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Diagnostic performance, stability, and acceptability of self-collected saliva without additives for SARS-CoV-2 molecular diagnosis

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European Journal of Clinical Microbiology & Infectious Diseases Aims and scope Submit manuscript

Abstract

Background

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV‐2) caused the coronavirus disease 2019 (COVID-19), leading to a global pandemic. The molecular diagnosis of this virus is mostly performed by collecting upper respiratory samples, which has many disadvantages, including patient discomfort and the need for trained healthcare professionals. Although saliva has emerged as a more comfortable sample, the use of additives to preserve viral RNA is expensive and, in some cases, difficult for self-collection.

Method

This study evaluated the diagnostic performance by RT-PCR and stability of self-collected saliva using wide-mouth specimen collection cups without stabilization and/or inactivation buffers for SARS-CoV-2 detection, compared to nasopharyngeal samples and saliva collected with additives. Additionally, the study assessed the acceptability of this sample collection method among participants and healthcare personnel.

Results

The study included 1281 volunteers with a 24.6% positive infection rate. Saliva demonstrated comparable diagnostic performance to nasopharyngeal samples, with a sensitivity of 87.6% and specificity of 99.6%, for a total percent agreement of 96.4%. The study also showed that viral RNA in saliva remained stable for at least 72 h at different temperatures. Notably, saliva samples without additives exhibited a lower RdRp Ct compared to samples with additives, suggesting that the absence of stabilization and/or inactivation buffers does not significantly affect its performance. The study highlighted the acceptability of saliva among patients and healthcare personnel due to its noninvasive nature and ease of collection.

Conclusions

This research supports the implementation of self-collected saliva as a comfortable and user-friendly alternative sample for SARS-CoV-2 diagnosis.

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Data availability

The datasets generated during and/or analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request.

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Acknowledgements

We express our gratitude to Ayudas Diagnósticas SURA, as sponsoring and executing entity. We extend our heartfelt thanks to all the volunteers who willingly participated in the study. We would like to acknowledge the dedication and efforts of the healthcare personnel responsible for recruiting patients and collecting samples, as well as the molecular biology professionals who processed the collected samples. To the Biosciences management, and its research and development team, as well as the SURA personalized Medicine research group, for their unwavering support in implementing recruitment strategies. To all those involved, their contributions have been instrumental in the successful completion of this research.

Funding

This study was funded by Ayudas Diagnósticas SURA-Colombia.

Author information

Authors and Affiliations

  1. Molecular Biology Unit, Ayudas Diagnósticas SURA, Medellín, Colombia

    Catalina Marín-Echeverri, Lizet Pérez-Zapata, Laura Álvarez-Acevedo, Sebastián Gutiérrez-Hincapié, Melissa Adams-Parra, Didier Tirado-Duarte, Johan Bolívar-Muñoz, Marlon Gallego-Gómez, Yadira Galeano-Castañeda & Christian Piedrahita-Ochoa

  2. Scientific Management Direction, SURA, Medellín, Colombia

    Heiddy del Valle Arrieta

Authors
  1. Catalina Marín-Echeverri
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Contributions

Conceptualization: H del BA, S. G.-H, L.A.-A and C.M.-E. Methodology: L.P.-Z., S. G.-H., L.A.-A., Y.G.-C, C.M.-E., C.P.-O, J.B.-M. Statistical analysis: L.P.-Z. and C.M.-E. Drafting of the manuscript: C.M.-E. Analysis, or interpretation of data: L.P.-Z., S. G.-H., L.A.-A., Y.G.-C, C.M.-E., C.P.-O, Y.G.-C, M.A.-P, D.T.-D., J.B.-M., M.-G.-G. All authors reviewed and approved the final version.

Corresponding author

Correspondence to Catalina Marín-Echeverri.

Ethics declarations

Financial interest

The authors declare no financial interests.

Ethics approval

The Committee of Ethics and Good Clinical Practices in Health Research (CEI-SURA) approved the study (Act number 62).

Patient consent

All volunteers who participated in the study signed an informed consent. For children who agreed to participate, the informed consent was signed by their father/mother or legal representative.

Conflict of interest

The authors declare no conflicts of interest with this study.

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Marín-Echeverri, C., Pérez-Zapata, L., Álvarez-Acevedo, L. et al. Diagnostic performance, stability, and acceptability of self-collected saliva without additives for SARS-CoV-2 molecular diagnosis. Eur J Clin Microbiol Infect Dis (2024). https://doi.org/10.1007/s10096-024-04819-6

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