Multicentre Performance Evaluation of the Elecsys Anti-SARS-CoV-2 Immunoassay as an Aid in Determining Previous Exposure to SARS-CoV-2.
Elena Riester,Mario Majchrzak,Annelies Mühlbacher,Caroline Tinguely,Peter Findeisen,Johannes Kolja Hegel,Michael Laimighofer,Christopher M. Rank,Kathrin Schönfeld,Florina Langen,Tina Laengin,Christoph Niederhauser,Christoph Niederhauser +12 more
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TLDR
The Elecsys anti-SARS-CoV-2 immunoassay (Roche Diagnostics) as mentioned in this paper was used for the in vitro qualitative detection of antibodies to severe acute respiratory syndrome coronavirus (SARS)-2.Abstract:
We performed a multicentre evaluation of the Elecsys® Anti-SARS-CoV-2 immunoassay (Roche Diagnostics), an assay utilising a recombinant protein representing the nucleocapsid (N) antigen, for the in vitro qualitative detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Specificity was evaluated using serum/plasma samples from blood donors and routine diagnostic specimens collected before September 2019 (i.e., presumed negative for SARS-CoV-2-specific antibodies); sensitivity was evaluated using samples from patients with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 infection. Point estimates and 95% confidence intervals (CIs) were calculated. Method comparison was performed versus commercially available assays. Overall specificity for the Elecsys Anti-SARS-CoV-2 immunoassay (n = 9575) was 99.85% (95% CI 99.75–99.92): blood donors (n = 6714; 99.82%), routine diagnostic specimens (n = 2861; 99.93%), pregnant women (n = 2256; 99.91%), paediatric samples (n = 205; 100.00%). The Elecsys Anti-SARS-CoV-2 immunoassay demonstrated significantly higher specificity versus LIAISON SARS-CoV-2 S1/S2 IgG (99.71% vs. 98.48%), EUROIMMUN Anti-SARS-CoV-2 IgG (100.00% vs. 94.87%), ADVIA Centaur SARS-CoV-2 Total (100.00% vs. 87.32%) and iFlash SARS-CoV-2 IgM (100.00% vs. 99.58%) assays, and comparable specificity to ARCHITECT SARS-CoV-2 IgG (99.75% vs. 99.65%) and iFlash SARS-CoV-2 IgG (100.00% vs. 100.00%) assays. Overall sensitivity for Elecsys Anti-SARS-CoV-2 immunoassay samples drawn at least 14 days post-PCR confirmation (n = 219) was 93.61% (95% CI 89.51–96.46). No statistically significant differences in sensitivity were observed between the Elecsys Anti-SARS-CoV-2 immunoassay versus EUROIMMUN Anti-SARS-CoV-2 IgG (90.32% vs. 95.16%) and ARCHITECT SARS-CoV-2 IgG (84.81% vs. 87.34%) assays. The Elecsys Anti-SARS-CoV-2 immunoassay showed significantly lower sensitivity versus ADVIA Centaur SARS-CoV-2 Total (85.19% vs. 95.06%) and iFlash SARS-CoV-2 IgG (86.25% vs. 93.75%) assays, but significantly higher sensitivity versus the iFlash SARS-CoV-2 IgM assay (86.25% vs. 33.75%). The Elecsys Anti-SARS-CoV-2 immunoassay demonstrated very high specificity and high sensitivity in samples collected at least 14 days post-PCR confirmation of SARS-CoV-2 infection, supporting its use to aid in determination of previous exposure to SARS-CoV-2.read more
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References
More filters
Journal ArticleDOI
Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China
Chaolin Huang,Yeming Wang,Xingwang Li,Lili Ren,Jianping Zhao,Yi Hu,Li Zhang,Guohui Fan,Jiuyang Xu,Xiaoying Gu,Zhenshun Cheng,Ting Yu,Jia'an Xia,Yuan Wei,Wenjuan Wu,Xuelei Xie,Wen Yin,Li Hui,Min Liu,Yan Xiao,Hong Gao,Li Guo,Jungang Xie,Guang-Fa Wang,Rongmeng Jiang,Zhancheng Gao,Qi Jin,Jianwei Wang,Bin Cao +28 more
TL;DR: The epidemiological, clinical, laboratory, and radiological characteristics and treatment and clinical outcomes of patients with laboratory-confirmed 2019-nCoV infection in Wuhan, China, were reported.
Journal ArticleDOI
A new coronavirus associated with human respiratory disease in China.
Fan Wu,Su Zhao,Bin Yu,Yan-Mei Chen,Wen Wang,Zhi gang Song,Yi Hu,Zhao Wu Tao,Jun Hua Tian,Yuan Yuan Pei,Ming Li Yuan,Yu Ling Zhang,Fa Hui Dai,Yi Liu,Qi Min Wang,Jiao Jiao Zheng,Lin Xu,Edward C. Holmes,Edward C. Holmes,Yong-Zhen Zhang,Yong-Zhen Zhang +20 more
TL;DR: Phylogenetic and metagenomic analyses of the complete viral genome of a new coronavirus from the family Coronaviridae reveal that the virus is closely related to a group of SARS-like coronaviruses found in bats in China.
Journal ArticleDOI
Virological assessment of hospitalized patients with COVID-2019.
Roman Wölfel,Victor M. Corman,Wolfgang Guggemos,M Seilmaier,Sabine Zange,Marcel A. Müller,Daniela Niemeyer,Terry Jones,Terry Jones,Patrick Vollmar,Camilla Rothe,Michael Hoelscher,Tobias Bleicker,Sebastian Brünink,Julia Schneider,Rosina Ehmann,Katrin Zwirglmaier,Christian Drosten,Clemens M. Wendtner +18 more
TL;DR: Detailed virological analysis of nine cases of coronavirus disease 2019 (COVID-19) provides proof of active replication of the SARS-CoV-2 virus in tissues of the upper respiratory tract.
Journal ArticleDOI
Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study.
Kelvin K. W. To,Owen Tak Yin Tsang,Wai Shing Leung,Anthony Raymond Tam,Tak Chiu Wu,David Christopher Lung,Cyril C. Y. Yip,Jian Piao Cai,Jacky Man Chun Chan,Thomas Shiu Hong Chik,Daphne Pui-Ling Lau,Chris Yau Chung Choi,Lin Lei Chen,Wan Mui Chan,Kwok-Hung Chan,Jonathan Daniel Ip,Anthony Chin-Ki Ng,Rosana W.S. Poon,Cui Ting Luo,Vincent C.C. Cheng,Jasper Fuk-Woo Chan,Jasper Fuk-Woo Chan,Ivan Hung,Zhiwei Chen,Honglin Chen,Kwok-Yung Yuen +25 more
TL;DR: The serial respiratory viral load of SARS-CoV-2 in posterior oropharyngeal saliva samples from patients with COVID-19, and serum antibody responses from patients infected with severe acute respiratory syndrome coronavirus 2 are ascertained.
Journal ArticleDOI
Coronavirus infections and immune responses.
Geng Li,Geng Li,Yaohuao Fan,Yanni Lai,Tiantian Han,Zonghui Li,Peiwen Zhou,Pan Pan,Wenbiao Wang,Dingwen Hu,Xiaohong Liu,Qiwei Zhang,Qiwei Zhang,Jianguo Wu,Jianguo Wu +14 more
TL;DR: An update on CoV infections and relevant diseases, particularly the host defense against CoV‐induced inflammation of lung tissue, as well as the role of the innate immune system in the pathogenesis and clinical treatment is provided.