Emerging Microbes and Infections (Jan 2020)

Establishing a high sensitivity detection method for SARS-CoV-2 IgM/IgG and developing a clinical application of this method

  • Chunyan Zhang,
  • Lei Zhou,
  • Hao Liu,
  • Sibing Zhang,
  • Yaping Tian,
  • Junli Huo,
  • Fei Li,
  • Yao Zhang,
  • Bo Wei,
  • Dan Xu,
  • Jinwei Hu,
  • Jiayi Wang,
  • Yuxuan Cheng,
  • Wenjie Shi,
  • Xiuli Xu,
  • Jianping Zhou,
  • Peipei Sang,
  • Xudong Tan,
  • Weiwei Wang,
  • Minjie Zhang,
  • Bin Wang,
  • Yujun Zhou,
  • Kan Zhang,
  • Kunlun He

DOI
https://doi.org/10.1080/22221751.2020.1811161
Journal volume & issue
Vol. 9, no. 1
pp. 2020 – 2029

Abstract

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ABSTRACTCOVID-19 is caused by SARS-CoV-2 infection and was initially discovered in Wuhan. This outbreak quickly spread all over China and then to more than 20 other countries. SARS-CoV-2 fluorescent microsphere immunochromatographic test strips were prepared by the combination of time-resolved fluorescence immunoassay with a lateral flow assay. The analytical performance and clinical evaluation of this testing method was done and the clinical significance of the testing method was verified. The LLOD of SARS-CoV-2 antibody IgG and IgM was 0.121U/L and 0.366U/L. The specificity of IgM and IgG strips in healthy people and in patients with non-COVID-19 disease was 94%, 96.72% and 95.50%, 99.49%, respectively; and sensitivity of IgM and IgG strips for patients during treatment and follow-up was 63.02%, 37.61% and 87.28%, 90.17%, respectively. The SARS-CoV-2 antibody test strip can provide rapid, flexible and accurate testing, and is able to meet the clinical requirement for rapid on-site testing of virus. The ability to detect IgM and IgG provided a significant benefit for the detection and prediction of clinical course with COVID-19 patients.

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