评估四种商业化的全自动 SARS-CoV-2 抗体检测试剂盒提示需要对西门子 SARS-CoV-2 IgG 检测试剂盒进行修订。

Evaluation of four commercial, fully automated SARS-CoV-2 antibody tests suggests a revision of the Siemens SARS-CoV-2 IgG assay.

机构信息

Central Institute of Clinical and Chemical Laboratory Diagnostics, University Hospital of Innsbruck, Innsbruck, Austria.

Department of Internal Medicine II, Infectious Diseases, Pneumology, Rheumatology, Medical University of Innsbruck, Innsbruck, Austria.

出版信息

Clin Chem Lab Med. 2021 Jan 15;59(6):1143-1154. doi: 10.1515/cclm-2020-1758. Print 2021 May 26.

DOI:10.1515/cclm-2020-1758

PMID:33554557

Abstract

OBJECTIVES

Serological tests detect antibodies against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in the ongoing coronavirus disease-19 (COVID-19) pandemic. Independent external clinical validation of performance characteristics is of paramount importance.

METHODS

Four fully automated assays, Roche Elecsys Anti-SARS-CoV-2, Abbott SARS-CoV-2 IgG, Siemens SARS-CoV-2 total (COV2T) and SARS-CoV-2 IgG (COV2G) were evaluated using 350 pre-pandemic samples and 700 samples from 245 COVID-19 patients (158 hospitalized, 87 outpatients).

RESULTS

All tests showed very high diagnostic specificity. Sensitivities in samples collected at least 14 days after disease onset were slightly lower than manufacturers' claims for Roche (93.0%), Abbott (90.8%), and Siemens COV2T (90.3%), and distinctly lower for Siemens COV2G (78.8%). Concordantly negative results were enriched for immunocompromised patients. ROC curve analyses suggest a lowering of the cut-off index for the Siemens COV2G assay. Finally, the combination of two anti-SARS-CoV-2 antibody assays is feasible when considering borderline reactive results.

CONCLUSIONS

Thorough on-site evaluation of commercially available serologic tests for detection of antibodies against SARS-CoV-2 remains imperative for laboratories. The potentially impaired sensitivity of the Siemens COV2G necessitates a switch to the company's newly filed SARS-CoV-2 IgG assay for follow-up studies. A combination of tests could be considered in clinical practice.

摘要

目的

血清学检测可在当前的 2019 冠状病毒病（COVID-19）大流行中检测到针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的抗体。独立的临床外部验证对于性能特征至关重要。

方法

使用罗氏 Elecsys Anti-SARS-CoV-2、雅培 SARS-CoV-2 IgG、西门子 SARS-CoV-2 总抗体（COV2T）和 SARS-CoV-2 IgG（COV2G）这四种全自动检测试剂，对 350 份大流行前样本和 245 例 COVID-19 患者（158 例住院，87 例门诊）的 700 份样本进行了评估。

结果

所有检测均显示出非常高的诊断特异性。在发病至少 14 天后采集的样本中，灵敏度略低于罗氏（93.0%）、雅培（90.8%）和西门子 COV2T（90.3%）的制造商声明，而西门子 COV2G 的灵敏度明显较低（78.8%）。免疫功能低下患者的一致性阴性结果更为丰富。ROC 曲线分析表明，西门子 COV2G 检测的截断指数降低。最后，当考虑边界反应性结果时，两种抗 SARS-CoV-2 抗体检测的联合是可行的。