Clinical Transplantation Laboratory, 3rd Floor Pathology & Pharmacy Building, 80 Newark Street, London E1 2ES, United Kingdom; The University of Manchester, Oxford Road, Manchester M13 9PL, United Kingdom.
Immunology Laboratory, Royal Sussex County Hospital Barry, Eastern Rd, Brighton BN2 5BE, United Kingdom.
J Immunol Methods. 2023 Jun;517:113472. doi: 10.1016/j.jim.2023.113472. Epub 2023 Apr 12.
Detection of SARS-CoV-2 antibodies is essential in establishing the parameters of an individual's immune response to COVID-19, from both natural infection and vaccination. Despite this, there is currently limited clinical guidance or recommendations for serological methods for their measurement. Here, we evaluate and compare four Luminex-based assays for the multiplex detection of IgG SARS-CoV-2 antibodies.
The four assays tested were Magnetic Luminex Assay, MULTICOV-AB Assay, Luminex xMAP SARS-CoV-2 Multi-Antigen IgG Assay and LABScreen COVID Plus Assay. Each assay's ability to detect antibodies to SARS-CoV-2 Spike (S), Nucleocapsid (N) and Spike-Receptor Binding Domain (RBD) was evaluated using 50 test samples (25 positive, 25 negative), previously tested by a widely used ELISA technique.
The MULTICOV-AB Assay had the highest clinical performance detecting antibodies to S trimer and RBD in 100% (n = 25) of known positive samples. Both the Magnetic Luminex Assay and LABScreen COVID Plus Assay showed significant diagnostic accuracy with sensitivities of 90% and 88% respectively. The Luminex xMAP SARS-CoV-2 Multi-Antigen IgG Assay demonstrated limited detection of antibodies to the S antigen resulting in a sensitivity of 68%.
Luminex-based assays provide a suitable serological method for multiplex detection of SARS-CoV-2 specific antibodies, with each assay able to detect antibodies to a minimum of 3 different SARS-CoV-2 antigens. Assay comparison identified there is moderate performance variability between manufacturers and further inter-assay variation of antibodies detected to different SARS-CoV-2 antigens.
检测 SARS-CoV-2 抗体对于确定个体对 COVID-19 的免疫反应参数至关重要，无论是自然感染还是接种疫苗。尽管如此，目前对于用于测量的血清学方法，临床指导或建议非常有限。在这里，我们评估并比较了四种基于 Luminex 的检测方法，用于同时检测 IgG SARS-CoV-2 抗体。
测试的四种检测方法是磁珠 Luminex 检测法、MULTICOV-AB 检测法、Luminex xMAP SARS-CoV-2 多抗原 IgG 检测法和 LABScreen COVID Plus 检测法。使用 50 个测试样本（25 个阳性，25 个阴性），通过广泛使用的 ELISA 技术之前对每个检测方法检测 SARS-CoV-2 刺突（S）、核衣壳（N）和刺突受体结合域（RBD）抗体的能力进行了评估。
MULTICOV-AB 检测法在 100%（n=25）已知阳性样本中对 S 三聚体和 RBD 抗体具有最高的临床性能。磁珠 Luminex 检测法和 LABScreen COVID Plus 检测法均显示出显著的诊断准确性，灵敏度分别为 90%和 88%。Luminex xMAP SARS-CoV-2 多抗原 IgG 检测法对 S 抗原的抗体检测能力有限，灵敏度为 68%。
基于 Luminex 的检测方法为 SARS-CoV-2 特异性抗体的多重检测提供了一种合适的血清学方法，每种检测方法都能够检测到至少 3 种不同的 SARS-CoV-2 抗原的抗体。检测方法比较确定了制造商之间存在中等性能变异性，并且对不同 SARS-CoV-2 抗原的抗体检测存在进一步的检测方法间变异性。
