Multicenter evaluation of four immunoassays for the performance of early diagnosis of COVID-19 and assessment of antibody responses of patients with pneumonia in Taiwan

doi:10.1016/j.jmii.2021.02.003

Observational Study

. 2021 Oct;54(5):816-829.

doi: 10.1016/j.jmii.2021.02.003. Epub 2021 Feb 23.

Multicenter evaluation of four immunoassays for the performance of early diagnosis of COVID-19 and assessment of antibody responses of patients with pneumonia in Taiwan

Affiliations

¹ Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.
² Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan.
³ Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
⁴ Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
⁵ Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. Electronic address: shuhsingcheng@gmail.com.
⁶ Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; Center for Quality Management, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: erdrcsy@gmail.com.
⁷ Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. Electronic address: hsporen@ntu.edu.tw.

PMID: 33676864
PMCID: PMC7900773
DOI: 10.1016/j.jmii.2021.02.003

Observational Study

Multicenter evaluation of four immunoassays for the performance of early diagnosis of COVID-19 and assessment of antibody responses of patients with pneumonia in Taiwan

Yi-Chun Lin et al. J Microbiol Immunol Infect. 2021 Oct.

. 2021 Oct;54(5):816-829.

doi: 10.1016/j.jmii.2021.02.003. Epub 2021 Feb 23.

Authors

Affiliations

¹ Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.
² Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan.
³ Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
⁴ Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
⁵ Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. Electronic address: shuhsingcheng@gmail.com.
⁶ Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; Center for Quality Management, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: erdrcsy@gmail.com.
⁷ Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. Electronic address: hsporen@ntu.edu.tw.

PMID: 33676864
PMCID: PMC7900773
DOI: 10.1016/j.jmii.2021.02.003

Abstract

Background/purpose: Our study goals were to evaluate the diagnostic performance of four anti-SARS-CoV-2 antibodies tests and the differences in dynamic immune responses between COVID-19 patients with and without pneumonia.

Methods: We collected 184 serum samples from 70 consecutively qRT-PCR-confirmed COVID-19 patients at four participating hospitals from 23 January 2020 to 30 September 2020. COVID-19 pneumonia was defined as the presence of new pulmonary infiltration. Serum samples were grouped by the duration after symptom onset on a weekly basis for antibody testing and analysis. The four immunoassays: Beckman SARS-CoV-2 IgG/IgM (Beckman Test), Siemens (ADVIA Centaur®) SARS-CoV-2 Total (COV2T) (Siemens Test), SBC COVID-19 IgG ELISA (SBC Test) and EliA SARS-CoV-2-Sp1 IgG/IgM/IgA P2 Research (EliA Test) were used for detecting the SARS-CoV-2 specific antibodies.

Results: The sensitivity of all tests reached 100% after 42 days of symptom onset. Siemens Test, the only test detecting total anti-SARS-CoV-2 antibodies, had the best performance in the early diagnosis of COVID-19 infection (day 0-7: 77%; day 8-14: 95%) compared to the other 3 serological tests. All tests showed 100% specificity except SBC Test (98%). COVID-19 patients with pneumonia had significantly higher testing signal values than patients without pneumonia (all p values < 0.05, except EliA IgM Test). However, Siemens Test and SBC Test had highest probability in early prediction of the presence of COVID-19 pneumonia.

Conclusion: Chronological analysis of immune response among COVID-19 patients with different serological tests provides important information in the early diagnosis of SARS-CoV-2 infection and prediction of the risk of pneumonia after infection.

Keywords: Antibody responses; COVID-19; False positive; Immunoassays; Pneumonia.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest All authors declare no conflict of interest.

Figures

**Fig. 1**
Percentage of serum samples showing positive antibody findings when examined using the four studied serological assays after symptom onset. (A) Positive results of Beckman SARS-CoV-2 IgG/IgM (positive results of either IgG or IgM), Siemens SARS-CoV-2 Total (COV2T), SBC COVID-19 IgG ELISA Kit, and EliA SARS-CoV-2-Sp1 IgG/IgM/IgA P2 Research (positive results of either IgG, IgM, or IgA), (B) Positive results of Beckman SARS-CoV-2 IgG, Beckman SARS-CoV-2 IgM, and Beckman SARS-CoV-2 IgG/IgM (positive results of either IgG or IgM), (C) positive results of EliA SARS-CoV-2-Sp1 IgG P2 Research EliA SARS-CoV-2-Sp1 IgM P2 Research, EliA SARS-CoV-2-Sp1 IgA P2 Research, and EliA SARS-CoV-2-Sp1 IgG/IgM/IgA P2 Research (positive results of either IgG, IgM, or IgA).

**Fig. 2**
Signal values of the four immunoassays for anti-SARS-CoV-2 antibodies detection after symptom onset (A) Beckman SARS-CoV-2 IgG/IgM, (B) Siemens SARS-CoV-2 Total (COV2T), (C) SBC COVID-19 IgG ELISA Kit, and (D) EliA SARS-CoV-2-Sp1 IgG/IgM/IgA P2 Research.

**Fig. 3**
Comparison of signal values of the four immunoassays in patients with COVID-19 with or without pneumonia (A) Beckman SARS-CoV-2 IgG/IgM-IgG, (B) Beckman SARS-CoV-2 IgG/IgM–IgM, (C) Siemens SARS-CoV-2 Total (COV2T), (D) SBC COVID-19 IgG ELISA Kit, (E) EliA SARS-CoV-2-Sp1 IgG/IgM/IgA P2 Research-IgG, (F) EliA SARS-CoV-2-Sp1 IgG/IgM/IgA P2 Research-IgM, (G) EliA SARS-CoV-2-Sp1 IgG/IgM/IgA P2 Research-IgA.

See this image and copyright information in PMC

Cited by

Immunogenicity and safety of homologous and heterologous ChAdOx1-S and mRNA-1273 vaccinations in healthy adults in Taiwan.
Kang CM, Lee NY, Lin CH, Hsu YS, Chang YC, Chung MY, Lee YF, Tseng WP, Wu JL, Chen SY, Lu MC, Ko WC, Lee PI, Hsueh PR. Kang CM, et al. J Clin Virol. 2022 Jun;150-151:105156. doi: 10.1016/j.jcv.2022.105156. Epub 2022 Apr 6. J Clin Virol. 2022. PMID: 35413588 Free PMC article.
To PCR or not? The impact of shifting policy from PCR to rapid antigen tests to diagnose COVID-19 during the omicron epidemic: a nationwide surveillance study.
Chi H, Chiu NC, Chen CC, Weng SL, Lien CH, Lin CH, Hu YF, Lei WT, Tai YL, Lin LY, Liu LY, Lin CY. Chi H, et al. Front Public Health. 2023 Jul 20;11:1148637. doi: 10.3389/fpubh.2023.1148637. eCollection 2023. Front Public Health. 2023. PMID: 37546311 Free PMC article.
A systematic review and meta-analysis of the sensitivity of antibody tests for the laboratory confirmation of COVID-19.
Makoah NA, Tipih T, Litabe MM, Brink M, Sempa JB, Goedhals D, Burt FJ. Makoah NA, et al. Future Virol. 2021 Nov:10.2217/fvl-2021-0211. doi: 10.2217/fvl-2021-0211. Epub 2021 Dec 15. Future Virol. 2021. PMID: 34950219 Free PMC article. Review.
State-wide random seroprevalence survey of SARS-CoV-2 past infection in a southern US State, 2020.
Cardenas VM, Kennedy JL, Williams M, Nembhard WN, Zohoori N, Du R, Jin J, Boothe D, Fischbach LA, Kirkpatrick C, Modi Z, Caid K, Owens S, Forrest JC, James L, Boehme KW, Olgaard E, Gardner SF, Amick BC 3rd. Cardenas VM, et al. PLoS One. 2022 Apr 27;17(4):e0267322. doi: 10.1371/journal.pone.0267322. eCollection 2022. PLoS One. 2022. PMID: 35476717 Free PMC article.

References

1. Zhu N., Zhang D., Wang W., Li X., Yang B., Song J. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382(8):727–733. - PMC - PubMed
1. Yang X., Yu Y., Xu J., Shu H., Xia J., Liu H. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020;8(5):475–481. - PMC - PubMed
1. Chen S.Y., Lee Y.L., Lin Y.C., Lee N.Y., Liao C.H., Hung Y.P. Multicenter evaluation of two chemiluminescence and three lateral flow immunoassays for the diagnosis of COVID-19 and assessment of antibody dynamic responses to SARS-CoV-2 in Taiwan. Emerg Microb Infect. 2020;9(1):2157–2168. - PMC - PubMed
1. Lee P.I., Hsueh P.R. Emerging threats from zoonotic coronaviruses-from SARS and MERS to 2019-nCoV. J Microbiol Immunol Infect. 2020;53(3):365–367. - PMC - PubMed
1. Lai C.C., Liu Y.H., Wang C.Y., Wang Y.H., Hsueh S.C., Yen M.Y. Asymptomatic carrier state, acute respiratory disease, and pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): facts and myths. J Microbiol Immunol Infect. 2020;53(3):404–412. - PMC - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations
Medical
- MedlinePlus Consumer Health Information
- MedlinePlus Health Information
Miscellaneous
- NCI CPTAC Assay Portal

[1] Zhu N., Zhang D., Wang W., Li X., Yang B., Song J. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382(8):727–733. - PMC - PubMed

[2] Zhu N., Zhang D., Wang W., Li X., Yang B., Song J. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382(8):727–733. - PMC - PubMed

[3] Yang X., Yu Y., Xu J., Shu H., Xia J., Liu H. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020;8(5):475–481. - PMC - PubMed

[4] Yang X., Yu Y., Xu J., Shu H., Xia J., Liu H. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020;8(5):475–481. - PMC - PubMed

[5] Chen S.Y., Lee Y.L., Lin Y.C., Lee N.Y., Liao C.H., Hung Y.P. Multicenter evaluation of two chemiluminescence and three lateral flow immunoassays for the diagnosis of COVID-19 and assessment of antibody dynamic responses to SARS-CoV-2 in Taiwan. Emerg Microb Infect. 2020;9(1):2157–2168. - PMC - PubMed

[6] Chen S.Y., Lee Y.L., Lin Y.C., Lee N.Y., Liao C.H., Hung Y.P. Multicenter evaluation of two chemiluminescence and three lateral flow immunoassays for the diagnosis of COVID-19 and assessment of antibody dynamic responses to SARS-CoV-2 in Taiwan. Emerg Microb Infect. 2020;9(1):2157–2168. - PMC - PubMed

[7] Lee P.I., Hsueh P.R. Emerging threats from zoonotic coronaviruses-from SARS and MERS to 2019-nCoV. J Microbiol Immunol Infect. 2020;53(3):365–367. - PMC - PubMed

[8] Lee P.I., Hsueh P.R. Emerging threats from zoonotic coronaviruses-from SARS and MERS to 2019-nCoV. J Microbiol Immunol Infect. 2020;53(3):365–367. - PMC - PubMed

[9] Lai C.C., Liu Y.H., Wang C.Y., Wang Y.H., Hsueh S.C., Yen M.Y. Asymptomatic carrier state, acute respiratory disease, and pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): facts and myths. J Microbiol Immunol Infect. 2020;53(3):404–412. - PMC - PubMed

[10] Lai C.C., Liu Y.H., Wang C.Y., Wang Y.H., Hsueh S.C., Yen M.Y. Asymptomatic carrier state, acute respiratory disease, and pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): facts and myths. J Microbiol Immunol Infect. 2020;53(3):404–412. - PMC - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Multicenter evaluation of four immunoassays for the performance of early diagnosis of COVID-19 and assessment of antibody responses of patients with pneumonia in Taiwan

Affiliations

Multicenter evaluation of four immunoassays for the performance of early diagnosis of COVID-19 and assessment of antibody responses of patients with pneumonia in Taiwan

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Miscellaneous

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Related information

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Miscellaneous