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[Hydrashift 2/4达雷妥尤单抗检测法在消除达雷妥尤单抗对血清免疫固定电泳干扰中的应用]

[Application of Hydrashift 2/4 daratumumab assay in eliminating interference of daratumumab on serum immunofixation electrophoresis].

作者信息

Xu S, Liu Y, Wen L, Zhao L, Deng X, Rong R, Lu J

机构信息

Department of Clinical Laboratory, Peking University People's Hospital, Beijing 100044, China.

Department of Hematology, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing 100044, China.

出版信息

Zhonghua Xue Ye Xue Za Zhi. 2021 Oct 14;42(10):840-845. doi: 10.3760/cma.j.issn.0253-2727.2021.10.008.

DOI:10.3760/cma.j.issn.0253-2727.2021.10.008
PMID:34788924
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8607023/
Abstract

To investigate the interference of daratumumab on immunofixation electrophoresis after treating plasma cell diseases and methods to eliminate the interference. Serum samples of eight patients with plasma cell diseases treated with daratumumab in Peking University People's Hospital from April 2020 to March 2021 were collected for standard immunofixation electrophoresis and Hydrashift 2/4 daratumumab assay. After treatment, 81.3% (13/16) of the samples showed drug-induced monoclonal antibodies (IgG-κ) . The samples without drug-induced monoclonal bands were related to individual differences, administration intervals, and immunoglobulin levels. Among the samples with IgG-κ monoclonal bands, 76.9% (10/13) could be directly identified as endogenous or exogenous monoclonal bands by immunofixation electrophoresis, and the others (3/13) could be identified by Hydrashift 2/4 daratumumab assay. Hydrashift 2/4 daratumumab assay can remove the band of daratumumab on the immunofixation electrophoresis and help with efficacy evaluation.

摘要

探讨达雷妥尤单抗治疗浆细胞疾病后对免疫固定电泳的干扰及消除干扰的方法。收集2020年4月至2021年3月在北京大学人民医院接受达雷妥尤单抗治疗的8例浆细胞疾病患者的血清样本,进行标准免疫固定电泳和Hydrashift 2/4达雷妥尤单抗检测。治疗后,81.3%(13/16)的样本出现药物诱导的单克隆抗体(IgG-κ)。无药物诱导单克隆条带的样本与个体差异、给药间隔和免疫球蛋白水平有关。在出现IgG-κ单克隆条带的样本中,76.9%(10/13)可通过免疫固定电泳直接鉴定为内源性或外源性单克隆条带,其余(3/13)可通过Hydrashift 2/4达雷妥尤单抗检测鉴定。Hydrashift 2/4达雷妥尤单抗检测可去除免疫固定电泳上的达雷妥尤单抗条带,有助于疗效评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6e9/8607023/65e501475889/cjh-42-10-840-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6e9/8607023/3b01d0220c74/cjh-42-10-840-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6e9/8607023/0aeb3837c328/cjh-42-10-840-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6e9/8607023/65e501475889/cjh-42-10-840-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6e9/8607023/3b01d0220c74/cjh-42-10-840-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6e9/8607023/0aeb3837c328/cjh-42-10-840-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6e9/8607023/65e501475889/cjh-42-10-840-g003.jpg

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本文引用的文献

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Identification of Friend or Foe: The Laboratory Challenge of Differentiating M-Proteins from Monoclonal Antibody Therapies.识别敌友:区分M蛋白与单克隆抗体疗法的实验室挑战。
J Appl Lab Med. 2017 Jan 1;1(4):421-431. doi: 10.1373/jalm.2016.020784.
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Distinguishing Drug from Disease by Use of the Hydrashift 2/4 Daratumumab Assay.使用Hydrashift 2/4达雷妥尤单抗检测法区分药物与疾病。
J Appl Lab Med. 2019 Mar;3(5):857-863. doi: 10.1373/jalm.2018.026476. Epub 2018 May 31.
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Interference of Therapeutic Monoclonal Antibodies With Routine Serum Protein Electrophoresis and Immunofixation in Patients With Myeloma: Frequency and Duration of Detection of Daratumumab and Elotuzumab.
治疗性单克隆抗体对多发性骨髓瘤患者常规血清蛋白电泳和免疫固定的干扰:达妥木单抗和埃罗妥珠单抗的检测频率和持续时间。
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Monoclonal Antibodies in Multiple Myeloma: A New Wave of the Future.多发性骨髓瘤中的单克隆抗体:未来的新潮流。
Clin Lymphoma Myeloma Leuk. 2017 Sep;17(9):545-554. doi: 10.1016/j.clml.2017.06.030. Epub 2017 Jun 27.
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Treatment of multiple myeloma with monoclonal antibodies and the dilemma of false positive M-spikes in peripheral blood.单克隆抗体治疗多发性骨髓瘤及外周血中M峰假阳性的困境
Clin Biochem. 2018 Jan;51:66-71. doi: 10.1016/j.clinbiochem.2016.09.015. Epub 2016 Sep 21.
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Monitoring multiple myeloma patients treated with daratumumab: teasing out monoclonal antibody interference.监测接受达雷妥尤单抗治疗的多发性骨髓瘤患者:揭示单克隆抗体干扰。
Clin Chem Lab Med. 2016 Jun 1;54(6):1095-104. doi: 10.1515/cclm-2015-1031.
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Interference of daratumumab in monitoring multiple myeloma patients using serum immunofixation electrophoresis can be abrogated using the daratumumab IFE reflex assay (DIRA).达雷妥尤单抗会干扰多发性骨髓瘤患者的血清免疫固定电泳监测,使用达雷妥尤单抗免疫固定电泳反射检测(DIRA)可消除这种干扰。
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Daratumumab: First Global Approval.达雷妥尤单抗:全球首次获批。
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