Abstract
Objectives Serological assays for detection of SARS-CoV-2 antibodies are increasingly used during the COVID-19 pandemic caused by the SARS-Coronavirus-2. Here we evaluated the analytical and clinical performance of three commercially available SARS-CoV-2 antibody assays. Methods A total of 186 samples from 58 patients with PCR-confirmed COVID-19 infection were measured using SARS-CoV-2 antibody assays by Siemens Healthineers, Roche Diagnostics and Euroimmun. Additionally, 123 control samples, including samples collected before December 2019 and samples with potential cross-reactive antibodies were analyzed. Diagnostic specificity, sensitivity, agreement between assays and ROC curve-derived optimized thresholds were determined. Furthermore, intra- and inter-assay precision and the potential impact of interfering substances were investigated. Results SARS-CoV-2 antibody assays by Siemens and Roche showed 100% specificity. The Euroimmun assay had 98 and 100% specificity, when borderline results are considered as positive or negative, respectively. Diagnostic sensitivity for samples collected ≥14 days after PCR-positivity was 97.0, 89.4 and 95.5% using the Siemens, Roche and Euroimmun assay, respectively. Sensitivity of the Roche assay can be increased using an optimized cut-off index (0.095). However, a simultaneous decrease in specificity (98.4%) was observed. Siemens showed 95.8 and 95.5% overall agreement with results of Euroimmun and Roche assay, respectively. Euroimmun and Roche assay exhibited 92.6% overall agreement. Discordant results were observed in three COVID-19 patients and in one COVID-19 patient none of the investigated assays detected antibodies. Conclusions The investigated assays were highly specific and sensitive in detecting SARS-CoV-2 antibodies in samples obtained ≥14 days after PCR-confirmed infection. Discordant results need to be investigated in further studies.
Highlights
A new disease, known as coronavirus disease 2019 (COVID19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), emerged in the region of Wuhan (China) in December 2019 [1, 2]
To evaluate the diagnostic specificity of SARS-CoV-2 antibody assays we used control samples of patients collected before December 2019, which were considered true negative
The present study evaluated and compared three SARS-CoV-2 antibody assays by Siemens Healthineers, Roche Diagnostics and Euroimmun which were run on fully-automated platforms
Summary
A new disease, known as coronavirus disease 2019 (COVID19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), emerged in the region of Wuhan (China) in December 2019 [1, 2]. The virus spread subsequently all over the world and the WHO officially declared the novel SARS-CoV-2 infection a pandemic. An accurate and prompt detection of SARS-CoV-2 is essential for the diagnosis of infected patients, and for the establishment of infection control measures and prevention of virus spread [3, 4]. Real-time reverse transcription polymerase chain reaction (RT-PCR) using respiratory samples obtained with naso- or oropharyngeal swabs are considered as the reference method for screening and diagnosis of acute SARS-CoV-2 infection [3]. Serologic testing of anti-SARS-CoV-2 antibodies (IgG, IgM and IgA) can be performed by using venous blood samples. SARS-CoV-2 antibody assays are proposed to play an important role in diagnosis of
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