterregional Blood Transfusion SRC Ltd., Bern, Switzerland.ORCID https://orcid.org/0009-0005-9609-3209
Sophie WaldvogelLaboratoire d'immuno-hématologie transfusionnelle, Hopitaux Universitaires de Genève, Genève, Switzerland.
Charlotte EngströmBlood Transfusion Service Zurich SRK, Schlieren, Switzerland.
Serelina ColuzziAOU Policlinico Umberto 1-Sapienza, UOC Immunoematologia e Medicina Trasfusionale, Rome, Italy.
Antonella MatteocciAzienda Ospedaliera San Camillo - Forlanini, UOC Medicina Trasfusionale e Cellule Staminali, Rome, Italy.
Janis R HamiltonAmerican Red Cross, Michigan Region, Detroit, Michigan, USA.
Levent Tufan KumasAcıbadem Labmed, İstanbul, Turkey.
Karen M K de VooghtCentral Diagnostics Laboratory, UMC Utrecht, Utrecht, the Netherlands.
Jill R StorryDepartment of Clinical Immunology and Transfusion Medicine, Skåne University Hospital, Lund, Sweden.ORCID https://orcid.org/0000-0003-2940-2604
Jennylyn FloresChildren's National Hospital, Laboratory Blood Bank, Washington, DC, USA.
Núria NoguésImmunohematology Laboratory, Banc de Sang i Teixits, Barcelona, Spain.
Carlos CotorrueloLaboratorio de Inmunohematología, Universidad Nacional de Rosario, Rosario, Argentina.ORCID https://orcid.org/0000-0003-2289-3420
Molly RutherfordSynnovis Analytics LLP, Guy's and St Thomas' Hospital, London, UK.
Eveline B NilsenThe Blood Bank at Vestfold Hospital Trust, Tønsberg, Norway.
Monika Pelc-KłopotowskaInstitute of Hematology and Transfusion Medicine, Warsaw, Poland.
Jolanta KorzeniowskaRegionalne Centrum Krwiodawstwa i Krwiolecznictwa w Lublinie, Lublin, Poland.
Alessandra BaffaS.C. Banca del Sangue e Immunoematologia, Turin, Italy.
Inna SarenevaDepartment of Clinical Chemistry, Diagnostic Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Nor Hafizah AhmadNational Blood Centre, Immunohematology Reference Laboratory, Kuala Lumpur, Malaysia.
Katarzyna SzczudloRegional Blood Donation and Blood Therapy Center, Katowice, Poland.
Athif RahmanBlood Transfusion Department, Hammersmith Hospital, London, UK.
Laser SanalAnkara Bilkent City Hospital, Transfusion Center, Ankara, Türkiye.
Lise JørgensenDepartment of Immunology and Transfusion Medicine, Oslo University Hospital, Oslo, Norway.
Karolina Majewska RochowiakRegionalne Centrum Krwiodawstwa i Krwiolecznictwa w Krakowie, Kraków, Poland.
Monika SalwierzRzeszów - Regionalne Centrum Krwiodawstwa i Krwiolecznictwa, Rzeszów, Poland.
Elisaveta GrancharovaCenter of Transfusion Hematology, Military Medical Academy, Sofia, Bulgaria.
Bojana ZivkovicUKC Maribor, Maribor, Slovenia.
Jessica AlvarezUChicago Medicine, Center for Care and Discovery, Chicago, Illinois, USA.
Mareike RiedlBio-Rad AbD Serotec GmbH, Neuried, Germany.
Achim KnappikBio-Rad AbD Serotec GmbH, Neuried, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesDaratumumab, a therapeutic human anti-CD38 monoclonal antibody, improves multiple myeloma outcomes but interferes with pre-transfusion testing by binding CD38 on reagent red blood cells (RBCs), potentially masking clinically significant alloantibodies. This study aimed to evaluate the effectiveness of a novel high-affinity anti-idiotypic anti-daratumumab reagent in neutralizing daratumumab interference while preserving RBC alloantibody detection and ensuring compatibility with routine transfusion laboratory workflows. MATERIALS AND

methodsA non-interventional, multicentre study across 28 transfusion laboratories in 15 countries evaluated a novel anti-idiotypic anti-daratumumab reagent (DaraClear). In total, 443 daratumumab-containing plasma samples and 197 RBC alloantibody-containing samples were tested. All samples were initially tested at 10% (v/v), with stepwise escalation to 20% and 30% only if neutralization was incomplete. Neutralization efficiency, antibody detection, cross-match resolution and workflow integration were assessed, alongside comparisons with dithiothreitol (DTT), papain, trypsin and DaraEx.

resultsDaratumumab interference was neutralized in 99.5% of samples, with 86.2% resolved using the 10% protocol. Detection of 190/197 RBC antibodies (96.4%) was preserved, including weak/low-titre antibodies. Neutralization was superior to DTT (93.3%), papain/trypsin (84.9%) and DaraEx (68.4%; all p < 0.0001). Titration studies confirmed efficacy across various ranges of daratumumab titres. The reagent integrated seamlessly into workflows, remained stable over time and avoided RBC modification.

conclusionDaratumumab interference was efficiently neutralized while preserving alloantibody detection. The robust performance and workflow compatibility provide a practical solution for pre-transfusion testing in daratumumab-treated patients, supporting safe and timely transfusions with reduced laboratory burden.

Indexed as

Antibodies, Anti-IdiotypicAntibodies, MonoclonalBlood TransfusionErythrocytesIsoantibodiesBlood Grouping and CrossmatchingHumansMultiple MyelomaAntibodies, Anti-IdiotypicAntibodies, MonoclonaldaratumumabIsoantibodiesanti‐CD38anti‐idiotypic antibodydaratumumabmultiple myelomapre‐transfusion testingRBC alloantibodies

Identifiers

PMID42009611
PMCPMC13357004

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.