Evaluation of Three Immunoassays for the Rapid Detection of SARS-CoV-2 antigens

doi:10.1016/j.diagmicrobio.2021.115434

Comparative Study

. 2021 Oct;101(2):115434.

doi: 10.1016/j.diagmicrobio.2021.115434. Epub 2021 May 21.

Evaluation of Three Immunoassays for the Rapid Detection of SARS-CoV-2 antigens

Affiliations

¹ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
² Microbiology and Virology Unit, Careggi University Hospital, Florence, Italy.
³ Azienda USL Toscana Centro, Florence, Italy.
⁴ Azienda USL Toscana Centro, Prato Hospital, Prato, Italy.
⁵ Azienda USL Toscana Centro, Santa Maria Annunziata Hospital, Bagno a Ripoli, Italy.
⁶ Intensive Care Unit and Regional ECMO Referral Center, Neuromusculosketal and Sensory Organs Department, Careggi University Hospital of Careggi, Florence, Italy.
⁷ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Infectious and Tropical Diseases Unit, Careggi University Hospital, Florence, Italy.
⁸ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Microbiology and Virology Unit, Careggi University Hospital, Florence, Italy.
⁹ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Microbiology and Virology Unit, Careggi University Hospital, Florence, Italy. Electronic address: gianmaria.rossolini@unifi.it.

PMID: 34174523
PMCID: PMC8137375
DOI: 10.1016/j.diagmicrobio.2021.115434

Comparative Study

Evaluation of Three Immunoassays for the Rapid Detection of SARS-CoV-2 antigens

Ilaria Baccani et al. Diagn Microbiol Infect Dis. 2021 Oct.

. 2021 Oct;101(2):115434.

doi: 10.1016/j.diagmicrobio.2021.115434. Epub 2021 May 21.

Affiliations

¹ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
² Microbiology and Virology Unit, Careggi University Hospital, Florence, Italy.
³ Azienda USL Toscana Centro, Florence, Italy.
⁴ Azienda USL Toscana Centro, Prato Hospital, Prato, Italy.
⁵ Azienda USL Toscana Centro, Santa Maria Annunziata Hospital, Bagno a Ripoli, Italy.
⁶ Intensive Care Unit and Regional ECMO Referral Center, Neuromusculosketal and Sensory Organs Department, Careggi University Hospital of Careggi, Florence, Italy.
⁷ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Infectious and Tropical Diseases Unit, Careggi University Hospital, Florence, Italy.
⁸ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Microbiology and Virology Unit, Careggi University Hospital, Florence, Italy.
⁹ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Microbiology and Virology Unit, Careggi University Hospital, Florence, Italy. Electronic address: gianmaria.rossolini@unifi.it.

PMID: 34174523
PMCID: PMC8137375
DOI: 10.1016/j.diagmicrobio.2021.115434

Abstract

Three assays for SARS-CoV-2 antigen detection in nasopharyngeal swabs (Lumipulse® G SARS-CoV-2 Ag [LPG], STANDARD^TM F COVID-19 Ag FIA [STF] and AFIAS COVID-19 Ag [AFC] were evaluated. Compared to RT-PCR, LPG, AFC and STF showed a variable sensitivity (87.9%, 37.5%, and 35.7%, respectively) and an overall high specificity (> 95%).

Keywords: COVID-19; SARS-CoV-2; antigen; chemiluminescent assay; lateral flow immunofluorescence assay.

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Figures

Fig 1 — **Fig. 1**
Number of positive isolates detected by Lumipulse® G SARS-CoV-2 Ag, AFIAS COVID 19 Ag and STANDARD^TM F COVID-19 Ag FIA correlated to the N gene Ct value by RT-PCR. Samples with Ct≥ 40 have been considered as negative.

See this image and copyright information in PMC

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References

1. Aoki K, Nagasawa T, Ishii Y, Yagi S, Okuma S, Kashiwagi K, et al. Clinical validation of quantitative SARS-CoV-2 antigen assays to estimate SARS-CoV-2 viral loads in nasopharyngeal swabs. J Infect Chemother. 2020 doi: 10.1016/j.jiac.2020.11.021. - DOI - PMC - PubMed
1. Candel FJ, Barreiro P, San Román J, Abanades JC, Barba R, Barberán J, et al. Recommendations for use of antigenic tests in the diagnosis of acute SARS-CoV-2 infection in the second pandemic wave: attitude in different clinical settings. Rev Española Quimioter. 2020 doi: 10.37201/req/120.2020. Doi: - DOI - PMC - PubMed
1. Hirotsu Y, Maejima M, Shibusawa M, Nagakubo Y, Hosaka K, Amemiya K, et al. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis. 2020;99:397–402. doi: 10.1016/j.ijid.2020.08.029. - DOI - PMC - PubMed
1. Karimi S, Arabi A, Shahraki T, Safi S. Detection of severe acute respiratory syndrome Coronavirus-2 in the tears of patients with Coronavirus disease 2019. Eye. 2020;34:1220–1223. doi: 10.1038/s41433-020-0965-2. - DOI - PMC - PubMed
1. Li C, Zhao C, Bao J, Tang B, Wang Y, Gu B. Laboratory diagnosis of coronavirus disease-2019 (COVID-19) Clin Chim Acta. 2020;510:35–46. doi: 10.1016/j.cca.2020.06.045. - DOI - PMC - PubMed

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[1] Aoki K, Nagasawa T, Ishii Y, Yagi S, Okuma S, Kashiwagi K, et al. Clinical validation of quantitative SARS-CoV-2 antigen assays to estimate SARS-CoV-2 viral loads in nasopharyngeal swabs. J Infect Chemother. 2020 doi: 10.1016/j.jiac.2020.11.021. - DOI - PMC - PubMed

[2] Aoki K, Nagasawa T, Ishii Y, Yagi S, Okuma S, Kashiwagi K, et al. Clinical validation of quantitative SARS-CoV-2 antigen assays to estimate SARS-CoV-2 viral loads in nasopharyngeal swabs. J Infect Chemother. 2020 doi: 10.1016/j.jiac.2020.11.021. - DOI - PMC - PubMed

[3] Candel FJ, Barreiro P, San Román J, Abanades JC, Barba R, Barberán J, et al. Recommendations for use of antigenic tests in the diagnosis of acute SARS-CoV-2 infection in the second pandemic wave: attitude in different clinical settings. Rev Española Quimioter. 2020 doi: 10.37201/req/120.2020. Doi: - DOI - PMC - PubMed

[4] Candel FJ, Barreiro P, San Román J, Abanades JC, Barba R, Barberán J, et al. Recommendations for use of antigenic tests in the diagnosis of acute SARS-CoV-2 infection in the second pandemic wave: attitude in different clinical settings. Rev Española Quimioter. 2020 doi: 10.37201/req/120.2020. Doi: - DOI - PMC - PubMed

[5] Hirotsu Y, Maejima M, Shibusawa M, Nagakubo Y, Hosaka K, Amemiya K, et al. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis. 2020;99:397–402. doi: 10.1016/j.ijid.2020.08.029. - DOI - PMC - PubMed

[6] Hirotsu Y, Maejima M, Shibusawa M, Nagakubo Y, Hosaka K, Amemiya K, et al. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis. 2020;99:397–402. doi: 10.1016/j.ijid.2020.08.029. - DOI - PMC - PubMed

[7] Karimi S, Arabi A, Shahraki T, Safi S. Detection of severe acute respiratory syndrome Coronavirus-2 in the tears of patients with Coronavirus disease 2019. Eye. 2020;34:1220–1223. doi: 10.1038/s41433-020-0965-2. - DOI - PMC - PubMed

[8] Karimi S, Arabi A, Shahraki T, Safi S. Detection of severe acute respiratory syndrome Coronavirus-2 in the tears of patients with Coronavirus disease 2019. Eye. 2020;34:1220–1223. doi: 10.1038/s41433-020-0965-2. - DOI - PMC - PubMed

[9] Li C, Zhao C, Bao J, Tang B, Wang Y, Gu B. Laboratory diagnosis of coronavirus disease-2019 (COVID-19) Clin Chim Acta. 2020;510:35–46. doi: 10.1016/j.cca.2020.06.045. - DOI - PMC - PubMed

[10] Li C, Zhao C, Bao J, Tang B, Wang Y, Gu B. Laboratory diagnosis of coronavirus disease-2019 (COVID-19) Clin Chim Acta. 2020;510:35–46. doi: 10.1016/j.cca.2020.06.045. - DOI - PMC - PubMed

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Evaluation of Three Immunoassays for the Rapid Detection of SARS-CoV-2 antigens

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Evaluation of Three Immunoassays for the Rapid Detection of SARS-CoV-2 antigens

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