The quality of the Polyvac SARS-COV-2 IgG/M ELISA kits for detection of antibodies against SARS-COV-2 on the clinical samples

Authors

  • Ngô Thu Hường Center for Research and Production of Vaccine and Biologicals (POLYVAC), Hanoi
  • Ngô Thị Thanh Hương Center for Research and Production of Vaccine and Biologicals (POLYVAC), Hanoi
  • Trần Văn Sơn Center for Research and Production of Vaccine and Biologicals (POLYVAC), Hanoi
  • Ngô Tiến Thọ Center for Research and Production of Vaccine and Biologicals (POLYVAC), Hanoi
  • Vũ Thị Hường Center for Research and Production of Vaccine and Biologicals (POLYVAC), Hanoi
  • Phạm Thị Phương Thảo Center for Research and Production of Vaccine and Biologicals (POLYVAC), Hanoi
  • Nguyễn Thu Thuỷ National Institute of Hygiene and Epidemiology, Hanoi
  • Lê Thị Quỳnh Mai National Institute of Hygiene and Epidemiology, Hanoi
  • Đặng Đức Anh National Institute of Hygiene and Epidemiology, Hanoi
  • Nguyễn Đăng Hiền Center for Research and Production of Vaccine and Biologicals (POLYVAC), Hanoi

DOI:

https://doi.org/10.51403/0868-2836/2021/414

Keywords:

ELISA kit, SARS- CoV-2 antibodes, negative sample, positive samples

Abstract

This study aims to evaluated the diagnostic kits for the qualitative detection of IgG/M antibodies against SARS-CoV-2 by ELISA method (Polyvac SARS-CoV-2 IgG/M ELISA) were produced successfully by POLYVAC. It was evaluated on 633 serum samples including 302 positive samples and 331 negative samples from patients confirmed by RT-PCR.  200 positive samples and 200 negative samples were performed in parallel on Polyvac SARS-CoV-2 IgG/M ELISA and Elecsys Anti-SARS-CoV-2 (Roche Diagnostics). Compared to RT-PCR, the Polyvac SARS-CoV-2 IgG ELISA sensitivity and specificity were 86,42% and 100% respectively; the Polyvac SARS-CoV-2 IgM ELISA sensitivity and specificity were 85,43 % and 95,77%, respectively. At different times of 0 - 7 days, 8 - 14 days, >14 days after the symptom onset, the sensitivity of the kits were 34,15 % (95%CI: 21,56% - 44,45%), 92,05% (95%CI: 84,49% - 96,17%), 97,97% (95%CI: 94,21% - 99,31), respectively with IgG and 70,73% (95%CI: 55,22% - 82,39%), 78,41% (95%CI: 68,72% - 85,72%), 92,57% (95%CI: 87,18% - 95,8%) respectively with IgM. Compared to Elecsys Anti-SARS-CoV-2, the results showed that the negative percent agreement was 81% (95% CI : 76.49 - 86.09 %), the positive percent agreement was 98.04% (95% CI: 94.4-99.33%), the total percent agreement was 88,04% (95% CI: 84,45-90,83%). All results showed that Polyvac SARS-CoV-2 IgG/M ELISA could be used in serological test, epidemiological surveillance to determine history of exposure to SARS-CoV-2 and to aid in diagnosis at period after 7 days of symptom onset.

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Published

01-11-2021

How to Cite

Hường, N. T. ., Hương, N. T. T. ., Sơn, T. V. ., Thọ, N. T. ., Hường, V. T. ., Thảo, P. T. P. ., Thuỷ, N. T. ., Mai, L. T. Q. ., Anh, Đặng Đức ., & Hiền, N. Đăng . (2021). The quality of the Polyvac SARS-COV-2 IgG/M ELISA kits for detection of antibodies against SARS-COV-2 on the clinical samples. Vietnam Journal of Preventive Medicine, 31(8), 20–29. https://doi.org/10.51403/0868-2836/2021/414

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Section

Original Papers

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