Evaluation of Non-Invasive Gargle Lavage Sampling for the Detection of SARS-CoV-2 Using rRT-PCR or Antigen Assay

Viruses. 2022 Dec 19;14(12):2829. doi: 10.3390/v14122829.


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable disruption worldwide. For efficient SARS-CoV-2 detection, new methods of rapid, non-invasive sampling are needed. This study aimed to investigate the stability of SARS-CoV-2 in a novel medium for gargle-lavage (GL) self-sampling and to compare the performance of SARS-CoV-2 detection in paired self-collected GL and clinician-obtained nasopharyngeal swab (NPS) samples. The stability study for SARS-CoV-2 preservation in a novel medium was performed over 14 days (4 °C, 24-27 °C, and 37 °C). In total, 494 paired GL and NPS samples were obtained at the University Hospital in Olomouc in April 2021. SARS-CoV-2 detection in paired samples was performed with a SARS-CoV-2 Nucleic Acid Detection Kit (Zybio, Chongqing Municipality, Chongqing, China), an Elecsys® SARS-CoV-2 Antigen assay (Roche Diagnostics, Mannheim, Germany), and a SARS-CoV-2 Antigen ELISA (EUROIMMUN, Lübeck, Germany). The stability study demonstrated excellent SARS-CoV-2 preservation in the novel medium for 14 days. SARS-CoV-2 was detected in 55.7% of NPS samples and 55.7% of GL samples using rRT-PCR, with an overall agreement of 91.9%. The positive percent agreement (PPA) of the rRT-PCR in the GL samples was 92.7%, and the negative percent agreement (NPA) was 90.9%, compared with the NPS samples. The PPA of the rRT-PCR in the NPS and GL samples was 93.2% when all positive tests were used as the reference standard. Both antigen detection assays showed poor sensitivity compared to rRT-PCR (33.2% and 36.0%). rRT-PCR SARS-CoV-2 detection in self-collected GL samples had a similar PPA and NPA to that of NPSs. GL self-sampling offers a suitable and more comfortable alternative for SARS-CoV-2 detection.

Keywords: PCR; SARS-CoV-2; antigen assay; gargle lavage; non-invasive; self-sampling.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 Testing
  • COVID-19* / diagnosis
  • Humans
  • Nasopharynx
  • Reverse Transcriptase Polymerase Chain Reaction
  • SARS-CoV-2* / genetics
  • Sensitivity and Specificity
  • Therapeutic Irrigation

Grants and funding

This study was supported by Internal Grant Agency of Palacky University (IGA_LF_2022_012, O.B.), European Regional Development Fund-Project ENOCH (CZ.02.1.01/0.0/0.0/16_019/0000868, V.K.), the Ministry of Education, Youth and Sports of the Czech Republic (EATRIS-CZ project; CZ.02.1.01/0.0/0.0/16_013/0001818, M.H.; CZ.02.1.01/0.0/0.0/16_026/0008448 A-C-G-T, B.S., P.P.), the Horizon 2020—the European Union Framework Programme for Research and Innovation (EATRIS Plus; 871096, P.D., M.H.), Technology Agency of the Czech Republic (PerMed, TN01000013, P.D.), and by the project National Institute of virology and bacteriology (Programme EXCELES, ID Project No. LX22NPO5103)—Funded by the European Union—Next Generation EU (V.K.).