Immunochromatography and chemiluminescent enzyme immunoassay for COVID-19 diagnosis

doi:10.1016/j.jiac.2021.02.025

. 2021 Jun;27(6):915-918.

doi: 10.1016/j.jiac.2021.02.025. Epub 2021 Feb 25.

Immunochromatography and chemiluminescent enzyme immunoassay for COVID-19 diagnosis

Toshiaki Ishii¹, Masakazu Sasaki¹, Kageto Yamada², Daiki Kato³, Hiroyoshi Osuka³, Kotaro Aoki⁴, Toshisuke Morita⁵, Yoshikazu Ishii⁴, Kazuhiro Tateda⁴

Affiliations

¹ Department of Clinical Laboratory, Toho University Omori Medical Center, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan; Department of Microbiology and Infectious Disease, Toho University School of Medicine, 5-21-16, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan.
² Department of Clinical Laboratory, Toho University Omori Medical Center, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan; Department of Microbiology and Infectious Disease, Toho University School of Medicine, 5-21-16, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan. Electronic address: kageto.yamada@med.toho-u.ac.jp.
³ Department of Clinical Laboratory, Toho University Omori Medical Center, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan.
⁴ Department of Microbiology and Infectious Disease, Toho University School of Medicine, 5-21-16, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan.
⁵ Department of Clinical Laboratory, Toho University Omori Medical Center, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan; Department of Laboratory Medicine, Toho University Graduate School of Medicine, 5-21-16, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan.

PMID: 33676843
PMCID: PMC7906513
DOI: 10.1016/j.jiac.2021.02.025

Immunochromatography and chemiluminescent enzyme immunoassay for COVID-19 diagnosis

Toshiaki Ishii et al. J Infect Chemother. 2021 Jun.

. 2021 Jun;27(6):915-918.

doi: 10.1016/j.jiac.2021.02.025. Epub 2021 Feb 25.

Authors

Toshiaki Ishii¹, Masakazu Sasaki¹, Kageto Yamada², Daiki Kato³, Hiroyoshi Osuka³, Kotaro Aoki⁴, Toshisuke Morita⁵, Yoshikazu Ishii⁴, Kazuhiro Tateda⁴

Affiliations

¹ Department of Clinical Laboratory, Toho University Omori Medical Center, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan; Department of Microbiology and Infectious Disease, Toho University School of Medicine, 5-21-16, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan.
² Department of Clinical Laboratory, Toho University Omori Medical Center, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan; Department of Microbiology and Infectious Disease, Toho University School of Medicine, 5-21-16, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan. Electronic address: kageto.yamada@med.toho-u.ac.jp.
³ Department of Clinical Laboratory, Toho University Omori Medical Center, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan.
⁴ Department of Microbiology and Infectious Disease, Toho University School of Medicine, 5-21-16, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan.
⁵ Department of Clinical Laboratory, Toho University Omori Medical Center, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan; Department of Laboratory Medicine, Toho University Graduate School of Medicine, 5-21-16, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan.

PMID: 33676843
PMCID: PMC7906513
DOI: 10.1016/j.jiac.2021.02.025

Abstract

Introduction: The rapid and accurate detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is required to prevent the spread of COVID-19. This study evaluated the utility of two SARS-CoV-2 antigen detection methods.

Methods: We evaluated two types of antigen detection methods using immunochromatography (Espline) and quantitative chemiluminescent enzyme immunoassay (Lumipulse). RT-PCR was performed as a standard procedure for COVID-19 diagnosis. Lumipulse and RT-PCR were performed for all 486 nasopharyngeal swabs and 136 saliva samples, and the Espline test was performed for 271 nasopharyngeal swabs and 93 saliva samples.

Results: The sensitivity and specificity of the Espline test were 10/11 and 260/260 (100%), respectively for the nasopharyngeal swabs and 3/9 and 84/84 (100%), respectively for the saliva samples. High sensitivities for both saliva (8/9) and nasopharyngeal swabs (22/24) were observed in the Lumipulse test. The specificities of the Lumipulse test for nasopharyngeal swabs and saliva samples were 460/462 (99.6%) and 123/127 (96.9%), respectively.

Conclusion: The Espline test is not effective for saliva samples but is useful for simple and rapid COVID-19 tests using nasopharyngeal swabs because it does not require special devices. The Lumipulse test is a powerful high-throughput tool for COVID-19 diagnosis because it has high detection performance for nasopharyngeal swabs and saliva samples.

Keywords: Antigen detection; Espline; Lumipulse; RT-PCR; SARS-CoV-2.

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Conflict of interest statement

Declaration of competing interest None.

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References

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1. Wellinghausen N., Plonné D., Voss M., Ivanova R., Frodl R., Deininger S. SARS-CoV-2-IgG response is different in COVID-19 outpatients and asymptomatic contact persons. J Clin Virol. 2020;130:104542. doi: 10.1016/j.jcv.2020.104542. - DOI - PMC - PubMed
1. Fenollar F., Bouam A., Ballouche M., Fuster L., Prudent E., Colson P., et al. Evaluation of the PanBio COVID-19 rapid antigen detection test device for the screening of patients with COVID-19. J Clin Microbiol. 2020 doi: 10.1128/JCM.02589-20. - DOI - PMC - PubMed
1. Aoki K., Nagasawa T., Ishii Y., Yagi S., Kashiwagi K., MIyazaki T., et al. Evaluation of clinical utility of novel coronavirus antigen detection reagent. Espline® SARS-CoV-2. J Infect Chemother. 2020 - 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

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[1] Sohrabi C., Alsafi Z., O’Neill N., Khan M., Kerwan A., Al-Jabir A., et al. World Health Organization declares global emergency: a review of the 2019 novel coronavirus (COVID-19) Int J Surg. 2020;76:71–76. doi: 10.1016/j.ijsu.2020.02.034. - DOI - PMC - PubMed

[2] Sohrabi C., Alsafi Z., O’Neill N., Khan M., Kerwan A., Al-Jabir A., et al. World Health Organization declares global emergency: a review of the 2019 novel coronavirus (COVID-19) Int J Surg. 2020;76:71–76. doi: 10.1016/j.ijsu.2020.02.034. - DOI - PMC - PubMed

[3] Wellinghausen N., Plonné D., Voss M., Ivanova R., Frodl R., Deininger S. SARS-CoV-2-IgG response is different in COVID-19 outpatients and asymptomatic contact persons. J Clin Virol. 2020;130:104542. doi: 10.1016/j.jcv.2020.104542. - DOI - PMC - PubMed

[4] Wellinghausen N., Plonné D., Voss M., Ivanova R., Frodl R., Deininger S. SARS-CoV-2-IgG response is different in COVID-19 outpatients and asymptomatic contact persons. J Clin Virol. 2020;130:104542. doi: 10.1016/j.jcv.2020.104542. - DOI - PMC - PubMed

[5] Fenollar F., Bouam A., Ballouche M., Fuster L., Prudent E., Colson P., et al. Evaluation of the PanBio COVID-19 rapid antigen detection test device for the screening of patients with COVID-19. J Clin Microbiol. 2020 doi: 10.1128/JCM.02589-20. - DOI - PMC - PubMed

[6] Fenollar F., Bouam A., Ballouche M., Fuster L., Prudent E., Colson P., et al. Evaluation of the PanBio COVID-19 rapid antigen detection test device for the screening of patients with COVID-19. J Clin Microbiol. 2020 doi: 10.1128/JCM.02589-20. - DOI - PMC - PubMed

[7] Aoki K., Nagasawa T., Ishii Y., Yagi S., Kashiwagi K., MIyazaki T., et al. Evaluation of clinical utility of novel coronavirus antigen detection reagent. Espline® SARS-CoV-2. J Infect Chemother. 2020 - PMC - PubMed

[8] Aoki K., Nagasawa T., Ishii Y., Yagi S., Kashiwagi K., MIyazaki T., et al. Evaluation of clinical utility of novel coronavirus antigen detection reagent. Espline® SARS-CoV-2. J Infect Chemother. 2020 - PMC - PubMed

[9] 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

[10] 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

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Immunochromatography and chemiluminescent enzyme immunoassay for COVID-19 diagnosis

Affiliations

Immunochromatography and chemiluminescent enzyme immunoassay for COVID-19 diagnosis

Authors

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Abstract

Conflict of interest statement

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