三种全自动化学发光免疫分析平台检测 SARS-CoV-2 抗体的诊断准确性比较。
Diagnostic accuracy comparison of three fully automated chemiluminescent immunoassay platforms for the detection of SARS-CoV-2 antibodies.
机构信息
Department of Microbiology, ICMR-Regional Medical Research Centre (Dept. of Health Research, Ministry of Health & Family Welfare, Govt. of India), Chandrasekharpur, Bhubaneswar, 751023, India.
Department of Microbiology, ICMR-Regional Medical Research Centre (Dept. of Health Research, Ministry of Health & Family Welfare, Govt. of India), Chandrasekharpur, Bhubaneswar, 751023, India.
出版信息
J Virol Methods. 2021 Jun;292:114121. doi: 10.1016/j.jviromet.2021.114121. Epub 2021 Mar 5.
BACKGROUND
Serological test is an essential surveillance tool to track down the extensiveness of SARS-CoV-2 transmission and subsequently to move out from the enforced lockdown stage.
OBJECTIVE
The study measures the diagnostic accuracy of three popular chemiluminescent immunoassay (CLIA) based automated platforms for the detection of anti-SARS-CoV-2 antibodies and compares their agreements.
STUDY DESIGN
Serum samples of 594 COVID-19 positive patients and 100 samples from pre-COVID cases were tested by three CLIA based automated platforms: Abbott architect i2000SR, Roche cobas e411 and Yhlo iFlash 1800 and their diagnostic accuracy were compared by the area under the curves (AUC) value obtained from receiver operator characteristic (ROC) curves. Cohen's kappa statistic and McNemar's test were used to interpret the agreement between the platforms.
RESULTS
All three platforms showed high specificity as claimed by the manufacturer. Sensitivity was calculated as 64.48 % (58.67-70.3) for Abbott, 80.48 % (76.62-84.34) for Roche and 76.94 % (72.65-81.23) for Yhlo. AUC was maximum for Roche (0.929). The Cohen's kappa value was determined in between 0.69-0.89 as the inter-rater agreements.
CONCLUSION
The overall statistical analysis demonstrated cobas e411 as the diagnostically most accurate platform among the three.
背景
血清学检测是追踪 SARS-CoV-2 传播范围并随后从强制封锁阶段过渡的重要监测工具。
目的
本研究评估了三种基于化学发光免疫分析（CLIA）的自动化平台检测抗 SARS-CoV-2 抗体的诊断准确性，并比较了它们的一致性。
研究设计
对 594 例 COVID-19 阳性患者和 100 例 COVID-19 前病例的血清样本进行了三种基于 CLIA 的自动化平台检测：雅培 architect i2000SR、罗氏 cobas e411 和逸昊 iFlash 1800，并通过受试者工作特征（ROC）曲线获得的曲线下面积（AUC）值比较它们的诊断准确性。采用 Cohen's kappa 统计量和 McNemar 检验来解释平台之间的一致性。
结果
所有三种平台均表现出制造商宣称的高特异性。灵敏度计算结果为 Abbott 为 64.48%（58.67-70.3）、Roche 为 80.48%（76.62-84.34）、Yhlo 为 76.94%（72.65-81.23）。AUC 以 Roche（0.929）最高。Cohen's kappa 值介于 0.69-0.89 之间，表明各评分者之间具有中度至高度一致性。
结论
总体统计分析表明，cobas e411 是三种平台中诊断最准确的平台。
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