Clinical eHealth (Dec 2022)

A large-scale clinical validation study using nCapp cloud plus terminal by frontline doctors for the rapid diagnosis of COVID-19 and COVID-19 pneumonia in China

  • Dawei Yang,
  • Tao Xu,
  • Xun Wang,
  • Deng Chen,
  • Ziqiang Zhang,
  • Lichuan Zhang,
  • Jie Liu,
  • Kui Xiao,
  • Li Bai,
  • Yong Zhang,
  • Lin Zhao,
  • Lin Tong,
  • Chaomin Wu,
  • Yaoli Wang,
  • Chunling Dong,
  • Maosong Ye,
  • Yu Xu,
  • Zhenju Song,
  • Hong Chen,
  • Jing Li,
  • Jiwei Wang,
  • Fei Tan,
  • Hai Yu,
  • Jian Zhou,
  • Chunhua Du,
  • Hongqing Zhao,
  • Yu Shang,
  • Linian Huang,
  • Jianping Zhao,
  • Yang Jin,
  • Charles A. Powell,
  • Jinming Yu,
  • Yuanlin Song,
  • Chunxue Bai

Journal volume & issue
Vol. 5
pp. 79 – 90

Abstract

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Background: The outbreak of coronavirus disease 2019 (COVID-19) has become a global pandemic acute infectious disease, especially with the features of possible asymptomatic carriers and high contagiousness. Currently, it is difficult to quickly identify asymptomatic cases or COVID-19 patients with pneumonia due to limited access to reverse transcription-polymerase chain reaction (RT-PCR) nucleic acid tests and CT scans. Goal: This study aimed to develop a scientific and rigorous clinical diagnostic tool for the rapid prediction of COVID-19 cases based on a COVID-19 clinical case database in China, and to assist doctors to efficiently and precisely diagnose asymptomatic COVID-19 patients and cases who had a false-negative RT-PCR test result. Methods: With online consent, and the approval of the ethics committee of Zhongshan Hospital Fudan University (NCT04275947, B2020-032R) to ensure that patient privacy is protected, clinical information has been uploaded in real-time through the New Coronavirus Intelligent Auto-diagnostic Assistant Application of cloud plus terminal (nCapp) by doctors from different cities (Wuhan, Shanghai, Harbin, Dalian, Wuxi, Qingdao, Rizhao, and Bengbu) during the COVID-19 outbreak in China. By quality control and data anonymization on the platform, a total of 3,249 cases from COVID-19 high-risk groups were collected. The effects of different diagnostic factors were ranked based on the results from a single factor analysis, with 0.05 as the significance level for factor inclusion and 0.1 as the significance level for factor exclusion. Independent variables were selected by the step-forward multivariate logistic regression analysis to obtain the probability model. Findings: We applied the statistical method of a multivariate regression model to the training dataset (1,624 cases) and developed a prediction model for COVID-19 with 9 clinical indicators that are accessible. The area under the receiver operating characteristic (ROC) curve (AUC) for the model was 0.88 (95% CI: 0.86, 0.89) in the training dataset and 0.84 (95% CI: 0.82, 0.86) in the validation dataset (1,625 cases). Discussion: With the assistance of nCapp, a mobile-based diagnostic tool developed from a large database that we collected from COVID-19 high-risk groups in China, frontline doctors can rapidly identify asymptomatic patients and avoid misdiagnoses of cases with false-negative RT-PCR results.

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