Performance evaluation of Meso Scale Discovery (MSD) quantitative serological assays for detection of binding (IgG, IgA, IgM) and ACE2 inhibitory antibody levels for SARS-CoV-2

IF 1.7 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS

Journal of immunological methods Pub Date : 2026-07-01 Epub Date: 2026-06-12 DOI:10.1016/j.jim.2026.114081

Camila Macedo Cincotta, Dante Coleman, Steven Padilla, Jennifer Enoch, Ines Lakhal-Naouar, Matthew Bell, Jason Ouellette, Sheida Mansouri, Oussama M'hamdi, Janice Darden, Jennifer Malia, Sheila A. Peel, Kristina K. Peachman

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引用次数: 0

Abstract

A performance evaluation of a quantitative research use only (RUO) immunological assay utilizing the Meso Scale Discovery (MSD) platform for assessing IgM, IgA, and IgG binding and SARS-CoV-2 pseudo-neutralization was performed. Comparative analyses of antibody quantification of IgA, IgG, and IgM isotypes against SARS-CoV-2 nucleocapsid, spike, Receptor Binding Domain (RBD) and N-Terminal Domain (NTD) antigens were performed using MSD multi-spot electro-chemiluminescent V-PLEX COVID-19 test kits, and two well characterized serological panels. Cross reactivity was assessed against COVID-19 negative/Influenza samples. Precision was assessed by comparing variation between duplicate values within run; accuracy was assessed by comparing values obtained across runs against expected values. The MSD IgG, IgA, and IgM binding, and ACE2 inhibitory antibody assays demonstrated acceptable precision and accuracy within the expected 20%/30% variability, respectively per manufacturer's protocol; no cross reactivity with influenza samples was observed. Different MSD plate configurations, multiple (two) MSD analysis instruments, and multiple operators did not impact antibody quantification; thus, confirming the robustness of both assays. Comparative analysis between MSD and commercial Euroimmun, Siemens ADVIA, and Beckman Coulter DXLTM ACCESS assays demonstrated better performance overall for the MSD assay.

Importance

This work describes and validates the MSD platform, as a highly flexible, customizable, operator independent, and reliable platform for antibody assessment of COVID-19 response which is highly adaptable to immune assessment of emerging or re-emerging pathogens.

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Meso Scale Discovery （MSD）血清定量检测SARS-CoV-2结合抗体（IgG、IgA、IgM）和ACE2抑制抗体水平的性能评价

利用Meso Scale Discovery （MSD）平台评估IgM、IgA和IgG结合和SARS-CoV-2伪中和的定量研究用途（RUO）免疫测定的性能评估。采用MSD多点电化学发光V-PLEX COVID-19检测试剂盒和两种特征明确的血清学检测试剂盒，对SARS-CoV-2核衣壳、刺突、受体结合域（RBD）和n端结构域（NTD）抗原进行IgA、IgG和IgM同型抗体定量比较分析。对COVID-19阴性/流感样本进行交叉反应性评估。通过比较运行中重复值之间的变化来评估精度；通过将运行期间获得的值与期望值进行比较来评估准确性。MSD IgG、IgA和IgM结合以及ACE2抑制抗体检测显示出可接受的精确度和准确度，分别在每个制造商方案的预期20%/30%的可变性范围内；未观察到与流感样本的交叉反应。不同的MSD板配置、多(2)台MSD分析仪器和多名操作人员不影响抗体定量；因此，确认两种分析的稳健性。MSD与商用euroimmune、Siemens ADVIA和Beckman Coulter DXLTM ACCESS检测方法的比较分析表明，MSD检测方法的总体性能更好。重要性：本工作描述并验证了MSD平台，作为一种高度灵活、可定制、独立于操作人员且可靠的COVID-19抗体评估平台，该平台高度适用于新出现或再出现病原体的免疫评估。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of immunological methods 医学-免疫学

CiteScore

4.10

自引率

0.00%

发文量

120

审稿时长

3 months

期刊介绍： The Journal of Immunological Methods is devoted to covering techniques for: (1) Quantitating and detecting antibodies and/or antigens. (2) Purifying immunoglobulins, lymphokines and other molecules of the immune system. (3) Isolating antigens and other substances important in immunological processes. (4) Labelling antigens and antibodies. (5) Localizing antigens and/or antibodies in tissues and cells. (6) Detecting, and fractionating immunocompetent cells. (7) Assaying for cellular immunity. (8) Documenting cell-cell interactions. (9) Initiating immunity and unresponsiveness. (10) Transplanting tissues. (11) Studying items closely related to immunity such as complement, reticuloendothelial system and others. (12) Molecular techniques for studying immune cells and their receptors. (13) Imaging of the immune system. (14) Methods for production or their fragments in eukaryotic and prokaryotic cells. In addition the journal will publish articles on novel methods for analysing the organization, structure and expression of genes for immunologically important molecules such as immunoglobulins, T cell receptors and accessory molecules involved in antigen recognition, processing and presentation. Submitted full length manuscripts should describe new methods of broad applicability to immunology and not simply the application of an established method to a particular substance - although papers describing such applications may be considered for publication as a short Technical Note. Review articles will also be published by the Journal of Immunological Methods. In general these manuscripts are by solicitation however anyone interested in submitting a review can contact the Reviews Editor and provide an outline of the proposed review.