采用罗氏电化学免疫分析法对干血斑样本中的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）抗体进行分析。
Analysis of SARS-CoV-2 antibodies from dried blood spot samples with the Roche Elecsys Immunochemistry method.
作者信息
Fontaine Elizabeth, Saez Cristian
机构信息
CoreMedica Laboratories, Inc, Lee's Summit, Missouri, USA.
出版信息
Pract Lab Med. 2021 May;25:e00234. doi: 10.1016/j.plabm.2021.e00234. Epub 2021 Apr 28.
OBJECTIVES
The aim of this study was to evaluate the application of the Roche Elecsys anti-SARS-CoV-2 assay to capillary dried blood samples for high throughput analyses on Roche COBAS 6000 systems.
DESIGN AND METHODS
The performance of the of the Elecsys anti-SARS-CoV-2 assay was assessed using three sets of dried blood spot samples. Method correlation was performed using spiked blood samples. Sensitivity and specificity were calculated using paired donor samples. An additional cohort of 50 individuals, including COVID-19 convalescent cases, was used for the evaluation of at-home collection for mail transport, and stability studies.
RESULTS
The Elecsys anti-SARS-CoV-2 assay using dried blood spot samples showed an excellent agreement of 98.9% with results obtained using their paired serum samples, and 86.7% accuracy with dried blood spots collected after 9 days from diagnostic (PCR) tests.
CONCLUSIONS
Capillary dried blood spot samples can be confidently used on Roche COBAS automated analyzers to monitor the epidemiology of COVID-19, and are suitable for use in large-scale screening programs.
目的
本研究旨在评估罗氏电化学发光法抗SARS-CoV-2检测在罗氏cobas 6000系统上对毛细血管干血样本进行高通量分析的应用。
设计与方法
使用三组干血斑样本评估罗氏电化学发光法抗SARS-CoV-2检测的性能。采用加标血样进行方法相关性分析。使用配对的供体样本计算敏感性和特异性。另外选取50名个体组成队列，包括新冠康复病例，用于评估居家采集后邮寄运输的情况以及稳定性研究。
结果
使用干血斑样本的罗氏电化学发光法抗SARS-CoV-2检测与配对血清样本的检测结果一致性极佳，达98.9%，且对于诊断（PCR）检测9天后采集的干血斑样本，准确率为86.7%。
结论
毛细血管干血斑样本可放心用于罗氏cobas自动分析仪，以监测新冠疫情的流行病学情况，适用于大规模筛查项目。
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