PDF(Pubmed)
Abstract：
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.
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.
摘要：
背景：SARS-CoV-2抗体的检测对于从自然感染和疫苗接种中确定个体对COVID-19的免疫应答参数至关重要。尽管如此,目前对血清学方法的临床指导或推荐有限.这里,我们评估并比较了4种基于Luminex的IgGSARS-CoV-2抗体多重检测方法.
方法：测试的四种方法是磁Luminex测定，MULTICOV-AB测定,LuminexxMAPSARS-CoV-2多抗原IgG测定和LABScreenCOVIDPlus测定。每种检测方法检测SARS-CoV-2Spike（S）抗体的能力，使用50个测试样品（25个阳性，25负），以前通过广泛使用的ELISA技术进行测试。
结果：MULTICOV-AB测定在100％（n=25）的已知阳性样品中检测针对S三聚体和RBD的抗体的临床性能最高。磁性Luminex测定法和LABScreenCOVIDPlus测定法均显示出显着的诊断准确性，敏感性分别为90％和88％。LuminexxMAPSARS-CoV-2多抗原IgG测定显示对S抗原的抗体的有限检测,导致68%的灵敏度。
结论：基于Luminex的测定为SARS-CoV-2特异性抗体的多重检测提供了合适的血清学方法，每个测定能够检测至少3种不同SARS-CoV-2抗原的抗体。测定比较确定,在制造商之间存在中等的性能变异性,并且检测到针对不同SARS-CoV-2抗原的抗体的进一步的测定间变异。
方法：测试的四种方法是磁Luminex测定，MULTICOV-AB测定,LuminexxMAPSARS-CoV-2多抗原IgG测定和LABScreenCOVIDPlus测定。每种检测方法检测SARS-CoV-2Spike（S）抗体的能力，使用50个测试样品（25个阳性，25负），以前通过广泛使用的ELISA技术进行测试。
结果：MULTICOV-AB测定在100％（n=25）的已知阳性样品中检测针对S三聚体和RBD的抗体的临床性能最高。磁性Luminex测定法和LABScreenCOVIDPlus测定法均显示出显着的诊断准确性，敏感性分别为90％和88％。LuminexxMAPSARS-CoV-2多抗原IgG测定显示对S抗原的抗体的有限检测,导致68%的灵敏度。
结论：基于Luminex的测定为SARS-CoV-2特异性抗体的多重检测提供了合适的血清学方法，每个测定能够检测至少3种不同SARS-CoV-2抗原的抗体。测定比较确定,在制造商之间存在中等的性能变异性,并且检测到针对不同SARS-CoV-2抗原的抗体的进一步的测定间变异。
