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Point-of-care test system for detection of immunoglobulin-G and -M against nucleocapsid protein and spike glycoprotein of SARS-CoV-2.
Peng, Tao; Sui, Zhiwei; Huang, Zhenghui; Xie, Jie; Wen, Kai; Zhang, Yongzhuo; Huang, Wenfeng; Mi, Wei; Peng, Ke; Dai, Xinhua; Fang, Xiang.
  • Peng T; Center for Advanced Measurement Science, National Institute of Metrology, Beijing, 100029, PR China.
  • Sui Z; Center for Advanced Measurement Science, National Institute of Metrology, Beijing, 100029, PR China.
  • Huang Z; Wuhan Jinyintan Hospital, Wuhan, 430024, PR China.
  • Xie J; Center for Advanced Measurement Science, National Institute of Metrology, Beijing, 100029, PR China.
  • Wen K; College of Veterinary Medicine, China Agricultural University, 100193, Beijing, PR China.
  • Zhang Y; Center for Advanced Measurement Science, National Institute of Metrology, Beijing, 100029, PR China.
  • Huang W; Center for Advanced Measurement Science, National Institute of Metrology, Beijing, 100029, PR China.
  • Mi W; Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, 430071, PR China.
  • Peng K; Center for Advanced Measurement Science, National Institute of Metrology, Beijing, 100029, PR China.
  • Dai X; Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, 430071, PR China.
  • Fang X; Center for Advanced Measurement Science, National Institute of Metrology, Beijing, 100029, PR China.
Sens Actuators B Chem ; 331: 129415, 2021 Mar 15.
Article in English | MEDLINE | ID: covidwho-1009880
ABSTRACT
The coronavirus disease 2019 (COVID-19) epidemic continues to ravage the world. In epidemic control, dealing with a large number of samples is a huge challenge. In this study, a point-of-care test (POCT) system was successfully developed and applied for rapid and accurate detection of immunoglobulin-G and -M against nucleocapsid protein (anti-N IgG/IgM) and receptor-binding domain in spike glycoprotein (anti-S-RBD IgG/IgM) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Any one of the IgG/IgM found in a sample was identified as positive. The POCT system contains colloidal gold-based lateral flow immunoassay test strips, homemade portable reader, and certified reference materials, which detected anti-N and anti-S-RBD IgG/IgM objectively in serum within 15 min. Receiver operating characteristic curve analysis was used to determine the optimal cutoff values, sensitivity, and specificity. It exhibited equal to or better performances than four approved commercial kits. Results of the system and chemiluminescence immunoassay kit detecting 108 suspicious samples had high consistency with kappa coefficient at 0.804 (P < 0.001). Besides, the levels and alterations of the IgG/IgM in an inpatient were primarily investigated by the POCT system. Those results suggested the POCT system possess the potential to contribute to rapid and accurate serological diagnosis and epidemiological survey of COVID-19.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Observational study Language: English Journal: Sens Actuators B Chem Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Observational study Language: English Journal: Sens Actuators B Chem Year: 2021 Document Type: Article