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A new and rapid approach for detecting COVID-19 based on S1 protein fragments.

ABSTRACT: The pandemic of novel coronavirus disease 2019 (COVID-19) seriously threatened the public health all over the world. A colloidal gold immunochromatography assay for IgM/IgG antibodies against the receptor-binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 protein was established to assess its rapid diagnostic value. We first designed and manufactured all contents of the test cassette of SARS-CoV-2 rapid test kit: the colloidal gold-labeled mouse-antihuman lgM/lgG antibody, the recombinant SARS-CoV-2 antigen, the nitrocellulose membrane control line, and specimen diluents. Furthermore, reverse transcription-polymerase chain reaction (RT-PCR) assay, colloidal gold immunochromatography assay, serological validation of cross reaction with other common viruses, and clinical validation were performed. The kit was finally evaluated by 75 serum/plasma samples of SARS-CoV-2 infection cases and 139 healthy samples as control, with the result of that the sensitivity, specificity, and accuracy for IgM were 90.67%, 97.84%, and 95.33%, whereas for IgG were 69.33%, 99.28%, and 88.79%, respectively; the combination of IgM and IgG could improve the value: 92.00%, 97.12%, and 95.33%, respectively. Therefore, the rapid detection kit has high sensitivity and specificity, especially for IgM&IgG, showing a critical value in clinical application and epidemic control of COVID-19.

SUBMITTER: Li H

PROVIDER: S-EPMC7427819 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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A new and rapid approach for detecting COVID-19 based on S1 protein fragments.

Li Hua H Liu Zhe Z He Yue Y Qi Yingjie Y Chen Jie J Ma Yuanyuan Y Liu Fujia F Lai Kaisheng K Zhang Yong Y Jiang Liu L Wang Xiangdong X Ge Junbo J

Clinical and translational medicine 20200605 2

The pandemic of novel coronavirus disease 2019 (COVID-19) seriously threatened the public health all over the world. A colloidal gold immunochromatography assay for IgM/IgG antibodies against the receptor-binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 protein was established to assess its rapid diagnostic value. We first designed and manufactured all contents of the test cassette of SARS-CoV-2 rapid test kit: the colloidal gold-labeled mouse-antihuman lgM/lgG a ...[more]

PMID: 32508026

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Project description:We aimed at establishing a new COVID-19 risk scores, serving as a guide for rapidly screening the COVID-19 patients in order to reduce the risk of COVID-19 hospital-related transmission. As the COVID-19 disease is breaking out across the world, hospital-related transmission is one of the main factors accountable for the spread of COVID-19. For COVID-19 prevention it is urgent to establish a fast and efficient screening strategy for the COVID-19 patients. We analyzed 335 patients (including 124 patients with COVID-19). Five significant clinical attributes were selected as the components for establishing a COVID-19 risk score system, and every attribute was assigned a specific score according to their respective odds ratio values. We also compared three different screening schemes (Scheme I: temperature higher than 37.2 °C on admission, Scheme II: exposure to a source of transmission within 14 days in addition to fever, Scheme III: our new COVID-19 risk score) in terms of their respective receiver operating characteristic (ROC) curves, so as to evaluate their respective screening effectiveness. Five significant risk factors, which were exposed to a source of transmission (9 points), cluster onset (6 points), history of fever or temperature higher than 37.2 °C on admission (4 points), cough (1 point) and other atypical symptoms (1 point), were ultimately selected from many candidates to construct the new rapid COVID-19 screening program. Based on the screening scheme, the patients were quickly divided into three subgroups according to their respective COVID-19 risk scores: low risk (≤ 6 points, risk < 10%), medium risk (7-13 points) and high risk (≥ 14 points, risk > 80%). When the score of 10 points was selected as a cut-off point for differentiating the patients with COVID-19 from all of the other patients, the sensitivity was 93.6%, with a specificity of 86.3%. The area under the ROC curve (AUC) of COVID-19 risk score system was 0.96 (P = 0.000), much higher than the AUCs of Scheme I (0.56, P = 0.000) and Scheme II (0.85, P = 0.000), respectively. Our COVID-19 risk score system can help the clinicians effectively and rapidly identify and differentiate the patients with COVID-19 infections, to be mainly used in those areas where COVID-19 still exhibits epidemiological characteristics.

Dataset Information

A new and rapid approach for detecting COVID-19 based on S1 protein fragments.

Publications

A new and rapid approach for detecting COVID-19 based on S1 protein fragments.

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